Clinically proven broad spectrum proprietary anti-viral
By Nuumara Pharma
Summery
Influenza is a serious, sometimes fatal, illness caused by a group of related viruses that circulate in the fall and winter. Influenzas A and B have created global concern for their pandemic potential, having already resulted in over 500 million deaths in previous epidemics.
Treating influenza with pharmaceutical anti-viral agents can be problematic because the viruses mutate frequently in ways that render them resistant to drugs.
Natural antivirals may be less susceptible to resistance because they combine several virus-killing agents in one product. This also gives them the potential to be effective against more than one kind of pathogen.
V871 is a product based on the Traditional Chinese Medicine (TCM) formula called Shuang Huang Lian (SHL). The formula was originally developed in the 1960s, making it a modern combination, although the individual herbs have been used by TCM practitioners for centuries.
The strains of influenza viruses in vaccines are selected by experts according to their expectations of what will be active in a given flu season so they change from year to year. In contrast, TCM botanical treatments are not specific for particular viral strains. Instead, they improve the immune system’s response to the infection thereby lessening symptoms such as fever and coughing. They also prevent the viruses from reproducing which shortens the duration of the illness.
SHL has been extensively studied and was specifically recommended for the treatment of influenza by the Chinese Ministry of Health for the epidemic that occurred in 2009. With SHL as its foundation, V871 is expected to provide healthcare practitioners with a safe, effective and well-tolerated natural alternative to drugs for the treatment of influenza and other serious illnesses.
EXECUTIVE SUMMARY V871/SHL
The following report will provide evidence of safety and efficacy for the V871/SHL formulation. This product may be applied to the prevention and treatment of respiratory infections and is a wide spectrum anti-viral formulation. The active ingredients of V871/SHL are derived from a Traditional Chinese Medicine (TCM) formula called Shuang Huang Lian (SHL) consisting of three herbal ingredients: Flos Lonicerae, Radix Scutellariae and Fructus Forsythiae. All statements in this report will be supported by extensive scientific and clinical references. The report will conclude with an explanation of the proprietary and efficacious aspects of the formula.
As concerns about the flu pandemic grow globally, extensive efforts continue, including the development of new vaccines. However, experts warned that influenza virus is constantly mutating and flu vaccine is considered to be effective only against the same strain of influenza virus used to develop the vaccine.
Unlike the vaccines, which are made in response to flu strains as they are recognized early in each flu season, TCM herb therapies for influenza are not specific to any viral strain. Instead, they provide effects such as helping to boost the immune response so that it is able to eliminate the virus faster. Some also inhibit viral reproduction and relieve symptoms such as fever and coughing and therefore prevent the infection from developing into the full symptomatic disease. Others have a prophylactic effect and prevent viral replication.
Chinese herbs have proven to be effective in the recent pandemics. A recent WHO study on SARS treatment concluded that patients with normal SARS can be treated successfully by Traditional Chinese Medicine alone. The same report also confirmed SHL as an effective remedy for flu.
SHL has been used by TCM doctors as the preferred agent for flu and viral respiratory infections and has been used on a routine basis for pneumonia since 1960s. Since then, many clinical studies have proven SHL’s efficacy on various influenza diseases. China’s online scientific database www.wanfangdata.com alone has more than 2,000 SHL clinical papers. Some of those studies can be found in the appendix. SHL has also been recommended by China’s Ministry of Health in a newly released guideline for the diagnosis and treatment of influenza type H1N1 (Oct. 2009).
On a recent CBC radio interview, Dr. David Butler Jones, Canada’s Chief Medical Officer, revealed that 33% of those contracting H1N1 also have bacterial complications. These complications can often cause fatal consequences. Defeat/SHL has been shown to have a significant impact on ameliorating these complications.
The V871/SHL FORMULA
The V871/SHL formula has been used since the 1960s and is commonly used to treat respiratory tract infections and is considered to be a wide spectrum antiviral remedy. The formula is an herbal combination product containing extracts of the flower of Lonicerae japonicae, the root of Scutellariae baicalensis and the fruit of Forsynthia suspense. All three ingredients have a long history of safe use in TCM. In TCM, Forsythia suspense is often used in combination with Flos Lonicerae to clear infections and inflammations associated with External Wind Heat such as sore throat and fever. Many TCM formulations that are indicated for severe fever would also have Radix Scutellaria (dried root of Scutellariae baicalensis) included. The formula is usually prescribed in the form of an oral tincture and can also be administered intravenously or as an oral spray.
The SHL formula is well-established and is listed in the Pharmacopoeia of The People’s Republic of China. It is indicated for the removal of toxic heat and inducing diaphoresis (perspiration), and is commonly used to treat upper respiratory tract infection, acute bronchitis and light pneumonia. The formula has been available as a treatment for acute lower respiratory infections in hospital settings in China since 1973 and has been shown to be effective and free of toxic effects (Kong, 1993).
EFFICACY OF THE FORUMLA
The SHL formulation has a long history of use in the treatment of respiratory ailments. There are a significant number of peer-reviewed clinically valid trials demonstrating the efficacy of SHL. It is commonly prescribed in China for this purpose and is clinically effective in the treatment of respiratory disorders (Kong, 1993; Liu and Douglas, 1998).
A review of clinical trials using traditional Chinese formulations in the treatment of respiratory tract infections was performed by Liu and Douglas. In their review, they considered two trials performed using SHL as being of high methodological quality. The quality of and the results from the two trials led to the review author’s conclusion that “SHL is a promising remedy for the treatment of bronchitis and pneumonia.”
V871/SHL has been shown to have tremendous properties for the prevention and treatment of influenza A & B as well as rhinovirus. Furthermore, it is important to note that V871/SHL is effective for a host of post-influenza complications including viral myocarditis, pneumonia, and upper respiratory tract infections, among others.
ANTI-VIRAL EFFECTIVENESS
Various studies have demonstrated that the SHL formula exhibits antiviral properties on several viral pathogens including the respiratory syncytial virus (Wu et al., 2005; Yang and Liu, 2007, myocarditis (Lin et al., 2000), Hepatitis (Yi et al., 2006), and HIV (Zhang et al., 1999).
Influenza A & B Virus
In 1995, Nagai, Suzuki et al. reported in the Biological and Pharmaceutical Bulletin that they had found antiviral activity in a plant flavonoid derived from Scutellaria baicalensis against influenza A (H3N2) and B viruses. The agent suppressed replication of mouse-adapted viruses and those placed in canine kidney cells from six to 12 hours after incubation. [sub-subhed] H1N1 Virus
An animal study (Wu et al., 2009) demonstrated the effective antiviral properties of baicalein, the main active compound of Radix Scutellariae in treating rats infected with the H1N1 virus.
H1N1 – Ministry of Health – Central Chinese Government: The most significant message as to SHL effectiveness has come from the Ministry of Health-China (MOHC). In response to the H1N1 pandemic, the MOHC promptly issued its first treatment recommendations to the public in May 2009. This SHL formula was among the five TCM formulas recommended to treat infections, including those of the respiratory tract and pneumonia. With increased scientific information and evidence becoming available, the MOHC then issued a second report and then a third report of the recommended treatment schemes in July and October of 2009, respectively. The SHL formula has remained as one of the primary choices of TCM treatment in fighting H1N1 flu virus infection.
Viral Propagation Prevention (Prophylactic Effect: Many researchers have tested SHL’s effectiveness in inhibiting different viruses. For example, a study led by Yi Shihong in 2001 has shown that SHL has a significant effect on protecting cell tissue from influenza, respiratory syncytial virus, adenovirus, herpes simplex virus I and II, coxsackie virus B3, B4 and A16 and some effect on poliovirus III, ECHC virus 6, and the measles virus.
SARS: During the SARS pandemic, individual ingredients of the SHL formulation or the formulation itself were among the few protocols that were effectively used either to relieve SARS symptoms or to inhibit or reduce viral or inflammatory reactions (Lin, 2003; Tong et al., 2004). The antiviral mechanisms of the SHL formula in fighting SARS were further demonstrated in an in-vitrwwo study. Chen et al. (2004) found that baicalin and chlorogenic acid (an active compound of Flos Lonicerae) exhibited antiviral activities on the 10 strains of SARS coronavirus isolated from different SARS patients. Common Cold
Using SHL to treat the common cold has been the subject of many clinical studies.
Hu et al. (2008) studied the effectiveness of an SHL tablet in treating the common cold. The study was a randomized controlled clinical trial which involved 160 subjects. The study revealed an 83% effective rate within three days of treatment with SHL, as compared to 80% for the treatment with Lian Qiao Jie Du Wan, another well-known TCM formulation.
In another study by Jiang et al, the results were significant. The multicenter randomized clinical study was conducted to evaluate the efficacy of Shuang Huang Lian (SHL) Koufeye in treating common cold and wind-heat symptoms, and showed that 24.4% patients were fully recovered in three days, 65.33% were significantly healed in 3 days, and the total effective rate was 84.66
Antioxidant Effects
SHL has also been shown to have an antioxidant effect. In a study titled Characterization of Antioxidant Activity of Extracts from Flos Lonicerae, Wu Lan et al. noted:
“The present results demonstrate that all Flos Lonicerae extracts examined here exhibit antioxidant activity and chlorogenic acid is a major contributor to this activity, which implicates that the Flos Lonicerae extract may serve as potential source of natural antioxidants for treatment of some diseases.”
POST-INFLUENZA & COMMON COLD COMPLICATIONS
Bronchitis & Pneumonia: SHL formulation has been used to assist the treatment of infantile pneumonia. Ribavirin is commonly used to treat infections in the upper respiratory tract. When Ribavirin was administrated in combination with SHL, Sun & Ling (2007) found that this combination is significantly more effective in relieving pneumonia symptoms in infantile patients. In another animal study, Song et al. (2000) concluded that SHL and Angelica—a widely used TCM herb—were both individually effective in increasing the resistance of rats to Pseudomonas aeruginosa, a bacterium which may cause lung infections.
Kong et al. (1993) performed a single-blind randomized three arm study examining the use of SHL in the treatment of respiratory syncytial virus infection. The SHL formulation was evaluated for efficacy in the treatment of acute bronchitis on children by the Harbin Medical School in China. This study was collaboratively carried out between The University of Newcastle in Australia and Harbin Medical University in China using rigorous procedures.
Results from the study showed that treatment groups receiving the herbal formulation had significantly lower mean duration of symptoms, including cough, wheeze, chest crackles, chest wheezes and fever. Additionally, a significantly higher number of children demonstrated improvement of symptoms within two days of herbal treatment compared with those who were treated with antibiotics only. The authors also stated that the formulation could be of benefit to a wider spectrum of respiratory diseases.
The mean reduction of the course of the illness was significantly shorter in groups treated with SHL herbs than with antibiotics alone as shown in the following table:
In addition, there were more children with an improvement of symptoms within two days of starting SHL treatments, and fewer with symptoms persisting for one week, than with the non-SHL treatment.
The following two charts demonstrate the time advantage in symptom relief when SHL is compared to antibiotics.
The other trial reported in the review was a randomized clinical trial performed by Yu et al. comparing treatment of pneumonia with SHL and antibiotics (Liu and Douglas, 1998). Results showed the group receiving this herbal formula showed significantly better relief of fever, coughing/wheezing and chest cackles compared with antibiotic treatment.
Both the trials examined the use of an intravenous preparation for the treatment of their respective study indications. This particular type of treatment has been available as a treatment for acute lower respiratory infections in a hospital setting in China since 1973 and has been shown to be effective and free of toxic effects. It has been reported that results from preliminary studies administrating a nebulized (spray) solution of SHL is equally effective (Kong et al., 1993).
Upper Respiratory Tract Infections
Respiratory tract infections affect the nose, throat, and airways and may be caused by any of several different viruses. The SHL formulation has been used to treat respiratory tract infections in a hospital setting since 1973 (Kong et al., 1993) and continues to be the primary TCM treatment of choice for such an ailment. Various studies have shown that SHL is effective treating acute upper respiratory tract infections, bronchitis, pneumonia as well as common cold.
In treating acute upper respiratory infection, Chi & Qian (2007) compared the effectiveness of SHL injection with Ribavirin, a commonly used antiviral drug treatment. The study was randomized and involved 110 clinical subjects. The study revealed a 95% effective rate in SHL treatment as compared to 86% for Ribavirin. In a similar study, Zhang & Xi (2009) found SHL was more effective in treating acute URTI patients than Qingkailing, another commonly used antiviral TCM formulation. They observed that SHL was 91% effective as compared to about 81% for Qingkailing.
Viral Myocarditis: Viral myocarditis is severe disease developed from flu and commonly occurs in children. A study by Lin Guozhen et al. (2000) used SHL to treat viral myocarditis among 62 children. It showed that 81.2% were cured and 15.6% were improved in SHL group.
SAFETY OF THE FORMULA
As stated above, the formulation has a well-established history of use in TCM. The formula is described in the Pharmacopoeia of The People’s Republic of China, and is considered safe for its intended use. A history of safe use is associated with both the intravenous and the oral administrations. No serious adverse events or toxic reactions were observed in association with either of the clinical trials described above. Additionally, each of the medicinal ingredients in the formula is considered safe and has documented histories of safe use.
In the Kong et al. (1993) single-blind randomized three arm study examining the use of SHL in the treatment of respiratory syncytial virus infection, animal studies reported that the lethal dose (LD50) of SHL injection from animal studies is 56.1 or 7.1 ml/kg. This is an excellent result demonstrating that toxicity dangers are of no concern. The authors concluded that SHL was “safe and effective.”
BOTANICAL INGREDIENTS
The formula consists of extracts of three herbal ingredients: Flos Lonicerae, Fructus Forsythiae and Radix Scutellariae. Each of the three ingredients have a long term well documented use in TCM and are all indicated in TCM for treatment of respiratory ailments (Zhu, 1998; Xu and Wang, 2002; Hempen and Fisher, 2001; Wu, 2005; Tierra and Tierra, 2003; The State Pharmacopoeia Commission of China, 2000). Each of the ingredients has unique properties and is thought to work in synergy with each other to effectively treat respiratory disorders (Zhu, 1998; Xu and Wang, 2002; Hempen and Fisher, 2001; Wu, 2005; Tierra and Tierra, 2003).
Recent scientific studies have shown that the ingredients have antibacterial and antiviral properties. Additionally, the ingredients have been shown to have effects on the pathways that regulate the immune system and the inflammatory response. Furthermore, viral replication is inhibited. The ingredients also demonstrate potent antioxidant activity and effective free radical scavenging activity. It is through these direct and indirect actions that the ingredients are thought to elicit their therapeutic effects.
Flos Lonicerae
Flos Lonicerae is the flower of the honeysuckle (Lonicerae japonicae). The flowers are commonly brewed for tea in China (Hu, 2005). The flower also has a well recorded history of use as a popular ingredient in TCM (Zhu, 1998; Xu and Wang, 2002; Hempen and Fisher, 2001; Wu, 2005; Tierra and Tierra, 2003). It is used to clear heat, relieve toxicity, dissipate wind-heat, cool the blood, regulate Qi and to treat dysentery due to heat toxins (Zhu, 1998; Xu and Wang, 2002; Hempen and Fisher, 2001; Wu, 2005; Tierra and Tierra, 2003). The ingredient is indicated for sores occurring in the initial stage of warm diseases or resulting from infections caused by externally-contracted wind-heat and for dysentery due to heat toxins (Zhu, 1998; Xu and Wang, 2002; Hempen and Fisher, 2001; Wu, 2005; Tierra and Tierra, 2003). The ingredient is reported to be a broad spectrum antimicrobial herb used to clear infections and inflammations associated with External Wind Heat (Tierra and Tierra, 2003).
Extracts of the ingredient have been shown to inhibit bacteria, influenza viruses (Zhu, 1998) and respiratory syncytial virus (Ma et al. 2002). The ingredient also has anti-inflammatory effects (Zhu, 1998). Yoo et al. (2008) investigated the anti-inflammatory, anti-angiogenic and antinociceptive activities of a Lonicerae japonica extract. Through a variety of in-vivo and in-vitro assays, the authors demonstrated the extract’s acute anti-inflammatory action through various pathways. Yoo et al. also demonstrated the extract’s ability to inhibit angiogenesis, a contributor to various pathological conditions including inflammatory disease. They also found that the extract appeared to prevent the release of inflammatory mediators, suppress nitric oxide production through inhibition of Inducible Nitric Oxide Synthase (iNOS), and suppress Reactive Oxygen Species (ROS) generation due to lipopolysaccahride (LPS) treatment in macrophages. Xu et al. (2007) also reported extracts of the flower also demonstrated inhibition of other key inflammatory reaction inducers cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). Park et al. (2005) reported Lonicerae japonica extract had significant inhibition of NO production and TNF-alpha secretion.
The finding of inhibition of ROS generation by Yoo et al. also demonstrated the antioxidant activity of the ingredient. Lan et al. (2007) and Choi et al. (2007) also reported the antioxidant activity of Flos Lonicerae extracts. Lan et al. reported extracts of Flos Lonicerae scavenged free radicals and acted as a metal chelator. Flower extracts have also been shown to have antibacterial, antiviral and antifungal actions in in-vitro studies (Zhu, 1998).
The ingredient has a long history of safe use in TCM (Zhu, 1998; Xu and Wang, 2002; Hempen and Fisher, 2001; Wu, 2005; Tierra and Tierra, 2003). No precautions for its traditional use are noted (Zhu, 1998; Xu and Wang, 2002; Hempen and Fisher, 2001; Wu, 2005; Tierra and Tierra, 2003). Animal studies have produced no significant toxic reactions or any changes in respiration, blood picture and urine output (Zhu, 1998).
Fructus Forsythiae: Fructus Forsythiae is the fruit of forsythia (Forsythia suspensa). The fruit is used in traditional Chinese Medicine to clear heart-fire, relive toxicity of sores, regulate Qi and dissipate externally-contracted wind-heat. It is often prescribed for use for symptoms of fever, headache and thirst (Zhu, 1998; Xu and Wang, 2002; Hempen and Fisher, 2001; Wu, 2005; Tierra and Tierra, 2003).
The ingredient has been shown to have antibacterial, antipyretic and anti-inflammatory activity. It has also been demonstrated to have potent antiviral activity (Ma et al., 2002). Piao et al. (2009) demonstrated lignin from the plant had potent anti-oxidant activity, inhibiting ONOO-induced cell death in-vitro. Dai et al. (2009) isolated alkaloids from the plant with significant anti-inflammatory activities. Qu et al. (2008) reported the isolation of compounds in the ingredient that had antioxidant and antibacterial activities. Ko et al. (2006) demonstrated that Forsythia suspensa had a significant inhibitory effect on RANTES, a potent chemoattractant, released by influenza A virus (H1N1)-infected human bronchial epithelial cells in-vitro. In another study, Ko et al. (2005) also demonstrated the potent inhibition of RANTES in influenza A virus (H1N1)-infected human bronchial epithelial cell lines. The study also demonstrated the inhibition of another chemotatic protein-1 (MCP-1).
Ozaki et al. (2000) isolated a compound from the fruit that showed anti-inflammatory effect in rats. Zhang et al. (2002) reported the isolation of a compound in Forsythia suspense that had potent anti-viral activity against Respiratory Syncytial Virus (RSV).
The fruit has a history of safe use in TCM (Zhu, 1998; Xu and Wang, 2002; Hempen and Fisher, 2001; Wu, 2005; Tierra and Tierra, 2003).
Radix Scutellariae: Radix Scutellariae is the root of the Baikal skullcap (Scutellariae baicalensis) and is used in traditional Chinese Medicine to clear heat, dry dampness, drain fire, relieve toxicity, cool the blood, and quiet the foetus (Zhu, 1998; Xu and Wang, 2002; Hempen and Fisher, 2001; Wu, 2005; Tierra and Tierra, 2003). It is indicated for all diseases caused by damp-heat, such as damp-warm diseases, summerheat-warm diseases and fullness in the chest and abdomen due to damp-heat as well as for dysentery, diarrhea, jaundice and heat Lin syndrome (Zhu, 1998; Xu and Wang, 2002; Hempen and Fisher, 2001; Wu, 2005; Tierra and Tierra, 2003). It is also used to treat sore and swollen throat, toothache, dry stool due to stomach-fire, and cough due to Lung-heat. (Zhu, 1998; Xu and Wang, 2002; Hempen and Fisher, 2001; Wu, 2005; Tierra and Tierra, 2003).
The root has been shown to have anti-inflammatory and antipyretic effects. The root is reported to have a wide antibacterial spectrum, with decoctions showing activity in-vitro against hemolytic streptococcus, pneumococcus, meningococcus, Staphylococcus aureus, Bacillus diphtheria, B. dysenteriae, B. anthracis, B. typhosus, B. paratyphosus, B. proteus, E. coli, P. aeruginosa, Bordetella pertussis and Vibrio comma (Zhu, 1998). Decoctions of the ingredient have also demonstrated in-vitro anti-viral activity (Zhu, 1998). Zhu (1998) also describes studies demonstrating the ingredient’s anti-inflammatory and antipyretic effects.
Isolates from the root have demonstrated potent antiviral effects (Blach-Olszewska et al. 2008; Ma et al. 2002; Nagai et a. 1995;, Zhu, 1998). Blach-Olszewska et al. (2008) suggested that the anti-viral activity of the ingredient was due to flavonoids in the root regulating the innate antiviral immunity of the immune system through modulation of cytokine production and stimulation of human leukocyte resistance. Their study (Blach-Olszewska et al. 2008) demonstrated that a water extract of the root selectively inhibited IFN-alpha and IFN-gamma and stimulated TNF-alpha and IL-12 and IL-10 production in peripheral blood leukocytes. They also reported the augmentation of the resistance of the leukocytes to vesicular stomatitis virus infection. Nagai et al. demonstrated that flavones isolated from the plant inhibited influenza A and B virus’s proliferation through inhibition of the fusion of the viral envelopes. Ma et al. (2002) determined that the compounds wogonin and oroxylin A were the flavonoids with the greatest activity against reparatory syncytial virus in the plant extract. Their study also showed that baicalein and baicalin also demonstrated antiviral activity (Ma et al. 2002). Huang et al. (2000) also reported the compound wogonin to be demonstrating activity against Hepatitis B virus.
Yoon et al. (2009) demonstrated the anti-inflammatory activity of a water extract of the root. In their study, they showed that the extract was capable of significantly inhibiting the production of NO, a number of inflammatory cytokines and vascular endothelial growth in cells exposed to LPS. Liang et al. (2009) reported that baicalin, a major constituent of the ingredient, was able to regenerate beta-carotene and exhibited a strong synergistic effect with beta-carotene to significantly enhance the free radical scavenging and antioxidant activity of the molecule. Other flavonoid compounds isolated from the plant have also been shown to have anti-inflammatory activity (Chen et al. 2008; Hsieh et al. 2008; Burnett et al. 2007; Huang, 2007).
The root is a commonly prescribed ingredient in TCM and has a long history of safe use (Zhu, 1998; Xu and Wang, 2002; Hempen and Fisher, 2001; Wu, 2005; Tierra and Tierra, 2003). Side effects of the herb include mild gastro-intestinal irritation and diarrhea (Zhu, 1998).
Other Relevant Studies
Intravenous Versus Oral; Some of the enclosed studies were completed via an intravenous method and the question arises as to efficacy in comparison to oral. In a study conducted by Rong JR et al. (2001), the result was stated as follows:
“As the recovery rate as shown in the table, there was no significant difference in the efficacy of two forms of SHL. (P>0.05). Oral suspension, however, provides a safer and more convenient and cost effective option for the majority of common cold patients.”
It can be assumed that intravenous is a more direct and effective way to treat disease, however, here it was shown that there was not significant difference. That is, oral was just as effective. Furthermore, oral is more convenient and cost effective.
SHL vs Pharmaceuticals (Ribaviron and Antibiotics): In a trial titled, “Clinical Observation of 300 cases of Shuang Huang Lian in Treating Upper Respiratory Tract Infection,” Mou YG et al. found the following:
“By the end of the 3-day treatment period, the total effective rate of SHL for upper respiratory infection was 96.41%, and the control group was 64.48%. The total effective rate of SHL for amygdalitis (tonsillitis) was 91.66%, and the control group was 84.47%.”
SHL is significantly more powerful than a medically recognized pharmaceutical and antibiotics. Furthermore, pharmaceuticals and antibiotics have known short- and long-term side effects.
Help for Children: In 2009, the FDA removed numerous flu and cold remedies for children from the market citing that they were dangerous to their health. Finding non-toxic safe answers for children is challenging for parents globally. In a study titled, “Clinical and Experimental Study on Shuanghua Aerosol in Treating Infantile Upper Respiratory Tract Infection” by MA Bing-xiang et al the results were as follows:
“For children aged 3 to 13 years using SHL, the clinical total effective rate and percentage cured 94.11% and 44.12% respectively.”
Proprietary Control
Most natural health products on the market have a problem with inconsistent quality on a batch to batch basis. Another challenge is that there may be degradation of the active ingredients and this degradation is not monitored. There is yet a further problem in that some products may be “spiked” in order to enhance the active pharmacological ingredient (API) in the formula. If a manufacturer could demonstrate the ability to manage and control each of those industry challenges then a superior proprietary product would be created.
We have successfully developed a RRLC (Rapid Resolution Liquid Chromatography) method for the evaluation of each ingredient in the Defeat/SHL Shuang Huang Lian formula. This has allowed us to have full control and understanding over the actives in each batch of Defeat and also ensuring that the right actives are present in the batch and moreover during the course of the product’s shelf life. Compared with conventional HPLC techniques RRLC has the following advantages:
- Analysis speeds are up to 20 times faster than conventional HPLC (faster manufacturing)
- Achieves higher separation efficiency resulting in sharper peaks and higher signals.
- Uses less mobile phase organic solvent (environmentally) friendly.
To investigate the overall quality of SHL Shuang Huang Lian products on market, we collected numerous commercial samples on the market from Shuang Huang Lian manufacturers in China (note: No other commercial brands exist outside of China) and analyzed the chemical compositions of these products quantitatively by the new RRLC technique. The HPLC profiles of these samples are shown in Figures 1 to 4, respectively.
As shown in Figures 1 to 4, these samples contain significant amount of baicalin, which is considered as the marker compound of Scutellaria baicalensis Georgi. As we all know Shuang Huang Lian is made of three herbs and baicalin is only one of the three most important and effective chemical constituents in Shuang Huang Lian with anti-virus activity. Chlorogenic acid and forsythin, which are the marker compounds of Lonicera japonica (Thunb.) and Forsythia suspensa (Thunb.) Vahl, cannot be detected or are only found at very low concentrations (see low spikes on graphs). Obviously these Shuang Huang Lian products on the market do not have the same chemical composition like a fresh raw herb concoction should.
The results of HPLC analysis allow us to identify the industry’s key problems:
1. In the Pharmacopoeia of The People’s Republic of China, baicalin content is the only standard for Shuang Huang Lian products; therefore, these commercial Shuang Huang Lian products may be spiked with natural or synthetic baicalin compound to meet the standard.
2. In these Shuang Huang Lian products, chlorogenic acid and forsythin contents are very low, which brings doubt as to the stability of these active compounds in these commercial products.
All this means that the current SHL products on the market are not necessarily effective because only one of active ingredients is seen. Upon reading the studies and clinical trials enclosed in this report, it is assumed that that all active pharmacological ingredients were present and these actives were responsible for the excellent results. However, after a product is manufactured and if the actives are missing, it would not be credible to claim the results given by the studies. Therefore, many SHL products are overpromising and underperforming. Therefore, the best situation is that a manufacturer would be able to verify the APIs initially and over the shelf life of the product (through stability tests). We have created a breakthrough science methodology to do just that, RRLC.
Establishment of HPLC Profile for V871/SHL Formulation and Production: Over the last several years, we have been actively conducting R&D on all aspects of the formulation and have accumulated very important hands-on experience in the preparation, concentration and stability studies with two key focuses:
1. The successful establishment of an RRLC method for V871 analysis within 6 minutes.
2. Our manufacturing techniques were optimized to prepare for a world class product. As mentioned before, unlike other manufacturers where baicalin content is the only standard for SHL Shuang Huang Lian products; We have all three active compounds, namely chlorogenic acid, forsythin, and baicalin as standards for the V871t product line. This state-of-the-art HPLC and RRLC testing techniques ensure that finished products have identical chemical compositions as the raw herbs without any effective chemical constituents’ loss and degradation in the manufacturing process.
The HPLC profile of the V871 products we manufactured as seen in Figure 1 matches the HPLC profile of individual herbs namely, Lonicera japonica (Thunb.), Forsythia suspensa (Thunb.) Vahl, and Scutellaria baicalensis Georgi shown in Figure 2, 3, and 4, respectively.
Nuumara has a systematic quality control protocol and standard on the whole manufacturing process which was also set up to ensure the consistency of product quality. Nuumara has conducted extensive studies on the stability of V871 to guarantee that finished products meet the product standards and specification over the entire shelf life.
In summary, as a world leader in Phytopharmacology and our breakthrough manufacturing technology, we can ensure the V871 product line will stand alone in quality and efficacy.
