Study On The Industrial Competitiveness Of Concentrated Herb Granule (CHG) And The Key Technologies Of CHG Of Flos Lonicerae

Chinese materia medica, playing an important role in the thriving of the Chinese nation and human health, has different preparations, such as decoction, pill, powder, ointment and Dan in tradition and granule, tablet, capsule, dripping pill, oral liquid, and injection as modern formulations. Decoction has been most commonly used for thousands of years since the Shang dynasty because it reflects extensively the dialectical Principle of Traditional Chinese Medicine (TCM) during treatment towards various kinds of syndromes. However, with the development of the society and life style fast pacing, people’s healthcare concept has been changed. The traditional decoction cannot meet the demand of the modern life for its disadvantages:time-consuming when decoction and "inconvenient" to carry and store.As the birthplace of TCM, China has unique superiority in this field. However, TCM products have not integrated into the Western mainstream medical system for lack of objectivity, standardization and other reasons. Chinese Materia Medica takes a small share in the global botanical Drug market. Research on Concentrated Herb Granule (CHG) is carried out. Pilot production and application of the product has been carried out for nearly 20 years. However, its efficacy and price is still doubted by doctors and patients. The development of CHG in China mainland is relatively slower than Japan, Korea, Hong Kong and Taiwan. This project, combined with the manufacturing of Concentrated Herb Granule in CR 999 Medical and pharmaceutical CO., LTD, is to carry out demonstration researches on the key CHG technology and further define the development orientation of CHG industry, which will significantly promote the CHG development. Studies on Research &Development of Concentrated Herb Granule include literature research, field research, literature & field joint research, sampling studies, qualitative and quantitative analysis and comparative analysis. Researches on key technology of CHG industry mainly include manufacturing facility, process and quality standard. And Flos lonicerae japonicae was selected for the study of manufacturing process and quality control standard of CHG.The following is the summary of the main content and results.1. Technique background, origin and modern researchConcentrated Herb Granule (CHG), under the guidance of TCM theory, is made from a single recipe or compound recipe which goes through the modern manufacturing process of extracting, concentrating, drying, granulating and quantitative sub-packaging. The product is herbal granules with unified specification, unified dose and unified quality standard for direct clinical formulations. Compared with prepared medicinal herbs, CHG preserves the medicinal properties and efficacy of the original "Prepared Medicinal Herbs" and easy for addition or subtraction in treatment towards different syndromes. It is administered after dissolved with fewer dosage and portable, safe, and hygienic for direct use and storage. Therefore, CHG is called "solidified decoction" and "non-decoction Chinese materia medica".In Taiwan it’s also called "scientific Chinese Materia medica".The TCM powder (including powder for boiling) is the prototype of Concentrated Herb Granule. It is convenient for carrying and administering; it is relatively easy to be accepted and administered by patients, it is convenient to add and subtract towards different syndromes. The CHG R&D and pilot production began in the end of the 20th century in accordance with the TCM modernization. The rapid development of the world natural medicine market and the good development trend of TCM industry provide foundation and support to the development of CHG, and the development of CHG in Taiwan and abroad (Japan, South Korea, etc) also provided experiences for CHG development in the mainland.In recent years, the studies on CHG chemical composition, quality control standard, pharmacodynamics, efficacy and clinic use have been carried out. It is reported that the chemical composition in CHG is instable and at present there is no unified national standard for CHG. In clinical applications, CHG is easy for adding or subtracting in treatment towards different syndromes and convenient for those who need take Chinese materia medica but are unable to decoet the medicine. The clinic application of CHG shows a good development trend. 2. Analysis of CHG in TCM Industrial CompetitivenessInvestigation on the CHG situation and analysis of the industry development: the total assets, sales revenue, total profits, labor productivity, cost margins, asset-liability ratio, circulating asset turnover rate of the CHG enterprises were analyzed. The results showed that the CHG industry in the mainland have been showing a good development trend with more than a decade of development. Among the four enterprises investigated for CHG production, three companies have increased dramatically in sales, assets and profits, and one declined in sales revenue, but increased in profit on sales and enterprise assets. The four enterprises show good development capability. The increasing Labor rate and yield and growing cost margin shows that the enterprises’ production capacity and profitability have been enhanced and demonstrates that the enterprise management level has been improved and cost-control ability has increased. The declining asset-liability ratio (less than 50%) reflects strong solvency and good liquidity in the enterprises and demonstrates that the business risk has been reduced. The enterprise ability to use funds provided by creditors to engage in business activities is stronger. The accelerated rate of current assets utilization reflects the enterprise asset management efficiency is rising and operation capacity has been enhanced. A preliminary pharmacoeconomic study of CHG was carried out. According to the results, CHG is 1.6～6 times (most 2～3times) the price of the traditional prepared medicinal herbs. The Statistical result of 407 varieties of single-recipe Chinese medicine in hospital showed that 94.59% CHG is more expensive than its original prepared medicinal herb, up to7.27 times that of the original prepared medicinal herb; only 5.41% of the traditional prepared medicinal herbs are more expensive than CHG, up to 2.02 times. Literatures and clinical research data shows the price difference between the CHG and the original prepared medicinal herbs is diminishing, but the CHG price is still beyond the customers’acceptability.For some commonly used prescriptions, calculated on the basis of same dosage, some of the traditional Chinese patent medicine is more expensive than the CHG, as contrasted to the others. The statistical result showed that 31 out of 38 varieties of traditional Chinese patent medicine are more expensive than the CHG; Bazhenyimu capsule is 7.65 times the price of Bazhenyimu concentrated granule. Four varieties of traditional Chinese patent medicine are cheaper than concentrated granules. Yufengning tablet or Xinqingning tablet is single-recipe patent medicine. Yu(?)ing tablet is 1.32 times the price of Yufengning concentrated granule and Xinqingning tablet is 4.96 times the price of Xingqingning concentrated granule. It shows the price of traditional Chinese patent medicines is commonly higher than the CHG. The CHG may have price advantage compared with the traditional Chinese patent medicine. It is seen that at present the CHG price is still beyond most people’s acceptability and become the main obstruction of CHG promotion. Compared with the traditional Chinese patent medicine, CHG is easily added o subtracted in the treatment towards different syndromes; for a same prescription, the clinical price of CHG may be lower than that of the traditional Chinese patent medicine. The wide price variance between CHG and the traditional prepared medicinal herb in Taiwan is similar to that in mainland, but the price difference between the two in Hong Kong and Macao is small. Due to the statistical limitation at present, the result above can’t explain the differences in the essence, so it is necessary to collect a large number of samples for in-depth observations and research.According to the comprehensive analysis of literature and investigation data, the favorable and unfavorable factors in the industrialization of CHG are analyzed. The following five are favorable for CHG development:①there exists a good TCM development environment for CHG in the mainland,②CHG preserves dialectic advantages in clinic use;③CHG meets the standardization and objectivity requirements of modern medicine;④CHG industry has good social and economic benefits;and⑤Scientific and technical progress will promote the CHG development. However, there are some unfavorable factors for CHG R&D mainly including:curative efficacy, price, international competition, and no well-established theory and technique standard to orientate the R&D and application of CHG.3.Research on the key technology of CHG productionThe production technology of CHG was introduced by example of Lonicera japonica Thunb.. The process was established by the studies on the technologies of decoction, extraction, concentration, desiccation, molding technique, pilot scale production. The optimal production technology was as follows:the raw material drug were soaked in water in the ratio of 1:15 for 10 minutes, and then they were decocted for 0.5 hour. For the second time,13 times water was added and sustained for 0.5 hour. The filter liquor of decoction was concentrated to the fluid extract (p=1.05-1.10 g/cm3 with 60℃) by vacuum concentration. The fluid extract was dried by spray drying technology with inlet temperature 190℃and outlet temperature 90℃. And then, the dextrine was blended to the extract for palletizing.Based on the studies of Lonicera japonica Thunb. and other TCM, the preliminary production technology of dispensing granule was including extraction (with standard decoction, extraction, solid-liquid separation, desiccation), molding process, package technology, and so on.As a result of production technology studies, the guideline of CHG was as follows:First, under the direction of TCM theories, the production technology was formulated by the TCM specialty. Second, according to the history of Chinese herbal soup, the active ingredient of water extract could be preserved by the greatest degree. Third, the accessories could be reduced to a minimum in the process.The quality standard of CHG was showed by example of Lonicera japonica Thunb. The standard was established by the identification, description, fingerprint, checking, harmful elements, assay, other requirements. According to quality standard draft of Lonicera japonica Thunb., the quality control of CHG should be including raw material drug, intermediate product and product. The raw material drug could be inspected by the pharmacopoeia of People’s Republic of China (2010 edition) and Local TCM standards of China. The intermediate product could be examined by company quality standard. The products of CHG of TCM could be evaluated by the source of raw material drug, character, identification, fingerprint, checking, heavy mental, harmful elements, assay, etc. Furthermore, the on-line inspection technique is one of the key technologies of improving the quality of dispensing granule of TCM.4. The orientation of CHG industry developmentThe development orientation:CHG is developed on the basis of modern science and technology with high added value. Some common prescriptions may be developed into compound CHG or single CHG (SCHG) concentrated in clinical use. Promote the electronic allocation model:Follow the CHG development experiences in Taiwan and adopt the advanced electronic allocation and on-site packaging model. The model is easy for use during treatment towards different syndromes. The utilization of the model is convenient for patients and will lower the packaging cost for enterprises and reduce the pharmacy workload. Strengthen quality control:According to the analysis results of the key steps that may influence CHG quality and efficacy, it is showed that CHG manufacturing technology, equipments and processes are similar to some traditional Chinese patent medicine. Based On a set of technical system and standard platform for traditional Chinese patent medicine, the quality control system for the raw medicinal herbs, semi-finished products and finished products was formed. Therefore, the CHG is theoretically similar to traditional Chinese patent medicine in efficacy and should be promoted.Boost Clinical research and applications:In the clinical applications, with the efficacy core, the CHG may be administered alone o together with other preparations. The administering routs may be flexible. In order to create a multi-faceted system for CHG clinical research, a dynamic efficacy monitoring system in hospitals is needed.Develop pharmacoeconomic research on CHG:It seems that CHG more expensive than the traditional prepared medicinal herb. A Pharmacoeconomic analysis may explain its economic benefits and provided reference for CHG price. Lower the price of CHG:The most effective way for CHG promotion is to lower the price.Strengthen advocacy and policy support:End the trial state of CHG and legalize its medicinal status to promote the CHG development and application.Promote the CHG to the global Market:CHG is ready to join the European and American medicinal standard for its stable and controllable quality; CHG is easy for adding or subtracting in treatment towards different syndromes, it meets the demands of modern life and it is easy for customer’s recognition. Compared with traditional prepared medicinal herbs and Chinese patent medicine, CHG is most likely extended to the global market as a new preparation of TCM.