Discussion on the problems existing in the production enterprises of Chinese Herbal Pieces

Discussion on the problems of Chinese Herbal Pieces production enterprises in Dingli medical treatment: 1 The scale of Chinese Herbal Pieces production enterprises is uneven In recent years, the development of Chinese herbal medicine production enterprises is relatively rapid, but due to the unbalanced regional economic development, some enterprises pursue the interest maximization, reduce the production and operation costs, the enterprises do not put the experience on the development, and the scale is uneven There are relatively few modern, large-scale, standardized and standardized large-scale Chinese Herbal Pieces production enterprises in China, such as Kangmei pharmaceutical and Tongrentang, while the "scattered, disordered, poor and small" family and workshop processing Chinese Herbal Pieces production enterprises are common The low level of enterprise management, simple facilities and equipment, low quality of personnel and backward technology have become the main factors restricting the development of Chinese herbal medicine production enterprises to modern, large-scale, standardized and standardized large and medium-sized brand enterprises 2 There is a lack of professional technical personnel in the production enterprises of Chinese herbal pieces Chinese herbal medicine and Chinese herbal pieces are highly professional, and the methods to identify their quality are different from other drugs such as chemical drugs and Chinese patent medicines Many traditional identification methods and key points are irreplaceable in laboratory testing It can be said that the identification of the quality of Chinese Herbal Pieces depends on experience For example, the color of Chinese herbal medicines, such as black Scrophularia, red Rubia, and yellow Coptis, shows that their quality is good, such as Scutellaria turning green due to improper processing and preservation; the long-term storage section of Mianma Guanzhong will turn brown and black, which indicates the change of their quality and is not available for medicine Therefore, only with strong practical experience, rich experience in identification and processing, the "old pharmacists" who really understand Chinese medicine can identify the quality of Chinese herbal pieces, identify which Chinese herbal pieces are dyed, which are adulterated, which are fake, which are confused, etc., so as to ensure the quality in the process of Chinese herbal purchase and processing of Chinese herbal pieces and be competent in Chinese herbal medicine Responsibilities for acceptance, maintenance and processing of Chinese herbal pieces In reality, although the enterprises are equipped with relevant technical personnel of traditional Chinese medicine according to the regulations, there are many cases in which the theory is not practiced, the knowledge is half understood, and the experience of identification of traditional Chinese medicine pieces is less Even some small enterprises with family style and workshop style have no professional technical personnel at all The existence of these factors is also the main reason for the current phenomenon of Chinese herbal pieces, such as non-medical parts acting as medical parts, drug name confusion, drug mixing, counterfeiting and selling 3 Cut down on production and materials and do not process according to the standard Traditional Chinese medicine processing is the summary of long-term clinical medication experience of traditional Chinese medicine and the unique traditional pharmaceutical technology of traditional Chinese medicine Chinese herbal pieces can be processed to change drug properties, expand the scope of application, enhance drug efficacy and reduce drug side effects Appendix Ⅱ D (general principles of processing) of the first volume of Chinese Pharmacopoeia (2010 Edition) makes it clear that all herbs are called "pieces of Decoction" after being purified, cut or processed That is to say, Chinese herbal pieces are processed products of Chinese herbal medicines Whether the processing technology of Chinese herbal pieces is reasonable and the method is appropriate directly affects the clinical efficacy and the people's drug safety In order to reduce the operation cost and cut down on raw materials, some enterprises do not follow the standard processing and traditional processing technology, which affects the quality of Chinese herbal pieces and even causes poisoning In addition, the traditional Chinese medicine stir fry has clear fry and add auxiliary materials stir fry, which includes stir fry yellow, stir fry coke, stir fry carbon Add auxiliary materials to stir fry to have bran stir fry, earth stir fry, rice stir fry and so on According to the different degree of frying and the different efficacy of the added excipients Now many enterprises even use sawdust instead of bran stir fry, the micro fry of the stir fry and carbon can be, less than the standard requirements In addition, some Chinese herbal pieces that need honey use white sugar instead of honey, or use little honey More serious is that toxic drugs such as Chuanwu, Nanxing and Pinellia are not processed in accordance with the regulations, which can not achieve the purpose of reducing the toxicity The patients take them, resulting in poisoning 4 The production and processing facilities and equipment and inspection instruments are virtually empty Some Chinese herbal medicine enterprises are equipped with air separator, drying box, calcining oven and other facilities and equipment for production, processing and processing as well as analytical balance, microscope, liquid chromatograph, moisture and ash analyzer and other inspection and testing instruments required for inspection according to the requirements of start-up standards and GMP However, after passing the GMP certification, the idea of the enterprise is relaxed In order to reduce the production cost, the facilities and equipment for production and processing and the inspection and testing instruments have also become furnishings For example, those that can be dried in the sun do not need a drying box, and those that can be sorted and processed manually do not need a sorting machine and processing equipment In addition, according to the requirements of relevant regulations, the Chinese Herbal Pieces production enterprises shall conduct quality inspection on each batch of Chinese herbal medicines purchased and the pieces produced to ensure the quality of the pieces However, there are few enterprises that do the batch inspection of Chinese herbal pieces according to the requirements, and the laboratory test instruments are idle, so the inspection is not conducted and the inspection report is forged 5 Illegal production and operation are common First, the enterprise does not produce Chinese herbal pieces, purchases bulk Chinese herbal pieces from the Chinese herbal medicine market, and directly pastes and repackages them for sale The enterprise establishes a veritable "repackage factory" Second, the enterprise rents and lends the license, passes the ticket, provides the product false inspection report, the salesman organizes the source of goods by himself, prints the packing label, the certificate of conformity, carves the seal privately to engage in the Chinese medicine decoction piece business activity, the enterprise collects the certain benefit fee from the salesman, the enterprise provides the qualification, the sales bill and other convenient conditions for him Third, the production of Chinese Herbal Pieces beyond the production scope The production enterprise of Chinese herbal pieces shall produce according to the production varieties reported when applying for the drug production license or GMP certification Without approval, it is not allowed to increase the production range of Chinese herbal pieces without authorization The actual production varieties exceed the approved varieties.