The revised contents of red ginseng standard of Pharmacopoeia 2015 are being publicized!

[industry trends of China Pharmaceutical network] on December 5, the author found in the national pharmacopoeia committee that the announcement of the contents of the proposed revision of the red ginseng standard in the 2015 edition of China Pharmacopoeia aims to enhance the attention, attention and participation of pharmaceutical manufacturers in the proposed revision of the quality standard According to the public information, red ginseng is a kind of traditional Chinese medicine, which is a ripe product of ginseng It has the functions of invigorating vital energy, restoring blood vessels, Strengthening Qi and absorbing blood Red ginseng is processed by soaking, cleaning, sorting, steaming, drying and other processes In the previous "315" party, red ginseng often sounded the alarm It is reported that the market is full of some processed red ginseng boiled in sugar water, which may cause negative effects for patients Therefore, the relevant supervision and standards need to be improved The publicity involves the residue of organochlorine pesticides in red ginseng, the test of chromatographic conditions and system applicability, the preparation of mixed reference stock solution, the preparation of mixed reference solution, the preparation of test solution, determination method, etc According to the query, since 2018, the National Pharmacopoeia Commission has issued a number of public notices on the revision of Chinese medicine standards, involving Ginkgo biloba extract, Yaobitong capsule and other Chinese medicine products On September 21, the publication of the proposed revised standard of Ginkgo biloba extract in the 2015 edition of Chinese Pharmacopoeia was published On September 18, the announcement and release of Yaobitong capsule, the first part of 2015 edition of Chinese Pharmacopoeia, was made The author understands that since the implementation of the 2015 edition of the Chinese Pharmacopoeia, the society has constantly raised questions and opinions on the quality standards of traditional Chinese medicine products, which also forces the quality standards of traditional Chinese medicine products to be improved However, for some products, the road of standard revision is still far away In April this year, the State Drug Administration issued a notice on the technical guidelines for the revision of the processing specifications of traditional Chinese medicine pieces, which is conducive to strengthening the management of traditional Chinese medicine pieces, standardizing the revision of the processing specifications of traditional Chinese medicine pieces, and enhancing the controllability of the quality of traditional Chinese medicine pieces
However, in terms of quality standards, according to industry statistics, there are 618 kinds of medicinal materials in 2015 edition of Chinese Pharmacopoeia, including 823 pieces of Chinese medicine, 23 pieces of Chinese medicine, 25 kinds of special medicinal materials such as artificial bezoar, borneol and the same pieces of Chinese medicine, and 312 varieties (775 pieces of Chinese Medicine) need to be further improved under the remaining 59 kinds of medicinal materials, accounting for China 40% of the total number of standard pieces It can be seen that the project is so large that the quality standards of 312 kinds of Chinese herbal pieces have a long way to go, and there are also great difficulties in revision In fact, all of them emphasize the quality standard of drugs because of its necessity It is pointed out in the industry that the drug standard is formulated according to the nature, source, preparation process, storage and other aspects of the drug itself, so as to test whether the drug quality meets the requirements of the standard Its contents include quality index, inspection method, production process and other technical requirements That is to say, through the quality indicators and technical requirements set by the drug standards, we can ensure the quality of drugs, further effectively control the safety and efficacy of drugs, bring more "sense of safety" to people, and avoid drug accidents And through the publicity method, it is beneficial for pharmaceutical manufacturers to improve the attention and participation of quality standards Now that it has entered the end of the year, will the State Pharmacopoeia Commission continue to issue the publicity of the revision of Chinese medicine product standards? We can look forward to it According to the industry, if the published standard is selected by medical science, it may be reflected in the 2020 edition of Chinese Pharmacopoeia.