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Standards For Chinese Herbal Extracts

The vast majority of traditional Chinese medicine extracts are mainly exported. This may be related to the fact that there are still many differences in the views of Chinese medicine extracts on Chinese medicine extracts. Many people think that Chinese medicine extracts are very different from traditional Chinese medicine decoction pieces. It is a traditional Chinese medicine, because there are many subtle chemical reactions in the process of decocting traditional Chinese medicine. This is an effect that cannot be achieved when the traditional Chinese medicine extract is mixed. In fact, the Guangdong Yifang company’s research on traditional Chinese medicine granules has proved that Chinese medicine extracts can maintain most of the characteristics of Chinese medicine. At the same time, with the advancement of technology, the effective ingredients of Chinese medicine have become clear. The standard of Chinese medicine in the Chinese Pharmacopoeia is For reference, we must be able to formulate as soon as possible the preliminary standards of Chinese medicine extracts that meet the characteristics of Chinese medicine and are accepted by the world, and continue to improve in the process of implementation. This is also in line with the current law of development of botanicals.
The standardization and improvement of traditional Chinese medicine extracts are relatively lagging behind. With the implementation and continuous advancement of my country’s drug standard improvement plan, the national drug standard system has been initially established, the pace of drug regulatory information construction has accelerated, and the drug standard management work has become more standardized and improved. However, the standardization of traditional Chinese medicine extracts still lags behind, mainly in the following aspects:

① The standard is not established. Chinese medicine extracts are important raw materials for the production of Chinese patent medicines. According to statistics, about 29.8% of Chinese patent medicines use Chinese medicine extracts, but there are still some Chinese medicine extracts that have not yet established national standards. Due to the lack of statutory standards, demand-side standards and corporate standards are mostly adopted in production and business activities, and the quality clauses in the contract are used as the basis for product delivery, and the product quality inspection methods are rather confusing.

② The standard is not perfect. The complete standard items are the basis for effective control of the quality of Chinese medicine extracts. However, due to the prolonged promulgation of the standards for some Chinese medicine extracts, the standard items are not perfect. For example, some old traditional Chinese medicine extract standards lack pesticide residue limits and heavy metal determination items, some lack test standards for auxiliary materials, and some lack microbial limit checks.

③ Irregularities in standards. There are many standards for Chinese medicine extracts, and there are irregularities in naming, preparation methods, properties, and inspections. For example, some traditional Chinese medicine extracts have the same name but different preparation methods. Taking the extract of Scutellaria baicalensis Georgi as an example, it appears 12 times in the 2010 edition of the Chinese Pharmacopoeia and in the “Prescriptions of Traditional Chinese Medicine”. , “Final pH value before drying”, “Solution for washing crude product” and other key process parameters that affect the quality of finished products are quite different, which is easy to cause confusion in production and use.

④ The standard level is uneven. The standard level of traditional Chinese medicine extracts approved in the form of new drugs and included in the Chinese Pharmacopoeia is relatively high. However, other traditional Chinese medicine extracts still have problems such as inadequate technology and lack of core technology. In addition, most of the Chinese medicine extract manufacturers are small enterprises with relatively poor technical level and production capacity. They seldom optimize and research the production process of the product seriously, and lack in-depth product development, resulting in a relatively low production technology threshold for Chinese medicine extracts. Low and disorderly market competition.

⑤ The standard is not eliminated. Due to the lack of means to evaluate the implementation of Chinese medicine extract standards, some Chinese medicine extract standards “live but not die”, so that some standards that have not been updated or revised for many years are still in use, and there is an urgent need to establish a standard elimination mechanism

Post time: Sep-14-2020