"Expiry period" management should be implemented for bagged Chinese medicine decoction pieces

According to the author's observation, at present, most of the Chinese Herbal Pieces in circulation in the market are sold in plastic bags This kind of package is usually not tightly closed, and is very vulnerable to the invasion and influence of bacteria and microorganisms in the air In addition, the medicinal materials themselves have different components and properties, some contain more starch, some contain more sugar, some contain a lot of water, some are unstable Ding et al, it is more likely to deteriorate, so it is necessary to stipulate the validity period of Chinese Herbal Pieces in bags Traditional Chinese medicine pieces have been in the state of no "effective period" management for a long time, which has the following disadvantages: first, it is not conducive to the safe use of drugs In the daily inspection, the author found that due to the weather change or the poor safekeeping of the quality control personnel in the pharmaceutical trading enterprises, many pieces of Chinese herbal medicine in the pharmaceutical trading enterprises have mildew and moth eaten visible to the naked eye The staff only cleaned and dried the deteriorated pieces of Chinese herbal medicine and continued to sell them, but the pieces themselves are likely to have deteriorated and the degradation of the effective ingredients, or even The production of harmful ingredients, whose efficacy has been greatly affected, is obviously not conducive to public drug safety Second, it has become a regulatory blind spot Article 102 of the supplementary provisions of the drug administration law includes Chinese herbal medicine and Chinese Herbal Pieces in the definition of drugs Meanwhile, Article 49, paragraph 3, * defines drugs that do not indicate the period of validity or change the period of validity as substandard drugs, and Article 49, paragraph 3, paragraph 3, provides that drugs that exceed the period of validity shall be punished as substandard drugs However, these regulations can only be binding on drugs with expiration date marked on the external packaging, but not on Chinese herbal pieces without expiration date, which makes law enforcement officers lack direct law enforcement basis for Chinese herbal pieces that have deteriorated and become invalid In this case, only the pieces can be sampled, but the cost of sampling is high, the efficiency is low and the time is long, which brings great inconvenience to the daily supervision Third, it is difficult for consumers to safeguard their rights Since the expiration date is not marked on the external package of the Chinese herbal pieces, consumers can't see whether the pieces have expired when they buy them Even if they buy the Chinese herbal pieces that have expired and deteriorated, they can't find them until they are opened for use There is no legal basis for complaints from relevant departments, which makes it very difficult to protect their rights The effective period management of Chinese herbal pieces is a complex process Many factors should be taken into account when making a scientific and reasonable effective period The author believes that the effective period of Chinese herbal pieces should at least consider the following factors: first, the influence of the production process of Chinese herbal pieces on the effective period management In 2010 edition of Chinese Pharmacopoeia, the processing of decoction pieces can be divided into three forms, namely, the purifier is the pure medicinal materials, the chopper is the slicer and the processor is the baked products In the process of processing, due to the addition of different auxiliary materials and technological processes, the stability of Decoction pieces is not the same, and the length of validity period is not the same The second is the influence of the storage conditions of Chinese herbal pieces on the period of validity management Some Chinese herbal pieces have high requirements for storage conditions, and the quality of storage conditions has a great impact on the quality of Chinese herbal pieces Wet Chinese herbal pieces are easy to mildew, high temperature and volatile substances are easy to lose efficacy, oil-bearing seed pieces are easy to pan oil, Chinese herbal pieces are well stored, with a relatively long period of validity, poor storage and a relatively short period of validity Therefore, it is necessary to mark the storage conditions of Chinese herbal pieces as well as the validity period of Chinese herbal pieces to remind the management and users The third is the effect of packaging materials of Chinese herbal pieces on validity management For some pieces that need to be kept away from light, black opaque packaging materials can be used; some pieces need to be strictly moisture-proof, and moisture-proof packaging materials can be used; vacuum packaging materials have good sealing performance, and the validity period of Chinese medicine pieces is longer At the same time, the size of packaging has a great impact on the quality of Chinese herbal pieces For example, the use of small packaging pieces is relatively less affected by the environment and other factors, while the time for deployment of large packaging may be very long due to the environment and other factors, so it is necessary to consider that the validity period of small packaging pieces of Chinese herbal medicine is a little longer, and that of large packaging is relatively short Fourth, the influence of the stability of Chinese herbal pieces on the effective period management For some pieces of Chinese herbal medicine with stable chemical properties and easy to preserve, such as magnetite and Longzhi of ore, the period of validity can be longer; for some pieces of Chinese herbal medicine with unstable chemical properties, strong volatility, light and easy to change color, such as peppermint and agastache, the period of validity is shorter; for those pieces of Chinese herbal medicine with more sugar and starch, easy to absorb moisture, moth eaten and mildew, For example, dangshen and huaishanyao should have a shorter period of validity.