Does the package of Chinese herbal pieces have a shelf life? Why?

[market analysis of chinapharma.com] recently, in the interactive exchange column of Anhui food and drug administration, someone asked, "is there a shelf life for the packaging of Chinese herbal pieces?" The FDA replied that there is no requirement for the shelf life in laws and regulations (does the package of Chinese herbal pieces have a shelf life? Why?) The author has learned that, in fact, there has been a long discussion in the industry about whether there should be a shelf life for the packaging of Chinese herbal pieces Some people think that "any medicine should have a period of validity, and Chinese herbal pieces should be no exception." In this regard, netizens agree that "the validity period should be set, and the specific time limit should be fixed." It is also pointed out that "Chinese herbal pieces are only stored for a certain period of time Our company is usually one year, can recheck again increase half a year So, is it necessary to set the validity period of Chinese herbal pieces? Why? According to the data query, there is no specific requirement for the validity period of Chinese Herbal Pieces in laws and regulations, and there is no requirement to write the validity period for the label of Chinese herbal pieces According to the GMP appendix, Article 33 of Chinese Herbal Pieces shows that "Chinese herbal pieces shall be packed with packaging materials or containers that can ensure their quality during storage and transportation The package must be printed or pasted with a label, indicating the product name, specification, place of origin, production enterprise, product batch number, production date and implementation standard, and the drug approval number must also be indicated for the Chinese herbal pieces under the approval number management " It can be seen that the laws and regulations do not require the validity period of decoction pieces According to the industry, there are several main reasons for not requiring the expiration date of the decoction pieces First, most of the Chinese herbal pieces belong to living plants Mildew and moth are very common phenomena in the storage process, so even if the expiry date is specified, it is difficult to ensure that this situation does not occur in the storage process At the same time, there are different climates in different parts of the world, and the period of validity is also limited to the manufacturers in different places Secondly, some mineral medicinal materials can be stored for a long time, so it is difficult to determine the specific expiry date Third, the quality of Chinese herbal medicines varies greatly from place to place, so it is impossible to ensure that the pieces of Chinese herbal medicines under stable investigation are representative in the world Fourthly, there are many kinds of Chinese herbal pieces It is also human and material resources to set the validity period Even the company cannot guarantee to complete the task The industry pointed out that at present, the management of materials only requires a retest period According to the provisions of Article 36, a retest period shall be established for Chinese herbal medicine and Chinese herbal pieces, and they shall be retested on schedule In case of any abnormality affecting the quality, they shall be retested in time Therefore, what we need to do is to establish the retest period In addition, from the above reasons, the storage of Chinese herbal pieces also needs more attention from enterprises Specifically, the commonly used maintenance methods of decoction pieces include lime drying method, alcohol pest control method, chemical pest control method (sulfur fumigation method), air conditioning method, anti storage method and cold storage method In addition, it is easy to be affected by climate and environmental protection, so there are specific requirements in these aspects For example, the warehouse of Chinese Herbal Pieces generally requires drying and ventilation to avoid direct sunlight The indoor temperature is not more than 20 ℃, the relative temperature is 45% - 75%, and the water content of Chinese herbal pieces is controlled below 13% (except for special pieces) In addition, the high temperature and humidity in summer make it easy to be eaten by insects (temperature 20-35 ℃, relative humidity 70% - 80%, water content over 13%), mildew (temperature 20-35 ℃, relative humidity over 75%, water content over 15%), oil drain, discoloration, odor loss and other phenomena, which directly affect the clinical treatment effect, and even can not cure the disease and cause disease Therefore, it is very important to store pieces in summer.