Recently, the official website of the State Food and Drug Administration issued:Notice on 20 batches of drugs not in compliance with the regulations.
The situation of non-compliance with the regulations
Inspected by the Food and Drug Inspection Institute of Guangxi Zhuang Autonomous Region, The 12 batches of Dendrobium Yeguang pills produced by Jilin Tonghua Boxiang Pharmaceutical Co., Ltd., Jilin Shuangshi Pharmaceutical Co., Ltd., and Jilin Tiantai Pharmaceutical Co., Ltd. do not meet the requirements. Items that do not meet the requirements are identified.
Inspected by Shanxi Provincial Food and Drug Inspection Institute, it was labeled as a batch of clarithromycin sustained-release tablets produced by Hainan Puli Pharmaceutical Co., Ltd.Does not meet the regulations, the items that do not meet the regulations are loss on drying.
Inspected by Fujian Institute of Food and Drug Quality Inspection, it was labeled as a batch of Allo for injection produced by Shanxi Qianyuan Pharmaceutical Group Co., Ltd. Cillin sodium does not meet the regulations. The item that does not meet the regulations is the clarity of the solution.
Inspected by the Inner Mongolia Autonomous Region Drug Inspection and Research Institute, it was marked as 2 batches produced by Hebei Guojin Pharmaceutical Co., Ltd. and Guangzhou Huacheng Pharmaceutical Co., Ltd.Compound honeysuckle granules do not meet the regulations, and the items that do not meet the regulations are the difference in the filling quantity.
Shenzhen Institute for Drug Control and China Institute for Food and Drug Control respectively inspected and labeled as one batch produced by Anhui Zehua Chinese Medicine Decoction Pieces Co., Ltd.Rhodiola and the first batch of Sichuan Wu do not meet the requirements, and the items that do not meet the requirements are all traits.
Inspected by Dalian Drug Inspection and Testing Institute, it was marked as a batch of Qianhu produced by Anguo Tongkang Pharmaceutical Co., Ltd. Non-compliance, non-compliance items are traits and identification.
Inspected by Shanxi Provincial Food and Drug Inspection Institute, it was marked as a batch of Qin produced by Hunan Naturetang Traditional Chinese Medicine Decoction Pieces Co., Ltd. >艽 does not meet the requirements, and the items that do not meet the requirements are traits.
List of non-compliant drugs
Source:State Drug Administration official website
Small knowledge of non-compliant items
1. The identification items are mainly used to distinguish the characteristics of drugs. The methods include microscopic identification, spectral identification, etc. Thin layer chromatography is a commonly used identification method.
2. Loss on drying means that the medicine is dried under specified temperature and pressure conditions, and the percentage of weight loss before and after drying is calculated by weighing. . Loss on drying is mainly used to control the moisture in the medicine, but also includes other volatile substances, such as the residual organic solvents in the production process of the medicine.
3. The clarity of the solution is to compare the drug solution with the prescribed turbidity standard liquid phase to check the clarity of the solution. The clarity of the solution can reflect the purity of the drug to a certain extent, is a fast, simple and accurate method for drug quality inspection.
Four, the difference in the loading volume is an index reflecting the uniformity of the drug, and it is one of the important parameters to ensure accurate drug delivery.
V. Appearance, odor, taste, solubility and physical constants are recorded under the item of properties, which reflect the quality characteristics of the drug to a certain extent. The properties of decoction pieces of traditional Chinese medicine do not meet the requirements, which may involve deviations in the species of the medicinal materials, defects in the processing technology, and improper storage.
For the above-mentioned non-compliant drugs, the drug supervision and administration department has requested relevant enterprises and units to adopt suspension of sales, use, and recall
strong>Wait. Risk control measures, investigating the reasons for non-compliance with regulations, and effectively rectify them.
The State Drug Administration requires relevant provincial drug regulatory authorities to comply with the”Pharmaceutical Administration Law of the People’s Republic of China” Organize investigations into the above-mentioned enterprises and units for production and sale of counterfeit and inferior drugs, and publicize the investigation results in accordance with regulations.