10 batches of drugs are not compliant! Shexiaoer Ganmao granule, Chuanbei cough syrup, etc
2022-06-21
Screenshot of the official website of the State Food and Drug Administration According to the official website of the State Food and drug administration, the State Food and Drug Administration recently issued a notice that 10 batches of drugs such as Xiaoer Ganmao granules, which were marked as produced by 9 enterprises including Guangxi golden throat Pharmaceutical Co., Ltd., did not meet the requirements after inspection by 8 drug inspection institutions including Fujian food and drug quality inspection institute. According to the notice, one batch of adapalen gel marked as produced by Fuyuan Pharmaceutical Co., Ltd. failed to meet the requirements after inspection by Heilongjiang Institute of drug inspection, and the item failing to meet the requirements is pH value. It is reported that pH value is the hydrogen ion concentration index, which is used as a measure of acid-base degree. According to the inspection conducted by Yunnan food and drug supervision and Inspection Institute, one batch of Chuanbei cough syrup marked as produced by Guangxi kangshiyuan Pharmaceutical Co., Ltd. of Rongkang group is not in conformity with the regulations, and the item not in conformity with the regulations is the loading capacity. It is reported that the loading capacity is an indicator reflecting the weight or capacity of drugs. It is applicable to solid, semi-solid and liquid preparations. It is stipulated that the minimum loading inspection method should be used for inspection. Failure to comply with the regulations will lead to insufficient clinical dosage. According to the inspection conducted by the food and Drug Inspection Institute of Guangxi Zhuang Autonomous Region, one batch of guanguanning capsules marked as produced by Jiangxi Sangao Pharmaceutical Co., Ltd. is not in conformity with the regulations, and the items that do not comply with the regulations are identified; One batch of guanwanning tablets (plain tablets) marked as produced by Shandong Haofu Pharmaceutical Group Pharmaceutical Co., Ltd. is not in conformity with the regulations, and the non-conforming items are weight differences. It is reported that the identification item is mainly used to distinguish the characteristics of drugs. Its means include microscopic identification, spectral identification, etc. thin layer chromatography is a commonly used identification method. Weight difference is an indicator of drug uniformity and one of the important parameters to ensure accurate drug delivery. According to the inspection of Fujian Institute of food and drug quality inspection, the two batches of Xiaoer Ganmao granules marked as produced by Guangxi golden throat Pharmaceutical Co., Ltd. do not meet the requirements, and the items that do not meet the requirements are identified. According to the inspection conducted by Hunan Institute of drug inspection and testing, one batch of xuanmai Ganju granules marked as produced by Sichuan Fengchun Pharmaceutical Co., Ltd. is not in conformity with the provisions, and the item not in conformity with the provisions is the content determination. It is reported that content determination refers to the determination of the content of active ingredients in raw materials and preparations by specified test methods. Generally, chemical, instrumental or biological determination methods can be used. According to the inspection conducted by Qinghai provincial drug inspection and testing institute, one batch of Zhituo Jiebai pills marked as produced by Tibet manna Tibetan Medicine Co., Ltd. is not in conformity with the regulations, and the items that do not comply with the regulations are differences in properties and weight. It is reported that the appearance, odor, taste, solubility and physical constants recorded under the property item reflect the quality characteristics of drugs to a certain extent. The character items of the prepared pieces of traditional Chinese medicine do not meet the requirements, which may involve the species deviation of the medicinal materials, defective processing technology, improper storage, etc. According to the inspection of Sichuan Institute of drug inspection (Sichuan Medical Device Testing Center), one batch of Achyranthes bidentata, which is marked as produced by Bozhou Tzu Chi Tang traditional Chinese medicine decoction pieces Co., Ltd., does not meet the requirements, and the items that do not meet the requirements are properties. According to the inspection conducted by Gansu Institute of drug inspection, one batch of Rubia cordata produced by Beihai Nengxin traditional Chinese Medicine Co., Ltd. does not meet the requirements, and the items that do not meet the requirements are properties and identification. The State Food and Drug Administration said that the drug regulatory authorities have required relevant enterprises and units to take risk control measures such as suspension of sales and use, recall, etc. to investigate the reasons for the non-compliance and make practical rectification. In addition, the State Food and drug administration requires the relevant provincial drug regulatory departments to organize the investigation of the suspected illegal acts of the above-mentioned enterprises and units in accordance with the drug administration law of the people's Republic of China, and make the investigation results public as required. (outlook new era)
Edit：Yuanqi Tang Responsible editor：Xiao Yu
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