Finishing: Shang Feng
In mid-October, the State Food and Drug Administration's website published the "Notice of the State Food and Drug Administration on 7 Batches of Drugs Not Complying with the Regulations (No. 78 [2021])": After inspection by four drug inspection agencies including the Hunan Provincial Institute of Drug Inspection and Research, 7 batches of drugs such as orlistat capsules produced by 5 enterprises including Zhongshan Wanhan Pharmaceutical Co., Ltd. did not meet the regulations. These include:
First, orlistat capsules, marked as Zhongshan Wanhan Pharmaceutical Co., Ltd. production, unqualified items, that is, specific unqualified quality items: [identification] ((2) infrared spectrum), [inspection] (dissolution), official interpretation: dissolution refers to the speed and degree of dissolution of active drugs from the preparation, non-compliance will affect the absorption of drugs, reduce bioavailability.
Non-conforming specifications: 60 mg. The sampling locations of unqualified orlistat capsules were: Dalian Renji Dekangda Pharmacy Chain Co., Ltd., batch number: 02200626; Sichuan Yujin Pharmaceutical Co., Ltd., batch number: 02200621; Lanzhou Jointown Pharmaceutical Co., Ltd., batch number: 02200623.
Second, orlistat capsules, marked as Hunan Dino Pharmaceutical Co., Ltd. production, unqualified items are [identification] ((1) infrared spectroscopy), according to the official interpretation, the identification items are mainly used to distinguish the characteristics of the drug, the means include microscopic identification, spectral identification, etc., thin layer chromatography is a commonly used identification method. That is, this drug is inconsistent with the standard spectrum of orlistat.
Unqualified specifications: 0.12 grams, the batch number of this batch of unqualified orlistat capsules is 201235, and the sampling location is Guangzhou Zhenkang Pharmaceutical Co., Ltd.
According to the survey, at present, orlistat tablets or orlistat capsules are the most important legal weight loss drugs, and the orlistat capsules of these two manufacturers are also the mainstream varieties of weight loss drugs in many pharmacies at present.
Third, chloroquine phosphate tablets, marked as Sancai Shiqi Pharmaceutical Co., Ltd. production, by the Dalian Municipal Drug Inspection and Testing Institute inspection, there is a batch of non-compliance with the regulations, do not meet the requirements of the item for content determination.
Fourth, compound licorice oral solution, marked as Qinghai Baojiantang Chinese Pharmaceutical Co., Ltd., after the Wuhan Pharmaceutical and Medical Device Inspection Institute tested, there is a batch of non-compliance with the regulations, the non-compliance items for the determination of guaiac glycerol ether and glycyrrhizic acid content.
Fifth, pediatric cough syrup, marked as Wuhu Zhang Hengchun Pharmaceutical Co., Ltd. production, by the Jiangsu Provincial Food and Drug Supervision and Inspection Institute inspection, there is a batch of non-compliance with the regulations, do not meet the requirements of the item for ammonium chloride content determination.