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The State Drug Administration announced that 15 batches of drugs are not compliant
Release time: 2018-09-08 & nbsp & nbsp & nbsp Source: Anonymous

Recently,The National Drug Administration issued a notice,15 batches of medicines produced by 10 companies such as Henan Ming Shantang Pharmaceutical Co., Ltd. do not meet the regulations。

Drugs that do not meet the prescribed specifically are: 1 batch of 1 batch of hydrochloride tablets produced by Xinhua Pharmaceutical (Gaomi) Co., Ltd.,It is marked as Hainan Zhuotai Pharmaceutical Co., Ltd.、Tai Chi Group Sichuan Taiji Pharmaceutical Co., Ltd.,It is marked as Anhui Huilong Traditional Chinese Medicine Drinking Film Co., Ltd.、3 batches of betel nut produced by Huazhou Guanghua Traditional Chinese Medicine Drinking Co., Ltd.,Lamed as Jiangsu My stake betting appRed stake betting appDou Traditional Chinese Medicine Drinking Piection Co., Ltd.、2 batches of Dihuang,3 batches of Muxiang Shunqi Pills produced by Henan Ming Shantang Pharmaceutical Co., Ltd.,It is marked as Anhui Yaoyao Qiancao National Medicine Co., Ltd.、Two batches of yam produced by Guangdong Tiantai Pharmaceutical Co., Ltd.,1 batch of inflammatory removal capsules produced by Yichun Wujia Pharmaceutical Co., Ltd.。

 

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Tips that do not meet the specified projects

1. Inspection items in the drug standard include test methods and limits that reflect the safety and effectiveness of the drug、All -ity and purity of the preparation process requirements and other content;,refers to the impurities that the drug may contain or produce and control in the process of production and normal storage (such as residual solvents、related substances, etc.); When changing the production process。Inspection items have water according to the characteristics of different drugs、Total gray points、Yellow Glove Toxin、Smooth time limit and other sub -items。

Water refers to the water content in the medicine。High water is usually due to the poor packaging of the medicine,Caused by dampness during storage and circulation。High moisture will cause a decrease in drug stability,It may cause drug hydrolysis、Mold Change, etc.。

Gray division refers to the inorganic substance left after the drug is burned by high temperature,Mainly inorganic salts and mineral stake sports betting appMy stake betting appsalt。Usually measured gray points are called total ash points,The purpose of the total gray division is to ensure the quality and degree of cleanliness of Chinese medicine。

Glimal toxin can be galcoprobulin yellow mold、Paramark、Four types of fungi of peak molds and pseudoemotoma,It is a derivative compound of a group of two -呋 喃 citrles with similar chemical structures。Chinese medicine is storage、Preparation、If improper preservation during transportation,Perhaps it may contaminate yellow glimoin toxin due to moisture mildew。Strictly controlling the residual amount of gemyl toxin is of great significance to ensure drug safety。

Smoothing time limit is the pills all collapsed and dissolved or forming crushed grains within the specified time。Among them, in addition to insoluble coating materials,It should be all through the screen; if there is a small amount, you cannot pass the screen,But softened or light -quality drifting without hard heart,can be used as the theory of compliance。Pills are not dissolved or dissolved for too long in the medium,Reflect that the main medicine is not effective or the efficacy starts to have a certain delay,Its main reason is related to improper process control。

Solubility refers to the rate and degree of active drugs dissolved from the preparation。The degree of dissolution does not meet the regulations caused by multiple factors,Improper production process My stake betting appstake sports betting appcontrol, etc.。The degree of dissolution does not meet the regulations that will affect the absorption of the drug,Reduce biological utilization。

visible foreign body refers to the existence of injection、In the eye preparation,The insoluble substance that can be observed under the specified visual conditions,Its particle size or length is usually greater than 50 micron。This project does not meet the regulations that may cause local circulation disorders and other medication safety risks。It may involve craft control、Packaging materials, etc.。

2. The content measurement item in the drug standard refers to the content of the ingredients in the ingredients and the effective ingredients in the preparation of the test method,General chemistry can be used、Instrument or biological measurement method。The content measurement is related to the efficacy of the drug。The content determination does not meet the regulations and the amount of feeding、Investment quality and technology。

3. The immersion item in the standard of Chinese medicinal materials and slices refers to the measurement of water or other suitable solvents to determine the soluble substances in Chinese medicinal materials and slices。The size of the measurement value of the immersion material can reflect the amount of the inner components of Chinese medicinal materials and slices,directly related to its quality advantages and disadvantages。Chinese medicinal materials and slices、growth period、Harvest season、Processing method、Stake Sports BettingThe stake betting appirregular production links such as the processing process and other production links may cause the content of its impregnation to not meet the regulations。