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Reference (standard) is a kind of physical control for the implementation of drug quality standards. It is an important carrier of the reported quantity value, a special measuring tool for checking the quality of drugs, a reference for determining the quality of drugs, a material comparison for determining the quality of drugs, and a material standard for checking the calibration of instruments and methods. As far as the national drug standard is concerned, it is a kind of drug measurement and quality standard substance published by the state. Pharmaceutical reference materials must have the c...
Date: 2020 / 04 / 29
The choice of purification method depends on the value and properties of the active ingredients to be obtained.The selective crystallization of water-soluble compounds is a simple and low-cost method, but the relative purity is required in the early stage.Fat soluble compounds are complex. A common method is solvent extraction, followed by distillation, and then based on the purity to determine whether chromatography is needed.If the purity of polysaccharide is not high, ethanol precipitation effect is relatively good. To find high purity polysaccharide, membrane filtration can be considered.T...
Date: 2020 / 03 / 24
Amoxicillin Capsules, escitalopram oxalate tablets, entecavir dispersible tablets, entecavir capsules and other four drugs have reached three manufacturers through the conformity assessment of quality and efficacy of generic drugs. The trading qualification of the drug centralized purchase platform in some regions of the above drugs that failed to pass the conformity assessment of quality and efficacy of generic drugs has been suspended.Temporary adjustment of the marketAmoxicillin is a famous drug. Moreover, with the continuous promotion of consistency evaluation, the drug market is expected ...
Date: 2020 / 02 / 19
1、 What is reference formulation?Reference formulation refers to the reference drug used for the consistency evaluation of quality and efficacy of generic drugs, which is usually the object to be imitated, such as the original drug or internationally recognized drug of the same kind. The reference formulation should be a drug with reasonable prescription, stable quality and definite curative effect.The original research drug refers to the first drug allowed to be listed at home and abroad, with complete and sufficient safety and effectiveness data as the basis for listing.The internationally r...
Date: 2020 / 01 / 09
Don't think the more famous the drug is the better, and imported drugs are better than domestic drugs. In fact, these are all medication errors! So, what are the right drugs? Now the import drug registration agent will show you.  ① Drug descriptionWhat circumstances can not be used, which drugs and which drugs can not be used together, these are important contents in the drug manual, which must be read carefully before use.② Combined with the actual situationThe choice of drugs should consider their own situation, and choose what is suitable for them and affordable...
Date: 2019 / 12 / 23
Why do doctors prescribe more imported drugs? Are domestic drugs and imported drugs the same? What's the difference? Now  the import drug registration agent will show you.  The difference between imported drugs and domestic drugsIn the treatment of hypercholesterolemia drugs - alexin and Lipitor, for example, both are statins, both of which have the same composition and efficacy. Lipitor is crystalline atorvastatin calcium, and aloe is amorphous atorvastatin calcium. The difference between them is that the content of impurities in amorphous atorvastatin calcium is ...
Date: 2019 / 11 / 13
The source of safety and effectiveness of drugs lies in the quality assurance of raw materials. When selecting suppliers that meet the criteria of supplier selection and evaluation, different selection methods are selected according to the actual procurement situation. In order to obtain the lowest procurement cost and risk, it is necessary to establish long-term cooperation with suppliers with the highest product quality.First of all, raw material supply enterprises must pass the national GMP certification, without data integrity problems, and long-term stable supply. If you change the API ve...
Date: 2019 / 10 / 23
In recent years, the price of raw materials has risen rapidly. Some people think that the important reason is industry monopoly, but why does monopoly suddenly increase? Let's take a look at the relevant policies in the past few years, such as the two vote system, business to value-added system, generic drug consistency evaluation, etc. The purpose of these policies is very good, and can be said to be the right medicine, but the so-called 'three poisons of medicine'. The side effects of these policies are gradually emerging, which leads to the increase of industry concentration and...
Date: 2019 / 09 / 24
On August 28, the drug evaluation center of the State Food and Drug Administration issued the publication of the catalogue of the 23rd batch of chemical generic reference formulations, with the publication date from August 28 to September 10. This time, there are 318 product specifications, involving 169 drugs (see the attached table at the end of the article for details). Among them, 170 injection specifications accounted for 53.5%.2224 reference formulations have been published, with 630 injection varietiesAccording to statistics, up to now, FDA has released a total of 2224 reference fo...
Date: 2019 / 08 / 30
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