The important role of Chinese medicine standard products

The study of Chinese medicine standard products is of great significance for promoting the quality control level of Chinese medicine, ensuring the quality of medicines and the safety and effectiveness of people's medicine; we can see in the pharmacopoeia that the number of standard products is increasing year by year, and with the continuous development of the Chinese medicine industry, There are higher requirements for the types and quantity of Chinese medicine standard products.

Requirements for HPLC determination standards of Chinese traditional medicine standards

For the standardization of standard products, the area normalization method can only be used for HPLC; I personally feel that there will be a slight difference under different conditions. Two different conditions are used to measure separately, which can increase the reliability. Sex; this is a bit like extracting and separating monomer compounds from Chinese herbal medicine (I do n’t know how you are in the extraction and separation of Chinese herbal medicine?), Generally when separating the monomer compounds in Chinese herbal medicine, when you suspect that you run out with a developing agent If the point is a monomer, you usually need to change 1-2 completely different developing agents for expansion, or you should change the silica gel to polyamide or dextran gel or something; if you change the various conditions, it is still one Point, it can basically be determined to be a monomer compound, and then go to spectrum to determine the structure.

Using HPLC (UV detector) to establish a content determination method for a new drug, the condition itself is established in the process of continuous exploration; although it cannot be said that each method is correct, as long as this method meets the needs of various parties, Then this method can be used.

There are different opinions about the standard of HPLC determination of traditional Chinese medicine standards. This is not difficult to understand. After all, there are a large number of traditional Chinese medicine standards, but here, the technicians of Shanghai Yuanmu Standard Product Network recommend the non-aqueous titration method, as long as you determine the standard titration If the concentration of the liquid is correct and the titration method is appropriate, there will not be too many problems; when we did not have a standard product before, we will use the titration method to determine the content of the standard product, and all pass.

It is more in favor of the non-droplet method; first of all, you must determine the content of your standard, at least normal phase, reverse phase, DAD detection; as for different instruments, testing between different laboratories is another matter; generally speaking , HPLC method to determine the content, you need a reference substance, regardless of the external standard method, internal standard method are required; and you are doing a new class of drugs, there is definitely no reference substance; therefore, there needs to be a method for methodology Research; but certainly not HPLC method, you can use non-aqueous titration method, use the potential to indicate the end point, make a titration curve; if there is a suitable indicator, you can compare it, if the potential of the titration end point and the indicator discoloration end point can be unified, it can also be used The indicator indicates the end point; but data such as linearity, precision, stability, recovery rate, etc. are still required; when necessary, influencing factors, acceleration, and long-term tests are required to investigate the stability of the reference substance.

The first choice for the determination of the contents of chemical drugs is the chemical method. According to the nature of the chemical itself, the method is non-aqueous titration, acid-base titration, potentiometric titration or others. Although you are making a class of drugs, you should be relatively clear about the basic classes. You should refer to the method for determining the content of raw materials in similar products for methodological exploration. As long as your chemical properties are clearly analyzed, it should not be a problem. .

The determination of the content of raw materials is a chemical method; now everyone is used to the instrument, and they always like to use the HPLC method at the beginning; in fact, everyone looks at the content of the new drug research guide. The raw material drug is preferably the chemical method, only if the chemical method cannot Only HPLC is used; if you want to use HPLC, you need to use standard products. You have to do the content determination of chemical standard products, of course, you need to use chemical methods.

The answer of the Drug Control Institute is also very official; because you may be able to pass it, but why not find a good chemical method to do the content determination method yourself? The liquid phase method is the first choice for preparations, you can use chemical method to determine your own purification Good APIs are standard products. Standardization should not be a matter of measuring the content. The premise of measuring the content is that there is a reference substance. How to ensure the accuracy of the measurement without the reference substance? How to evaluate the method?

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