Standard goods, that is, standard goods, is the Chinese medicine standard standard products research center agent as a measuring standard; When used as a drug, it is the standard content in the content determination. Standards include stoichiometric standards, metallurgical standards and drug testing standards. The following is a small edition of Bolinda to introduce the importance of standards in drug research and development.

The importance of standards in drug research and development:

(1) The standard products used have been issued and provided by the Institute (refer to the Appendix X ⅤG of the second part of the 2000 edition of the Chinese Pharmacopoeia), and the method of use is the same, the current batch number standard products provided by the institute should be used, and its label and instruction manual should be provided to explain the batch number, and other sources should not be used;

If the method of use is different from the manual method of use (such as qualitative standard for quantitative use, titer standard for physical and chemical determination, UV or volumetric standard for chromatography, etc.), the appropriate method should be re-calibrated, and the calibration method and data should be provided; If the standard for chromatographic content determination is used as UV method or volumetric method, and the standard for quantitative use is used as qualitative, etc., it can be directly applied without re-calibration.

2. When applying for clinical studies, if the Institute does not have any supply, in order not to affect the registration progress, you can contact the Institute for preparation and calibration in advance, and provide calibration reports, labels (which should indicate titer or content, batch number, use validity period) and instructions for use when applying; It can also be calibrated in cooperation with the provincial institute, and provide the standard product or the research data of the standard product at the time of application, "explaining its source, physical and chemical constants, purity, content and determination methods and data";

When calibration is difficult, standards issued by foreign drug administration authorities or pharmacopoeia committees or working standards of foreign pharmaceutical companies can be used for standard formulation and other basic research, but their labels (which should indicate their content) and instructions for use should be provided to ensure the traceability of their quantitative values; Standard products provided by foreign reagent companies can also be used.

However, the test report of the batch of standard products of the reagent company should be provided (when used for content determination, the content data should be determined), if the test report of foreign reagent companies is provided for high-purity reagents (when used for content determination, the content data should be determined), it can also be used, and it should be able to ensure the traceability of its quantitative value, but the applicant should contact the CCI in time for the calibration of the standard products. This work is done during clinical studies.

3, directly declare the production varieties, if the CCI does not have the supply, you can refer to the requirements in 2, and provide the corresponding research data, but the applicant should contact the CCI during the standard trial period and complete the calibration matters.

Some views on its calibration work are put forward in order to discuss and exchange with colleagues in the industry. It is also hoped that in the process of drug research and development, the research unit should pay attention to the preparation and calibration of the CCI in time to ensure the continuity of research and development work.

The above content is the introduction of the importance of standard products in drug research and development. On the other hand, although China's antibiotic research has made great progress, the quality of some antibiotics still has a certain distance from the requirements of developed countries. The correct use of standard products in each link is particularly important to ensure the safety and effectiveness of products, and great attention should be paid to this part of the research, and it is also suggested that the applicant further strengthen the research work on this part.