Progress in the revision of the 2020 edition of the Chinese Pharmacopoeia (section on universal testing methods and guidelines)

On December 15, China Food and Drug Regulatory Magazine media released the article “The Latest Progress in the Preparation of the 2020 Edition of the Chinese Pharmacopoeia”, revealing the revision of the 2020 edition of the Pharmacopoeia.

544 botanical drugs, in the industry's opposition, but still established a common standard

For the industry's opposition to the strong voice of heavy metals, pesticide residues standard development issues, as can be seen from the article, or still using the universal standard, and not in accordance with the October 20 this year, the Party Central Committee and State Council “on the promotion of the inheritance of traditional Chinese medicine innovation and development of the views of” the views pointed out: subregional, sub-species to improve the pesticide residues of Chinese herbal medicines, heavy metal limit standards; the establishment of the most rigorous standards.

The preparation of the 2020 version of the Pharmacopoeia is already in the final stage, in which the general testing methods and guidelines are partially sorted out, summarized as follows:

(1) For example:

(1) Updating the method of heap density and vibration density determination; adding anti-II a factor and anti-X a factor determination to heparin bioassay; adding heparin binding titration to ichthyospermine sulfate potency determination; revising the method of histamine examination and the method of antihypertensive substance examination.

X-ray Fluorescence Spectrometry and Solid Density Measurement were added.

③ Update polymerase chain reaction method, specific surface area method, bacterial DNA characteristic sequence identification method; relative density determination method new oscillating densitometer method; revised microbial counting method, bacterial endotoxin inspection method, residual solvent determination method.

(2) Reflecting the transformation of the results of the consistency evaluation of the quality and efficacy of generic drugs. For example, the new flow cell method and reciprocating cylinder method for dissolution determination.

(3) For example:

① revised pesticide residue determination method.

② update five mycotoxins (aflatoxin, ochratoxin A, zearalenone, vomitoxin, penicillin) and a variety of mycotoxin determination method; revise the microbial limit standards for non-sterile drugs.

(iii) Updating the microbial limit examination method for Chinese medicine tablets.

(4) For example, revising the sterilization method.

(5) For example:

(① Establishing a platform for pharmacopoeial standards system for molecular biology testing technology. Is being built.

② Update the guidelines for the establishment of standard nucleic acid sequences and the guidelines for DAN sequencing technology.

(iii) Updated bacterial DAN feature sequence identification method.

(4) Updated polymerase chain reaction method.

(6) For example

① Revision of the Bioassay Statistical Method.

② Revision of the guidelines for analytical method validation.

(iii) Updated guidelines for transfer of analytical methods and guidelines for confirmation of analytical methods.

(7) For example:

①Added monocyte activation reaction assay to the guidelines for the application of injection safety inspection method.

② Revision of the guidelines for microbiological monitoring and control in pharmaceutical clean laboratories.

(iii) Updated guidelines for bio-indicators for sterilization, guidelines for bio-indicator tolerance testing method; revised guidelines for validation of isolation systems for sterility testing.

(8) For example:

① Revision of the guidelines for stability testing of raw drugs and preparations.

② Update the guidelines for the control of genotoxic impurities, the guidelines for the limit and determination of elemental impurities.

③ Revision of the guiding principles for extended-release, controlled-release and delayed-release formulations.

(9) For example:

① Update the guidelines for DAN sequencing technology.

② Update the guidelines for the application of bacterial endotoxin examination method.

③ Revision of the guidelines for quality management of pharmaceutical microbiology laboratories, microbial identification guidelines.