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New Progress in 2020 Pharmacopoeia

Read: 189 Release time: 1/8/2020

New Progress in 2020 Pharmacopoeia

Chinese Pharmacopoeia (Traditional Chinese Medicine)

I. Revisions related to effectiveness

1. Strengthen the specificity and integrity of Chinese medicine standards.

The following examples (partial)

① Andrographis paniculata. One standard multi-test method measures 4 main components at the same time.

② Ginkgo biloba extract. The fingerprint of the test product should show 17 chromatographic peaks corresponding to the fingerprint of the control extract.

③ Guanmaining capsule. A method for the determination of salvianolic acid B in salvia and puerarin in pueraria root was established by liquid chromatography conditions.

2. Focus on the research of biological evaluation and measurement methods based on the clinical efficacy of traditional Chinese medicine. The following examples (partial)

① Honeysuckle. Cyclic ether terpenoid glycosides control was added to the feature map project.

② Rehmannia glutinosa and cooked rehmannia glutinosa. Rehmannin D was added as an indicator of the content of cooked rehmannia decoction pieces, and the index of verbascoside was deleted.

③ Ligustrum and Ligustrum. The former content index is ligustrin, and the latter is revised to salidroside.

Second, the amendments related to security

1. Formulate the limit standards for heavy metals, harmful elements, and pesticide residues.

① Establish and improve the limit standards for heavy metals, harmful elements, and pesticide residues, and include them under the corresponding general rules. Lead must not exceed 5 mg / kg, cadmium must not exceed 1 mg / kg, arsenic must not exceed 2 mg / kg, mercury must not exceed 0.2 mg / kg, and copper must not exceed 20 mg / kg. Prohibited pesticides must not be detected.

② Revised the General Method 2341 Method for the Determination of Pesticide Residues, and updated the method for the determination of prohibited pesticides in medicinal materials and decoction pieces (plants). ③ Revise the general rule 9302 to establish guidelines for the limits of harmful residues in Chinese medicine.

2. Establish the limit of mycotoxins in mildew-prone Chinese medicinal materials and decoction pieces.

The following examples (partial)

① The apiary and earthworm have increased the limit requirements of Huangqumeisu.

② Coix kernel increased the limit of zearalenone.

3. Effectively control the impact of endogenous toxic ingredients on the safety of traditional Chinese medicine, and focus on solving the prediction and evaluation methods of liver and kidney toxicity that meet the characteristics of traditional Chinese medicine. The following examples (partial)

① Study on the limit standard of the nephrotoxic component "Aristolochic acid" in Jiuweizhihuo Pill.

② Study on the limit standard of psoralen dihydroflavone in psoralen.

③ Study on the limit standard of Aconitum carmichaeli in Aconite.

Third, the amendments

1. Revised 218 standards for medicinal materials (excluding heavy metals and quantities involved in prohibited pesticides);

2. There are 544 standards for heavy metals and banned pesticides involving plant medicinal materials contained in the Pharmacopoeia;

3. Seven vegetable oils and extracts are planned to be revised;

4. Chinese patent medicine plans to add 117 new varieties and revise 160 varieties.

Chinese Pharmacopoeia 2 (Chemical Medicine)

I. Effectiveness (example)

(1) To further improve the detection methods of dissolution and release of conventional solid preparations. E.g,

Aluminum Magnesium Carbonate Chewable Tablets——Research on acidity: The third method of dissolution is used in the standard. With reference to the BP acidity term, the pH of the solution should be in the range of 3.0 ~ 4.2 at 10 minutes and 20 minutes. The end point of the titration of acid and acid power was revised from the indicator method (bromophenol blue indicator solution) to the pH indicator method (titration to pH 3.5). Examination of clotrimazole Yindao expansion suppository, econazole nitrate Yindao expansion suppository to increase the expansion rate.

(2) In terms of overall quality control, further draw on international requirements and gradually keep in line with international requirements. For example, ceftizoxime sodium refers to the Japanese Pharmacopoeia (JP16) to amend the content limit range from "not less than 90.0%" to "should be 92.5% ~ 96.5%".

Second, security

A total of 125 new breeds are planned to be added and 113 new breeds are to be revised.

Intended to contain species:

① Transfer five varieties (recombinant human insulin, recombinant human insulin injection, protamine recombinant human insulin injection, recombinant human growth hormone, recombinant human growth hormone for injection).

② The State Food and Drug Administration has cancelled the two varieties whose production numbers have been suspended.

③ 1 cultivar to be excluded from pharmacological selection (compound aluminum hydroxide tablets, due to lack of quality control items for Belladonna flow extract in the standard).

Third, the amendments

A total of 125 new breeds are planned to be added and 113 new breeds are to be revised.

Intended to contain species:

① Transfer five varieties (recombinant human insulin, recombinant human insulin injection, protamine recombinant human insulin injection, recombinant human growth hormone, recombinant human growth hormone for injection).

② The State Food and Drug Administration has cancelled the two varieties whose production numbers have been suspended.

③ 1 cultivar to be excluded from pharmacological selection (compound aluminum hydroxide tablets, due to lack of quality control items for Belladonna flow extract in the standard).

Chinese Pharmacopoeia Part III (Biological Products)

I. Specific situation

(1) Further improve the quality control requirements of the whole process of biological products.

For example: ① Re-evaluation and revision of human rabies vaccine residual DNA and HCP limit standards. ② Blood products of human and animal origin: to further enhance the requirements for virus safety and impurity control. ③ Therapeutic recombinant protein products: improve the impurity control requirements of recombinant cytokine products.

(2) Further supplement and improve biological detection technologies, methods and related technical guidelines; promote the application of theoretical analysis methods in the quality control of biological products.

For example, the research has established and completed the international general introduction of PEG-modified recombinant protein drugs, new gene therapy products, general mite allergen products, and human horse immune serum products.

(3) Improve the variety loading category and establish relevant general technical requirements for therapeutic biological products; expedite the acceptance of mature vaccines and therapeutic biological drugs approved for marketing in China in recent years.

For example: ① New preventive vaccines related to global public health safety issues and increasing demand, such as polio vaccines (bOPV, IPV) and pneumonia vaccines. ② A self-innovated anti-vascular endothelial growth factor receptor antibody fusion protein (Compaqip) for fundus macular degeneration was added.

Second, the overall situation

Variety monographs: 22 new breed standards and 140 revised breed standards. General: 4 new generals, 4 revised generals. General technical requirements for biological products: 2 new and 8 revised. General rules (test methods and guidelines): 14 new and 4 revised.

The Fourth Part of Chinese Pharmacopoeia

First, medicine packaging materials

1. Variety monographs

① The outline of the 2020 edition of the Chinese Pharmacopoeia requires 30 varieties of medicinal packaging materials. ② In 2015 ~ 2019, a total of 36 varieties of projects were initiated (10 in 2015, 25 in 2016, and 1 in 2017). Twelve drafts have been submitted and four have been closed.

2. General technical requirements for pharmaceutical packaging materials

(1) Four general technical requirements related to pharmaceutical packaging materials are planned to be contained in four:

① General rules for pharmaceutical packaging materials (revised on the basis of the general requirements for pharmaceutical packaging materials).

② General rules for medicinal glass materials and containers (revised on the basis of guidelines for medicinal glass materials and containers).

③ General rules for medicinal plastic materials and containers (new).

④ General rules for medicinal rubber seals (new).

(2) 18 general testing methods: boron trioxide determination method; inner surface water resistance measurement method; glass internal stress measurement method; 121 ° C glass particle water resistance measurement method; peel strength measurement method; heat seal strength measurement method Tensile property measurement method Gas transmission method Water vapor transmission method Density method Packaging material infrared spectroscopy method Light transmittance method Hemolysis test method Pyrogen test Method ; Acute systemic toxicity test method; Determination of puncture force of rubber stoppers and gaskets for injections; Determination of puncture and chipping of rubber stoppers and gaskets for injections

Second, accessories

1. Monographs on varieties of medicinal excipients

In the 2020 edition of the Chinese Pharmacopoeia, it is planned to add about 50 varieties of pharmaceutical excipients and revise 120.

2. General technical requirements for pharmaceutical excipients

(1) The 2020 edition of the Chinese Pharmacopoeia is expected to include four general technical requirements for medicinal excipients: General Rule 0251 medicinal excipients (revised), 9601 guidelines for functional indicators of medicinal excipients (revised), animal-derived medicinal excipients Guiding principles (new), premixed and co-processed pharmaceutical excipients (new).

(2) The standards for the formulation and revision of pharmaceutical excipients have the following characteristics:

① The number of commonly used excipients, new excipients, and excipients for high-risk / high-risk preparations increased significantly.

② Standard descriptions are more precise, such as dilute hydrochloric acid, corn mash, and activated carbon.

③ increase the specificity of stronger identification, if glue.

④ Use more objective detection methods, such as butane.

⑤ Increase functional indicators, such as white clay and stearic acid.

⑥ Increase safety indicators, such as corn oil.

⑦Increase the inherent mass discrimination of products, such as sodium dodecyl sulfate.

⑧Add special requirements for special applications, such as potassium dihydrogen phosphate.

⑨Description of normative traits (solubility, taste, odor), sterility, microbial limit, bacterial endotoxin, etc. in monographs.

Third, the general part of the preparation

General rules for preparations: 36 general rules for preparations were revised; 15 related testing methods were updated; 9 guidelines were added; 30 testing methods were revised and 11 guidelines were improved.

(1) For example:

① Revised the general rules for 0100 preparations. In order to further guide enterprises to pay full attention to the quality control of preparations and overall requirements, the preamble of the "General Formulations" has been added and enriched as "the bottom line for each preparation", which mainly includes 6 aspects: unit dose uniformity, stability , Safety and effectiveness, dosage form and route of administration, packaging and storage, labeling and instructions.

② Revised the general rules for 35 preparations.

(2) Increase the inclusion of mature new dosage forms for domestic marketed drugs. For example, suppositories are added to the suppository.

General testing methods and guidelines

(1) For example:

① Updated bulk density and tap density measurement methods; heparin bioassay method added anti-factor II a, anti-X a factor method; protamine sulfate titer method added heparin binding force titration method; revised histamines Inspection method, step-down substance inspection method.

② Updated X-ray fluorescence spectrometry and solid density measurement.

③ The polymerase chain reaction method, specific surface area measurement method, and bacterial DNA characteristic sequence identification method were updated; the relative density measurement method was added with a shaking densitometer method; the microorganism counting method, bacterial endotoxin test method, and residual solvent measurement method were revised.

(2) Transformation of the results reflecting the consistency evaluation of the quality and efficacy of generic drugs. For example, dissolution measurement methods include flow cell method and reciprocating cylinder method.

(3) For example:

① Revised the method for measuring pesticide residues.

② Updated five mycotoxins (huangqumei, ochratoxin A, zearalenone, vomitoxin, and penicillin) and a variety of mycotoxins; revised the microbial limit standards for non-sterile drugs.

③ The microbial limit inspection method for Chinese medicine decoction pieces was updated.

(4) For example, revise the sterilization method.

(5) For example:

① Establish a pharmacopoeia standard system platform for molecular biology detection technology. Building.

② Updated guidelines for establishing standard nucleic acid sequences and guidelines for DAN sequencing technology.

③ The bacterial DAN characteristic sequence identification method was updated.

④ Update the polymerase chain reaction method.

(6) For example:

① Revise the bioassay statistics method.

② Revise the guidelines for analytical method validation.

③ Add guidelines for analysis method transfer and confirm guidelines for analysis method.

(7) For example:

① The guidelines for the application of the injection safety test method have been updated to measure the monocyte activation response.

② Revise the guidelines for microbial monitoring and control in pharmaceutical clean laboratories.

③ Updated guidelines for sterilization biological indicators and guidelines for bioindicator tolerance test; revised guidelines for verification of isolation systems for sterility inspection

(8) For example:

① Revise the guiding principles for stability testing of raw materials and preparations.

② Updated guidelines for genotoxic impurity control, elemental impurity limits and determination guidelines.

③ Revise the guiding principles of sustained-release, controlled-release and delayed-release preparations.

(9) For example:

① Updated guidelines for DAN sequencing technology.

② Updated guidelines for the application of bacterial endotoxin test.

③ Revise the guidelines for the quality management of pharmaceutical microbiology laboratories and the guidelines for microbial identification

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