Pharmaceutical Grade Berberine National Drug Standard API, Medical Grade Berberine GMP Certified with Qualifications.

Pharmaceutical Grade Berberine National Drug Standard Code API Medical Grade Berberine GMP Certified with Qualifications

According to the "Chinese Pharmacopoeia 2020 Edition", the quality standards for pharmaceutical grade berberine mainly include the following:

- Description: Yellow crystalline powder; odorless. Soluble in hot water, slightly soluble in water or ethanol.

- Identification:

- Take about 0.1g of the sample, add 10ml of water, heat gently to dissolve, then add 4 drops of sodium hydroxide test solution. After cooling, turbidity occurs.

- Take about 5mg of the sample, stir, and it shows cherry red color.

- The infrared absorption spectrum should be consistent with the reference spectrum (Spectrum Set 320).

- Take about 0.1g of the sample, add 20ml of water, heat gently to dissolve, then add 0.5ml of nitric acid. Cool, let stand for 10 minutes, filter, and the filtrate shows the identification reaction for chlorides.

- Tests:

- Related substances: Determined by high-performance liquid chromatography. In the chromatogram of the test solution, if there are peaks with retention times consistent with jatrorrhizine and palmatine peaks, calculate by external standard method using peak area, neither should exceed 1.0%; the sum of other impurity peak areas should not be greater than the peak area of berberine in the reference solution (2.0%).

- Synthetic products must be tested according to regulations and should comply.

- Organic nitriles: For synthetic products, test by thin-layer chromatography. The test solution should not show impurity spots at the positions corresponding to the main spots of the reference solution.

- Water: Water content should not exceed 12.0%.

- Residue on ignition: Residue should not exceed 0.2% (extracted product) or 0.1% (synthetic product).

- Heavy metals: Synthetic products should contain heavy metals not more than 20 ppm.

- Assay: Calculated on the anhydrous basis, the content of C₂₀H₁₈ClNO₄ should be not less than 97.0% for extracted products and not less than 98.0% for synthetic products.

Pharmaceutical Grade Berberine National Drug Standard Code API Medical Grade Berberine GMP Certified with Qualifications

The medical uses of berberine are mainly as follows:

- Treatment of intestinal infections: Mainly used for treating gastroenteritis, bacterial dysentery, and other intestinal infections caused by sensitive pathogens such as Shigella and Vibrio cholerae. Its mechanism of action involves inhibiting various Gram-positive and Gram-negative bacteria, with the strongest antibacterial effect against Shigella.

- Other effects: Berberine also has some inhibitory effects on hemolytic streptococci, Staphylococcus aureus, Neisseria meningitidis, Salmonella typhi, Corynebacterium diphtheriae, etc. It also shows some inhibitory effects on influenza viruses, amoebae, leptospira, and certain skin fungi, so it has been used clinically as an adjunct treatment for related diseases. Additionally, some studies have found that it has antiarrhythmic effects, but it has not been widely used in clinical practice.