Enterprise for Production Filing of Panax Notoginseng Saponins Traditional Chinese Medicine Extract

This product is the total saponins processed from the main root or rhizome of Panax notoginseng (Burk.) F.H.Chen, a plant of the Araliaceae family. 

 [Preparation] Crush Panax notoginseng into coarse powder, extract with 70% ethanol, filter, concentrate the filtrate under reduced pressure, filter, pass through a styrene-type non-polar or weakly polar copolymer macroporous adsorption resin column, wash with water, discard the washings, elute with 80% ethanol, concentrate the eluate under reduced pressure, decolorize, refine, concentrate under reduced pressure to an extract, and dry to obtain the product. 

 [Characteristics] This product is an off-white to pale yellow amorphous powder; taste bitter, slightly sweet. 

 [Tests] Loss on drying: Dry the product at 80°C to constant weight; the loss in weight should not exceed 5.0% (General Rule 0831). Residue on ignition: Should not exceed 0.5% (General Rule 0841). Color of solution: Dissolve an appropriate amount of the product in water to prepare a solution containing 25 mg of Panax notoginseng total saponins per 1 ml; compare with the yellow No. 4 standard color solution (General Rule 0901); the color should not be deeper. 

 Test according to the method under [Assay], record the chromatogram. Using the traditional Chinese medicine chromatographic fingerprint similarity evaluation system, the similarity between the test sample fingerprint and the reference fingerprint after 5 minutes should not be less than 0.95. [Assay] Determine by high-performance liquid chromatography (General Rule 0512). Chromatographic conditions and system suitability test: Use octadecylsilane-bonded silica gel as the filler; use acetonitrile as mobile phase A and water as mobile phase B, perform gradient elution according to the specifications in the table below; flow rate is 1.5 ml per minute; detection wavelength is 203 nm; column temperature is 25°C. The resolution between ginsenoside Rg1 and ginsenoside Re should be greater than 1.5. The theoretical plate number calculated for the ginsenoside Rg1 peak should not be less than 6000. Preparation of reference extract solution: Accurately weigh an appropriate amount of Panax notoginseng total saponins reference extract, dissolve in 70% methanol, and dilute to prepare a solution containing 2.5 mg per 1 ml. Preparation of test sample solution: Accurately weigh 25 mg of the product, place in a 10 ml volumetric flask, dissolve with 70% methanol, dilute to volume, and mix well. Assay: Precisely inject 10 μl each of the reference extract solution and the test sample solution into the liquid chromatograph, and determine. Calculated on the dried basis, the product contains not less than 5.0% of notoginsenoside R1 (C47H80O18), not less than 25.0% of ginsenoside Rg1 (C42H72O14), not less than 2.5% of ginsenoside Re (C48H82O18), not less than 30.0% of ginsenoside Rb1 (C54H92O23), and not less than 5.0% of ginsenoside Rd (C48H82O18). The total content of notoginsenoside R1, ginsenoside Rg1, ginsenoside Re, ginsenoside Rb1, and ginsenoside Rd should not be less than 75% (for oral use) or 85% (for injection use).