Study On Enterprises Quality Standard Of Polygonatum Sibiricum Red

Polygonatum sibiricum Red. is a genus of perenniall herb, which belongs to the family Liliaceae Polygonatum, and the dried rhizome can be used for medicine. Now a large number of pharmacological research and clinical applications demonstrate that Polygonatum sibiricum Red. Has the efficacy of Yin-enriching and Qi-Reinforcing, moistening lunglungs, invigorating spleen and benefit kidney. Most used for spleen and kidney deficiency, thirst and loss of appetite,tired and acratia,spleen deficiency and dry cough,internal heat diabetes. Polygonatum polysaccharide known as the effective chemical composition has been developed into a variety of dosage form drugs due to its functions, such as strengthening immune system,anti-tumor, anti-radiation and so on. Saponins is another effective chemical composition, which plays a key role on reducing blood lipid, lowering blood sugar, enhancing immunity, anti-tumor and improving memory. Polygonatum sibiricum Red. has now been developed into a variety of pharmaceutical dosage forms. It is widely distributed in China, mainly in the northeast, north, northwest, east and Henan, Hubei, Sichuan, Guizhou and other regions,where includes more than 30 species. This study was mainly to evaluate the quality standards,which in order to provide the reliable scientific basis of quality standards for for enterprise. The main results are as follows:1.Exterior features:nodular curved cylindrical, long 3-11cm, diameter 0.5-2cm; inter-node 2～4cm, having short branch; Surface yellowish brown or grayish yellow, translucent, with longitudinal wrinkles and fibrous scar; Stem scar obvious, round, slightly concave, diameter 5～8mm; hard and pliable, unease break, section pale yellow to yellow-brown.smell micro, slightly sweet, chewing sticky.2.Microscopic characteristics:an epidermal cells, outer cuticle; partially visible 4-5 column cork cells;vascular bundle hash column, near a small cortical vascular bundles, arranged in a ring, inward gradually, more outside phloem; parenchyma has more mucous cells containing calcium oxalate crystal beam.3.Physical and chemical identification characteristics:① saponins compounds:adding dropwise acetic anhydride solution to dissolved samples and then adding concentrated sulfuric acid/acetic anhydride (10:1), the solution’s color from yellow to brown-yellow, and finally becomes reddish brown,② polysaccharide compound:adding dropwise 2 to 3 drops α- naphthol ethanol solution to the sample extract, mixed well, and then added dropwise concentrated sulfuric acid along the tube wall, which sink to the lower layer, purple ring appears on the interface layer, shaking, becomes purple solution;TLC:extracting and separating the sample, the diosgenin as reference, the test products’ chromatography has the same tan colored spots with the reference in corresponding position in daylight;4.according to Chinese Pharmacopoeia Commission for medicine quality standards’ require, study for moisture, total ash, acid-insoluble ash, water (alcohol) soluble extract and index components, etc. of four batches,quality standards are as follows:①.moisture content:the first order should not exceed 15.0%; the second order should not exceed 14.5%; the third order should not exceed 14.0%. ②Total ash:the first order should not more than 2.5%, the second order should not higher than 3.0%,the first order should not higher than 3.5%;③acid-insoluble ash:the first order should not higher than 0.35%, the second order should not higher than 0.40%,the third order should not higher than 0.45%.④ water-soluble extract:use hot-dip method, the first order should not less than 45%, the second order should not less than 50.0%, the third order not lower 45.0%; ⑤alcohol-soluble extract: adopt hot dipping use 60% ethanol as solvent extraction, should not less than 55%; ⑥polysaccharide content:should not less than 12.5%; ⑦total saponin content:should not less than 1.0%.