Drug Guide: Danshen Pill Products – Danshen dripping pills, alcohol – pharmaceutical industries
Salvia March 7 borneol Properties This product is brown Pill; air, smell and taste slightly bitter.
Identification (1) goods from the 15 balls, small study, to trace sublimation, from white sublimate, plus a new formulation of 1% vanillin sulfuric acid 1 drop, droplet starting to prove the edge of the red rose.
(2) 40 pills of this product, add methanol 10ml, shaking for 10 minutes at 4 for 24 hours, so full of polyethylene glycol precipitation, filtration, the filtrate taken as the sample solution. Notoginsenoside R1 an alternative reference substance, add methanol is made with 5mg per 1ml of solution, as the control solution. According to TLC (Appendix B) test, to learn for the test solution 15 l, control solution 5 l, each point in the same silica gel G plate and n-butanol – ethyl acetate – water (4:1:5 ) upper solution as developing agent, started out, dried, sprayed with sulfuric acid ethanol solution (1 10), heated at 105 for about 10 minutes. Chromatography of the test sample, corresponding with the reference standard chromatographic position, were the same color of the spots.
(3) of 15 balls to take this product, add methanol 3ml, ultrasonic treatment for 20 minutes, filtration, the filtrate taken as the sample solution. Another take Salvia sodium reference substance, add methanol made with 1mg per 1ml of solution, as the control solution. According to TLC (Appendix B) test, to learn for the test solution 10 l, control solution 5 l, each point in the same silica gel G thin layer plate with chloroform – acetone – formic acid (25:10:4) as developing agent, started out, dried, smoked home after ammonia vapor, home UV light (365nm) under review. The sample was chromatography, chromatography with reference substance corresponding position on the same color of fluorescent spots.
(4) goods from the 15 balls, plus a small amount of water, stirring Shi Rongjie diluted with water to 100ml, shake, take 2ml, add water to 25ml, shake, according to spectrophotometric method (Appendix A) measured at 283nm The wavelength of maximum absorption.
Check pills should be consistent with the provisions under the relevant (Appendix IK).
Content according to high performance liquid chromatography (Appendix D) determination.
Chromatographic system suitability test with octadecyl silane bonded silica as a filler; methanol-IPR-B7 reagents (sodium heptane solution) – water (3:2.5:97) as mobile phase; The detection wavelength was 280nm. Number of theoretical plates shall be calculated according to peak Danshensu not less than 1200. Preparation of access control solution
salvianic appropriate reference standard, precision, said set, each made of methanol, 1ml containing added 0.16mg (equivalent to Danshensu 0.14mg) solution, which was.
Preparation of test solution for goods from the five pills, buy 10ml volumetric flask, add appropriate amount of methanol, ultrasonic treatment 2 hours, let cool, add methanol to the mark, shake, with microporous membrane (0.45 m) filtration, the filtrate obtained, that was. Determination of precise lessons were
control solution for the test solution with 5 l 5 ~ 10 l, into the liquid chromatograph to determine, that was.
This product per Pill Salvia to Danshensu (C6H10O5) dollars, not less than 0.08mg.
Functions and Indications blood circulation, for the population. For chest feel oppressed, angina pectoris.
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