Pharmacopoeia Committee of Publication: 6 varieties of traditional Chinese medicine landmark trial standards rise GB – Pharmacopoeia Commission – the pharmaceutical industry
More Qiwei, Xuan Ming powder add water, adequate heating Shirong Jie, filtration, the filtrate standby; take rhubarb 111g boiling water and Picrorhiza three times, each time 1 hour, combined decoction, filtration, the filtrate combined with the Xuan Ming powder solution, concentrated to the relative density of 1.30 ~ 1.32 (50 ~ 60 ) of thick paste; catechu, Hong Mo and the remaining amount of rhubarb mixed with 75% ethanol, Run, nausea 1 hour, dry (60 ~ 80 ), crushed into fine powder , and the thick paste mixing, drying, grinding into a fine powder, made of particles; bear bile powder and borneol research fine, and the amount of starch granules and mixing, into capsules, made of 1000, that was.
Properties This product is hard capsule, the contents of beige to brown granules; Qi Hong, slightly fishy, bitter taste.
Identification (1) the contents of this product, and research fine, set under the microscope: calcium oxalate crystal clusters large, diameter 60 ~ 140 m. Irregular lumps black or dark brown.
(2) the contents of this product appropriate to carry out micro-distillation, sublimation home under the microscope shows that the amorphous colorless flaky crystal, plus the new system of 1% vanillin sulfuric acid 1 drop, purple starting to prove.
(3) the contents of this product 4g, research and small, add methanol 20ml, heat reflux for 30 minutes, filtered, filtrate and dry then add sodium hydroxide solution residue (1 10) 10ml, shake, home 120 heating 4 hours, let cool, PH value adjusted with hydrochloric acid to 2 ~ 3, extracted with ethyl acetate and shake 4 times (15ml, 15ml, 15ml, 10ml), combined with ethyl acetate, evaporation to dryness, residue plus 1ml Shi Rongjie ethanol as sample solution. Another take ursodeoxycholic acid and chenodeoxycholic acid reference substance reference standards, were added with ethanol made from 1mg per 1ml of solution, as the control solution. According to TLC (Chinese Pharmacopoeia 2005 1 Appendix VIB) test, to learn for the test solution 5ul, control solution the 1 l, were spotted on the same silica gel G plate and to iso-octane – ether – butanol – acetic acid – water (10:5:1:5:1) of the upper solution for the developing agent, started out, dried, sprayed with 20% sulfuric acid solution, heated at 105 to spot color clarity. Test products for chromatography, chromatography with reference substance corresponding position on the same color of the spots.
(4) the contents of this product 0.3g, research and small, add methanol 20ml, soaking 1 hour, filtration, the filtrate obtained 5ml, evaporation to dryness, residue water 10ml, hydrochloric acid 1ml, refluxed for 30 minutes, immediately cooling , extracted with diethyl ether and shake 2 times 20ml, combined ether solution, and dry then add chloroform residue 1ml Shi Rongjie, as for the test solution. Another take emodin reference substance, add methanol made from 1mg per 1ml solution containing, as a control solution. According to TLC (Chinese Pharmacopoeia 2005 1 Appendix VIB) test, to learn of the two solutions the 4 l, respectively, at the same point with sodium carboxymethyl cellulose adhesive layer of silica gel H plate to petroleum ether (30 ~ 60 ) – ethyl – formic acid (15:5:1) as developing solvent the upper solution, expand, remove, dry, home UV light (365nm) under review. The sample was chromatography, chromatography with reference substance corresponding position, was the same color of fluorescent spots.
(5) the contents of this product 3g, research and small, add ethyl ether 50ml, ultrasonic treatment for 10 minutes, filtered, filtrate and dry then add methanol 2ml Shi Rongjie residue, as for the test solution. Another take catechin reference standard, plus methanol made with 0.2mg per 1ml of solution, as the control solution. According to TLC (Chinese Pharmacopoeia 2005 1 Appendix VIB) test, to learn of the two solutions each 10 l, respectively, at the same point with sodium carboxymethyl cellulose as adhesive silica gel G plate and to petroleum ether (60 ~ 90 ) – ethyl acetate – glacial acetic acid (6:3:0.5) as developing agent, started out, dried, sprayed with 5% vanillin sulfuric acid solution, the spot was heated to 105 Color clear. The sample was chromatography, chromatography with reference substance corresponding position on the same color of the spots.
(6) the contents of this product 5g, research and small, add methanol 20ml, heat reflux 1 hour, filtration, filtrate and dry then add chloroform residue 2ml Shirong Jie, and the supernatant as the test sample solution. Another take vanillic acid and cinnamic acid reference substance reference standards were made for each additional 1ml chloroform solution containing 1mg, as the control solution. According to TLC (Chinese Pharmacopoeia 2005 1 Appendix VIB) test, to learn each of the three solution 10 l, respectively, at the same point with sodium carboxymethyl cellulose as the adhesive layer plate of silica gel GF254 to hexane – ethyl ether – acetic acid (5:5:1) as developing agent, started out, dry, home UV light (254nm) under review. The sample was chromatography, chromatography with reference substance corresponding position on the same color of the spots.
Milestone Swine, cattle, sheep, ox gall bile were taking medicine, medicinal herbs were all sheep guts 0.1g, according to [differential] (3) under preparation for the test solution, respectively, were made from medicinal solution. Then take hyodeoxycholic reference substance, add ethanol made with 1mg per 1ml of solution, as the control solution. According to TLC (Chinese Pharmacopoeia 2005 1 Appendix VIB) test, learn [differential] (3) under the sample solution, and the solution of the two control medicines 5ul, control solution 1 l, of separate in the same silica gel G plate and to iso-octane – ethyl ether – n-butanol – acetic acid – water (10:5:1:5:1) of the upper solution as developing agent, development to about 10cm, remove, dry dry, then the agent started to show about 15cm, removed, dried, sprayed with 20% sulfuric acid solution, heated at 105 to spot color definition. Chromatography in the test sample, the reference standard chromatographic control medicines and the corresponding position, not the main spots were the same color.
Other capsules should meet under the relevant provisions of the (Chinese Pharmacopoeia 2005 1 Appendix IL).
Content according to high performance liquid chromatography (Chinese Pharmacopoeia 2005 1 Appendix VID) determination.
Chromatographic system suitability tests on octadecyl silane bonded silica as a filler; methanol -0.1% phosphoric acid (85:15) as mobile phase; the detection wavelength was 254nm. Number of theoretical plates shall be calculated according to peak chrysophanol not less than 3000. Preparation
access control solution chrysophanol appropriate reference standard, precision, said set, each made of methanol increases with 4 g 1ml solution, that was.
Preparation of test solution to remove the goods under the load difference of contents, research and fine, and mix, taking about 0.2g, said precision set, home 25ml volumetric flask, add methanol of about 20ml, ultrasonic treatment ( power 250W, frequency of 33kHz) 30 minutes, let cool,
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