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1.Study On Preparation And Quality Standard For Liyan Granules 2.Study On The Compatible Stability Of Fleroxacin Injection Mixing With Anti-infection Traditional Medicine Injection

Posted on:2004-12-01Degree:MasterType:Thesis
Country:ChinaCandidate:Y M ZhuFull Text:PDF
GTID:2144360125467623Subject:Pharmacy
Abstract/Summary:PDF Full Text Request
Acute pharyngitis is a common pharyngeus disease in clinic which is popular in spring, autumn and winter. It can be induced by many factors and lots of people are susceptible to it. Once suffering from the disease, the inflammation will diffuse easily if it isn't treated in time or individuals are not in good health, which will result in other diseases. So the effective and timely treatment is necessary. Now, only limited Chinese traditional patent medicine was found to treat the disease. Liyan granules, a kind of the third category new drug which developed from Chinese traditional prescription, provided an effective treatment to this disease. This prescription is based upon the principle of clearing heat, removing toxic substance, and ameliorating congested throat to reduce edema and it is composed of fructus arctii, radix sophorae tonkinensis, radix scutellariae, rhizoma belamcandae, radix stephaniae tetrandrae, flos chrysanthemi indici and so on.To develop the new drug, we conducted the study on extraction technics, preparation technics and quality standard according to the requirements of complex preparation of Chinese traditional medicine.As per liyan granules characteristics, the best extraction condition of flos chrysanthemi volatile oil was selected. And the optimum extracting condition of baicalin and other eight ingredients was determined through the orthogonal design, which was indicated by the content of baicalin and solid substances. The extraction condition of flos chrysanthemi was: adding 20 timesamount of water, extracting for 5h. The extraction condition of baicalin was: adding 10 times amount of hot water and extracting for 2 times, 1.5h once. The extraction condition of the rest eight drugs was: soaking for Ih with 8 times amount of water, extracting for 2 times, l.Sh once.Mixed well the filtrate of baicalin, flos chrysanthemi and other eight ingredients, condensed the mixed solution and deposited it by ethanol solution, recycled the ethanol. The aqueous solution was dried to an extract powder by spraying drying. Added baicalin and excipients, made granules and sprayed volatile oil onto the granules. Sealed the container and placed overnight. Then the finished product was obtained by repacked.To control the quality of liyan granules effectively, the TLC method was used to identify fructus arctii, rhizoma belamcandae and radix scutellariae. The content limit test of radix sophorae tonkinensis was conducted using TLC method because of its toxicity. The TLC condition of actiin was: using chloroform-methanol-water(40:10:l) as developing solvents on silica gel G, using 10% H2SO4 as visualizing agent, drying at 105癈 until the blotch displayed purple gray. The TLC condition of radix scutellariae was: using acetic ether-butanone-methanoic acid-water(6:6:l :1) as developing solvent on polyamide membrane, using FeCI3 ethanol solutions as visualizing agent, the blotch displayed dirty green. The TLC condition of rhizoma belamcandae was: using chlorform-methanol-butanone (4:3:3) as developing solvent on polyamide membrane, the blotch displayed yellow fluorescence which can be detected under UV 365nm, the blotch displayed blue fluorescence using AIC13 ethanol solutions as visualizing agent. The TLC condition of radix sophorae tonkinensis was: using cyclohexame-acetic ether-acetone-concentrated ammonia water(4:6:8:0.5) as developing solvent on silica gel G, using potassium iodobismuthate TS as visualizing agent, the blotch displayed orange red.To avoid the toxic reaction of radix sophorae tonkinensis, which toxic component were maybe matrine and oxrmatrine, a TLCS method for the quantitation of matrine in liyan granules was developed to control the content of radix sophorae tonkinensis.TLC and TLCS condition: Silica gel G plate; developing solvent: cyclohexame-acetic ether-acetone-concentrated ammonia water (4:6:8:0.5); visualizing agent: potassium iodobismuthate TS. The Silica gel G plate was covered with a same size glass plate aftervisualized and sealed with sticky tape around. The determina...
Keywords/Search Tags:Liyan granules, Arctiin, Matrine, TLC, TLCS, SPE, HPLC
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