Study On Xiaoer Jinlian Effervescent Granules

Objective: To establish a preparation method of Xiaoer Jinlian effervescent granules and establishthe controllable qualitys Pecifieation; to consider its stability, effectiveness and security. The preparations for the development of new drug of TCM to Provide the basis.Methods:1 Preparation process: The conditions for th eextraction Process With water were optimized by orthogonal test,employing the eontent of extraet ratio, and ehlorogenie aeid as indexes, Study on concentration, drying and molding process.2 Studyonqualitystandard: Chinese herbal medicine in Xiaoer Jinlian effervescent granules were identified by TLC, the eontent of the main component--chlorogenic acid, Baicalin and Phillyrin in Chinese herbal medicine was determined by HPLC.3 Stability study: according to the quality standard(Draft) and the stability test, the stability of the drug in the long-term test conditions of the first 0, 3, 6, 9, 12 months, the record test data.4 Pharmacology and toxicology studies: the use of direct method, the inhibition test and acute toxicity test results for their effectiveness, safety, preliminary evaluation.Results:1 Preparation process: Take traditional Chinese medicinal materials according to the prescription, plus 12 times the amount of water soaking for 1 hours, extracting 2 times, 2 hours each time. Discarded drug residues. Merge two extraction liquid together, standing for 24 hours, the supernatant was taken to concentrat to a thick paste under reduced pressure, and take it into fine powder by spray drying, spareing; in the preparation technology of effervescent agent than were screened, selected optimization formula for the ratio of citric acid and sodium bicarbonate is 0.80:1(g:g), the amount of PEG 6000 was 4.6%, take polyethylene glycol to coate process, sodium bicarbonate melt inclusions, solve the acid-base respectively granulation caused by particle moisture problems; the drug powder, effervescent agent, stevioside and lactose crushing, over 80 mesh sieve mixing dry granulation.2 Studyonqualitystandard: Establish the TLC method of honeysuckle flowe, Forsythia, and other six Chinese traditional Chinese Medicine and the HPLC method of the content determination about chlorogenic acid, phillyrin and baicalin.The precision, linearity, stability, repeatability and recovery of the method were in accordance with the requirements of the method.3 Stability study: with 0 months as a reference, the change and change rate of test results were compared with that of 0 months. The results showed that there was no significant difference in grain size, moisture, melting, loading and microbial limit and content.4 Pharmacology and toxicology studies: the use of direct method, the inhibition test and acute toxicity test results for their effectiveness, safety, preliminary evaluation.Conclusion:Xiaoer Jinlian effervescent granules was successfully prepared by the experimen, the TLC and HPLC method for the determination of scientific and reasonable, accurate and feasible, can be used to control the quality of Xiaoer Jinlian effervescent granules; maintain stability under the condition of room temperature test; has significant in vitro inhibition toxicity, at the dose of non-toxic and safe.