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Qingyan Buccal Tablet Preparation Process And Quality Standards Research

Posted on:2008-12-18Degree:MasterType:Thesis
Country:ChinaCandidate:X J ZhangFull Text:PDF
GTID:2191360212989006Subject:Chinese medicine pharmacy
Abstract/Summary:PDF Full Text Request
Objective: To study Qin Yan buccal tablets extraction and the confectioning technology, as well as its new preparation suitable for clinical practice, and the establishment of its quality specification.Methods: (1) According to the physico-chemical properties of the active ingredients in each herb used in this prescription, chose eligible extraction method, and optimized the extraction process by orthogonal experiment. (2) According to nature of the extraction and clinical practice request, appropriate excipients were chosen by single factor consideration, whose proportion is later optimized by the central composite design combining effective surface plots methodology, and the index weight was determined, even comprehensively evaluated by mathematical statistics method; then on the basis of the determined prescription, Qin Yan buccal tablets were obtained by wet granulation, tabletting. (3) TLC qualitative distinction was used to inspect each ingredients in the prescription; the assay method of Irisflorentin in belamcandae and Chlorogcnic acid in honeysuckble were established through methodology investigation.Results: (1) extraction process of belamcandae was determined: to extract with 10-time 70% ethyl alcohol backflow for 2 times, each time for 1.5 hour; extraction process of honeysuckble and forsythia suspensa was: to extract with water decoction for 2 times, each time 10-time water for 1.5 hour, using 65% ethyl alcohol for precipitation; extraction process of licorice root was: to extract with water backflow for 2 times, each time 10-fold water for 1.5 hour, using 85% ethyl alcohol for percolation, clear supernatant liquid was obtained. (2) Extracts of each ingredients was condensed and arescented, and the eligible dosage of them optimized by the central composite design combining effective surface plots method :mannitol 30 g/100 tablets, the menthol 2.0g/100 tablets, polyvidone K30 9g/100 tablets, by wet granulation and tabletting. (3) quality specification of Qin Yan buccal tablets was Established. The methodology consideration result indicated that: the precision, the stability, the reproduction quality and application of sample recovery rate can meet the requirement.Conclusion: Extraction process of each ingredients in a prescription was reasonable, the data was reliable; The confectioning process improved the taste and the stability problem of Qin Yan buccal tablets effectively. Qin Yan buccal tablets conformed to regulations of the tablet item in 2005 edition of Chinese Pharmacopoeia. quality specification of Qin Yan buccal tablets was established. Assay method and experimental data was stable and reliable.
Keywords/Search Tags:Chronic pharyngitis, Buccal tablets, Central composite design, Target weight, Praeparatum technology, Quality specification
PDF Full Text Request
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