The Research On Preparation Process And Quality Standard Of Compound Dandelion Buccal Adhesive Tablets

Objective: Adopt new preparation techniques of compound dandelion buccal adhesive tablets to conduct a comprehensive study on extraction process, molding process, and quality standards, which will lay the foundation for the successful development of herbs adhesive tables suitable for curing dental ulcer. Methods: 1.Research on extraction process of buccal adhesive tablets: Using central composite design experiment, adopt boiling water to extract dandelion and bletilla from components; apply HPLC to measure the active ingredient content of dandelion extraction; take chlorogenic acid, caffeic acid and the cream rate as the marker to analyze; optimize to get the best extraction process of dandelion; conduct alcohol precipitation on bletilla extract; use UV spectrophotometry to determine the active ingredients in bletilla; take polysaccharide and oil rate as the target for analysis; optimize to get the best extract process of bletilla. 2.The research on the molding process of buccal adhesive tablets: Single factor experiments were used to select adhesion, flow agents and fillers to choose the best reagents; orthogonal design experiments were adopted to inspect the proportion, drug content of adhesion agent, and the amount of filler; take adhesion and release as inspective indicators to conduct weighted analysis; then get the best molding process after optimizing. 3.Set quality standards of buccal adhesive tablets(1) Measure tablets weight variation and hardness according to the 2010 edition of "Chinese Pharmacopoeia".(2) Identify dandelion, bletilla, and indigo herbs by thin-layer chromatography(3) Determine index components, chlorogenic acid and caffeic acid, of the finished product with HPLC.(4) Establish a HPLC fingerprint method of dandelion buccal adhesive tablets, and compare different batches of adhesive sheets. Results:1.Optimal conditions for the extraction process:Add 13 times water as much as dandelion; soak it for 30min; then boil 2 times for 70min; concentrate the extract to 1.20-1.30 times of the relative density; add ethanol content to 60%; alcohol precipitation overnight, get the filtrate after filtering; concentrate, dry, and crush dandelion to obtain extract powder. To bletilla, add 14 times water, boil three times each for 120min; concentrate the extract to 1.10-1.30 times of the relative density; add ethanol to 80% alcohol content, alcohol precipitation overnight; centrifuge it to get precipitation-polysaccharides of bletilla; dry and crush to get coarse polysaccharides powder of bletilla. 2.The molding process optimum conditions: Take Carbopol(CP): hydroxypropylmethyl cellulose(HPMC) = 1: 2 as an adhesive, which contains 50% of drug content; and add 4% lactose as filler powder; finally, use direct compression to acquire tablets. 3. Tentative quality standards: Adopt thin layer chromatography to identify dandelion, bletilla, and indigo, qualitative identification; chlorogenic acid, caffeic acid content is determined by HPLC method, provisional compound dandelion buccal adhesive tablets contain no less than 0.06135% of caffeic acid, and no less than 0.03856% of chlorogenic acid. 4.HPLC fingerprint method of compound dandelion buccal adhesive tablets: chromatographic column: Dalian Elite Hypersil ODS C18 column(4.6 × 200 mm);mobile phase: methanol-0.2% phosphoric acid water gradient system; recording time: 120min; column temperature: 25℃; the injection volume: 10μL; flow rate: 0.7mLmin-1; detection wavelength: 323 nm. Conclusion: Through the study of the compound dandelion buccal adhesive tablets, we found this process feasible, quality controllable; establish quality standards for adhesive tablets. This method is of high sensitivity, high accuracy, and good reproducibility, for controlling quality of adhesive tablets scientifically.