Breath Effervescent Preparation Process And Quality Standards

[Objective]To inspect eligible extraction condition and determine extraction technology of Fresh breath effervescent tablets; screening eligible materials and its matching, determine its modeling technique; to establish the controllable quality specification. The preparations for the development of new drug of TCM to provide the basis.[Methods]1.Study on the extractionThe conditions for the extraction process of Flos Lonicerae and Hawthorn with water were optimized by orthogonal test, employing the content of extract ratio,organic acid and chlorogenic acid as indexes.2.Study on the preparation processThe solution by vacuum concentration was misce bene with materials, then pulverization after vacuum drying during 40～50℃, pre-emergency. At 25℃,relative humidity under the condition of 75% all in the same dose of different materials and extract paste of all particles, comparison after its hygroscopic percentage, to inspect usage amount and denomination of acid,usage amount of PEG6000 and disintegrant,usage amount of moistening agent,composition and usage amount of lubricant and so on. Use thin layer chromatography to discriminate Flos Lonicerae and Hawthorn Fruit, reference official method to check the heavy metal, halo-arsenic and other items correlated with effervescent tablet. Use HPLC to assay the chlorogenic acid.3.Study on quality standardFlos lonicerae,Hawthorn in the tables were identified by TLC, the content of chlorogenic acid was determined by HPLC.4.out of body bacteriostasis testTo do some research about bacteriostasis test out-of-body[Results]1.Study on the extraction processThe optimum water extracting of Flos Lonicerae and Hawthorn condition was:12 times and 10 times of water for 2 cycles, the extracting time was 1.5 hour and 1 hour each time.2.Study on the preparation processPrescription:The best formulation is 20% Tartaric Acid:Citric Acid(2:1),15%Sodium Bicarbonate,1% PVP,8%CMS-Na,2%PEG6000, 0.5% glycyrrhizic acid;glycyrrhizin,0.3%Magnesium Stearate, and about 1-2.5% absolute alcohol as moistening agent.3.Study on quality standardUse high-performance liquid chromatography to determine content of chlorogenic acid, a good linear relationshio was noted at the range of 0.12～0.42μg of chlorogenic acid. The average recovery was 99.74%,RSD=1.58; The chromatographic spots were clear,without interferernce.4.out of body bacteriostasis testDo some research about bacteriostasis test out of body to support clinical application, the effect is obviously, especially to Gram-positive bacteria.[Conclusion]The established process of Fresh breath effervescent tablets was economic,reasonable and feasible. The methods and data coming from experiment can use for the preparation and quality control of Fresh breath effervescent tablets.