Preparation Technology And Quality Standard Of Cynanchum Bungei Decne Chelated Calcium Chewable Tablets

Objective: To prepare a simple prescription of calcium supplement for the middle-aged and elderly people by combining Cynanchum bungei Decne with chelated calcium.Meanwhile,the technological parameters during preparation process were optimized;the quality was assessed referring to the quality standard of chewable tablets in Chinese Pharmacopoeia(Part Four)and the related quality standards were formulated,in order to prepare a kind of chewable tablet with mature preparation technology and exact curative effect.Methods: A)The reaction of L-aspartic acid and calcium ions in aqueous medium was investigated,and the optimum reaction conditions were obtained by successively designing single factor test and orthogonal test with molar ratio,reaction time,temperature,pH value as the test factors and chelating rate as the index;by adopting all-powder compressing tablet,Cynanchum bungei Decne was added appropriate accessories after fully mixing with chelated calcium and completed tablet compressing.The optimum preparation technology of Cynanchum bungei Decne chelated calcium chewable tablets was determined by optimizing its prescription and preparation technology.B)Qualitative identification was conducted for the chelated calcium by sodium sulfide method and infrared spectroscopy;the chelating rate was calculated by complexometric titration using ethylenediamine tetraacetic acid(EDTA);qualitative identification was performed for Cynanchum bungei Decne by thin-layer chromatography(TLC);the content of Cynanchum bungei Decne diphenyl ketone inchewable tablets was detected by high performance liquid chromatography(HPLC),and the calcium content in chewable tablets was determined by EDTA titration;the quality control standard was established according to the results of quality research.Results: Optimum technology: the optimum preparation conditions of L-aspartic acid chelated calcium: the molar ratio of L-aspartic acid to calcium ions was 2:1,pH value was 7,chelated temperature was 80°C and chelated time was 90min;the solution after reaction was centrifuged,and supernatant was concentrated and purified,followed by adding ethanol for separation and purification,fully stirring,separating by centrifugation,drying and precipitating,thereby gaining the finished product.Then Cynanchum bungei Decne was taken for super-micro pulverization,and these two substances were mixed and added with suitable proportions of mannitol,adhesives and lubricants,followed by compressing tablets,thereby obtaining Cynanchum bungei Decne chelated calcium chewable tablets.By TLC,the test sample of Cynanchum bungei Decne and control medicinal materials displayed the same spots at the corresponding positions on the thin-layer plate.Through the quantitative analysis,it prompted that the content of Cynanchum bungei Decne diphenyl ketone could not less than 0.2mg/tablet,and calcium content over 12.0%.Conclusion: Cynanchum bungei Decne chelated calcium chewable tablets are characterized by sample and reasonable preparation technology as well as rational and reliable preparation process,and the finished product meets each criterion of chewable tablets in the 2015 edition of Chinese Pharmacopoeia(Part Four),which is an effective preparation can supply calcium,strengthen the bone and resist aging and worthy of further clinical research.