The Study Of Preparation Technology Of Tangkang Capsule

Tangkang Capsule, which is comprised of Momordica charantia and Evonymus alatus, is mainly used for treating type2diabetes mellitus. When administrated to type2diabetic animal models, Tangkang Capsule indicate a good effect for lowering the blood glucose in the pharmacological experiment. As the pharmacy part of researches on Tangkang Capsule, this investigation aims at designing pharmaceutical technology and establishing the primary quality standard of Tangkang Capsule by pharmaceutical researches.According to the functions and indications of this prescription, as well as the physical-chemical properties of the ingredients in it, the proper indexes were selected and then the experiments were carried out in terms of orthogonal experiments, then screening the best ethanol extraction process of Momordica charantia and Evonymus alatus. The optimal extract technologies of Momordica charantia and Evonymus alatus, were selected respectively by dosing the mice which have got the type2diabetes mellitus. The optimal adjuvant and its dosages of powdered extract were determined by the methods of both hydroscopicity curve and angle of repose. And by evaluating the critical relative humidity, the limitations of ambient humidity for preparation, subpackage and storage of Tangkang Capsule were determined. Finally the pattern number of the hard capsule for the finished granule was selected by evaluating its bulk density. Using HPLC method to determine the content of quercetin of the capsule. Meanwhile the identification methods for each ingredient in the finished product were established by TLC, and their methodology investigations were carried out as well.The optimal extract technology was determined through multi-index evaluations, which is that Momordica charantia should be decocted with70%ethanol for3times, with10times ethanol each time and for2h for each time; that Evonymus alatus should be decocted with70%ethanol for1time, with10times ethanol and for0.5h each time. The optimal extract technologies of effective part of Momordica charantia and Evonymus alatus, what were selected respectively by dosing the mice which have got the type2diabetes mellitus, were that Momordica charantia by aqueous extraction and Evonymus alatus by Ethanol extraction.Soluble amylum and calcium carbonate were determined as the adjuvant for powdered extract of the finished product, with a dosage of41%powdered extract.77.0%as the limitation of ambient humidity for preparation, subpackage and storage for this capsule,0as the hard capsule pattern number, and alum-plastic-plate as wrappage were also determined. Each capsule contain quercetin about34.0μg and saponin of Momordica charantia about40.0μg.Finally the TLC identification methods of the incorporated Momordica charantia and Evonymus alatus were established. The results of the primary pharmaceutical general information examination were consistent with the related regulations under the capsule item in’Chinese Pharmacopoeia’ of2010edition.The experimental results indicate that this preparation technology is reasonable and feasible, the quality is stable and controllable as well.