Pharmaceutical Research Of Yinhuang Oral Disintegrating Tablets

Yin Huang preparation has the effects of clearing heat and expelling wind, Liyan detoxification. For exogenous wind heat, lung and stomach heat, sore throat, throat caused by nuclear swelling, fever, thirst; acute and chronic tonsillitis, acute and chronic pharyngitis, upper respiratory tract infection symptoms like these. Orally disintegrating tablet developed rapidly as a new dosage form in recent years, the tablets can be disintegrated t in the oral cavitya, with the power to of swallow to the stomach.Compared with the ordinary tablets, it has many advantages,such as taking conveniently, fast acting, high bioavailability and good compliance. For the clinical medication needs, Yin Huang orally disintegrating tablets was developed. the extract preparation, preparation, preparation technology and quality standard were established by the test.In the part of the preparation of extracts, we investigated the extraction and purification technology of flos lonicerae. In the extraction process research, using single- factor experiment investigated the impact of extraction method, ethanol concentration, the amount of solvent, extraction time, extraction times on the extraction of chlorogenic acid and flavonoids. On the basis of single factor experiment, taking "OD" values of chlorogenic acid and flavonoids content as the evaluation index, Central composite design and response surface method was adopted for optimize ethanol concentration, amount of solvent and extracting time. The result showed the optimal condition was with refluxing extraction, ethanol concentration of 69%, solvent of 27 ml/g, extracting twice,37 minutes foe each time. In this condition, the extraction rate of chlorogenic acid in flos lonicerae was 5.55%, the yield of flavonoids was 11.41%. In the purification process study, using macroporous resin purification method, taking the content of chlorogenic acid as examining index optimized purification process honeysuckle extract. The result showed that after purification, the content of chlorogenic acid in flos lonicerae extract were above 20% and extraction yield of flavonoids in more than 60%.In the molding process study, we examined the Yin Huang orally disintegrating tablet prescription and granulating method.In the study’of the formulation, the single factor investigation and Central composite design and response surface method were used to optimize the material type and proportion. Preparation three batches of orally disintegrating tablets with the best prescription,these tablets were smooth and without spot, taste good. The tablet weight difference is within 5%, the hardness is about 40N, the disintegration time was (29 ±0.3) seconds, oral cavity disintegration time was (28 ± 0.5)seconds s. In granulating process study, we investigated the relationship between the ethanol concentration, the amount of ethanol and these characteristics of granules such as particle size, bulk density, powder flowability;and the relationship betweed forming and disintegrating properties of orally disintegrating tablets.In the study of quality standard, refer to "Chinese pharmacopoeia", extract and products were identified by thin-layer chromatography, the content of active ingredients in extracts and producst were measured by HPLC. The weight variation, disintegration time and dissolution inspect of the orally disintegrating tablets were studyed.The Studies have shown that the preparation process of Yin Huang orally disintegrating tablets is reasonable and feasible, the quality standard is controllable, nature of the formulation is stable.