Pharmaceutical Research Of YSTM Granules

YSTM granule is Chinese medicine processed preparation that made from pueraria lobata and ginkgo leaves and so on(YSTM is a shorthand for the prescription). Main function is promoting blood circulation by removing blood stasis, going through pulse and retinervus and reducing pain. It is used to people who have coronary heart disease and angina of blood stasis. Symdrome has chest pain, chest tightness, suffocation, palpitation, shortness of breath, fatigue, dizziness, headache and numbness. Using Chinese medicine theory to direct and using modern pharmaceutical technology, the subject researches pre-clinical pharmaceutical part of the granule.According to clinical needs and prescription components, determine to make into granule and develop a processing route. Evalution standards are Puerarin content and rate of the cream.Adopting the orthogonal method select the the extraction process as follows:Weigh medicine by the proportion of prescriptions. Reflux with 5 times of 60% ethanol for 2 times,2 hours each time, filter and combine the filtrate. Recycle the ethanol. Concentrate to a thick extract with a relative density of 1.10(60℃). Take 2/3 of the cream to spray-dry into powder, adding an amount of dextrin, mix up and go through 80 mesh sieve. Add moderate dextrin and 3 grams of aspartame, mix up, use it as the kernel. The other 1/3 of the cream is as the adhesives for boiling granulation. The three batches of the med-term tests prove that the development process is stable and possible.Focus on TLC and HPLC during the quality standard research. TLC is used to identify the ingredients in prescription respectively, among which ginkgo leaves, szechuan lovage rhizome and yanhusuo have comparatively better results. The content of puerarin in pueraria lobata is determined using HPLC as indicators of internal quality control, and the systematic methodology are accomplished. All results comply with the specified standards concerned, thus the method is included into the normal test of quality standard. Through determinatioan of the med-term tests samples, combining the actual production, the content of puerarin per package is no less than 105.0mg. Examine the long-term stability by observation methord at room temperature. The results show that three batches of the samples'chatacter, identification, examination and determination all meet the requirements.The results of above tests indicate that the preparation technology is reasonable and practical, the standard is controllable, and the quality of the sample is stable on the whole as well.