Pharmaceutical Research Of Wushao Zhiyang Granule

Wushao Zhiyang Keli, which consists of Radix Polygonum Multiflorum Preparata, Radix Paeoniae Rubra, Cortex dictamni, Rhizome Corydalis with vinegar, Radix Angelicae Sinensis and Radix Ampelopsis Japonica, is used to treat senile pruritus. It has the function of nourishing Yin and blood, expelling damp, alleviating fever, expelling wind and stopping itch. Under the guidance of TCM theory, this topic is to change the slice decotion into granules and using the modern pharmaceutical technology to study pre-clinical pharmaceutical research.Through the comprehensive analysis of the prescription’s indications function, the chemical composition’s pharmacological effects and its physical and chemical properties in each herb and the pharmacodynamics experiment results, Radix Polygonum Multiflorum Preparata and Cortex dictamni were extracted by ethanol, Radix Paeoniae Rubra, Rhizome Corydalis with vinegar,Radix Angelicae Sinensis and Radix Ampelopsis Japonica were extracted by water. With the orthogonal test and comprehensive evaluation, the best ethanol extraction technology was adding 8 times amount of 60% ethanol (one more time of solvent were added and soaking 60 minutes before the first extraction) to reflux extract for 3 times, lhour each time. The best water extraction technology was adding 10 times amount of water(one more time of solvent were added and soaking 60 minutes before the first extraction) to reflux extract for 3 times, 1hour each time. The ethanol extract were merged with the water extract after recovering solvent. The mixture were concentrated to the relative density was 1.18-1.22 and dried to extract powder under reduced pressure(60℃). At the same time, we also studied the quality standard of extract powder.In the study of the preparation process, the types of wetting agent and filler, the dosage of wetting agent were studied by single factor experiment, the optimal ratio of filler were studied by the D-optimum mixture design. The best molding process was as follows:Using the mixture of lactose-soluble starch-dextrin(0.335-0.360-0.305) as filler, which were mixed with extract power by 1:1. Using the 0.2 times of extract powers dosage’s 70% ethanol as wetting agent to make soft wood for granulation, drying(60℃) and granulation. The results of amplification process in laboratory showed that the process is stable and feasible.During the study of the quality standard, the TLC methods of were established, which were simple, specific and negative without interference. The HPLC methods of were established, which were accurate, reliable, time-saving, high sensitivity and negative without interference. In the same time, the properties, particle size, moisture content and melting were alse studied and the results were in line with the requirement of Chinese Pharmacopeia.In the stability test, the results of accelerated test and long-term test showed that all index in the observation period conform to the rules, means the sample stability is good.