Study On The Medical Preparations Of Rongshi Paishi Granules

Base on urolithiasis at clinic,we choose Rongshi Paishi Granules which from the experience prescription of Hubei Provincial Hospital of Chinese Medicine as research object.According to the claim,We research on the preparation process,stability,quality, and acute toxicity,which were the most important facts of Rongshi Paishi Granules,and providing materials research of treating urinary tract stones by Rongshi Paishi prescription at clinic, providing materials research for exploiting medical preparations of treating urinary tract stones.1.Research of preparation process Base on the action indications and demand at clinic,we identified decoction as the extraction process and Granules as the dosage forms.By orthogonal test and process of forming dosage forms,we identified preparation process as follows:The Herbal Pieces plus 10 times the amount of water to soak for 30 minutes, boiling and extracted 3 times,each 1.5 hours,the liquid was filtrated,then concentrated the filtrate into thick pastes.Adding some dextrin,mixed,dried and crushed into dry extract,adding dextrin by 1:1,wetted with 70% ethanol,granulation,drying at 60℃ to a moisture content of less than 6.0%,make granulation, packaging.2.Research of quality standardsWe used the TLC on stragalus and Phellodendron,the results show a clear map, good spot separation.After some times test, berberine hydrochloride,which can be used as indicators for controlling internal quality of the product.Batches of samples based on the measurement result,developed a content limit of the,Phellodendron(calculated by berberine chloride) contains not less than 4.0mg each bag.3.Research of stability Film sealed by the aluminium plastic composite,storage 12 months naturally in room temperatur,and placed 6 months consecutive under the conditions of 37-40℃,RH75%,The detection of indicators are in line with the product quality standards which indicated the product quality was stable.4.Research of acute toxicity The experiment was tested on mice,use the highest concentration(3.23 g crude drug·ml-1),the maximum volume(40ml·kg-1) intragastric administration twice a day(equivalent to 152 times of clinical dose),observed 14 days continuity,no toxic reaction occurred, Therefore,the maximum tolerated dose in mice which was fed whit the product is greater than 258.4g crude drug·kg-1.5.Summary of the experimental research On total efficiency,the treatment group was 85.7%,the control group was 70%,compared with the two groups after inspection,there were some statistically significant in the difference(P<0.05),which showed that the granules in the treatment of urinary tract stones had better curative effect.In the aspect of treatment with Qi stagnation and blood stasis type of urinary stone,the effective rate of the treatment group(87.1%),compared with control group(51.5%) by checking,(P<0.05),which showed that the effect of the granules was better than that of control group.In the aspect of rowing of stone,the rate of stone expulsion with treatment group(68.6%),the time of stone expulsion(31.5±10.3days),respectively compared with the control group(37.1%) and(40.4±13.9days) by checking,(P<0.05),which showed that the granules could promote the stone expulsion obviously.In treatment of calculus of different size,stone with 0.6cm<d<1.0cm,two groups had significant difference in efficiency(P<0.05),which showed that the treatment group had good effect in calculus with 0.6cm <d<1.0cm; calculus with d<0.6cm,two groups of efficiency compared by statistical test,difference had no statistical significance(P > 0.05); compared within treatment groups,there had no significant for calculus with d <0.6cm and 0.6cm <d<1.0cm(P >0.05),which showed that the granules for calculus with d<1.0cm had good therapeutic effect in urinary tract stones.In improvement of symptoms and signs,compared with the integral difference between two groups before and after treatment(P<0.05),which showed that the treatment group had side effects in improving the symptoms and signs than the control group.In the treatment of urinary stones with effusion,two groups had significant difference inefficiency(P<0.05),which showed that the granule had good effect on urinary calculi with effusion.