Study On Technology And Quality Standard Of Miniao Qinglin Tablets

The urinary tract infection(UTI)is a common and frequently-occurring disease of urinary system which causes disease through pathogenic bacteria invading the urinary tract, retrograding infection,upward adhesion epithelium of the urinary tract and secreting toxins. As the infection involves the urethra, the bladder, the renal pelvis and the renal parenchyma, and is not easy to be located, the UTI is referred to urinary system infection in clinical which belongs to "water" in Chinese medicine theory.Miniaoqinglin Tablet is the sixth category of national TCM drug classification and the prescription contains seven herbs, including Bupleuri Radix,Scutellariaeradix, Polygoniavicularis Herba. and so on, is used in the treatment of acute urinary tract infections in the clinical.According to the measures for the administration of drug registration and the technology related to developing new medicine, this reaearch mainly study on the preparation technology and the quality standard of the Miniaoqinglin Tablet guided by the traditional Chinese medicine theoty.The preparation process study:1. The extraction solvent study: The extraction solvent was screened according to the crude drug physichemical properties and the lieterature. The extraction solvent of Bupleuri Radix,Rhei Radixet Rhizoma,Linderae Radix was ascertained ethanol. The extraction solvent of Polygoni Avicularis Herba,Plantaginis Semen,Sophorae Flavescentis Radix was ascertained to water. The baicalin was prepared from Scutellaria baicalensis separately.2.Process optimization: Based on the principle of cost saving and environmental-ly frie ndly, the various ingredients were merged according to the extraction solvent. The orthog onal experiment and investigation and analysis of variance were carried out respectively. According to the validation test, the production process was optimized. The optimization results of Bupleuri Radix,Rhei Radix et Rhizoma,Linderae Radix were ascertained as follows: extracting for two times, each time for 2 hours, adding 8 times amount of 70% ethanol for the first time and adding 6 times amount of 70% ethanol for the second time. The optimization results of Polygoni Avicularis Herba, Plantaginis Semen, Sophorae Flavescentis Radix were determined as follows: adding 9 times amount of water, extracting for two times, the first 2 hours and the second 1.5 hours. The extraction of Scutellaria baicalensis with water was determined as follows: extracting for three times, adding 10 times amount for 2 hours for the first time, adding 8 times amount for 1 hours for the second and the third times. The baicalin was prepared by acidizing to the extract for thermal insulation and crys-tallization.3. The preparation of molding process: The preparation of molding process was studied and determined to the excipients dosage of wet granulation, the ethanol concentration of binder agent, the time of grain drying and other parameters. After the 3 batch of pilot test, the results showed that the process is stable and feasible.The quality stanard study:According to the new drug technical requirement, the TLC method was established for the Radix Bupleuri, Sophoraflavescentis Radix, Rhei Radix Et Rhizoma and Linderae Radix. The content of heavy metal and microbial limits was studied. The Baicalin content in Scutellariaeradix and the Matrine content in Sophoraflavescentis Radix were determined by using HPLC. The results showed that the method was simple and has good reproducibility, and it can be used to control the quality of Miniaoqinglin Tablet.