Studies On Development And Material Foundation Of Qianlie Shutong Tablets

Prostate inflammation will emerge if prostate was infected by specific or nonspecific infection. Chronic prostatitis was most frequent inflammatory disease in male genitourinary systemic disease. On the basis of statistical data, 35～40% men who was at the age of over 35 suffer from chronic prostatitis and the disease incidence is elevating year by year. It is hard to cure if only anti-infection or physicotherapeutics is applied. Though prostate disease has no threat to life, up to now, it still belong to world stubborn disease because it possesses many complex symptoms and suffering. So the aim of the research is to develop a kind of drug dosage which will be effective to treat prostatitis.The traditional Chinese medicine consider that the etiopathogenisis and pathogenesis of chronic prostatitis was principally caused by sluggish QI and blood, humid heat congealed in urinary bladder and deficient kidney-QI. So the primary mean of treating chronic prostatitis is promoting urine and humid heat to excrete. Meanwhile, the method of warming and invigorating the kidney are applied. The results of clinical trial show the complex prescription composed of Rhizoma et radix polygoni cuspidati, astragali membranaceus and Epimedium brevucornum Maxim are effective in treating chronic prostatitis. Coherent literatures and patents haven't been reported by investigation. Qianlie Shutong Tablets are made of effective constituents groups extracted from Rhizoma et radix polygoni cuspidate, astragali membranaceus and Epimedium brevucornum Maxim on basis of the theory of traditional Chinese medicines and drugs. The complex prescription possesses the efficacy for promoting urine and humid heat to excrete, dredging stagnated blood and alleviating pain. Qianlie Shutong Tablets is applied in treatment of chronic prostatitis with humid heat heap knot and stagnant blood nephrasthenia syndrome. Rhizoma et radix polygoni cuspidati possesses the efficacy of heat-clearing and detoxicating, inducing diuresis for treating strangurtia, eliminating stasis to activate blood circulation and treating boils. Astragali membranaceus and Epimedium brevucornum Maxim can warm and invigorate the kidney and assist Rhizoma et radix polygoni cuspidati to produce system healthy energy and increase airstream hematosis. The three herbs play an important effect on clearing humid heat and promoting urine to excrete, promoting blood to flow and removing blood stasis, warming and invigorating the kidney. So Qianlie Shutong Pian can be applied to treat chronic prostatitis with damp-heat in lower-JIAO and stagnant blood syndrome.The following investigations were carried out in order to establish the extraction technology and quality standard which fits large-scale industrial production and control the quality of the preparation preferably.The effective constituents of the medicine materials such as Rhizoma et radix polygoni cuspidati, astragali membranaceus and Epimedium brevucornum Maxim were obtained on the basis of the results of pharmacology study. According to the chemical property of the effective constituents, the extraction models of the three Chinese herbal drugs were established by orthogonal design test.The active contents of the crude drug and Qianlie Shutong Tablets were identified by TLC. The total flavonoids of Astragalus and the total flavonoids from Epimedium herb were determined by ultraviolet spectrophotometry. Resveratrol, astranoside A and icariin the crude drug and Qianlie Shutong Tablets were determined by HPLC. The dissolution in vitro of Qianlie Shutong Tablets was determined. The quality standard were established based on the experiments results, which fit to control the quality of the crude drugs.The stability results for three effective constituents and the preparation made of the three effective constituents showed that their stabilities could meet the new medicine requirement under stability conditions. At indoor temperature, their characters, discriminations, quantity difference, water content, disintegration time, contents and the hygiology index have no obvious variety and accord with the requirement for new drug dosage.The study of medicine compatibility comprise the following: firstly, the pharmacology models responding to the clinical curative effect were constructed according to condition of the clinical application; secondly, Several administration dosages were established on basis of the dosage of the effective constituents extracted from the herbs in order to obtain their respective optimal curative dose; thirdly, the optimal compatibility ratio of the effective constituents extracted from adix polygoni cuspidati, astragali membranaceus and Epimedium brevucornum Maxim was determined by orthogonal experiment according to the Chinese medicine theories and the results of pharmacology experiment. Finally, pharmacodynamics and toxicology experiments of Qianlie Shutong Tablets were carried out referring to the requirement for reporting new drugs to a higher authority.The results for the acute toxicity test and the long-term toxicity test indicated that the drug has little adverse reaction. The general pharmacology test indicated that the HR, electrocardiogram, BR and extent were normal after administration by duodenum. After administration by id, the activity of the mice is normal, it has no synergistic action with pentobarbital sodium.The results of pharmacodynamics indicated that reduplicative oral administration of Qianlie Shutong Tablets could markedly inhibit acute and chronic inflammatory reaction including paw tumefaction induced by ovoalbumin and granuloma induced by cotton-ball in rats, as well ear swelling induced by xylol and peritoneal fluid leuko(cyto)plania in mice. Acute nonbacterial prostatitis model induced by carrageenin and bacterial prostatitis model by Bacillus coli were constructed. The results indicated that Qianlie Shutong Tablets significantly elevated lecithine corpuscle density in the prostatic fluid in prostatitis rats, decreased the number of WBC, as well improved size dissimilarity of glandular cavity, intracavitary inflammatory cell infiltration, interstitial inflammatory cell infiltration and interstitial edema degree. The effects of Qianlie Shutong Tablets on chronic nonbacterial prostatitis model induced by hemorrhoid injection and bacterial prostatitis model by Bacillus coli were accorded with those of Qianlie Shutong Tablets on acute nonbacterial prostatitis model and bacterial prostatitis model. Meanwhile, Qianlie Shutong Tablets could significantly inhibite tartrate-resistant acid phosphatase (TRAP) induced by inflammation to increase. Qianlie Shutong Tablets could obviously decrease writhing response frequency induced by acetic acid and increase pain threshold hot plate method in mice. So we reach a conclusion that Qianlie Shutong Tablets possess analgesic effects. Qianlie Shutong Tablets had an obvious effect of relieving fever induced by carrageenin in rats and obvious diuretic effect on normal and hyperhydropexic rats, as well as increasing K+ and Na+ in the urine to excrete. The results of series of inflammatory models proved that Qianlie Shutong Tablets possessed the effect of anti-inflammatory, analgesia, relieving fever and diureses, which provide a science proof for its clinical application.In a word, all the above results provided the reliable theory foundation for the clinical test of the drug.