Secondary Development Of Zi-Shen Pills

Zi-Shen Pills(ZSP), are big honey pills originated in the book Secret Book of Orchid Chamber by Gao Li which are prepared with the powder of Rhizoma Anemarrhenae(Anemarrhena asphodeloides Bge.), Cortex Phellodendri Amurensis (Phellodendron amurense Rupr.) and a small amount of Cortex Cinnamomi (Cinnamomum cassia Presl). ZSP is a traditional Chinese medicinal formula with the effect to cure such illness as Benign prostatic hyperplasia, prostatitis or frequent urination by the kidney-tonifing.Such the illness are due to kidney yin deficiency or downward damp-heat,and the traditional use of ZSP has gotten good effect.But the formula Liao Shen Zi Ben Pill, that Cortex Cinnamomi is Subtracted from Zi-Shen Pill,is rarely used to cure BPH.Previous work by our group found that flavonoids and saponins of Rhizoma Anemarrhenae and alkaloids of Cortex Phellodendri Amurensis are main active ingredients for the treatment of BHP in rats;During the same time after the two group rats took different ingredients of Zishen pills orally,We found that there are more active ingredients left in the rats'excrements that had taken the powder of the fomula than the ethanol extract.On this basis, we have detected the Inhibitory effect of traditional Chinese medicine Zi-Shen Pill on benign prostatic hyperplasia in rats,by observing the effect of different percentage of Oleum Cinnamomi and Cinnamomi aqueous extract on prostatic index,the amount of urine and gastric function; The optimized dosage is the equal amount of ethanol extract of Rhizoma Anemarrhenae and Cortex Phellodendri Amurensis mixed with One-tenth of Cortex Cinnamomi powder. In another test,we found the extract of Rhizoma Anemarrhenae can inhibit the activity of the 5a-redutase in vitro.According to the traditional preparation process of Zi-Shen pill and the nature of the active components of herbs, orthogonal test was carried out to achieve the best extraction technology of the herbs of Rhizoma Anemarrhenae and Cortex PhellodendriAmurensis by the multiple guidelines grading method with the indicators of Berberine or Formononetin. The process of preparation of Zi-Shen tablets is scientific;The stability,hardness,breakage of the production of the products are qualified.In order to provide safe and effective medication for clinical use,the rats of BPH took different dosage of the Zishen tablets so that we determine the dosage when the patients should take. In the further test,we observed the acute toxicity of Zi-shenpill in Rat.Referring to Chinese Pharmacopoeia of 2010 edition,we combined Microscopic Identification,TLC and HPLC to establish the quality standard of Zi-Shen tablets. Zi-shen tablets are prepared from the powder of Cortex Cinnamomi and the ethanol extract of Rhizoma Anemarrhenae and Cortex Phellodendri Amurensis.So Microscopic Identification is used to identificate Cortex Cinnamomi while TLC to identificate Rhizoma Anemarrhenae and Cortex Phellodendri Amurensis by the compound such as Mangiferin,Neomangiferin, Timosaponin B-â…¡and Berberine. We also established a accurate method of high-performance liquid chromatography(HPLC) coupled with diode array detection (DAD)and evaporative light scattering detection(ELSD) in order to simultaneously determine Mangiferin,Neomangiferin, Timosaponin B-â…¡and Berberine in Zi-shen Tablet. the others of quality studies about Zi-shen tablet were performed according to the addenda general rule of the tablet in the 1 st section of Chinese Pharmacopoeia(2010 Edition).The quality of Zi-shen tablet were proved be steady during the observation time of six months by accelerated test while long-term sample observation tests are still being tested.