| Shenhe Prescription is a Chinese prescription treats ED based on experiences. It composed of Herba Epimedii, Fructus Corni, Fructus Schisandrae Chinensis, Fructus Lycii, Radix Ginseng, Semen Cuscutae, Cortex Cinnamomi, and Radix Cyathulae, with the actions of warming the kidney to invigorate yang, and indicated for impotence due to deficiency of kidney yang, manifested by impotence, cold extremities and aversion to cold, neurolysis, Aching and weakness of the loins and knees, deficiency of qi and disinclination to talk, frequent urination, pale tongue with white fur, deep and weak pulse, and erection functional impairment with above symptoms. We have done the experiment study on extractive techniques and the shaping process, the quality standard and the method for quality control, the stability of the granule. This thesis consists of three parts:Part one: Literatures and summarizationsWe have reviewed the literature about the chemical composition and quality control and pharmacological of each herb of Shenhe Prescription in the past 10 years, by citing 222 articles totally, and having a good hand of the present study of erectile dysfunction in traditional Chinese medicine. Part two: Experiment studies1. To establish the preparation process of Shehe granule. Based on the literature review, we have done the experiment study on preparation process. Optimizing the water extractive techniques of Herba Epimedii, Semen Cuscutae, and Radix Cyathulae by the orthogonal experiment, with the content of icariin as the index; optimizing the alcohol extractive techniques of Fructus Corni, Fructus Schisandrae Chinensis, Fructus Lycii, and Radix Ginseng by the orthogonal experiment, and indexed by schisandrin. The experiment indicated: the best water extraction condition is that Herba Epimedii, Semen Cuscutae, and Radix Cyathulae added to 14 times amount water and extracted 3 times with each time for 1 hour; The best alcohol extraction condition is that Fructus Corni, Fructus Schisandrae Chinensis, Fructus Lycii, and Radix Ginseng added to 4 times amount 70% alcohol and extracted 4 times with each time for 1.5 hour; the best extraction condition of Cortex Cinnamomi is that added to 8 times amount water without soak, and extracted for 8 hoursOptimizing the cyclodextrin inclusion process of volatile oil from Cortex Cinnamomi; study on the concentration process and the shaping process. The best inclusion process is that added 8gβ-cyclodextrin to 100ml water and dissolved completely, then added 1ml volatile at 40℃, mixed for 1 hour. The optimal matching of accessories is that adds 1-1.5 times cyclodextrin to 1 times extraction powder, and added 1.5% Aspartame as flavoring.2. To establish the quality standard and the method for quality control of Shehe granule. For control the quality of Shehe granule, we studied the quality standard of it. Determined the contents of icariin, loganin, and schisandrin by high efficiency liquid chromatography (HPLC); identified the icariin of Herba Epimedii, prunol of Fructus Corni, schisandrin of Semen Cuscutae, panaxsaponin Rg1 of Fructus Lycii and Radix Ginseng by thin layer chromatography (TLC). The experiment indicated that the established TLC identification method has a good reproducibility, and the TCL stain is distinctly, with a non-interferential control stain. At the same time, we did a systemic methodology research on the assaying method, and the blank is no interferential too; it indicated that icariin has a good linear relationship at a range of 0.1514μg~0.7570μg, the regression equation is Y=2268425.4X-2023.4,the coefficient correlation (r) is 0.9999; loganin has a good linear relationship at a range of 0.0771μg~1.1568μg, the regression equation is Y=1134748.9X+4539.2,the coefficient correlation (r) is 0.9999; schisandrin has a good linear relationship at a range of 0.0868μg~0.8680μg, the regression equation is Y=2195662X+ 10039, the coefficient correlation (r) is 0.9999; loganin has a good linear relationship at a range of 0.0771μg~1.1568μg, the regression equation is Y=1134748.9X+4539.2, the coefficient correlation (r) is 0.9999. The RSD of repetitiveness test results of icariin, loganin, and schisandrin are 0.64%,0.54%,0.87% respectively, and the average recovery are 99.50%,99.05%,99.8%, and RSD are 0.84%,0.84%,1.08% respectively.3. To investigate the stability of the granule. According to technical requirements for registration of pharmaceuticals, we investigated the stability of 3 lots of granule that packaged as market by sample-keeping observation method for 3 months. The experiment indicated that this granule could maintain stable in room temperature for 3 months.Part three: Result and discussionThe established preparation process of Shehe granule is reasonable and feasible, and the established quality standard and TLC identification method and HPLC determination of it is scientific and reasonable, it can control the quality of it in many sides. |
