Study Of Proclinical Pharmacy On Rehmanni A Glutinosa Oligosaccharides Capsule(The Class V Of New Chinese Drug)

Objective:Rehmannia glutilosa Libosch. (Dihuang) refers to the fresh or dry root of Rehmannia glutilosa, a herb of the Scrophulariaceae family. Rehmannia dride rhizome(Sheng Dihuang) has the effect of removing pathogenic heat from blood, nourishing Yin and promoting the production of body fluids. According to the Class V of New Chinese Drug in the classification of the Chinese herb1 medicine, natural medicine registration and request of Annex 1(the Provisions for Drug Registration by SFDA), Rehmannia glutinosa oligosaccharide (ROS) capsule has been researched on the pre-clinical pharmacy by using the modern pharmaceutical techniques.Methods:Orthogonal experiment design was applied to optimize the extractive procedure for Rehmannia glutinosa oligosaccharide evaluated by the yields of the extract and content of stachyose; The cation and antionion exchange chromatography and activated carbonchromatographic column were used to purify the different parts of Rehmannia glutinosa oligosaccharide; Hydroscopicity was selected as an evaluation parameter, the single factor test was adopted to select the best condition of the capsule. With the prescription and amplify to 10 times for pilot scale productin; The quality criteria was researched according to the《Pharmacopoeia of the People's Republic of China》, The quality standard of the drug was established by using TLC to determine the nature of the herb and HPLC to quantitate the content of stachyose in Rehmannia glutinosa oligosaccharide (ROS) capsule. The preliminary stability of the three samples was studied.Results:With the orthogonal experiment and statistics analysis, the optimum extracting conditions for Rehmannia glutinosa oligosaccharide were as follows:extracted with 10 volum of water for 1 hour,3 times. The extract was standed for dust removal, then concentrated and dried; The cation and antionion exchange chromatography and activated carbon chromatographic column were used to purify the different parts of Rehmannia glutinosa oligosaccharides, the content of stachyose in the elution part of 10% and 15% ethanol are higher than other parts; With the excipients screening test and pharmacodynamic test, minimal influence on hydroscopicity of extract in adjuvant and the requirement of clinical medication was gained when the ratio between Rehmannia glutinosa and lactose was 3 to 1; The dense extract and lactose were mixed fully, then granulate after vacuum drying. The result of zero angle indicated that the fluidness of granula satisfied the request of produce, the determinination of bulk density gave a suggestion of selecting the number one lorica, with critical relative humidity (CRH) of 60%; The finished product rate of pilot scale production are 93.82%,94.29%,91.68%, the conent of stachyose are23.78%.22.27%,23.76%。TLC was used to identify the herb, and the inspection, identification and assaying of semi-works production met the requirements; Preparation preliminary stability inspect that samples'character was stable during experiment period and each item of inspection data was within the normal range.Conclusion:The research results indicated that the extraction and preparation process was reasonable and feasible. The established quality standard was objective and practical for controlling the finished product quality and complied with the standards of Chinese pharmacopoeia.