Wantong Pill Bones And Rubi Shu Development Research

Wantongjingu pill and Rupishu capsule are traditional Chinese medicine compound prescriptions which were registered in the drug standards of the nation. The current subject is to achieve the basic pharmaceutical research of their related preparations Wantougjingu concentrated pill(WCP) and Rupishu pill(RP). The research concluded the selection of manufacturing techniques, establishment of quality standards and basic study on the preparations.WCP is made of twenty-five kinds of Chinese Herbs, such as Radix Aconiti, Radix Aconiti kusnezoffii, Herba ephedrae, Herba Epimedii, Radix Glycyrrhizae, and so on. Its efficiencies are cleaning away prolonged cold-damp obstruction, expelling cold and damp pathogen, warming meridian to activate, subduing swelling and alleviating pain, which is used to treat rheumatoid arthritis. With the guide of Chinese medicine theory, conduct the analyses on the medicine of the prescription, establish the distill method and conduct procedure depending on the component of Chinese medicine. The technology of water extracting were basically continued to use, but orthogonal design and equal comparing design were used to study the missed data in the processing of WCP, the missed data include soaking time, amount of water, extract time and number of extract times, method of preparing preparations were studied. As a result, the missed data were all made sure, processing technology of preparing concentrated pill was established.The study established quality standard for WCP. On the basis of the used standard, The TLC identified methods of Herba Ephedrae, Cortex Phellodendri, Rhizoma sea Radix Notopterygii, Radix Ginseng were improved, meanwhile, another three important ingredients in the prescription which are Radix Glycyrrhwere, Herba Epimedii, Flos Carthami were identified by TLC in current quality standard. Strychnine in WCP was determined by HPLC using the ODS reversed-phase column of Hypersil C₁₈ (4.6×200mm, 5μm), the mobile phase was composed of acetonitrile-a kind of mixed water solution consisted of 0.01mol·L^-1 sodium dodecylsulphate, 0.01mol·L^-1 sodium dihydrogen phosphate and 0.01mol·L^-1 triethylamine (40:60, pH was adjusted to 4.1 with glacial acetic acid). The content determined method of Strychnine had adequate accuracy and selectivity in the liner range of 0.016～0.16mg·mL^-1(r=0.9994).RP is made of seven kinds of Chinese Herbs, such as Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Paniculate Bolbostemma, and so on. RP is used to cure Hyptroplasia of mamma rygland, the current research studied the optimum preparation technological process of RP for mass production. The optimum conditions for the water extraction process were selected with orthogonal design, dry ointment yield and the content of tubeimosideⅠin the extract as markers were determined. By using single-factor test, preparation technology for the alcohol extraction process was optimized, dry ointment yield and the content of Paeoniflorin as marker weres determined. As a result, the related preparation technology parameters were made complete and optimized.According to the used standard, the study developed the method of quality assessment of RP. TLC method was used in qualitative identification of Paniculate Bolbostemma, Radix Paeoniae Rubra. An HPLC method to determine the content of Paeoniflorin was established, equipped with Kromasil C18 column(5μm, 4.6mm×25cm), using acetonitrile-water (82:18) as mobile phase. This method had adequate accuracy and selectivity in the liner range of 0.065～0.65mg·mL^-1, r=0.9997. As a result, the techniques and methodical control of quality of RP were convenient, feasible, stable and credible.