Studies On The Development Of Xianchan Capsules And Kunfukang Pills

For the purpose to develop the 8th kinds of new drugs Xianchan Capsules and Kunfukang Pills on the basis of Chinese preparation of Xianchan Pills which can cure cancer and Kunfukang Capsules that can treat pelvic inflammatory disease included in standards compiled by SFDA.1. Researched the preparing technology of Xianchan Capsules. Equal comparing design was used to study the speed and volume of solvent in percolating technology. The optimal process was studied by orthogonal design and contrast experiment with yield of extract and contents of ginsenoside Rg₁ and Re as indexes. Four factors were selected in this experiment, including the volume of water, soak time, the duration of extraction and times of extraction. Methods of granulating were studied, excipients were selected, stable and feasible processing technology of capsules was established.2. Established the quality criterion of Xianchan Capsules. On the basis of original standard, improved the identification methods of Radix Ginseng, Fructus Psoraleae, Venenum Bufonis, established TLC methods to identify Semen Strychni Pulverratum,Radix Astragali, Radix Angelicae Sinensis, Radix Curcumae and Herba Agrimoniae. The employed methods were simple and reliable, the spots of TLC chromatograms were clear. RP-HPLC was developed for the assay of deleterious compounds (strychnine, bufogenin and cinobufagin). The solvent system [ACN-0.01mol·L^-1 SDS—0.01mol·L^-1NaH₂PO₄(40: 30: 30 )(pH was adjusted to 4.0 by HOAc)] and ODS reversed-phase column of Hypertsil C₁₈(4.6×200mm, 5μm)were used in the quantitative analysis of strychnine. The linear range was 0.0042 0.0416mg·mL^-1(r = 0.9995). The quantitative analysis of bufpgenin and cinobufagin were performed on a Hypersil C|g column with the mobile solvent of 0.5% ammonium acetate -ACN (pH was adjusted to 7.0 with NH₃-H₂O). The linear ranges were 0.0108～0.1080 mg·mL^-1,.0094～0.0940 mg·mL^-1(r= 0.9998) respectively. This thesis improved the method that determined the content of strychnine, established the method which detect bufogenin and cinobufagin. The methods employed were accurate, and reliable, they provided modern quality criteria for Xianchan capsules'.3. Researched the preparing technology of Kunfukang Pills. Orthogonal design and equal comparing design were used to optimize the extraction process with yield of extract and content of matrine and oxymatrine as indexes. Four factors were selected in this experiment, including the volume of water, the soak time of medical material, the duration of extraction and times of extraction. Methods of granulating and tabletting were studied, stable and feasible processing technology of preparing pills was established.4. Established the quality criterion of Kunfukang Pills. On the basis of original standard, improved the identification methods of Radix Paeoniae Rubra, Radix Sophorae Flavescentis and Radix Linderae, established TLC method to identify Rhizoma Cyperi. The spots of TLC chromatograms were clear and reliable. The quantitative analysis of peoniflorin was performed on a Kromasil CI 8 (4.6×250mm, 5μm) colume with the mobile solvent of ACN—water (14: 86), The linear range was 0.0456～0.456 mg.mL^-1(r=0.9998). This thesis improved the method which assay peoniflorin. It was simple, sensitive, accurate, reliable, and provided the evidence for modernization of quality criteria of Kunfukang Pills.