Studies On The Extraction Methods And Determination Of Compound Xinnaokang Soft Capsules

The decoction of four Chinese herbal medicines can be used to improve the blood-supply of cardiac muscle; to treat hypertension and atherosclerosis; to prevent cerebral apoplexy and senile dementia etc. And the long history of its clinical applications has proved its excellent curable effects and low side effects.However its bitter taste, larger oral does, inconvenience of decocting and the inconstancy and inaccuracy of its active principle etc have been regarded as its shortages.Aiming at these problems, on the basis of traditional Chinese medical prescription, the extraction processes of each four herbal medicine components have been studied and improved while combining supercritical fluid extraction (SFE) with decocting process.Using the extracts of these four herbal medicines, a novel form of the drug----soft capsule has been developed, and is named as Xinnaokang compound soft capsule.And the RP-HPLC analytical method has been developed for the assay of the active principles of the capsules with UV-DAD as the detector. It provides the scientific basis for the composition of its quality standard.A.The studies of the extraction processA-i To the tanshinone hA, danshensu and protcate-chualdehyde of Salvia miltorrhiza Bge; puerarin of Pueraria lobata(Willd.)Ohwi; ferulicacid of Ligusticum chuanxiong Hort., the orthogonal design test method has been applied to optimize their extraction conditions and processes separately.1. SFE has been used for the extraction of the tanshinone hA from Salvia miltorrhiza Bge. The studies show that the parameters of the optimum extraction condition are: ethanol (95%) as the modifier in the ration of 35mL for 1 OOg raw herbal medicine; the temperature of extraction pot is 55c with the pressure of 3OMpa, and extract for 2.5h;The analytical method of CP (part one,2000) has been used for the assay of extract.2. The caput mortuum of SFE extracted Salvia miltorrhiza Bge has been utilized to obtain the danshensu and protcate-chualdehyde. The most suitable process has been proved as to decoct the SFE caput mortuum with eight-times-quantity by three times, 1 .5h per time. Then evaporate and concentrate the combined decoctions, get the solid extract by vacuum drying.RP-HPLC has been used to determine the assay of danshensu and protcate-chualdehyde in extract, with Cl 8 column and methanol/water (0.5% acetic acid) as the mobile phase.3. The process of puerarin from Pueraria lobata(Willd.)Ohwi is: to reflux the raw medicine with twelve-times-quantity 70% methanol three times, combine the decoctions, and then to recover methanol by decompression distillation, and the final extract can be obtained through vacuum drying.CP (part one, 2000) method has been used for the assay.4. To ferulicacid of Ligusticum chuanxiong Hort, the best SFE parameters are:C02 as the modifier with the flow rate of 25kg/br, the temperature of the extraction pot is 70c under the pressure of 35Mpa. And separator one is of 8Mpa and 45c; and separator two is 5 Mpa 40c;PR-HPLC with Cl 8 column and methanol/water (1% acetic acid) has been used for the assay.A-2Astragaloside IV of Astragalus membranaceus(Fisch.)Bge.To Astragaloside IV of Astragalus membranaceus(Fisch.)Bge., two extraction processes have been compared. One is water extracting then alcohol precipitating the Ministry-issued standard process for 搑adix astragali injection? The another one is SFE. The studies show that the improved Ministry-issued process is better thanSFE.PR-HPLC analytical method has been used for the assay of extract.B.The studies of assay method of Xinnaokang compound soft capsuleXinnaokang compound soft capsule as most of Chinese medicines is of complexcomponents and a lot of impurities. It has brought some difficulties to the accurate analysis.An RP-HPLC method has been developed to analyze five active principles in the capsules. The column is Zorbax SB-C8 (250X4.6mm) and the column temperature is 40c. The mobile phase is composed of acet...