The Study On Process And Quality Specification Of Shenqi Yiqi Buxue Capsules

The research is focused on Shenqi Yiqi Buxue Capsules, mainly to research extractionprocess and clathration process of volatile oil, extraction process with water andprocess and quality specification of the preparation. Include the following aspects.1. Research of extraction processIn the research procedure of extraction process, mainly investigate three partsaccording to the different characters of each ingredient in the prescription: douse timeof Atractylodis, Angelicae Dahuricae Radix and Angelicae Sinensis Radix. volatile oil,extract time and amount of water added. The best extraction process of volatile oilfinally determined is to add eight times water of the ingredients, douse for six hoursand extract for ten hours. Use orthogonal experiments to investigate the influencingfactors of volatile oil clathration (β－CD：ratio of volatile oil, clathration temperatureand clathration time). According to the orthogonal and verification experiments, thebest clathration process of volatile oil is to incluse with eight timesβ－CD at50℃for30min. Utilize orthogonal experiments to investigate the influencing factors ofextraction process with water in other ingredients extracted by water. According to theorthogonal and verification experiments, the best extraction process with water is toextract by eight times water twice, two hours each time.2. Research of preparation processIn the research procedure of the preparation, we have investigated alcoholconcentration, drying temperature, drying time, parameter angle of repose whichimpacts content uniformity, criticality hygroscopicity of granules during granulating.Determine finally to integrally granulate by90%alcohol after dried at50℃for1.5hours at60%relative humidity.3. Research of quality specificationThe article investigated the quality specification of capsules. We established thethin-layer chromatography methods of Astragali Radix, CodonopsisRadix,Atractylodis, Angelicae Dahuricae Radix, Angelicae Sinensis Radix. Weexamined water, content uniformity, disintegration time, microorganism, arsenic,heavy metals of the preparation, all results complied with the quality specification. Inthe assay determination, we established the assay determination method of peoniflorinin Paeoniae Radix Alba by HPLC using peoniflorin as the reference substance. Viaruggedness, precision, intermediate precision, repeatability and accuracy experiments,the assay determination method is suitable with good repeatability. It is defined thateach capsule contains not less than2.50mg peoniflorin. We also performed thethin-layer chromatography of other ingredient in the prescription, but the spots ofPoriae Cutis and Rehmanniae Radix Praeparata which use Glycyrrhizae Radix etRhizoma as adjuvant was not clear with bad repeatability, so the method is notincluded in quality specification.