Study On Formulation Design And Quality Standard Of Scutellarin

Erigeron breviscapus, family composite, was used to treat sequela of apoplexy by the minority nationality (e.g. the Miao) all through the ages. Since 1960's,it has been famous in treating paralysis by Doctor Luo and widely researched. In recent years, it has been widely used to harm cerebrovascular disease and all sorts of sequela caused by cerebrovascular disease (e.g. cerebral hemorrhage and paralysis) in clinic.As one of main ingredient in Erigeron breviscapus, scutellarin can obtain the better curative effect by used in dozes. Recently, there has no been scutellarin injection (packaged in transfusion mode) in the market. In this paper, scutellarin injection (packaged in transfusion mode) was overall studied on formulation design, optimization of preparation ,establishment of quality control criteria and stability investigation. By using the method of single factor investigation, the formulation and preparation of scutellarin injection (packaged in transfusion mode) was optimized and decided considering synthetically several evaluation quotas.In this paper, the quality standard of scutellarin injection (packaged in transfusion mode) was studied. Its chemical identification, determination of general and related substance and assaying were determined based on its structure property and its quality standard of scutellarin injection (packaged in transfusion mode) (protocol) was established. Volumetricprecipitation method was applied for the determination of content of Sodium Chloride; RP-HPLC was developed for the assay of content and drug-related Impurities. Scutellarin injection (packaged in transfusion mode) and its related substance were separated on the Dikma Diamonsil? Cig ft (200 mm><4.6 mm i.d., 5 am) with methanol -O.lmol-lT'acetic ammonium (45:55) (adding phosphate up to pH=2.5) as the mobile phase and detected at 335nm. The calibration curve was linear (r = 0.9993) within the range of0.32~ 1.60^ig for scutellarin, the detection limit was 0.2 u g (S/N=3) , the analysis precision RSD was less than 1.0 % (n=5), the repeatability precision RSD was 0.59% (n=5), and the average recovery was 98.9%, and the limit of drug-related impurities was 0.8ug. Its character content and related substance were also examined during 6 months' acceleration under 40°C and 1.5 year's standing under common temperature based on quality standard already established. This method was simple accurate and suitable for the quality control for scutellarin.As the main quality controlling of traditional Chinese medicine, fingerprints is widely applied in the world. In order to control internal quality of scutellarin injection, in this paper, the fingerprints of scutellarin and it'sinjection is studied.