Study On Quality Standard Of Several Compound Chinese Medicine

ObjectiveChinese traditional medicine quality control is the foundation of safe and effective medication, Suxiao Zhixie capsules, Tongmai granule and Jiangzhiling capsules for Min hai Pharmaceutical Co., Ltd. according to the ministerial standard of traditional Chinese medicine preparation production varieties. The three species are compound preparation, the audience is widely and Suxiao Zhixie capsules and Tongmai Granule there is no standard of quality control standards, in reference 2005 edition and the 2010 version of "Chinese Pharmacopoeia" and literature based on, combining the actual requirement of pharmaceutical factory production in the process of rapid detection, in this paper, the experimental study is carried out on the proprietary Chinese medicine.l.Ording to Suxiao Zhixie capsule in boxing and the main effective components of gallic acid and chlorogenic acid of two indicators established is simple, sensitive and accurate of RP-HPLC quantitative detection method and technology; Proposed in view of the Suxiao Zhixie capsule bistort Shared by multiple indicator elements to establish a strong specificity, simple and convenient method HPLC fingerprint qualitative identification method and technology.2.1entification of Radix and Radix Salvia miltiorrhiza in the prescription of Tongmai granule. Intends to puerarin and Danshen in the main effective components of Radix Puerariae prime and salvianolic acid B two components, through the establishment of Mai Granule by RP-HPLC quality control method and technology of; of 7 pharmaceutical factory production of Tongmai Granules common peak fingerprint identification and assignment, the source of some of the compounds were assigned. The establishment of fingerprinting.3.The Jiangzhiling capsules existing qualitative and quantitative methods were optimized. Make it more rapid, efficient, more in line with the actual needs of the pharmaceutical production line inspection.Methods1.In this paper, the use of high performance liquid chromatography, RP18 column, using acetonitrile and 0.10% formic acid as mobile phase, detection wavelength of 290nm, volume flow is 0.80ml/min, gradient elution, also of Suxiao Zhixie capsules of 50% methanol extraction solution of gallic acid and chlorogenic acid were quantitatively analyzed, collected by HPLC-MS of gallic acid and chlorogenic acid of qualitative analysis.2.In this paper, using thin-layer chromatography, respectively with chloroform methanol water 7:2:0.25 and toluene-chloroform-ethyl acetate-methanol-formic acid 2:3:4:0.5:2 as expansion agent, using high performance thin layer plate and the prescription of puerarin and Danshen for the qualitative identification. By high performance liquid chromatography, RP18 column, using acetonitrile-0.1 formic acid as mobile phase, detection wavelength of 286nm, volume flow rate was 1ml/ min, also of Tong Mai Granule 50% methanol extract liquid of Radix Puerariae and salvianolic acid B was determined quantitatively. The HPLC-MS identification and identification of some compounds in Tongmai granule.3.In this paper, by thin layer chromatography (TLC) by high performance thin layer plate and the qualitative identification of Jiangzhiling capsules of rhubarb, Radix Astragali and Flos Sophorae, Radix Polygoni Multiflori, medicinal materials were optimized. Using high performance liquid chromatography, RP18 chromatography column, acetonitrile water as mobile phase, the degree of elution, the volume flow rate of 1mL/min, the detection wavelength of 254nm, the quantitative identification of Puerarin in the original standard was optimized. Results1.Method for quantitative detection of the establishment of Suxiao Zhixie capsules, liquid phase, and the two components in Suxiao Zhixie capsules were determined. The results showed that gallic acid and chlorogenic acid in 573-183.39 ug/ml and in 6.52～of 208.65 u g/ml. the linear relations of good, and sample recovery rate (n=5) were 101.20%(RSD was 1.10%) and 103.60%(RSD= 0.80%). The method is simple, accurate and high sensitivity and can be used for the quality control of Suxiao Zhixie capsules.2.This paper establishes the Tongmai granule TLC identification method, through multiple batches of sample plate for test samples and in the control and reference for medicinal chromatograph corresponding position, show the same color fluorescent stripe, without the interference of negative control, accurate identification of puerarin and Danshen medicinal materials. In this paper, to establish a simultaneous determination of Tong Mai Granule in puerarin and salvianolic acid B content. The results show that puerarin and salvianolic acid B in 1554 to 497.35 u g/ ml and 14.82 to 474.20 u g/ml. the linear relations of good and sample recovery rate (n= 5), respectively 100.79%(RSD 1.22%) and 100.16%(RSD= 0.63%) with high performance liquid chromatography. This paper of puerarin and Danshen qualitative and quantitative identification method is simple, accurate and high sensitivity. It can be used for Tong Mai Granule quality control; on 7 pharmaceutical factory production of Tongmai granule common peaks to establish the fingerprint, fingerprint recognition of Tongmai Granules.3.In this paper, using high performance thin layer chromatography of four kinds of medicinal herbs in Jiangzhiling capsules were qualitative optimization, the tested samples and in the control and reference for medicinal chromatograph corresponding position, show the same color fluorescent stripe, without the interference of negative control can accurately identify Radix et Rhizoma Rhei, Radix Astragali and Flos Sophorae, Radix Polygoni Multiflori,4 medicinal herbs, with expansion agent consumption, small sample volume, efficient, quick advantage. For the determination of the content of Puerarin in the original standard has been optimized. The results show that puerarin in 6.31 to 202.07 u g/ml. the linear relations of good,10 minutes can be on Pueraria complete determination of content, compared to the original standard 30min compared, greatly reducing the detection time, saving chemical reagent, sample recovery rate was 99.70%(RSD=1.70), the measured content and pharmacopoeia standard had no significant difference, method is simple, high sensitivity, for the optimization of Jiangzhiling capsules, determination provides support. ConclusionsAbove research improves the Suxiao Zhixie capsules, Tongmai Granule, Jiangzhiling capsules, proprietary Chinese medicine quality control and provide qualitative and quantitative method for rapid and efficient for online detection of for the mass production of the manufacturers.