Study On Extraction Technology And Quality Standard Of Extract Of Xiaoshuan Oral Liquid

Objective:Extraction technology, quality standard, and initial stability studys of Xiaoshuan oral liqiud were systematically carried out, so as to ensure the stability and quality control of raw materials and intermediate goods. In order to improve deficiencies of original technology and quality standard, extraction method was further optimized, and a more comprehensive extract quality standard was established. It is a basis to develop Xiaoshuan oral liqiud secondly.Methods:1. The extraction technology research:To optimize the conditions of extraction techonolgy of the Astragaloside in extract of Xiaoshuan oral liqiuid by water boiling method, the L9(34) orthogonal design experiments were carried out, in which four influence factors, soaking time, amount of water, extraction time and boiling times were selected, and the rate of extract and Astragaloside amount were regarded as the evalutating indices.To choose the optimal conditions of alcohol precipitation test in the extract, the L9(34) orthogonal design experiments were used. Concentrated proportion, concentration of alcohol-precipitation, and depositing time as three influence factors have been investigated, and rate of extract and Astragaloside amount were regarded as the evalutating indices.2. The quality standard research:It was indentified for Astragalus Root, Szechwan Lovage Rhizome, Radix Paeoniae Rubra, Chinese Angelica in extract of Xiaoshuan oral liqiud by TLC. Accroding to related regulations in China Pharmacopoia, pH, relative density, the content limit of heavy metal and Arsenicum were analysised in extract of Xiaoshuan oral liqiuid. And it was determined for the content of Astragaloside amount in the extract by HPLC-ELSD, in which the chromatography conditions were that the DiamonsilTM C18 (4.6mm×250mm,5μm) column was used, the mobile phase were composed of acetonitrile:water (38:62), flow rate: 1.0ml·min-1, column temperature:30℃, ELSD, tube temperature:40℃, pressure of carrier gas:0.40MPa.Results:1. The extraction technology research:the optimium water boiling conditions for extract of Xiaoshuan oral liqiud, were that soking time was 0.5 hour, extracted three times and 1.5 hours for each time, the amount of water used was 11.4,10,10 times of the mixing medicinal materials respectively. The optimium alcohol precipitation conditions for the extract, were that cocentrated proportion was 2.5:1, concentration of alcohol-extracting was 75%, depositing time was 12 hours.2. The quality standard research:New methods were established to identify Szechwan Lovage Rhizome, Radix Paeoniae Rubra, Chinese Angelica in extract by TLC. The results shown that tested samples have the same color spots or fluorescent spots at corresponding position of the control medicines chromatography, while the negative control without any interference. Spots with strong clarity, repeatability and specificity, and these methods provided good reference for identification of these three medicinal herbs.A new method was developed, which was detected the content Astragaloside in extract of Xiaoshuan oral liquid, by HPLC-ELSD methods. The results shown that linear range of content Astragaloside was 1.24-7.44μg (r=0.9991). Precision (RSD) was 1.06%. Stability experiment results shown that samples were stability in 48 hours (RSD=1.60%). Repeatability (RSD) was 1.27%. Average recovery was 96.45% while RSD was 0.80%. Test results show that the method is accurate, reliable, and can be used to determine the content of Astragaloside in the extract.