Preliminary Study On Quality Control Of Raw Material And Preparations Of Mai Tong Oral Liquid

Mai Tong Oral Liquid is Chinese herb compound preparations, which is very effective on the treating for diabetes foot. This oral liquid is summarized by Professor Ji Luguang who works in Teaching Hospital of Chengdu University of T.C.M., on the basis of inheriting the essence of Chinese herb and 30 years personal clinical experience. For the improvement of the ambiguous efficacy material base and poor quality controllable which are generally present in Chinese herb currently, there is requirement for the further research.Objective:In this paper, The quality evaluation of Lonicera japonica Thunb. and Morus alba L. etc, are identified;the quality standard of the Morus alba L.is improved;the initially quality standard of the Mai Tong Oral Liquid has been established.Methods:1. Lonicera japonica Thunb. and Morus alba L., the major single herbs in the compound, is identified with microscope and TLC to evaluate the quality of the original herbs refering to China Pharmacopoeia.2 The optimal condition to extract polysaccharide in Morus alba L. is received by orthogonal test, and content is measured with Visible Absorption Spectroscopy.3 According to the Oral Liquid Standard, Mai Tong Oral Liquid is identified with microscopic and TLC method. The content of the polysaccharides and nucleoside,which are efficacy material base in Mai Tong Oral Liquid, is measured with UVAS and HPLC-ELSD method.Results:1. The microscopic characters of three samples of Lonicera japonica Thunb.and six samples of Morus alba L. conform with the identification descriptions in Chinese Pharmacopoeia (2010 edition). The TLC method has good peak resolution and clear spots of Lonicera japonica Thunb. and Loganin, same for Morus alba L.and its control medicinal materials. The quality of the original herbs is sTab. and reliable.2. The method for measuring the content of polysaccharide in Morus alba L. is established. The optimal extraction condition:extraction temperature 100℃, solid to liquid ratio 1:30,2 times, each 3 hours. The average recovery 100.24% and RSD 1.77% suggest good reliability of this method. 3. The TLC identification method is established for Astragalus membranaceus (Fisch.) Bge.,Panax notoginseng (Burk.) F. H. Chen,Angelica sinensis (Oliv.) Diels in Mai Tong Oral Liquid separately. The results show good peak resolution and clear spots. The content measurement result of Astragaloside IV shows good linear relationship within 2～8μg (r=0.9996). The measure of total polysaccharide shows good reliability with average recovery 100.89% and RSD 1.91%.Conclution:1. The quality evaluation of the raw material which are the lack of study in Mai Tong Oral Liquid are conformed.2. The methods to measure the content of polysaccharide in Morus alba L. is established, which would improve the quality standard of Morus alba L.3. The initially quality standard of the Mai Tong Oral Liquid has been established.