Study On The Quality Standard Of Longhui Pills

Longhui pills is the medicine which is in List of Chinese Basic Medical Insurance for urban workers. It was prescribed as: Radix Gentianae, Aloe, Radix Angelicae Sinensis, Radix et Rhizoma Rhei, Fructus Gardeniae, Radix Scutellariae, Indigo Naturalis, Costus Root. Efficacy: Clearing liver-fire and relax the bowels. Indications: Fire for liver and gallbladder, constipation, urinary astringent. The existing quality standard of Longhui pills is written in the tenth Drug Standard of the Health Ministry. However, It is difficult to control the quality of Longhui pills completely due to the lacking of the qualitative and quantitative control methods of main components in the medicine. To our knowledge, there is only a simple microscopic identification method to examine items under pills. The purpose of this research is to improve the quality standard of Longhui pills and control the quality effectively.This paper mainly includes the following content:1. We choose thin layer chromatography (TLC) to identify some Chinese herbal medicines. After experiments and research, the revelant spots in Aloe, Radix Angelicae Sinensis, Radix et Rhizoma Rhei, Fructus Gardeniae, Radix Scutellariae, Indigo Naturalis, Costus Root were indentified by TLC.2. It is the first time to establish a multi-wavelength HPLC method for the simultaneous determination of geniposide, gentiopicrin, aloin and baicalin in Longhui pills. A C18 column was used with the mobile phase of acetonitrile-0.2% phosphonic acid for gradient elution. The multi-wavelength detection were selected at 238 nm for geniposide, 280 nm for gentiopicrin and baicalin, 355 nm for aloin. The temperature of column was set at 25℃. The method is accurate, sensitive, and repeatable. Simultaneous determination of the four components in Longhui pills by HPLC is firstly carried out by our group, which has not been reported in the literature so far. The developed method not only saves analysis cost, but also directly dromatically improves the quality of the medicine. It also offers the reference for the determination of the relevant multi-component targets.3. We have established a HPLC method for the simultaneous determination of emodin, chrysophanol, physcion in Longhui pills. The chromatographic condition is: Mobile phase: acetonitrile-methanol-0.1% phosphonic acid (35:37:28); Detection: UV at 254 nm. The method is accurate, sensitive, and has good stability. It is not only serves as one of the method for quality standard of Longhui pills, but also serves as the determination of multi-component targets in the complex traditional Chinese medicine.The method of controlling the quality standard of Longhui pills was convenient, feasible and reproducible. In addition, it can also make up the lacking of the qualitative and quantitative criteria in the existing standard. The simultaneous determination of a variety of effective (target) components can be objectively, comprehensively, and economically used for quality control in Longhui pills.