Study On Quality Standard Of Jindan Tablets

Cholelithiasis is a common disease and has a high prevalence especially in recent years as physical examinations was extensively developed. There are many ways to treat cholelithiasis, such as drugs and surgery.In terms of drug treatment, the common cholagogues are armillarisin A, ursodeoxycholic acid, etc. but nausea, vomiting, constipation and other side effects is significantly. While the efficacy of traditional Chinese medicine is unique and outstanding. According to the traditional Chinese medicine theory, it usually start with Eliminating heat, nourishing gallbladder, regulating the flow of qi and alleviating pain.Jindan tablets is developed with modern pharmaceutical technology and Chengzhi He, the famous TCM doctor offered the tradional remedy which was handed down to 28 generations. Consisting of Lysimachiae Herbe, Gentian Radix et Rhizoma, Polygoni Cuspidati Rhizoma et Radix, Suis Fellis Pulvis and other traditional Chinese medicine, Jindan tablets have many beneficial effects such as heat-clearing, detoxifying, anti-inflammatory, nourishing gallbladder, removing calculus. It is used to treat biliary tract infections, especially the clinical treatment cholecystitis and cholelithiasis. With Jindan tablets, abdominal pain, the main symptoms of biliary tract diseases has obvious relief.Jindan tablets are compound preparations of traditional Chinese medicine, together with the complicated components, increasing the difficulty for the establishment of quality standard. So far, china pharmacopoeia haven’t collected about Jindan tablets quality standard. The current quality standard is still the ministerial standard with simple qualitative identification of Polygoni Cuspidati Rhizoma et Radix and Suis Fellis Pulvis. To provide a more comprehensive reference for Jindan tablets’ quality standards, we selected some index components in each prescription composition of Jindan tablets from different manufacturers or different batches tostudy. With RP-HPLC, microemulsion TLC and TLC on the indexes, a systematic research was made.Objectives: To provide references for improving and completing the quality standards of Jindan tablets.Methods: To establish a RP-HPLC method for the determination of quercetin and kaempferol in Lysimachiae Herbe; To establish the RP-HPLC methods for the respective determination of polydation, resveratrol and emodin, physcion in Polygoni Cuspidati Rhizoma et Radix; To establish a RP-HPLC method for the determination of gentiopicrin in gentian; To establish a microemulsion TLC method for the identification of stibenes and anthraguiones in Polygoni Cuspidati Rhizoma et Radix; To establish a TLC method for the identification of hyodeoxycholic acid in Suis Fellis Pulvis.Results: The calibration curves of quercetin were linear in ranges 1.03×10^-3 g·L^-1-2.07×10^-2 g·L^-1 with r of 0.9995. The average recoveries were 100.6% with RSD of 1.92%. The calibration curves of kaempferol were linear in ranges 2.62×10-4 g·L^-1-5.23×10^-3 g·L^-1 with r of 0.9995. The average recoveries were 100.3% with RSD of 1.60%. The calibration curves of polydatin were linear in ranges 8.00×10^-3 g·L^-1-6.40×10^-2 g·L^-1 with r of 1.0000. The average recoveries were 98.9% with RSD of 1.3%. The calibration curves of resveratrol were linear in ranges 5.63×10^-3 g·L^-1-5.63×10^-2 g·L^-1 with r of 1.0000. The average recoveries were 99.8% with RSD of 1.9%. The calibration curves of emodin were linear in ranges 4.00×10^-6 g·L^-14.00×10^-5 g·L^-1 with r of 0.9990. The average recoveries were 99.9% with RSD of 1.1%. The calibration curves of physcion were linear in ranges 1.00×10^-3 g·L^-11.00×10^-2 g·L^-1 with r of 0.9990. The average recoveries were 99.2% with RSD of 1.9%. The calibration curves of gentiopicrin were linear in ranges 4.60×10^-3 g·L^-16.40×10^-2 g·L^-1 with r of 0.9999. The average recoveries were 98.7% with RSD of 2.8%. TCL chromatograms were good with obvious characteristics, clear spots and the negative substance is non-interference.Conclusion: The methods is simple, accurate, high sensitivity and good reproducibility. It can provide scientific and effective methods and bases for Jindan tablets to establish the quality standards.