New Technology And Quality Control Of New Compound Daqingye Tablets

New compound daqingye tablet was specified in "Health of the People’s Republic of China Ministry of pharmaceutical standards the Chinese medicine Narikata preparations". It has been proved to be effective in anti-inflammatory, antipyretic efficacy. It is often used to treat colds, headache, runny nose, joint pain and so on. However, there are many quality problems such as moisture absorption and disintegration time overrun in the production and storage. And the method in the original standard inspection is relatively simple, so that it can not effectively control the quality of drugs. This paper aims to explore the applicability of the obtained optimal formulation and preparation process of the new compound Daqingye tablet based on the results of the lab-scale experiments in order to ensure the successful of the large-scale productions. The accurate and controllable quality criteria of the new compound Daqingye tablet had been established using the samples of pilot scale productions and the stability of the new compound Daqingye tablet were studied to verify the feasibility of the obtained formulation and preparation process and the controllability of quality criteria.The whole work included three parts:the optimization of the formulation, the set up of the quality criteria, and the stability studies. To obtain the optimized formulation and the preparation process of the new compound Daqingye tablet, the kinds, dosage, and usage of disintegrant were studied. We chose PVPP as dispersant (By3%). The process factors affecting drug quality were also investigated through orthogonal design in this paper. The factors of air intake’s temperature, coating fluid’s concentration and coating pan’s temperature were the main effect factors to affect coating quality. Under the conditions of experiments, the air intake’s temperature was75～80℃, the flow rate was0.3～0.35/kg.min-1, coating fluid’s concentration was12%. Which were the optimum conditions for the new compound Daqingye tablet.The quality control of the new compound Daqingye tablet was established referring to Pharmacopoeia of the P. R. China (2010). TLC method is used to indentify chrysophanol and emodin which are from Rhei Radix et Rhizoma (Dahuang) and chlorogenic acid of Lonicerae japonicea (Jinyinhua). HPLC method was used to determine the adenosine of Isatidis folium (Daqingye). The detective wavelength was set at260nm, the mobile phase consisted of methanol/water (8:92, V/V). The calibration curve of peak area v.s. concentration of adenosine was y=4431895x-21026(R=0.9997), where A:peak area and C:propofol concentration) with the average recovery of99.51%and RSD of0.44%. HPLC method was also used to determine the glallic acid of Bistortae rhizome (Quanshen). The detective wavelength was set at261nm, the mobile phase consisted of methanol/water/phosphoric acid (2:98:0.5, V/V/V). The calibration curve of peak area v.s. concentration of adenosine was y=1331093.55x-23060.50(R=0.9996), where A:peak area and C:propofol concentration) with the average recovery of99.21%and RSD of1.06%.The stability studies were carried out including high temperature test, high humidity test and highlight test. The results showed that the color of the new compound Daqingye tablet is a little faded at the highlight test, and it is slightly wet at the high humidity test. Therefore, the drug should be stored away from light and air. Taken all together, these results showed that the formulation and the preparation process were feasible, the quality was controllable and the products were qualified. The stability studies were carried out including accelerated stability test at40℃,75%±5%humidity for6months and long-term stability study for24months. For the accelerated stability test, each index fluctuations of the product was lesser, all products met quality standards. For the long-term stability study, the results showed that product quality test showed a slight change in disintegration time after18months, but the results still met quality control.Taken all together, these results showed that the formulation and the preparation process were feasible, the quality was controllable and the products were qualified.