Research On Heluoshugan Tablet Production Process And Quality Control

Heluoshugan Tablet is included in the preparation of Chinese medicine in second volume of the Drug Standard which issued by the Ministry of Health. The medicine is composed of Radix Paeoniae Alba, Rhizoma Atractylodis Macrocephalae, rhubarb and other twenty-seven kinds of Chinese herbal medicine, which has the rigorous prescription and embodies dialectical treatment by tranditional Chinese medicine.Heluoshugan Tablet can soothe the liver and regulate qi; cleare heat of wetting; promote blood circulation and remove blood stasis and nourish liver and kidney. And it has good therapeutic effect for chronic persistent hepatitis, chronic active hepatitis and early cirrhosis. Heluoshugan Tablets plays an important role in the treatment of liver disease, and has achieved good therapeutic effect. In the original standard, there isn’t content measurement. So it is difficult to control and ensure the quality of the products. In this paper, we develop the method of content determination, and determine the index component limits using the content of paeoniflorin as determination index. We also develop the test of TLC identification for the main fuctional compents of Atractylodes, Rhizoma Cyperi and other two kinds of traditional Chinese medicinal herbs, which provides stonge basis for the quality control of drugs. Taking the extract rate and the content of emodin as indicators for inspection, We optimize the extraction technology of Heluoshugan tablet. We determine the optimal condition for the spray drying and film coated by orthogonal experiments. The main results are as follows.Firstly, the optimization of the production technology. We take the heating reflux extraction method replacing the original process of decocting method. Compared with the old method, heating reflux extraction has high bioavailability, good stability, and can save a lot of water energy in the preparation process, extract completely, and mold easily and etc. Through the investigation of water volume, extracting time, we determine the best extraction techonogy. Taking the spray drying method instead of the original process of microwave vacuum drying method, we not only shorten the drying time; reduce cost; get better quality of the fine powder, but also improve the weakness that the extract obtained by the microwave vacuum drying is too viscous, and is not easy to form. We determine the spray drying, film coated condition through orthogonal test. And we also make an on-the-spot investigation of adhesive concentration on pelleting process and lubricant on tabletting process. All the work improve the medicine effective component content, and the quality of medicine.Secondly, the study of the improvement of the quality standard. We take the HPLC method to determine effective components of paeoniflorin in the prescription of monarch drug Radix Paeoniae Alba. The chromatographic conditions are:C18chromatographic column, mobile phase of methanol-water (28:72); the detection wavelength:230nm1.Oml/min; flow rate; the injection volume is20μ. L The results show that the HPLC method for the determination of drugs is simple, accurate, reproducible, and it is an effective method of quality control. Using TLC method in identifing the prescription of Atractylodes macrocephala, Radix Paeoniae Alba, zedoary, Rhizoma Cyperi, the results show that the color spot is stable, clear, without interference, and the results are reproducible, which shows the method can accurately realize the drug qualitative control.Thirdly, the study of the product stability. Using the new technology of production of Heluoshugan tablets, we carry out the accelerating test and stability test. The results show that the tablet using the method in the production has the stable quality, reliable performance, and it is suitable for industrialized production.In this paper, we optimize production technology of Heluoshugan Tablet; improve the product effective component content and save the production cost. Through improving the product quality standards, we realize the qualitative and quantitative control of the products, which lay a good foundation in the industrialization production. The study provides a benifical exploration for the application in Chinese medicine production process.