Nanjing Xinbai Pharmaceutical Co. Ltd.

Modified Simiaowan (MSW) is a traditional Chinese medicine formula that is composed of six herbs. It has been widely used in the treatment of gouty arthritis.

This study was designed to investigate the effect of MSW on gouty arthritis and explore the possible mechanisms.

The rat gouty arthritis model was established by intra-articular injection of Monosodium Urate (MSU) crystal, and then treated with MSW for 5 days. The perimeter of the knee joints was measured in a time-dependent manner and serum samples were collected for the detection of TNF-α, IL-1β, and IL-6 protein levels by ELISA. The protein expressions of MMP-3, TIMP-3, STAT3, and p-STAT3 in cartilage tissues and C28/I2 cells were detected by Western blot, and the levels of proteoglycan in primary chondrocytes and cartilage tissues were determined by toluidine blue staining. In addition, AG490 and IL-6 were used in vitro to explore the function of IL-6/STAT3 pathway in the protective effect of MSU.

MSW reduced the joint swelling rate in gouty arthritis model and inhibited MSU induced up-regulation of IL-1β, TNF-α, and IL-6 protein levels in serum and synovial fluid. IL-1β induced an increase in p-STAT3 and MMP-3 protein expression in C28/I2 cells, as well as a decrease in TIMP-3. MSW serum inhibited the protein expression changes induced by IL-1β in vitro. Furthermore, inhibition of STAT3 signaling negated the effect of MSW serum on p-STAT3, MMP-3, and TIMP-3 protein levels in C28/I2 cells. MSW also increased the content of proteoglycan significantly both in vivo and in vitro.

Our data indicated that MSW protected rats from MSU-induced experimental gouty arthritis and IL-1β/IL-6/STAT3 pathway played an essential role in the protective effect of MSU against GA.

The freeze-dried powder injection is a relatively complex type of medicine with aseptic filling of productionAccording to the requirements of the "Drug Production Management Regulations(the 2010 Revision)" and its appendices, medium simulation filling should be carried out.Aseptic process and aseptic assurance level should be comprehensively evaluated in the test, to prove the effectiveness of the methods and procedures used in the aseptic filling process, and to confirm whether the aseptic process production level meets the requirements under the worst conditions.Full verification of the aseptic potting process is an important part of GMP(good manufacturing practices) management.

The vast majority of drugs are composed of various chem. elements, and many drugs can be called chems.In order to ensure the safety of drugs, it is necessary to analyze the drug components in all directions and control the impurities in chems. in real time reasonably, professionally and strictly.In recent years, China's pharmaceutical industry has developed very rapidly, especially in the control of impurity spectrum based on drug impurity characteristics, which further determines the physiol. activities and impurity limits of various chems., and lays a good foundation for the continuous improvement of the safety and quality of China's pharmaceutical industry.This paper will analyze the present situation and prospect of chem. impurity control, and make corresponding arrangement and summary according to the actual situation.