[Finding Analysis of Medical Device Manufacturer Audit in Suzhou Industrial Park for the Last Three Years].

OBJECTIVE: Common findings are to be found from 144 different type of medical device manufacturers' audit reports which are from Jan. 2017 to Jun. 2019. Advise is to be provided for medical device manufacturers on continual improvement. METHODS: Classify and analyze the on-site audit findings from different type of medical device manufacturers. RESULTS: The frequency of findings from chapter production management, buildings and facilities, quality control are comparatively high. CONCLUSIONS: The key to improve the quality management system is to cultivate the staff sense of continual improvement of quality system, improve the staff ability of finding and solving problems, encourage staff participation in quality system, fit the quality system on product realization.

[Study on percutaneous absorption of Xuetie Dingchuan Plaster].

OBJECTIVE: To filtrate prescription of the adhesive plaster, kind and amount of percutaneous absorption reagent, etc. METHODS: In vitro percutaneous absorption of Xuetie Dingchuan Plaster was studied by HPLC using magnolin as the content of the marker substance, in the condition of equal effective component of samples, drawing graphs with time as abscissa and area of peak as ordinate. RESULTS: 40% ethanol was used as receptor liquid, prescription with Polyethylene Glycol 6000 as bases, azone as percutaneous absorption reagent. The amount of azone was 1.8%. CONCLUSION: The prescription of Xuetie Dingchuan Plaster, with 1.8% azone as percutaneous absorption reagent, and Polyethylene Glycol 6000 as bases, is preferable.