Study on the correlation between the quality parameters of silicone rubber and the releasing of fluorouracil implants

HU Chaoqi

doi:10.3969/j.issn.1006-0111.2019.01.015

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Objective To analyze the effect of the molecular weight and viscosity of silicone rubber on the release of fluorouracil implants. Methods According to GN/T21863-2008 standard and Chinese Pharmacopoeia, the molecular weight and viscosity of different batches silicone rubber were tested, number average molecular weight, molecular weight distribution and viscosity were recorded, which as X variables. 20 different silicone rubber samples were produced by same preparation process, and WS1-(X-103)-2005Z were used to test the release of each sample, which as Y variable. Minitab 16 software was used to determine the key quality parameters of silicon rubber by multiple regression analysis. Results Number average molecular weight and viscosity were the key quality parameters of silicon rubber, P<0.05, molecular weight distribution was not the key quality parameter of silicon rubber, P>0.05; The linear regression equation was:Y=-0.3+3.76 X₁+0.267X₃. Conclusion Number average molecular weight and viscosity of silicone rubber were the key factors affecting the quality parameters of fluorouracil implants releasing, thus strictly control treatment should been implemented on the two quality parameters during production process, for reducing the effect of silicone rubber on the quality stability of the product maximally.

Study on the correlation between the quality parameters of silicone rubber and the releasing of fluorouracil implants

Quality Management Department, Wuhu Simcere Sino-implant Pharmaceutical Co. Ltd., Wuhu 241080, China

Received Date: 2018-01-02

Rev Recd Date: 2018-06-12

Key words:

Abstract: Objective To analyze the effect of the molecular weight and viscosity of silicone rubber on the release of fluorouracil implants. Methods According to GN/T21863-2008 standard and Chinese Pharmacopoeia, the molecular weight and viscosity of different batches silicone rubber were tested, number average molecular weight, molecular weight distribution and viscosity were recorded, which as X variables. 20 different silicone rubber samples were produced by same preparation process, and WS1-(X-103)-2005Z were used to test the release of each sample, which as Y variable. Minitab 16 software was used to determine the key quality parameters of silicon rubber by multiple regression analysis. Results Number average molecular weight and viscosity were the key quality parameters of silicon rubber, P<0.05, molecular weight distribution was not the key quality parameter of silicon rubber, P>0.05; The linear regression equation was:Y=-0.3+3.76 X₁+0.267X₃. Conclusion Number average molecular weight and viscosity of silicone rubber were the key factors affecting the quality parameters of fluorouracil implants releasing, thus strictly control treatment should been implemented on the two quality parameters during production process, for reducing the effect of silicone rubber on the quality stability of the product maximally.

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Reference (11)

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Study on the correlation between the quality parameters of silicone rubber and the releasing of fluorouracil implants

doi: 10.3969/j.issn.1006-0111.2019.01.015

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