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Cleanliness detection method of rubber plugs for sterile powder for ultraviolet absorbance evaluative injection

A technology of sterile powder and detection method, applied in the measurement of color/spectral characteristics, etc., can solve the problems of long time period, complex rubber stopper composition, and high detection cost, and achieve the effect of saving cost and improving the accuracy and efficiency of research and development.

Inactive Publication Date: 2016-12-07
郑州翱翔医药科技股份有限公司
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  • Application Information

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Problems solved by technology

Although this method is relatively perfect, the time period is long and the detection cost is high; moreover, the composition of the rubber plug is complex, including various vulcanizing agents such as sulfur, zinc oxide, phenolic resin, peroxide, amines, etc., as well as calcined clay and Different kinds of fillers such as talc powder

Method used

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  • Cleanliness detection method of rubber plugs for sterile powder for ultraviolet absorbance evaluative injection

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Embodiment 1

[0016] Ultraviolet absorbance of the present invention evaluates the detection method of the cleanliness of the rubber stopper for sterile powder for injection as follows:

[0017] Select two basic production formulas to produce rubber stoppers for sterile powders for injection, product specification 20-B, carry out rapid evaluation according to the method of the present invention, and initially compare the cleanliness of the rubber stoppers; Sodium drug powder was accelerated for 6 months for compatibility test, and the key index of drug clarity was selected for comparison, so as to verify the effectiveness of the rapid test method. Based on the basic production formula, follow the conventional production process of rubber stopper for sterile powder for injection, such as compounding, rubber mixing, vulcanization, punching, cleaning and packaging, etc., and produce according to the corresponding process conditions.

[0018] The rubber stopper for sterile powder for injection ...

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Abstract

The invention provides a cleanliness detection method of rubber plugs for sterile powder for ultraviolet absorbance evaluative injection. The cleanliness detection method includes soaking the rubber plugs into an ethanol solution with the mass concentration of 15%, an isopropanol solution with the mass concentration of 50% and normal saline respectively before storing; putting the rubber plugs into a thermostat, and soaking the rubber plugs at the temperature of 60 DEG C for one month; measuring ultraviolet absorbances of extracts at the positions of 220nm, and recording absorption spectra in different solvents; according to different ultraviolet absorbances, comparing ultraviolet absorption conditions of the plug rubbers for different sterile injection powder in the same solvent, and judging the cleanness of the formula rubber plugs. The cleanliness detection method has the advantages that the cleanness of the rubber plugs for the sterile powder for ultraviolet absorbance evaluative injection can be judged quickly and simply, and the foundation is laid for research on compatibility between the rubber plugs and drugs as well as for product screening; the method is simple to operate and easy to popularize.

Description

technical field [0001] The invention belongs to the field of detection methods for pharmaceutical packaging materials, and in particular relates to a detection method for evaluating the cleanliness of a rubber stopper for sterile powder for injection by ultraviolet absorbance. Background technique [0002] In recent years, a lot of work has been done on the compatibility of rubber stoppers for sterile powders for injection. At present, the conventional method for judging the cleanliness of rubber stoppers for sterile powders for injection is mainly through accelerated tests and long-term experiments on rubber stoppers and drugs. Place it for 6 months, take it out at 0, 1, 2, 3, and 6 months, and test it; the long-term test is to store the test product at 25°C ± 2°C for 12 months, and test it at 0, 3, 6, and 6 months respectively. Take it out at 9 and 12 months for testing. Although this method is relatively perfect, the time period is long and the detection cost is high; m...

Claims

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Application Information

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IPC IPC(8): G01N21/33
CPCG01N21/33
Inventor 马东风刘海洪刘梅玲杨敬鹏李向阳慎朝臣胡跃磊杨明真
Owner 郑州翱翔医药科技股份有限公司
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