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Key words: butyl rubber stopper; upper rate; compatibility; puncture and chipping natural rubber stopper due to its complex composition, the presence of heterogeneous protein susceptibility, etc., leaving a serious hidden danger to the safety of medication, according to the State Food and Drug Administration The relevant regulations for the elimination of natural rubber stoppers by the Administration, the medicinal butyl rubber stoppers began to embark on the historical stage due to their good air tightness, good heat resistance, good acid and alkali resistance and high internal cleanliness. In the medicinal butyl rubber plug family, halogenated butyl rubber plugs (hereinafter referred to as butyl rubber plugs) are mainly used.
According to the production process requirements of the aseptic preparation, before the butyl rubber stopper enters the stoppering process, it needs to be cleaned, sterilized, dried, etc., and the dry weight loss can be detected before being put into use. In this paper, we will discuss some problems in the production and sales of butyl rubber plugs in the company's cephalosporin powder injections, in order to pay more attention to this.
1 The problem of the probability of rubber stopper In the process of automatic dispensing and filling of powder injection, the phenomenon of plugging and plugging is often not occurred, which will affect the production efficiency of the drug. Now some reasons for the above phenomenon are analyzed:
(1) Rubber plug and bottle size matching problem: The bottle is a B-type bottle, and the plug neck diameter, crown height and total height of the rubber plug should match the size of the bottle. This requires the size of the bottle and the rubber plug to be inspected when the package is filled. If the tolerance of the fit is exceeded, the return and stop treatment should be done.
(2) Equipment running status: The equipment should be commissioned to the good operating state of zui, and the success rate of the rubber plug on the machine should be improved. This point involves a wide range of aspects. For the parting machine plugging part, there are mainly the positioning of the drop plug to the center, the plug position and so on.
For the application of the silicidation process, it also involves the problem of determining the degree of silicification: the plug siliconization is to coat the surface of the rubber plug with a silicone oil film, so that the plug of the rubber plug can prevent the medicine from sticking to it during storage, and at the same time Reduce the friction between the drug and its surface during transportation and transportation, and avoid the occurrence of debris particles caused by friction. If the silicidation is not difficult, the moving machine is not smooth; and if the silicidation is too large, the phenomenon of bucking rebound, jumping, and falling off is prone to occur. Therefore, pharmaceutical companies should select different silicidation requirements according to the needs of their own equipment.
2 Compatibility problems As a packaging material for direct contact with drugs, whether the rubber plug is adsorbed or migrated with the drug will have an impact on the quality of the drug. The rubber plug must also be added with various chemical additives, and it needs to undergo a vulcanization process. Therefore, the various components and sulfide products remaining in the rubber plug are stored in the rubber plug, especially after high temperature sterilization (usually 121 ° C, 30 min) will migrate to the surface of the rubber plug or be extracted, thereby affecting or contaminating the drug. The compatibility of the rubber stopper with the drug depends largely on these migrations or extracts.
For the problem of excessive clarity of ceftriaxone sodium for injection, the industry believes that there is a problem in the compatibility between the rubber stopper and the drug. To this end, the State Food and Drug Administration commissioned the Institute of Intermediate Inspection to develop an accelerated experimental method for the compatibility of ceftriaxone sodium for injection and butyl rubber stopper. The method is as follows: in a 60 ° C incubator, placed inverted for 5 days, to examine the clarity of the drug solution. Used to screen rubber plugs. Subsequently, the SFDA Food and Drug Administration [2009] No. 110 requires each batch of cephalosporin injection to be tested according to the accelerated accelerated test method before leaving the factory. In order to control the source, eliminate the factors affecting the quality of the raw materials and ensure the quality of the products. We also conduct experiments on the cephalosporin raw materials according to the rubber plug compatibility scheme, and then put them into use after passing the test.
Some market feedbacks indicate that the clarity of cefazolin sodium for injection is also excessive, but the reason is still inconclusive. We also carried out an accelerated acceleration test on this, and prepared a powder injection using the cefazolin sodium raw material of Harbin Pharmaceutical Co., Ltd. for compatibility with the same rubber stopper manufacturer, the same rubber stopper batch number, and the batch number of each of the three batches. The experiment was accelerated and the results are shown in Table 1. It can be seen from Table 1 that the rubber stopper has a certain influence on the clarity of the cefazolin sodium solution for injection. Especially when placed in an inverted position, the powder is in contact with the butyl rubber plug to a large extent, and thus the impact is also large. 
(1) Improve the purity of the rubber plug formulation, reduce the formulation components, and reduce the migration and extractables.
(2) Select excellent vulcanization conditions to reduce residual monomers.
(3) Select a suitable plastic film plug. However, the film used for film rubber plugs is different and the manufacturing process is different. There is no uniform standard for packaging materials in the country. At present, rubber stopper enterprises are controlled according to the self-standard standards, but the phenomenon of stripping is found in the use, and the quality standard is to be treated. further improvement.
3 Puncture and chipping problem The standard for the injection of sterile powder with a halogenated butyl rubber stopper (YBB00052005) stipulated that the puncture debris is ≤ 5 grains / 10 pieces (the outer diameter of the injection needle is 0.8 mm), and a small amount of chipping is allowed.
Puncture and chipping is also one of the main indicators to control the quality of butyl rubber plugs. The factors affecting puncture and chipping are mainly related to the puncture needle, the puncture rate, the thickness of the puncture site rubber plug, and the rubber plug material. To reduce puncture and chipping, you can choose a suitable needle with better quality. You can use a side hole needle to reduce the thickness of the rubber plug at the needled part.
4 Conclusion The quality of the rubber plug directly affects the quality of the drug. The pharmaceutical company should strengthen the supplier audit of the rubber plug manufacturer, enhance the information exchange with the rubber stopper manufacturer, and strengthen the rubber plug and drug compatibility test and stability test. Screen the appropriate rubber plugs to track problems in product marketing and user use. At the same time, butyl rubber stopper manufacturers should strictly control the quality of raw materials, improve the formulation and process of rubber stoppers, and solve the adverse effects of rubber stoppers on drugs under the synergy of butyl rubber stoppers and pharmaceutical companies, and improve the quality of drugs. Medication safety.
Discussion on the application of butyl rubber stopper in the use of powder injection
Abstract: According to the application of halogenated butyl rubber stopper in the production of powder injection for sterile powder for injection, some problems existed and some methods for solving these problems were discussed.
Table 1 Results of the clarity test in the rubber plug compatibility accelerated test
To solve the problem of rubber plug and drug compatibility, you can consider the following aspects: