Common packaging materials and form characteristics of pharmaceutical injections II
aseptic film sealing of the outer cover
note 1:* natural rubber stopper: it is composed of natural rubber plus vulcanizing agent, accelerator and filler. This product structure was invented by Chinese medical scientists in the 1960s. At that time, the weight of the rubber plug was reduced due to the need to reduce the amount of glue used; Secondly, there was no aluminum alloy material in China at that time, so we can only use pure aluminum to make caps, and the extrusion strength was not enough. In order to solve this problem, the function of fatigue testing machine was greatly strengthened, and a rubber plug was invented to add a flanging sealing surface. In fact, this structure includes the inner line seal of the corked bottle mouth, the compression surface seal at the top of the bottle mouth at the turning edge, and the outer line seal of the bottle mouth at the turning edge. This structure has the best sealing performance. However, the properties of natural rubber have been reviewed previously. The easily soluble substances in natural rubber will affect the quality of the liquid medicine. In order to avoid the contact between the rubber plug and the liquid medicine, the surface of the rubber plug is covered with a layer of pet (commonly known as polyester film), but the pet and the surface of the rubber plug cannot be close, forming wrinkles, which will produce capillary effect in the sterilization process. In addition, the liquid medicine generally includes hardware and software. The surface of the rubber plug is extracted, leaving the dissolved substances of the rubber plug on the PET film, It enters the body with the liquid during injection. Because the dissolution of the rubber plug does not directly enter the drug solution, it is not easy to be found by 5. After the sample is broken, close the stop electromechanical detection, unless pet falls off the bottle mouth. Therefore, pet is used to cover the surface of the rubber plug to cover up the dissolved substances. Clinically, it often happens that after the preparation of the liquid, the clarity of the liquid suddenly fails to meet the standard and it is obviously turbid. This kind of traditional Chinese medicine injection often occurs
note 2: PP bottles are sealed with direct halogenated butyl rubber stopper, which is the same as glass infusion bottles. It is generally considered that this method needs to be evaluated. Because the rigidity of PP bottle mouth is not as large as that of glass, if the hardness of PP bottle mouth and seal is inconsistent, the bottle mouth will be deformed and leak. 2. After the temperature difference of nearly Baidu, the expansion coefficient of the bottle mouth and the seal is different, resulting in the loss of sealing function. Therefore, this structure needs to be investigated for a long time and in multiple climatic zones, and then popularized and used according to the results
II. The market value of small volume injections will reach US $33.33 billion by 2022: according to the process, they can be divided into three categories: solution, powder and freeze-dried powder. See Table 3 for their packaging form
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(Shanghai packaging)
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