Compatibility test of glass

Drug packaging here refers to the packaging of drugs in direct contact, such as glass bottles, plastic bottles, aluminum foil, butyl gaskets, rubber plugs, aluminum caps and so on.Like these direct contact with the quality of drug packaging is directly affected by the drug.Compatibility basically covers any interchange between products and packaging.Incompatibility may be related to reaction, migration, leakage, adsorption, absorption and extraction, resulting in the gain and loss of components and physical or chemical changes.These exchanges can be manifested as changes in organ sensation, enhancement of toxicity or irritation, gain and loss of microbial effects, precipitation, turbidity, color change, pH shift and degradation, etc.On the other hand, other external factors can catalyze, initiate or eliminate chemical changes.Chemical changes may accompany further chemical reactions.Chemical reactions or contamination may also be caused by impurities in the component, by accidental components produced in the production process, or by wear and tear between contact surfaces.
at present, there are more than 60 kinds of packaging materials and containers directly in contact with drugs in five categories of pharmaceutical glass, metal, pharmaceutical gelatin products, rubber, plastic (container, sheet material, film) and composite sheet (film) in China.Despite the great development of pharmaceutical packaging materials in recent years under the influence of internationalization, the promotion of market demand and the support and guidance of relevant policies in China, China's pharmaceutical packaging material manufacturers and pharmaceutical packaging products are still relatively backward, the overall level of pharmaceutical packaging is low, and the contribution rate of packaging materials to the development of pharmaceutical economy is low.The overall level of pharmaceutical packaging, including the quality of packaging, packaging material quality and the contribution rate of packaging to pharmaceutical economy are significantly lower than that of developed countries.
although there are large enterprises in China's existing pharmaceutical packaging material manufacturing enterprises, most of them are township collective enterprises with small scale, low personnel quality, equipment, technology and management level, and unstable product quality.At present, the existing packaging material technology of many pharmaceutical packaging material manufacturers is backward and the market disorder is quite serious, especially in the face of the emergence of endless pharmaceutical enterprises to develop new products, new dosage forms, the development and production of physical and chemical characteristics of the drug packaging material matching the following up speed is too slow and other problems have not been solved.Less innovation and more imitation of existing packaging materials are the survival path of pharmaceutical packaging material manufacturers. The phenomenon of packaging different drugs with one kind of pharmaceutical packaging material always exists. < br / > for a long time, companies pay close attention to the safety of the drug in new drug research and development, often only consider the research and development of new drugs in the traditional sense of the drug (active ingredient) safety, drug own safety is concerned, mainly drug toxicology, the relevant features, and in the clinical use of adverse reactions resulting from (severe adverse reactions and unintended adverse reactions and side effects), etc.However, the potential factors that can affect the quality of drugs, such as bulk drugs and packaging materials of pharmaceutical preparations, have not attracted the attention of all people.This concept exists in both drug packaging material manufacturers and drug packaging material users.Improper drug packaging, improper selection of packaging materials and the impact of storage environment will bring certain negative effects on drug quality.
the packaging materials and containers that come into direct contact with drugs are an integral part of drugs, which accompany the production and circulation of drugs.The whole process of open storage and use.Due to the differences in drug packaging materials, container composition formula, selected raw and auxiliary materials and production process, some components may be dissolved by the drug in contact, transferred to the drug, and released toxic and harmful substances.Or interact with drugs, adsorption of active ingredients in drugs, reduce the content of effective ingredients and affect the efficacy of drugs.However, the quality of the alligators will be directly affected by the long-term immersion corrosion of the alligators.Some substances may even lead to accelerated degradation of drugs, not only because the reduction of effective ingredients affects the clinical efficacy of drugs, but also because some of the degradable ingredients may bring serious safety risks to public medication due to toxic side effects.
, e.g. Retort.Infusion bottle (bag), if not for different drugs with different formula and production process, often there will be component dissolution and glass chip phenomenon, generally can not be found in the conventional drug test.The isotropic proteins dissolved in natural rubber plug can induce boson sensitization in human body, and the pyridine compounds dissolved are the positive factors of carcinogenesis, teratogenicity and mutagenesis.Some additives in butyl gum cold alone can produce serious hemolysis phenomenon, and some additives alone are very toxic, if added)JuN in the finished product in butyl gum cold is not appropriate proportion, the results can be imagined.While the glass infusion bottle in the small glass chip is blocked blood vessel thrombosis or pulmonary granuloma hidden danger, iodine preparation can seriously corrosion packaging of its aluminum foil, resulting in iodine volatilization and so on.On the other hand, because of the variety of drugs and the complexity of their effective parentheses, the requirements for packaging materials and containers in direct contact with them are much higher than those for other products.< br / > the country's "(pharmaceutical administration law of the People's Republic of China)) stipulated in article 52" direct contact with drugs packaging materials and containers, must conform to the requirements for medicinal use, conform to the safeguard human health and safety standards ". Article 53 rules "drug packaging must meet the specific quality requirements, convenient storage, transportation and medical use". The national SFDA issued ((drug packaging material container management method ", ": the regulations on drug packaging, label and manual two chief, as to fundamentally ensure medication safety, efficacy, and uniformity.It is pointed out in the regulations that drug packaging includes inner packaging and outer packaging.And emphasize the requirements of internal and external packaging respectively: before selecting the packaging container (material) for drugs, it is required to verify whether it is suitable for the intended use, to fully evaluate its impact on drug stability, and to evaluate its long-term storage process under different environmental conditions (such as temperature and humidity).Light, etc.), in the process of transport to use (such as contact with the drug reaction, adsorption of drugs, etc.), container (material), the protection of drug effect and the physical, chemical and biological inert itself, should be selected according to the nature of the drug packaging materials, and the stability of the corresponding experiment, so before using drug packaging materials need to do is test and drug packaging materials and the compatibility of medicines;According to the characteristics of drugs, packaging materials that are not easy to be damaged should be selected for external packaging to further ensure the safety of drugs in transportation, storage and use.< br / > in this kind of request, so companies need to know more about drugs packaging materials products technical quality standards, testing methods, to understand the relationship between medicine and packaging materials, and the experimental contents, methods, and according to the requirements of the different varieties of drugs scientific and rational selection and use of different packaging materials, avoid drug quality accident caused by improper selection, in order to ensure the people are safe and effective drug use, drug packaging materials production enterprises need to know more packaging materials products technical quality standards, testing methods, medicine and the general rule of the interaction of packaging materials,In particular, it is necessary to adapt to the requirements of new drugs on packaging materials to provide pharmaceutical enterprises with satisfactory products and services and improve their product competitiveness.
for packaging materials or containers that come into direct contact with drugs, drug manufacturers must comply with the guiding principles for drug stability test in the appendix to the Chinese pharmacopoeia and the guiding principles for drug packaging materials and drug compatibility test in YBBOOl42002, a trial standard of the state food and drug administration.According to the test results, the drug packaging materials produced by the packaging and printing enterprises should be strictly examined and the appropriate packaging forms and materials should be selected.And when it comes to drug registration.An application shall be submitted together to confirm that the packaging forms and packaging materials selected by the applicant and the registered new drugs conform to the requirements of the new drug registration administration measures.
the principle of compatibility test between drug packaging material and drug should basically follow the following principles:
(I) when selecting drug packaging materials and containers, drugs should first consider their protective functions, and then consider the characteristics and properties of materials and containers, including chemical, physical, biological, morphological and other properties.
(ii) the coating material shall have good chemical stability, low mobility, oxygen resistance, water resistance, impact resistance and no biological activity.The microorganism number has good coordination with other packaging materials in the control range and is suitable for automatic packaging equipment.
(iii) drug packaging materials and drugs should meet relevant standards before evaluation.
(iv) all items that can pass the drug stability test shall be considered in the drug packaging material and drug compatibility test.
when inspecting drug packaging materials, containers made of three batches of packaging materials should be selected to conduct compatibility tests on a batch of drugs.When inspecting drugs, the compatibility test should be carried out after three batches of drugs are packed with a batch of packaging materials or containers to be marketed.Reference can be made to the standard design experiment of the drug and the packaging material.
during the whole process of the test, the drug should simulate the actual use, so that the drug is in full contact with the packaging container.Such as liquid preparations, ointment preparations should be considered inverted, side.Multi-dose packages should be opened multiple times.
glass container should focus on the impact of the release of alkaline ions in glass on the pH of drug solution, the release of harmful metal elements, the dissolution of colorants in colored glass bottles, glass chip removal, etc.
metal packaging materials should focus on the drug corrosion of metal materials, metal ions on drug stability.Plastic packaging containers should focus on the investigation of water vapor, oxygen permeability, sealing, dissolution of the test.
rubber packaging material is usually used as the gasket and plug of the container, and the influence of dissolution of various additives in the rubber plug on the physical and chemical properties of the drug should be mainly investigated. The adsorption of rubber on the drug, and the container should be inverted in the investigation of liquid preparation and powder injection, so that the drug can fully contact with the rubber plug. < br / > although the development of pharmaceutical packaging materials in China is nearly 20 years, especially in the past decade, China's pharmaceutical packaging materials production through the introduction of technology and equipment have r great progress and development, but the degree of innovation and new drugs and still stay in the shallow, low levels of repetitive production packaging materials, this is bound to affect the quality of the new drug research and development in China, if you want to stand firm in the domestic market, if you want to go out to occupy a larger market, must have their own new technology and intellectual property rights, to be able to better combined with the quality of new drugs.With the progress of science and technology and the development of social demand, the scale, production technology, management, product variety and quality of pharmaceutical packaging materials in China will have qualitative changes and progress.Outdated products and test methods will eventually be eliminated, and new packaging material products suitable for the development of new drugs will be more widely used.