Physical and chemical properties and specifications of medicinal glass
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Take the standard of medicinal glass products as an example, there are 9 existing standards. With the development of the market, the structure and use of medicinal glass bottles have undergone fundamental changes. The use of some varieties is becoming less and less, and the relevant standards are no longer appropriate. For example, most of the large-sized bottles and jars used to hold tablets are replaced by plastic bottles, aluminum foils, etc. Currently, most of the oral liquid preparations used in the market for various health care medicines and nutritional medicines are high-grade. Development and small standardization. Threaded mouth control glass bottles are mainly used for oral medicines such as tablets and powders. With the replacement of new materials such as plastic bottles and aluminum foils, the dosage is gradually reduced. "Pharmaceutical Glass Bottle" is the longest standard in the standard of medicinal glass products. It is far from being able to adapt to market demand and product status. Therefore, the State Drug Administration has included the product standard in the restriction and revision plan. For the development of the pharmaceutical industry and the demand for biomedical and biopharmaceutical drugs, the 2000 version of the pharmaceutical industry standards that have not yet been officially announced will refer to relevant international standards.
<br> <br> pharmaceutical glass detection test items of medicinal products according to their use of glass divided into physical and chemical properties, size and appearance of the three items. After being in line with international pharmaceutical glass standards and testing methods, it is necessary to increase the chemical composition of the glass and the detection of the leaching content of harmful substances.
Physical and chemical properties <br> <br> physical and chemical properties of pharmaceutical glass is an important quality indicators and test items, the intrinsic quality of the product is reflected and embodied a direct impact on the quality of drugs. The items that belong to physical and chemical properties testing include: water resistance, internal stress, internal pressure resistance, thermal shock resistance, freeze resistance, breaking force, acid resistance and resistance.
Water resistance: water resistance is the chemical stability of medicinal glass. Since medicinal glass is a packaging container that directly contacts pharmaceuticals, it cannot be deteriorated or invalidated due to changes in chemical properties during the shelf life of the drug. Therefore, chemical stability The pros and cons are directly related to the quality of the drug.
The water resistance test is divided into a particle method and a container method, and the test principle is to neutralize the content of the surface or the inside of the glass container with a certain amount of acid solution. The particle method is the detection of the chemical properties of glass materials. The test method standard is GB12416.2-1990 "Test and classification of glass particles at 121 °C water resistance", GB/T6582 "glass test and classification of water resistance at 98 °C" 》. The container method is to test the chemical properties of the inner surface of the glass. The standard of the test method is GB12416.1-1990 "Testing method and classification of water resistance of medicinal glass containers", GB/T4548-1995 "Test method for water erosion resistance of inner surface of glass containers" And grading.
In addition, in order to be in line with international standards, a draft of the national standard “Measurement and classification of water-resistant properties of glass products and glass containers by flame spectrometry†has been prepared. This standard quantifies the water-repellent release and release of glass surfaces.
Internal stress: Internal stress is the annealing quality or annealing characteristics of the glass. Glass containers with poor annealing quality are prone to breakage or burst during use, which affects the safety of medicines and medications. The commonly used standard for detecting internal stress is GB12415-1990 "In-situ stress test method for medicinal glass containers". The test principle is to determine the internal stress in the glass container by the optical path difference of different wavelengths. Currently, the LRR-85A digital display is commonly used. Quantitative stress tester.
Internal pressure resistance: Internal pressure is a measure of the comprehensive strength of a glass container. The internal structure of the glass, the uneven thickness of the glass wall and the defects of the surface appearance all affect the strength of the glass. The test method standard is GB/T4546-1998 "Test method for internal pressure resistance of glass bottle cans". Commonly used testing instruments are: TYJ-B linear pressurized internal pressure testing machine.
Thermal shock resistance: Thermal shock resistance is the ability to inspect a glass container against temperature changes, generally expressed as a heat resistant temperature difference. The test method standard is GB4547-1991 "Test method for thermal shock resistance and thermal shock resistance of glass containers". Commonly used detection instruments are digital display self-regulating heat and cold blastometers.
Freezing resistance: Freezing resistance is a test item for measuring the low temperature performance of glass. It is mainly used for the inspection of lyophilized glass bottles. The testing equipment is: -43 °C freezer.
Breaking force: Breaking force is a project to detect the easy folding performance, and is also an important indicator to measure the performance of safety. Commonly used testing instruments are: ZLY-2000 digital display folding instrument.
Acid resistance: Acid resistance is a measure of the chemical stability of glass. The test method is GB6582-1986 "Flame emission or atomic absorption spectrometry method for corrosion resistance of glass at 100 °C", GB/T15728-1995 "Boiling resistance Hydrochloric acid weight test method and classification, GB/T6580-1997 "Test method and classification of glass resistant mixed aqueous solution". The main testing instruments are: flame photometer, atomic absorption spectrometer and laboratory routine instruments.
Size <br> <br> Size is the major pharmaceutical glass forming process quality, consistency and good stability Size is the basis for the production of pharmaceutical packaging, for pharmaceutical filling, sealing and storage use have a great impact.
Geometric size: The geometrical dimensions of the bottle mouth and the bottle body are generally measured by a digital display electronic caliper, a vernier caliper or a height gauge.
Bottle wall, bottle bottom, bottle mouth thickness: commonly used measuring instruments are: digital display bottle bottom thickness, wall thickness measuring instrument, digital display bottle edge thickness measuring instrument.
Vertical axis deviation: The detection item of the verticality of the bottle. The test method standard is GB8452-1987 "Glass Container - Glass Bottle Vertical Axis Deviation Test Method", and the measuring instrument is: ZPY-10 digital display axis deviation measuring instrument.
Straightness: Straightness is a test item for the degree of bending of a glass tube. Common measuring instruments are: LSR-1000 digital glass tube straightness meter.
Weight, capacity: weight, capacity test is to measure the weight and volume of the bottle by weighing and titration.
<br> <br> appearance quality appearance quality is to detect various types of defects in the glass surface of the container projects, are: stones, bubbles, streaks, bubble streaks, cracks, etc. overpresses, appearance quality of the detection by visual or project generally Magnifying glass with scale.
<br> <br> chemical composition and chemical composition testing harmful substances and harmful substances that improve the quality of pharmaceutical glass containers, with international standards of important test items.
The forthcoming pharmaceutical industry standard "Classification of pharmaceutical glass components and its test methods" is non-equivalent to ISO12775-1997 "normal mass production of glass by composition and its test methods", this standard for the composition of various types of pharmaceutical glass , material requirements, performance and application range have been clearly classified and specified.
In the raw materials for the production of medicinal glass, As2O3 and Sb2O3 are often used as clarifying agents to introduce glass components. International standards have regulations on the release of these substances. China is currently formulating relevant control and testing standards, and harmful elements from the perspective of safety and health. Limited.