China's national standard 5 packaging general terminology 6 package definition: / in the circulation process to protect products, convenient storage and transportation, promote sales, according to a certain technical methods used in the container, materials and auxiliary materials, etc. The packaging of medicines refers to the selection of appropriate materials or containers, the use of packaging technology to separate (filling), sealing, loading, labeling and other semi-finished or finished products of pharmaceutical preparations, providing quality protection for pharmaceuticals, signing trademarks and instructions. The general term for the processing process, the packaging of the drug is divided into inner packaging and outer packaging.
1 The role of pharmaceutical packaging
1.1 Protection function Drugs often go through a long period of time during production, transportation, storage and use. Due to improper packaging, the physical or chemical properties of the drug may be changed, resulting in drug reduction, failure, and adverse reactions. Pharmaceutical packaging should consider protection as a primary factor. The protection function mainly includes the following two aspects: (1) Barrier function: According to the packaging materials and methods, the packaging can ensure that the drugs in the container do not penetrate or leak, and can also block the outside air, light, moisture, heat, foreign matter and microorganisms. Waiting for contact with the drug. (2) Buffering effect: The pharmaceutical packaging has a buffering function, which can prevent the vibration, impact and extrusion of various external forces during transportation and storage.
1.2 Convenient application of pharmaceutical packaging should be convenient for patients and clinical use, and help physicians and patients to use medicine scientifically and safely.
(1) Labels, instructions and packaging labels Labels are an important part of pharmaceutical packaging. They introduce people to the scientific and accurate introduction of the basic content and characteristics of specific drugs. The labels of medicines are divided into inner packaging labels and outer packaging labels. The contents of the inner packaging label and the outer packaging label shall not exceed the contents of the drug label approved by the State Food and Drug Administration; the text expression shall be consistent with the instructions. The drug product specification should contain basic scientific information about the safety and efficacy of the drug. The packaging mark is a special mark designed to help the user identify the medicine.
(2) Easy access and sub-dosage to improve patient compliance: with the development of packaging materials and packaging technology. Drug packaging is diversified, such as dose-based packaging, convenient for patients to use, is also suitable for pharmacies to sell drugs; such as travel health kits, containing essential oils such as essential oils, painkillers, berberine; such as coronary heart disease first aid kit, It contains nitroglycerin tablets, quick-acting remedy pills, and musk baoxin pills. In the conventional packaging under complicated treatment schemes, a large number of packaging containers will appear, which is not conducive to patient compliance. Some manufacturers have now designed a new packaging box. Multiple drugs can be packed in one box at the same time. The box is divided into several parts according to the number of days per week, and each part is divided into 4 small rooms according to the number of times of daily medication, which simplifies the medication procedure and improves the compliance of medication. The patient's dose can be monitored, especially for elderly patients, thereby improving the therapeutic effect.
1.3 Commodity promotion drugs are special commodities. First of all, they should pay attention to their quality and application. From the perspective of commodity quality, the scientific and modernization of product packaging will help to show the quality and production level of products to a certain extent, and can give people a sense of trust. , security, and help marketing.
2 Types of pharmaceutical packaging materials
Pharmaceutical packaging materials and containers are referred to as pharmaceutical packaging materials. The drug package material can be classified into metal, glass, plastic (thermoplastic, thermosetting polymer compound), rubber (thermosetting polymer compound), and a combination of the above components (such as aluminum-plastic composite cover, composite film for pharmaceutical packaging).
2.1 Metallic metals In the formulation and packaging materials, only tin, aluminum, iron and lead are used, which can be made into rigid containers, such as cylinders, barrels, hoses, metal foils, etc. Containers made of tin, aluminum, iron, lead and other metals are not permeable to light, liquids, gases, odors and microorganisms; they are resistant to high temperatures and low temperatures. In order to prevent internal or external corrosion or chemical action, a protective layer is often required on the inner and outer walls of the container.
2.2 Glass glass has excellent protection, and it is stable, inexpensive and beautiful. The glass container is a commonly used packaging container for pharmaceutical products. The glass is clear and bright, basically chemically inert, impervious, hard, non-aging, with a suitable plug or cover and cover can be protected from any foreign matter, but the light can penetrate. Drugs that need to be protected from light can be used in brown glass containers. The main disadvantage of glass is its heavy weight and fragility.
2.3 Rubber rubber has high elasticity, low gas permeability and water permeability, sterilization resistance, good compatibility, etc. Therefore, rubber products are widely used in medicine, including butyl rubber, halogenated butyl rubber, nitrile rubber, Ethylene-propylene rubber, natural rubber and cis-butyl rubber can be used to make the basic elements of pharmaceutical packaging systems))) Medicinal stoppers. In order to prevent contamination and leakage of drugs during storage, transportation and use, rubber stoppers are often used as seals for packaging pharmaceutical products, such as infusion stoppers, lyophilizer stoppers, blood test tube stoppers, pre-filled injection needles. Cylinder pistons, insulin injection pistons and seals for various aerosol bottles.
2.4 Plastics and composites Plastics is a synthetic polymer compound with many superior properties. It can be used to produce rigid or flexible containers. The plastic is lighter than glass or metal and is not easily broken, but it is breathable, moisture permeable and chemically stable. Heat resistance is not as good as glass. In recent years, in addition to traditional packaging materials such as polyester, polyethylene and polypropylene for pharmaceutical packaging, various new materials such as aluminum-plastic, paper-plastic and other composite materials are also widely used in pharmaceutical packaging, effectively improving the quality of pharmaceutical packaging. And the grade of medicines shows the broad development prospects of plastics.
2.4.1 Aluminum-plastic blister packaging The aluminum-plastic blister packaging of medicines, also known as blister packaging, referred to as /PTP0, is a solid medicine for tablets, pills or granules, capsules, etc. after first forming a transparent plastic rigid sheet. It is filled in the groove and heat-bonded to the adhesive-coated aluminum foil to form a separate sealed package. This kind of packaging is one of the widely used and rapidly developing forms of flexible pharmaceutical packaging in the pharmaceutical industry. It is gradually replacing traditional glass packaging and bulk packaging, becoming the mainstream of solid pharmaceutical packaging. Compared with bottled drugs, blister packs have the advantage of being easy to carry, reducing the contamination of the drug during carrying and taking, and the blister packaging in gas barrier, moisture resistance, safety, production efficiency, and dose accuracy. Other aspects also have obvious advantages.
2.4.2 Composite film strip packaging The strip packaging uses two layers of medicinal strip packaging film (SP film) to sandwich the medicine in the middle, the unit medicine is separated by a certain distance, and the two layers around the medicine are placed on the strip packaging machine. The inside of the SP film is heat-sealed and the dents are pressed between the medicines to form a unit package form (single package or small package). When the medicine is taken, the SP film can be torn along the tooth marks. The strip packaging laminating film not only can package tablets, but also is the main packaging form of granules, powders and other dosage forms, and is suitable for medicines with large dosage, high hygroscopicity and sensitivity to ultraviolet rays. The strip package can be operated continuously on the strip packaging machine, which is especially suitable for large-volume automatic packaging.
2.4.3 Infusion soft bag packaging Infusion soft bag packaging has the following advantages: soft bag packaging is lighter than infusion bottle, not afraid of collision, easy to carry; especially suitable for large dose dosing, do not leak after dosing, after infusion bottle dosing Increasing the pressure inside the bottle causes the liquid to leak out from the gas selection tube, which wastes the medicine and increases the chance of pollution. The soft bag packaging liquid is completely sealed, and there is no looseness or crack in the bottle liquid bottle; the flexibility is strong and can be self-shrinking. Under the pressure of the atmosphere, the liquid can be infused through the closed infusion line to eliminate the danger of embolism caused by air and air bubbles, and is beneficial to the pressurized use in the emergency vehicle; the infusion bag can complete the film (cleaning) printing in the infusion production. Bag forming, bag welding, filling, airless or vacuuming, sealing; and the production line can complete online leak detection and clarity inspection.
3 Quality requirements for pharmaceutical packaging materials
In order to confirm that the medicine packaging materials can be used for wrapping medicines, it is necessary to carry out quality control on these materials. The medicine packaging materials should have the following characteristics: (1) Protecting medicines from environmental influence during storage and use, and maintaining the original medicines There are attributes; (2) the drug package material and the packaged drug cannot have chemical or biological reaction; (3) the drug package material itself should have good stability during storage and use; (4) medicine The packaging material shall not pollute the production environment of the medicine when wrapping the medicine; (5) The medicine packaging material shall not have the property of affecting the packaged medicine which cannot be eliminated during use.
With the continuous advancement of modern science and technology, the pharmaceutical industry is also developing rapidly. It is necessary to select appropriate pharmaceutical packaging materials according to the different properties of various drugs. Therefore, packaging materials with high safety, quality meets requirements, low cost and environmental protection type Will play an important role in product packaging.
Source: Community Medicine Journal
The human tongue has a range of specific taste sensation neural receptors called taste receptors which are organized mainly as papillae on the tongue. When stimulated by chemicals, natural or synthetic, organic or inorganic, cations or anions, the receptors send signals to the brain which interprets the stimulations as sweet, bitter, sour, salty, and savory (unami, meaty taste). For examples, cations such as Na+ present in the table salt evoke the salty taste, and H+ presents in acids evokes a sour taste. Organic compounds such as sugars, dextrins and glycerol result in sweet taste, glutamate results in savory taste, while many toxic compounds such as nicotine, morphine, caffeine, quinine, etc. result in bitter taste. The sensation of tastes is an evolution trait for defense against poisons (normally evoke bitter taste), and for allowance of nutrients intake (normally evoke sweet or savory taste).
Sugar is a natural sweetener as well as a nutrient consumed in vast quantity around the world. It is one of the major calorie intakes by humans. Over consumption of sugar often leads to obesity and other related medical conditions. High blood sugar level (hyperglycemia) is a manifestation of the disease diabetic mellitus; if not managed properly, it could lead to a range of medical complications. To combat these medical conditions, high potency Sweeteners with no calorie or low calorie intake are often being used to substitute sugar. Proper control of calorie intake, coupled with the use of these sugar substitutes has been very effective in managing the medical conditions.
Besides the medical indications, using sugar substitutes brings the economic benefit of lowering the cost of many foods and consumer products, from soft drinks to cakes, pasties, and even toothpastes.
A variety of chemical compounds, natural or synthetic, can evoke sweet taste, but not all of them are safe (for example lead acetate has a sweet taste but it is extremely toxic), nor are sweet taste specific (for examples, many of synthetic sweeteners can also evoke other senses of taste such as bitterness or metallic sensation). Therefore, selection of the right sweetener for a specific use depends not only on the cost, but also more importantly on the health and safety, the sweetening potency, the effectiveness under various physical conditions such as cooking temperature (heat stability) and pH, as well as other unwanted tense of tastes of the sweetener.
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