Development status of the hottest oral pharmaceuti

The development status of plastic packaging materials for oral medicine continues

at present, the packaging forms of direct contact with oral solid preparations are as follows:

1. Plastic bottle

plastic bottle is one of the packaging containers used more for oral preparations at present. It is reported that 70% of oral solid preparations abroad are packed in plastic bottles. Since the early 1980s, China began to introduce the injection and blowing three position bottle making equipment, the output and quality of pharmaceutical plastic bottles have been greatly improved

plastic bottles for solid preparation packaging are generally made of polyolefin (PE or PP), and titanium dioxide is added as a colorant to avoid light. There are also colorless transparent or brown transparent plastic bottles made of pet. Plastic bottles for liquid oral preparations are generally made of PP or pet

in recent years, more and more medical plastic bottles use sealing films. The sealing film may be beneficial to the stability of drugs during transportation and storage. However, it is impossible to change the bottled drugs. Once a piece (tablet) is taken out of the bottle, the remaining drugs in the bottle will inevitably be affected by external gases

the bottle cap is generally equipped with a safety ring. Once the bottle cap is opened, the safety ring will fall off by itself, which is conducive to safe medication. There is another kind of bottle cap called safety cap. Ensure that children under the age of 5 cannot open and take it by themselves, which belongs to children's safety packaging. For the requirements and test methods of children's safety packaging, China is formulating national standards (equivalent to international standards)

2. Single dose blister packaging

blister packaging refers to a packaging form in which hard plastic tablets are heated into small bubbles, one tablet or one capsule is filled in the bubbles, and then aluminum foil coated with adhesive is used as the covering material to seal. It is generally called PTP packaging

PTP packaging has been used for tablets and capsules for more than 30 years, and its main advantages are:

1 For single dose packaging, after taking out one tablet (tablet), others hope that the drug is still packaged completely and has the function of single sealing

2. The problem of fluoroscopy testing machine can be solved, and the contents of the file package can be checked

3. Light package and convenient transportation

so far, the molding material of PTP packaging is mainly PVC hard sheet. PVC hard sheet is easy to form, with good transparency, but poor barrier to water vapor. For this reason, PP and pet hard films are now available. At the same time, there are pvc/pvdc, pvc/cfe (CFE polytetrafluoroethylene), pvc/pe/pvdc and other composite hard films that can retain the advantages of PVC hard films and overcome their shortcomings

pvdc and CFE have excellent gas barrier, with a thickness of 250 μ The moisture permeability of PVC hard sheet of M is 2.5g/m ﹤ 2 · 24h. Compound a layer 30 μ The moisture permeability of PVDC can be reduced to 0.3g/m 2 · 24h. As a single dose blister package, the other side is aluminum foil for drug packaging (commonly known as "PTP" aluminum foil). As the main material, metal aluminum should be completely isolated from light and gas. It is generally believed that the thicker the aluminum foil, the smaller the possibility of pinholes. Blister packaging is generally put into cartons. The function of cartons: 1 Protection; 2. Printing; 3. Light blocking

3. SP packaging

has the forms of single dose strip packaging and single dose or multi dose bag packaging

strip packaging is a kind of unit packaging, which uses two layers of strip SP film to place tablets, capsules or suppositories in the middle, heat seals the inner side of the two layers of SP film around the drug, and presses tooth marks between the tablets to form a unit packaging. When using, tear it gradually according to the tooth mark. The advantage of strip packaging is that it is easy to use, but the disadvantage is that it must be operated on a special SP packaging machine. Generally, cartons are also needed for packaging. Bag type packaging is generally a small flat bag sealed by hot pressing on three or four sides, which can be single dose or multi dose. Suitable for packing powder, granule, tablet and capsule

the packaging materials used for SP packaging are various composite films. Composite films can be divided into plastic/plastic composite films, paper/plastic composite films, plastic/aluminum/plastic composite films, etc. from the base material structure. From the perspective of composite method, it can be divided into dry composite film, coextrusion composite film and extrusion coating composite film. Requirements of composite membrane (1) hygiene, which must meet the hygiene requirements. (2) For protection, drugs must maintain their medicinal value within their validity period. To achieve this, we must have a certain physical strength, good moisture resistance and gas resistance. (3) This technology solves the problems of obtaining high-purity products, forming and efficient utilization of low value raw materials. It has good adaptability to filling and sealing machinery and good heat sealing performance. (4) Simplicity, safety, portability, etc. (5) Good merchantability and printing performance. (6) Economy, low price, easy transportation, storage, etc

the main single film in the composite film is divided into the following:

(1) polyethylene film

polyethylene film is a film used in a considerable amount of pharmaceutical composite film. In the composite film, it is often used as the inner seal of direct contact with drugs, and generally low-density polyethylene film is used, Single layer polyethylene shall be corona treated before printing and dry compounding. There is also a linear low-density polyethylene film, which is more and more used in composite films at present. It is characterized by excellent heat sealing performance, wide heat sealing temperature range and better mechanical strength than low-density polyethylene. Generally, some linear low-density polyethylene can be mixed into low-density polyethylene to make film/composite film to improve the heat sealing performance

(2) polypropylene film

among the polypropylene single films used in the composite film, there are two kinds of stretched polypropylene film and salivary polypropylene. The stretched polypropylene film is transparent and bright, which can be used as the outer layer of the composite film, and the salivary polypropylene film can be used as the inner seal of the composite film

(3) polyester film

polyester film is one of the main substrates for the production of various high-performance composite films. It is the main component of high-temperature steaming composite films and vacuum packaging composite films. It has the advantages of high strength, good toughness, good oil resistance, transparency and brightness

(4) aluminum foil metal has an absolute barrier effect on gas and light. Using aluminum foil as an intermediate layer can greatly improve its barrier property