Time Limit for disintegration of Health Foods of Tablet or Capsule

Health food can be produced into oral liquid, paste, tablet, capsule, etc. according to the composition and properties of its contents. For solid oral preparations such as tablets and capsules, before being absorbed, the physiologically active ingredients in the health food must undergo a process of disintegration and dissolution and then turn into a solution. If it is extremely slow, there may be problems with the absorption rate or extent of the physiologically active ingredients in the preparation. Therefore, disintegration is the initial stage of the dissolution of the physiologically active ingredients. It must first disintegrate in the body before it can be dissolved and absorbed by the human body. Therefore, the disintegration time limit is an important indicator of health food testing.

1. Tablets

For the health food compressed into tablets, the end point of the disintegration time limit is easy to observe. Only when the tablet is completely disintegrated, disintegrated or broken into granules, and passes through the sieve, and there is no residue in the sieve, the disintegration is complete. Most tablet-type health foods disintegrate within 15 minutes, but there are also some varieties that far exceed this time limit. For samples with a longer disintegration time, the composition and properties of its components, as well as processing technology and storage conditions, may affect the disintegration time. If the ingredients in the sample are less water soluble and the tablet is denser after compression, then it forms in an aqueous solution and takes longer to granulate. On the other hand, in the case of a lozenge or chewable tablet, it is desirable to impart a certain texture and maintain a certain dissolution time in the oral cavity. Therefore, the disintegration time for such tablets may be longer. The standard for the disintegration time of this variety of health food should be different from that of the swallowed type.

2. Hard capsules

Capsules are made of medicinal gelatin as raw material, adding colorants and sunscreens conforming to GB2760. The hard capsule is cylindrical, which is an empty capsule formed by a cap and a body, and has different locking forms. Its varieties are transparent, opaque, translucent, and clear. At present, conventional hollow hard capsules are prepared with gelatin. The gelatin is mainly derived from animal bones, skins and white connecting tissues. The main component is animal protein (92%) and contains a small amount of animal fat (2.2%). The water content of hollow hard capsules is 12.5% to 17.5%, and it is brittle when the water content is less than 10%. The capsule shell of the hard capsule in the health food is very soluble in water. Most of the hard capsule type health food disintegrates within 10min.

The last kind of American ginseng and yak strong bone powder capsules could not be completely disintegrated within 90 minutes. It is not that the capsule shell is difficult to break. On the contrary, the capsule shell has been completely dissolved in water within 10 minutes. However, its contents are located at the bottom of the glass tube in the shape of a complete capsule, and the up-and-down movement of the baffle does not help it to dissolve much, until 90min, and part of the contents of each tube has not been dissolved and passed through the screen. The main reason for the increased disintegration time is that the contents form solid lumps in contact with water.

3. Soft capsules

At present, the vast majority of soft capsules produced by domestic pharmaceutical factories and nutritional health care product factories are oral gastric-soluble varieties. Compared with other oral preparations, oral soft capsules are suitable for hydrophobic drugs, low melting point drugs, various health care oils, easily oxidized drugs, and other oral drugs due to their high bioavailability, safe sealing, accurate content, and beautiful appearance. Preparations are difficult to hide their bad taste of drugs, etc., so they are more and more valued by manufacturers and welcomed by consumers. In foreign countries, soft capsules have been widely used in pharmaceutical, food, cosmetics and household products, chemical and other industries. Since the introduction of advanced transfer mode soft capsule manufacturing machines in the late 1970s, production has developed rapidly. So far, there are more than 30 manufacturers with about 60 advanced manufacturing machines. The initial Maitong capsules have grown to nearly 40 types. Soft capsules used in health food are mainly some health-care oils, such as conjugated linoleic acid, seal oil, wheat germ oil, etc., as well as easily oxidizable substances such as beta-carotene and some special odors health products.

The vast majority of health food soft capsules are made of gelatin. Gelatin is an animal, and the polysaccharide is very easy to absorb water and swell, so it brings certain difficulties to the determination of the end point of the disintegration time limit. Because although the capsule moves back and forth in the water for a long time, the capsule shell is not as easy to dissolve and rupture as the hard capsule, but constantly absorbs water and swells, and the content still cannot be released in the capsule and cannot be disintegrated. Only long enough for the capsule shell to absorb water to a certain extent, a crack appears in some relatively thin places, and the content seeps out of this crack. Therefore, the disintegration time of soft capsule health food is generally longer.

There are many factors that affect the disintegration time of soft capsules: the composition and properties of the contents, the bloom force of gelatin, the composition, moisture content, thickness and processing and storage conditions of the capsule film (capsule shell, rubber skin), etc. Affect disintegration. Domestic experts and scholars generally believe that the disintegration time limit of soft capsules mainly composed of gelatin during the storage period is unqualified, which is caused by the aging of gelatin over time. Tests have confirmed that oxygen is the direct cause of aging and degeneration of gelatin capsules. The higher the storage temperature and the longer the storage time, the collagen micelles in the network structure of gelatin will be denatured, and the structure of the glue will change drastically. Once the collagen and micelles have this structure, the soft capsule becomes difficult to dissolve, and the disintegration time is obvious. Prolonged, after comparing the soft capsule stored at 40°C for 4 months with the same sample refrigerated at 6°C, the former takes 100 minutes to disintegrate, while the latter only takes 25 minutes to disintegrate. For samples stored at room temperature for more than one year, the disintegration time is extended by more than 20 minutes. The contents also have an effect on the disintegration of soft capsules. Aldehydes can tannize gelatin, and alkaline liquids can alkali-tannize gelatin, which affects the solubility of the capsule wall. Tracking observation and analysis of the disintegration time limit of samples of multiple varieties and batches of soft capsules found that the soft capsules containing vitamins and E‚ natural carotene (15mg) as the main drug disintegrated within the industrial responsibility period. , it is speculated that the aging speed of gelatin may be continued due to the antioxidative effect of these drugs.

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