The "poison capsule" incident that occurred in April last year made the public panic about the drugs (food) of all capsule preparations, and how to eliminate potential safety hazards and ensure the safety of capsule drugs (foods) has become an urgent problem to be considered. A few days ago, Professor Feng Guoping, former deputy director of the Drug Registration Department of the State Food and Drug Administration and vice president of the China Pharmaceutical Packaging Association, said that due to the artificial incorporation of animal gelatin capsules or artificial pollution caused by heavy metals exceeding the standard, it is difficult to cure, and the way of artificial pollution of plant capsules may be small, so replacing animal capsules with plant capsules is the fundamental way to solve the stubborn disease of capsule pollution, but the reality is that the cost of plant capsules is slightly higher.
With the outbreak of infectious diseases of animal origin around the world, the international community is increasingly concerned about the safety of animal products. Plant capsules have outstanding advantages over animal gelatin capsules in terms of applicability, safety, stability, and environmental protection.
A few years ago, plant hollow capsules appeared so far, in developed countries in medicines and health care products using plant capsules in the proportion of higher and higher. The United States also requires that the market share of plant capsules reach more than 80% within a few years. The plant capsules produced by Jiangsu Chenxing Marine Biotechnology Co., Ltd. have passed the identification of national high-tech products, which are superior to animal gelatin capsules in all aspects, and are especially suitable for anti-life and anti-inflammatory drugs, traditional Chinese medicine and high-end health care products. Therefore, plant capsules are an inevitable substitute for animal gelatin capsules.
In the following points, we will briefly talk about the superiority of plant hollow capsules over animal gelatin hollow capsules.
1. Plant hollow capsule is an industry that does not pollute the environment
As we all know, the production and extraction of animal gelatin is made by fermenting the skin and bone of animals as raw materials through chemical reactions, and a large number of chemical components are added in the process. Anyone who has been to the gelatin factory knows that the raw plant process emits a great odor, and it will use a lot of water resources, causing serious pollution to the air and water environment. In Western developed countries, due to national regulations, many gelatin manufacturers relocate their factories to third world countries to reduce pollution to their own environment.
Many of the extraction of plant gums is to take the method of physical extraction, extracted from marine and terrestrial plants, which will not produce a rotten odor, and also greatly reduce the amount of water used and reduce environmental pollution.
In the production process of the capsule, no harmful substances are added, and there is no environmental pollution. The waste reuse rate of gelatin is low, and a large number of pollution sources are generated when the waste is disposed of. Therefore, our plant capsule production enterprises can be called "zero emission" enterprises.
2. Stability of raw materials for plant hollow capsules
The raw materials for the production of gelatin come from different animal carcasses such as pigs, cattle, sheep, etc., and the mad cow disease, avian influenza, blue ear disease, foot-and-mouth disease and so on that have been prevalent in recent years are derived from animals. When traceability of a drug is required, it is often difficult to trace when capsule raw materials are taken into account. The plant glue comes from natural plants, which can better solve the above problems.
The US FDA issued earlier guidance, hoping that in recent years, the market share of plant hollow capsules in the US market will reach 80%, and one of the main reasons for this is also the above problem.
Now, many pharmaceutical companies have repeatedly depressed the supply enterprises of hollow capsules because of cost problems, and hollow capsules can only use cheap gelatin in order to gain a foothold in a difficult living environment. According to the survey of China Gelatin Association, the current market price of regular medicinal gelatin is about 50,000 yuan / ton, while the price of blue alum leather glue is only 15,000 yuan - 20,000 yuan / ton. Therefore, some unscrupulous manufacturers are driven by interests to use blue alum leather glue (gelatin processed from old leather clothes and shoes) that can only be used in industry as edible, medicinal gelatin or doped. The result of such a vicious circle is that the health of ordinary people is difficult to guarantee.
3. Plant hollow capsules do not have the risk of gelling reaction
Plant hollow capsules have strong inertness and are not easy to crosslink with aldehyde-containing drugs. The main ingredient of gelatin capsules is collagen, which is easy to crosslink with amino acids and aldehyde-based drugs, resulting in adverse reactions such as prolonged capsule disintegration time and reduced dissolution.
4. Low water content of plant hollow capsules
The moisture content of gelatin hollow capsules is between 12.5-17.5%. Gelatin capsules with high water content tend to easily absorb the moisture of the contents or be absorbed by the contents, making the capsules soft or brittle, affecting the drug itself.
The water content of the plant hollow capsule is controlled between 5 - 8%, which is not easy to react with the contents, and can maintain good physical properties such as toughness for the contents of different properties.
5. Plant hollow capsules are easy to store, reducing the storage cost of enterprises
Gelatin hollow capsules have stricter requirements for storage conditions and need to be stored and transported at a relatively constant temperature. It is easy to soften and deform at high temperature or high humidity, and it is easy to crunch and harden when low temperature or humidity is low.
Plant hollow capsules have more relaxed conditions. Between the temperature 10 - 40 ° C, the humidity is between 35 - 65%, there is no softening deformation or hardening and brittleness. Experiments have proved that under the condition of humidity of 35%, the brittleness rate of plant capsules ≤2%, and at 80 °C, the capsule changes ≤1%.
Looser storage requirements can reduce the storage cost of enterprises.
6. Plant hollow capsules can isolate contact with external air
The main component of gelatin hollow capsules is collagen, and the nature of its raw materials determines that its breathability is strong, making the contents susceptible to adverse effects such as moisture and microorganisms in the air.
The raw material nature of plant hollow capsules determines that it can effectively isolate the contents from the air and avoid adverse effects with the air.
7. Stability of plant hollow capsules
The validity period of gelatin hollow capsules is generally about 18 months, and the shelf life of the capsules is shorter, which often directly affects the shelf life of the drug.
The validity period of plant hollow capsules is generally 36 months, which significantly increases the expiration date of the product.
8. Plant hollow capsules have no residue such as preservatives
Gelatin hollow capsules in the production to prevent the growth of microorganisms will add preservatives such as methyl parahydroxybenzoate, if the amount of addition exceeds a certain range, it may eventually affect the arsenic content exceeding the standard. At the same time, gelatin hollow capsules should be sterilized after the production is completed, and at present, almost all gelatin capsules are sterilized with ethylene oxide, and there will be chloroethanol residues in the capsules after sterilization of ethylene oxide, and chloroethane residues are prohibited in foreign countries.
9. Plant hollow capsules have lower heavy metals
According to national standards, the heavy metal of animal gelatin hollow capsules cannot exceed 50ppm, and the heavy metals of most qualified gelatin capsules are 40 – 50ppm. In addition, many unqualified products of heavy metals far exceed the standard. In particular, the "poison capsule" incident that has occurred in recent years is caused by the excess of heavy metal "chromium".
10. Plant hollow capsules can inhibit the growth of bacteria
The main raw material of animal gelatin hollow capsules is collagen, which is colloquially known as a bacterial culture agent that contributes to the proliferation of bacteria. If not handled properly, the number of bacteria will exceed the standard and will multiply in large quantities.
The main raw material of plant hollow capsules is plant fiber, which not only does not multiply bacteria in large quantities, but also inhibits bacterial growth. The test proves that the plant hollow capsule is placed in the ordinary environment for a long time and can maintain the number of microorganisms within the national standard range.
11. Plant hollow capsules have a more relaxed filling environment, reducing production costs
Animal gelatin hollow capsules have high requirements for the temperature and humidity of the environment when filling the contents in the automatic filling machine. The temperature and humidity are too high, and the capsules are soft and deformed; The temperature and humidity are too low, and the capsules are hardened and crunchy; This will greatly affect the on-machine pass rate of the capsule. Therefore, the working environment should be kept at about 20-24 ° C, and the humidity should be maintained at 45-55%.
Plant hollow capsules have relatively relaxed requirements for the working environment of the filled contents, with temperatures between 15 – 30 ° C and humidity between 35 – 65%, which can maintain a good machine pass rate.
Whether it is the requirements of the working environment or the machine pass rate, the cost of use can be reduced.
12. Plant hollow capsules are suitable for consumers of different ethnic groups
Animal gelatin hollow capsules are made mainly of animal skin, which is resisted by Muslims, Koshers, and vegetarians.
Plant hollow capsules are made of pure natural plant fibers as the main raw material, suitable for any ethnic group.
13. Plant hollow capsule products have high value-added
Although the market price of plant hollow capsules is slightly higher, it has more outstanding advantages than animal gelatin hollow capsules. In the high-grade drugs and health care products are adopted, significantly improve the grade of the product, help the health of consumers, especially suitable for anti-inflammatory drugs, traditional Chinese medicine and high-end health care products and other products, so that the product has a high value-added and competitiveness.
Whether it is a pharmaceutical or a health care product, capsules are the main dosage form. But 50% of the health products registered in more than 10,000 countries are capsule forms. China produces more than 200 billion capsules a year, all of which are gelatin capsules so far.
In recent years, the "poison capsule" incident has exposed many problems of traditional gelatin capsules, and also exposed many unhealthy insiders in the capsule industry. The plant hollow capsule is an important result that can solve the above problems. Plant hollow capsule multi-production workshop, high requirements of multi-production process, coupled with the raw material source used are a single plant fiber, can effectively prevent low input, low cost, low technology small enterprises to join, but also effectively prevent low-cost, unqualified, harmful gelatin become the main material of the capsule.
In early 2000, the United States invented the plant capsule, and its sales price dropped from more than 1,000 yuan to more than 500 yuan now. In the market of developed countries such as the United States and Europe, especially in recent years, the market share of plant capsules has risen to nearly 50%, growing at a rate of 30% per year. The growth rate is very alarming, and the application of plant capsules in developed countries has become a trend.
Combined with the above, plant hollow capsules have more and irreplaceable advantages compared with animal gelatin hollow capsules. Plant capsules are less likely to be artificially polluted, so replacing animal capsules with plant capsules is the fundamental way to solve the persistent disease of capsule pollution. It is more and more valued in foreign developed countries, and is gradually used in various products in the pharmaceutical industry, health care product industry, and food industry. It can be seen that although plant hollow capsules cannot completely replace gelatin capsules, they must be an important replacement product for animal gelatin hollow capsules.
Post time: May-11-2022