APPLICATION OF GELATIN IN HOLLOW CAPSULES

Issuing time:2021-10-16 17:16

Hollow capsule

Hollow capsule is an important raw material for the outer packaging box of capsule medicine in the pharmaceutical manufacturing industry [1]. The hollow capsule is divided into two sections: cap capsule shell and body capsule shell. It is mainly used to contain solid drugs such as self-made medicine noodles, health products or drugs. The success of the hollow capsule helped the patients solve the difficulties of difficult safe passage and poor taste, and solved the constraint of good medicine.

So, everyone has been exposed to so many capsules for a long time. Do you know why the capsule shell can be taken? What is its composite material? Does it affect your body? Why should some drugs be made into capsules? Isn't it good to be lumpy? Next, we will eliminate the puzzles one by one and step into the world of capsule shell together!

Preparation of hollow capsules

At present, the global efficacy and function of hollow capsules are important, and animal origin is also the core. Its main component is Arabic gum. Efficacy and function Arabic gum is a milky white or light yellow solid concentrated from a part of collagen in the hoof of animal skin or human bones according to a series of treatment. It has no color, no smell, can dissolve boiling water, and has various characteristics such as colloidal suspicion, solid-water solubility, solubility and so on. More than 95% of Chinese capsules are also animal gum arabic hollow capsules. Since gum Arabic is so strange, let's have a good look.

The molecular formula of collagen protein is a gram-negative bacterium established by the mutual winding of three polypeptide chains. According to the treatment of production and processing technology, the molecular formula of collagen protein is transformed into a polypeptide chain( α- Chain) α- Composition and consists of two α Chain composition β- Composition and composition α Chain composition γ- Composition, and in period and less than α- Composition or excess γ- Molecular chain fragments of components. It can be seen that Arabic gum is a polydispersive system with a certain relative molecular weight. Its relative molecular weight varies due to differences in standards and specifications, and affects the biochemical characteristics of Arabic gum.

(1) Ammonia alkali Arabic gum: the method of preparing Arabic gum with alkaline solution to solve the raw materials containing collagen protein is called ammonia alkali method. It generally refers to the quicklime powder method and sodium hydroxide solution method. The quicklime powder method is used to produce Arabic gum from pork skin. The production process is generally as follows: raw material finishing - lime powder prepreg - degreasing of Hydropower Station - lime powder prepreg - cleaning and melting - glue boiling - concentration, bleaching solution and suspected gelatinization.

#2

(2) Acid Arabic gum: the method of preparing Arabic gum by acid leaching to hydrolyze collagen into active peptides with different relative molecular weight is called acid method. Acid Arabic gum mainly selects hydrochloric acid, sulfuric acid, ammonium sulfate, lactic acid bacteria beverage, sodium citrate, glacial acetic acid and other single or composite acids to deal with the expansion of raw materials in the pre production process, and further uses acid or strong acid to destroy intermolecular thermal polymerization and crack molecular bonds, so as to melt the skin into the acid solution, also known as gum extraction.

#3

(3) Enzymatic Arabic gum: the method of preparing Arabic gum by dissolving collagen with enzyme treatment is called enzymatic method. The crushed bone or skin collagen protein is treated with an enzyme solution, and then stirred in an acidic solution to obtain a collagen solution, which is then alkali melted to the isoelectric point of collagen or hydrolyzed with salt protein to obtain the accumulation of synthetic fibers of collagen protein. After extraction and accumulation, it is heated up to obtain Arabic gum. The other is enzymatic Liming, The enzyme solution is used to replace the sodium bisulfate in the traditional alkali gum to treat collagen, osteogen or skin, and then carry out the remaining production process in the traditional form. This kind of technical method is more suitable for the preparation of bone Arabic gum than the first method. General manufacturing process of enzymatic gel: leather products - Preparation and solution - Enzymatic Hydrolysis - Enzymatic stainless steel passivation - colloidal solution - separation and purification - finished products.

Why can I take it?

The hollow capsule is made from the key raw material of efficacy and function Arabic gum plus auxiliary materials such as melanocytes, tackifiers and tackifiers [2], and its important raw material Arabic gum is also suitable for the growth and development of microorganisms, which is easy to be contaminated by external microorganisms, such as highly pathogenic anaerobic bacteria, orange glucose, water gram-negative Streptococcus and Escherichia coli, Bacillus subtilis, Aspergillus flavus, etc. cause the decay, deterioration, gasification and mildew of fruit adhesive. In order to solve the difficulty of serious environmental pollution caused by hollow capsule microorganisms, at present, most of the hollow capsule microbial sterilization methods of Arabic gum hollow capsule manufacturing enterprises use ethylene oxide (EO) gas sterilization of the finished hollow capsule.

As early as 2000, the Chinese Pharmacopoeia included the product quality specification website of Arabic gum hollow capsules, aiming at microbial indicators, such as total bacterial count, intestinal Ehrlich bacterial count, Aspergillus flavus and yeast count; And the physical and chemical properties of hollow capsules, such as brittleness, viscosity, disintegration time limit and tightness, are specified in detail. By 2010, the Chinese Pharmacopoeia had adjusted the product quality specifications of Arabic gum hollow capsules, improved the inspection items such as ethylene oxide composition, freezing force and chromium, and improved the latest detection items of Salmonella. Therefore, when taking capsules, don't worry about the risks or the strange difficulties of digestion.

Although Arabic gum capsule has many advantages, it also has disadvantages:

1) Due to the isomerism of functional groups such as aldehyde group, imine or macrolide, the capsule is easy to cause thermal polymerization during storage, resulting in relatively stable Arabic gum Internet technology, reducing the total mixing of the capsule and reducing its dissolution;

2) Arabic gum comes from animal skin or bone, so it is inconvenient for vegetarians to take medicine;

3) The raw material of Arabic gum capsule shell comes from animal skin or bone, which is easy to spread infectious sponge tissue neurological symptoms - mad cow disease; 4) The industrial equipment characteristics of soft capsule capsule shell are vulnerable to weather and water - the addition of tackifier in the capsule shell improves the oxygen market share and the transfer of water between the capsule shell and the capsule contents. A small amount of water change will cause great damage to the total mixing of drugs;

5) There is also drug migration in soft capsules. Therefore, it is necessary to find modified engineering plastics Arabic gum or Arabic gum substitutes to improve the defects of Arabic gum capsules.

The alternatives of Arabic gum capsules include gum (konjac gum, Arabic gum, etc.), microbial gum (konjac gum, gellan gum, etc.), algae gum (konjac gum, alginate phosphate, etc.), cassava starch, etc.


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Gelatin hollow capsu
4. Four major types of hard hollow capsules
The traditional mainstream capsule shell, made from animal gelatin (such as bovine bone or pig skin), is the most widely used: for chemical drugs, health supplements, and traditional Chinese medicine hard capsules; it has low cost, good transparency, and stable dissolution; drawbacks: restricted for vegetarians, halal / kosher certification, some religions and overseas vegetarian markets prohibit its use, prone to softening in high humidity, and not resistant to some acidic contents.
Plant hollow capsule
4. Four major types of hard hollow capsules
The source material contains no animal components, suitable for vegetarian / halal / kosher diets; it has better moisture resistance than gelatin, and is suitable for some sensitive powder medications; it is a must-have for overseas dietary supplements and organic health products; drawbacks: the unit price is higher than that of gelatin, the production process requires higher standards, and some filling parameters are not compatible with gelatin capsules.
Enteric-coated capsu
4. Four major types of hard hollow capsules
The capsule shell is equipped with an enteric coating that does not dissolve in the stomach and only disintegrates and releases in the intestine (small intestine). It is used for: drugs that stimulate the gastric mucosa, and raw materials that need to be absorbed by the intestine (probiotics, some raw medicinal ingredients, fish oil, herbal extracts). Core advantages: stability of the coating process, resistance to gastric acid testing, consistency of dissolution among batches, and compliance with strict standards of the European and American pharmacopoeias (USP/EP).
Pearl capsules
4. Four major types of hard hollow capsules
An appearance-modified version of gelatin / plant capsules. The capsule shells are added with pearlescent pigments, presenting a pearlescent luster. It has no special drug-release function and focuses on appearance differentiation. It is mainly used in high-end health supplements, internal beauty capsules, and high-end dietary supplements to enhance product value. Compliance key points: The pearlescent coloring agents comply with the food / medicinal pigment regulations of various countries.
empty gelatin capsul
Domestic pharmaceutical companies, small and medium-sized health supplement factories, Southeast Asian and South American basic pharmaceutical factories Global mass market, with large demand volume High cost performance, universal compatibility, abundant supply
Plant hollow capsule
European and American dietary supplement brands, organic health products, vegetarian health product enterprises North America, Europe Union, Australia (the vegetarian market is mature) Halal, kosher, vegan certification, plant-based
Enteric-coated hollo
Specialty raw material drug enterprises, probiotic enterprises, digestive health supplement factories High-end formulations for Europe and the United States, functional health supplements market Stable for intestinal absorption, addressing the pain points of stomach irritation
Pearl Pearlshine Cap
High-end oral beauty health products, brand-customized health product manufacturers European and American luxury dietary supplements, high-end health products from Southeast Asia Appearance quality, differentiated packaging, brand premium pricing
The global hollow ca
Medicinal gelatin capsules remain the main product category. Plant-based capsules have the fastest growth rate (due to the trends of veganism and clean label consumption). Enteric-coated capsules belong to a high-value-added niche market segment.
structure of supply
The mature production capacity of hollow capsules in China is concentrated in Zhejiang, Shandong and Anhui. The core value of the import and export company: integrating factory supplies, qualification documents, customs declaration, multilingual documents, overseas customer connection, and one-stop supply of multiple categories.
Pure foreign trade b
Purchase 4 types of capsules from the upstream capsule factory, integrate and package the products for export; Advantages: Light asset footprint, multiple factory price comparison, flexible supply arrangement; Disadvantages: No core technological barriers, prices are easily bypassed by the upstream factory or direct customers.
Own production plant
With the establishment of the capsule production line and the registration of an import and export company for overseas sales; advantages: controllable quality, strong customization capability, higher profit, capable of undertaking OEM pearl color customization; disadvantages: heavy assets, high investment in compliant GMP factory.
Analysis of Product
✔ Advantages: Full matrix coverage - basic volume product (gelatin capsules) + growth product (plant capsules) + high-profit technical product (enteric-coated capsules) + differentiated customized product (pearl pearl-golden capsules), can meet the needs of buyers in one step: Customers don't have to search for multiple suppliers. With a single order, they can purchase all capsule categories. This is the core competitiveness for foreign trade orders;
❌ Risk points: The production processes, certifications, and testing standards for the four types of capsules are completely different. If it's just a trader, the difficulty of quality control management is high. Once a certain type of product exceeds the standards for dissolution, heavy metals, or microorganisms, the overseas reputation of the entire enterprise will be damaged.
Classification of ov
Pharmaceutical enterprises: Purchase gelatin capsules and enteric-coated capsules. Require GMP and complete sets of pharmacopoeia materials. Large order volume, long payment period, strict compliance requirements; high value, high entry threshold.
Dietary supplement / health product brand manufacturers: Purchase all categories. There is a strong demand for plant capsules and pearl-like capsules. European and American customers value vegetarianism and organic certification. They are the growth drivers, with higher profits than basic pharmaceutical enterprises.
Health supplement contract manufacturers (CM/OEM): One-stop package purchase of 4 types of capsules. Order stability, price sensitivity; core focus on delivery, price, and complete qualification. 
Import distributors / ingredient wholesalers: Stock in large quantities and distribute to local small and medium-sized manufacturers. They value price advantages and stable delivery periods.
Business planning pr
Gelatin hollow capsules: Best-selling product for volume growth
Positioning: It serves as a lead-in for customer acquisition, not aiming for high profits; used for developing new customers, sold together with other high-profit products; focuses on improving the complete pharmaceutical standard certificate (COA), emphasizing stable delivery time.
Plant hollow capsules: Growth main product
Emphasize completing the Vegan, Halal, and Kosher full set certifications; target the North American, European, and Australian health supplement markets, serving as a core promotional product to increase overall profit margin.
Enteric-coated hollow capsules: High-profit benchmark product
Build the company's technical brand image; prepare a complete enteric dissolution test report, connect with probiotics and specialty formulation customers; suitable for participating in professional pharmaceutical excipient exhibitions (CPHI Global Pharmaceutical Raw Materials Exhibition).
Pearl lustrous capsules: Dif
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