Multicolor hard empty capsules
Many people do not like to take medicine and feel bitter, so when the hollow capsule came out, it was widely welcomed by everyone, realizing the real medicine does not taste bitter. It also extends the validity of the drug.
Gelatin hollow capsule composition
Most capsules are made from gelatin. Gelatin is used in many foods, such as puddings, sweets, preserves, chewable candies, icing, food douches and dips. In food, gelatin helps solidify, thicken, stabilize, aerate, and is a popular nutritional and low-fat food ingredient. Gelatin itself is a water-soluble protein extracted from collagen, the main natural protein component of connective tissue. Gelatin is obtained from the animal’s skin and bones through a controlled extraction process.
There are many types of gelatin. Capsules are made from pharmaceutical grade gelatin, which meets stringent requirements for use in pharmaceutical products. Capsules are made by forming a thin gelatin film on a stainless steel mold. The gelatin film then dries and hardens to form a capsule, which is then removed from the mold. There are generally two sizes of mold, one for the capsule body and the other for the larger diameter of the capsule cap.
Color gelatin empty color capsule specifications
|Product Name：||Qualified multicolor hot sale gelatin pill shell empty capsules for medical|
|Sizes：||0#1# 2# 3# 4# 5#|
|Specification：||Using halal gelatin raw materials, dissolved in the stomach.|
|Color||Transparency or customized color|
|Lead Time:||10-20 days|
Classification of hollow capsules
Hollow capsules according to different components can be divided into animal hollow capsules and plant hollow capsules, according to whether the main material is made of gelatin can be divided into gelatin hollow capsules and non-gelatin hollow capsules. Animal capsules belong to gelatin hollow capsules, plant capsules belong to non-gelatin hollow capsules.
Microbial control status of gelatin hollow capsule
Gelatin hollow capsule is made of pharmaceutical gelatin and auxiliary materials, gelatin is susceptible to infection by external microorganisms, as we all know, some microorganisms are harmful to human health. Due to the equipment, technology, personnel, production process control and management of gelatin hollow capsule production plant, as well as the quality of raw materials, auxiliary materials, water, the control of microbial indicators is not stable. Sometimes the microbial index will be detected to exceed the standard, some gelatin hollow capsule factory to add some preservatives or fungicides to sterilize gelatin hollow capsule, thus playing a certain role, but the microbial index is still unstable. And preservatives and fungicides added too much, will cause certain damage to the human body.
The benefits of gelatin capsules
Gelatin hollow capsule is composed of capsule cap shell and capsule body shell. Capsule preparation is a more common dosage form of drug preparation, it has such advantages as easy to carry, easy to swallow, easy to protect drug components, can make the drug directly to the patient parts. In addition, gelatin capsules can cover up the bad smell and taste of the drug itself; It can improve the bioavailability of drugs, disperse quickly and absorb well in gastrointestinal tract. It can improve drug stability and is not affected by oxygen, humidity and temperature in the air. Sustained-release preparation and compound preparation can be made;
Accurate and uniform dose; The recipe is simple. Gelatin capsules have become more and more popular among drug manufacturers and consumers in recent years.
Capsules can contain various powders, liquids, semisolids and tablets. In addition, capsules have good bioavailability due to the rapid, reliable and safe dissolution of capsules. In addition, the capsules can be printed with text, logos and patterns to create a unique custom look. And some drugs must be kept under the shade, so the choice of color hollow capsule filling is the best, but also to extend the validity of drugs. Color capsules can also help us distinguish between drugs.
Gelatin hollow capsule production process
Gelatin hollow capsule is mainly based on gelatin as the main material, and then add all kinds of auxiliary materials in accordance with a certain production process, gelatin hollow capsule production process is the main gelatin and auxiliary materials, melt glue, dip in the embryo, extraction, cutting, lamp inspection, set, printing, general inspection, sterilization and outsourcing.
1. Sol. Weigh and take qualified capsules soaked with gelatin and purified water, make it fully water absorption expansion, and then add enough hot water and other additives, at 80 oC heating test to dissolve into uniform glue. The glue was filtered into the insulation barrel with a 200 mesh filter bag and kept at 50±2 oC for static insulation. Note: sol temperature should not be too high, time should not be too long.
2, forming. Remove the skin and foam of the glue solution in the insulation bucket, adjust the concentration and wait for use. Select suitable specifications of the capsule mold, evenly coated with demoulding oil, automatic dipping machine will be immersed in the capsule mold slowly rise, and automatically turned into the drying line, drying line temperature is 34~36 oC, relative humidity 60~70%.
3. Film removal. Use demoulding machine to take off the empty sac on the mold, demoulding pay attention to the dryness of the blank, such as too dry or too damp can not demoulding, take back furnace (over damp) stay a few minutes (too dry) demoulding again. Take off the capsule blank into a plastic bag in time, fill in the process card, follow the capsule to the cutting place.
4, cutting. Before cutting, carefully check whether the specifications of the steel mold of the automatic cutting machine are consistent with the specifications of the blank sac cut, and whether the operation is normal. After checking, the blanks will be placed on the automatic cutting machine for continuous cutting. The semi-finished products shall be transferred to the semi-finished products inspection department together with the completed process card, and the waste products shall be stored separately. Note: the incision should be smooth, without burrs and small tails.
5. Inspection of semi-finished products. The cut semi-finished capsules are placed on the lamp inspection table for visual inspection, and the capsules with black spots, sand holes, flower heads, lace, bubbles, cracks and deformation are removed. The genuine product after inspection and the completed process card shall be transferred to the nesting place.
6, set. The two parts of the cap body are fitted with the fitting equipment to make it a finished product. In the process of nesting, attention should be paid not to insert the wall, and the lock mouth should be appropriate. Waste and defective products should be removed in time, and the closed capsules should be put into plastic bags in time, and transferred to the inner bag together with the filled process card.
7. Physical and chemical testing. The drying weight loss, viscosity, friability, disintegration time limit, burning residue, heavy metal, sulfite and microbial limit of gelatin hollow capsules were sampled by the laboratory, and the inspection standards were carried out according to relevant standards and accessories under gelatin hollow capsules of the People’s Republic of China Pharmacopoeia 2010 edition.
8. Packaging. The qualified finished products will be divided into batch measurement packaging. The number of gelatin hollow capsules per 100g is taken immediately to ensure the correct measurement of packaging. When measuring the packaging, put the certificate together into the outer packaging carton, and paste the packing list on the carton. There should be specifications, color, production license, registered trademark, receiving unit, quantity, production lot number, heat proof, moisture proof, pressure proof, upward sign, etc.
Microbial control in gelatin hollow capsule production
Selection of microbial indicators qualified raw materials and accessories. Gelatin hollow capsule is gelatin as raw material, and then add some auxiliary materials prepared from 111, and gelatin is an excellent culture medium for bacterial reproduction, so in order to make the hollow capsule qualified microbial indicators, we must strictly control the health indicators of gelatin. The raw materials and auxiliary materials used in the production of gelatin hollow capsules should be tested for microbial indicators before use, and the raw materials and auxiliary materials with qualified microbial indicators should be selected.
In the process of gelatin hollow capsule production, each production process is in a specific production workshop, so the environmental health conditions of the production workshop largely determine whether the microbial indicators of gelatin hollow capsule can be qualified. In aseptic production of pharmaceutical industry, it is necessary to control not only suspended aerosol particles in the air, but also the number of microorganisms. Therefore, disinfection of workshop environment is an important measure to control the number of microorganisms. The GMP(2010 Revision), promulgated in 2011, has raised the cleanliness requirements of aseptic workshop environments. Sterile drug production workshop environment is an important part of the quality of the drug, so the production process must control the environment of the air, personnel and workshop surface microbes, the production workshop microbial indicators qualified is a necessary condition for the release of sterile drugs. The current production workshop environment sterilization in China generally has the following methods:
(1) China’s pharmaceutical industry mostly uses formaldehyde fumigation, formaldehyde has the advantages of sterilization, broad spectrum, stable properties, storage resistance, etc. However, formaldehyde has certain toxicity and irritation, and is harmful to human body. Therefore, sufficient exhaust time must be guaranteed after fumigation with formaldehyde. Its residue will adhere to the surface of the production workshop, which needs to be erased and the formaldehyde residue is controlled within the specified range, so the sterilization operation is troublesome.
(2) Lactic acid fumigation is also a commonly used sterilization method in the production workshop. Its sterilization efficiency is slightly lower than formaldehyde fumigation, and it is more troublesome to operate, but it is not toxic to the human body.
(3) Peracetic acid fumigation, sterilization speed, air disinfection effect is very good, but has a strong irritation to human respiratory tract.
(4) Ultraviolet disinfection technology has the advantages of good broad spectrum, high disinfection efficiency, no disinfection by-products and safety and reliability, and ultraviolet disinfection technology also has no reserve of dangerous chemicals, disinfection operation process.
(5) good ultraviolet disinfection technology has a broad spectrum, high disinfection efficiency, do not produce disinfection by-products, and the advantages of safe and reliable, and the ultraviolet disinfection technology also has no reserves to dangerous chemicals sterilization, disinfection process simple operation, contact time is short, and the advantages of inactivated virus efficiently, widely used in indoor environment air effective disinfection sterilization, However, ultraviolet disinfection and sterilization has a certain shadow invalid area, which reduces the sterilization efficiency of ultraviolet lamp, and ultraviolet lamp has a certain life.
(6) the ozone sterilization method is widely used in China in recent years a good sterilization effect of sterilization method and molecular structure of ozone in normal temperature and pressure is not stable, will soon be decomposed into oxygen and oxygen, oxygen has strong activity, can of microorganisms to produce strong oxidation and killed, its sterilization efficiency is very high, application range is very wide, Such as containers, pipes, pharmaceutical water, closed space, etc., can use this method of disinfection and sterilization, but ozone also has a certain stimulating effect on the human body, when sterilization operators should avoid the sterilization area.
Clean room air disinfection and sterilization is the technical guarantee of qualified microbial indicators of products, so it is necessary to strengthen the detection of sterilization efficiency in production and compare the sterilization effect of different methods. In order to ensure product quality and safety, reasonable workshop environmental sterilization methods must be selected on the basis of fully considering product process, harm to human body, difficulty of implementation, cost and environmental requirements for sterilization.
Gelatin hollow capsule
Non gelatin hollow capsule
Non-gelatin hollow capsule mainly refers to plant capsules, plant capsules are made of hydroxypropyl methyl cellulose extracted from plants as the main material, auxiliary materials and pigments. Hydroxypropyl methyl cellulose is a natural polymer in plants. As the raw material of hollow capsules, it can be taken with a variety of drugs, and it is not easy to breed microorganisms, which can avoid the residue of preservatives and sterilizers in plant capsules from the source. The latest research types of non-gelatin hollow capsules mainly include: alginate, which is composed of low viscosity alginate, carrageenan plus edible glycerin, potassium chloride,
Seaweed polysaccharides are mainly prepared from seaweed polysaccharides. And hydroxymethyl glucose-soybean protein isolate complexes. Plant-based capsules have the advantages of low water content, wide applicability, convenient storage and not easy to breed microorganisms. It is also a popular medicinal object for vegetarians. Although it is unlikely that the plant capsules will replace the traditional gelatin hollow capsules, the plant capsules have many advantages and will be the main trend of the development of hollow capsules in the future.