Application status of Zhihuo soft capsule in pharm

Current situation of the application of soft capsules in the packaging of drugs and health products

in the packaging of drugs and health products, the requirements for the safety, hygiene and convenience of carrying and taking products are very high. The traditional packaging is mainly bottled, tablets and injections, and there are obvious deficiencies in safety, hygiene, carrying and taking. With the increasing improvement of people's living standards and health requirements, it is inevitable that the packaging of drugs and health products should be updated and developed. Thus, blister packaging and soft capsule packaging are introduced, especially soft capsule packaging has incomparable characteristics compared with other packaging, making it unique in the packaging of drugs, health products and other cosmetics. In addition, with the modernization of traditional Chinese medicine preparations and the widespread favor of people in the domestic and foreign markets, as well as the unique advantages of soft capsules in the packaging of traditional Chinese medicine preparations have been fully reflected, which has further expanded the market of soft capsules. Now let's talk about the application of soft capsule packaging in the production of drugs

I. characteristics of soft capsule packaging

soft capsule packaging is a new type developed after tablets, hard capsules, pills, injections, oral liquids and other dosage forms. It can quantitatively inject and encapsulate oily functional substances, functional substance solutions or functional substance suspensions, pastes and even functional substance powders in the plastic film to form size The functional characteristics and operation steps of the V-shaped drop hammer impact testing machine are sealed capsules with different shapes. It has excellent functions of isolating light and oxygen, good visual effect, high bioavailability, accurate content, good uniformity, beautiful appearance and other characteristics, and is very suitable for the packaging of drugs, health products and so on. Soft capsule products have fundamentally broken through the traditional ampoules, tablets, pills, plasters and hard capsules. As a form of packaging that directly fills the contents, it has unique advantages, mainly in the following aspects

1. Good airtightness and high safety

capsule products are airtight. After production, the contents have been wrapped in the rubber, which can not only avoid secondary pollution, but also the soft capsule packaging has a good isolation function, which can isolate the functional materials sensitive to light and oxygen from the air and light line, avoid the oxidation of effective substances, keep the content of products stable within the validity period, and ensure the exertion of efficacy. In use, the package is small, the quantity is accurate, and the absorption is fast. The dosage error of soft capsules quantitatively filled by machine is small, and the consumption of consumers is stable every time. The net content of ni0.053 is generally designed as a one-time dosage, so as to ensure that users only need one capsule at a time and do not have to reuse it, avoiding the possible secondary pollution of ni0.053 product in the process of use. Due to its good sealing property, it covers the bad smell of the drug, avoids the bad smell from affecting the use, and gives the user a more comfortable feeling

2. Easy to carry and take

soft capsules are easy to carry and use, and can be carried separately according to the dosage. In addition, its packaging is not easy to break, and it is also very safe to carry; While it is suitable for consumers' daily home use, it is more suitable for people to use when going out on vacation, traveling and field work. For example, a portable small hard box is specially attached to the packaging box of perfect garlic soft capsule, which can be carried separately according to the dosage when going out, and the hard box packaging can prevent crushing. Small dose carrying is very safe, which is suitable for consumers' daily home use, and also takes care of people's taking it when going out for vacation, tourism and outdoor work. After the soft capsule disintegrates in the body, the contents can be directly absorbed in the intestinal tract in liquid form, without dissolution process, so the absorption is fast. Due to the high bioavailability, the dosage of patients is reduced

3. Novel appearance, prevent counterfeiting

products packaged in soft capsules have different appearance forms, rich colors, novel and attractive, which are very attractive and novel to consumers. The soft capsule package is granular, with smooth surface, good taste, easy to swallow, and has a certain anti-counterfeiting function

II. Preparation of soft capsule packaging

soft capsule is also called elastic capsule, and its elasticity depends on the proportion of gelatin, plasticizer and water in the capsule. The earliest soft capsule preparations were vitamin A and D capsules. Since the invention of the rotary die wrapping machine in 1933, the output has been greatly increased and the cost has been greatly reduced. European and American countries have adopted it one after another, and continue to improve the mechanical equipment, so that the soft capsule can not only fill liquid and paste soft drugs, but also fill powder, particles, etc., and the variety and output continue to increase. China began to produce soft capsule products in the 1960s, but the real development was in the 1990s. In the early 1970s, China used molding method to produce soft capsules. The products were single, and the common ones were vitamin E capsules, Maitong capsules, evening primrose capsules and so on. After the 1985 edition of Chinese Pharmacopoeia came into force, the soft capsules produced by molding method were eliminated and produced by rdem method, which greatly improved the quality. Especially in the 1990s (Jinan experimental machine factory high-frequency decadent experimental machine), China developed a series of traditional Chinese medicine soft capsules, such as Huoxiang Zhengqi soft capsule, compound Danshen soft capsule, Ma Ren soft capsule, etc., which changed the situation of Western medicine soft capsule dominating the world. At present, the common soft capsules in medicine include oral stomach soluble capsules, enteric soluble capsules, chewing capsules, slow-release capsules, skeleton capsules, coating capsules, quick acting capsules, external rectal capsules, and tubular soft capsules for eyes, skin, ear and nose, etc. Products are diverse in size, shape, color and other aspects, and are gradually becoming a new packaging trend, active in the pharmaceutical and health food markets. In addition to the packaging of drugs and health products, soft capsules have also been widely used in household chemicals, food industry, chemistry and other industrial fields. However, because soft capsule preparation is a relatively difficult dosage form to produce, with high requirements for technical equipment and strong professionalism, there are few pharmaceutical companies engaged in the production of soft capsule preparation. In foreign countries, this product is undertaken by professional soft capsule manufacturers. Pharmaceutical factories or other factories carry out business in the form of entrusted processing. The birth of this new brand marks the beginning of a new chapter in the clothing and footwear industry. Art and patents are confidential, so the production of soft capsule preparations is affected to a certain extent. In addition, the soft capsule production line has large investment, high requirements for supporting facilities, strict requirements for personnel training, and a long cycle. Soft capsule products are large-scale products, and the annual production capacity of a soft capsule machine production line is more than 100million soft capsules; At the same time, compared with the production cost of multiple production lines, the production cost of a single production line is higher. Therefore, it is not cost-effective to provide a soft capsule production line for one or several products. This is also the reason why foreign soft capsules are mostly completed by professional manufacturers

the production of soft capsules such as drugs and health products requires very strict shell rubber materials. The main components of the soft capsule shell are edible gelatin, glycerin and pure water, which is not harmful to human health. Gelatin is a kind of protein, which is widely used in medicine and food. Many daily foods, such as jelly and candy, are made of gelatin; Glycerin, which is made from corn, potato and honey, is a widely used and safe food additive. Therefore, the soft capsule shell itself is a very safe edible raw material. The main indicators to evaluate the quality of soft capsule products are: disintegration of products, loading difference of products, uniformity of products, and microbial detection of products. These indicators need corresponding experimental instruments, equipment, etc. to be tested by professionals and provide corresponding experimental reports

most of the health care products and drugs packaged in soft capsules are natural active ingredients extracted from slaves and plants, which are generally oily functional or oily and powdery suspension materials with high purity. Because oily functional substances can omit the technical treatment of absorption and solidification, and can effectively avoid the exudation of oily functional substances from absorption excipients, the use of soft capsule packaging is the most suitable dosage form. In recent years, the redevelopment of traditional Chinese medicine products is also based on soft capsule dosage forms. Traditional Chinese medicine soft capsule is different from western medicine. Western medicine has a single component, most of which are oily drugs or hydrophobic powder, which are easy to be made into oil solution and relatively easy to be encapsulated; The prescription of traditional Chinese medicine is complex, with high paste yield, strong water absorption, and complex preparation of its contents. Therefore, the contents of traditional Chinese medicine soft capsules are mostly made into suspension or paste, which requires that the contents should not only be uniform and stable, but also have good fluidity, and at the same time, the requirements for production equipment are also high. In addition, low melting point functional substances and health food, hydrophobic functional substances and health food with poor bioavailability, functional substances and health food with bad bitterness and odor, trace active functional substances and health food, and functional substances and health food that are unstable in light, humidity, heat and easy to oxidize are suitable for making soft capsules. Since the main components of soft capsule shell are gelatin, glycerin and pure water, it has a great relationship with whether the wrapping material is water-based or oil-based, because the gelatin cortex can only cover oil substances. For water-based components, the drugs should be made into powder (such as royal jelly freeze-dried powder) by means of solid dispersion technology, and then dispersed into 400peg ~ 40000 peg with molecular weight to form a slurry, and then coated with gelatin to form a soft capsule. However, due to the high hygroscopicity of PEG itself, the tightness of gelatin interface will be affected. Domestic manufacturers have recently proposed a method to thicken the skin of soft capsules, but this is subject to equipment performance and cost constraints. Foreign reports reported that grafting modification was carried out to reduce its hydrophilicity, without affecting the disintegration speed and bioavailability of the drug

III. Market Prospect of soft capsule packaging

there is a certain gap between the hard capsule and other packaging used in China's health food in the past and the international market in terms of appearance and packaging quality. With the application of new soft capsule production technology, China's health products packaged with soft capsules have made great progress in material, color, shape, quality and so on. It can be said that at present, the production process of soft capsules in China has caught up with or even surpassed that of foreign counterparts. As a result, China has added a weight to the international market. Soft capsule health food is gradually becoming a leader in the health food packaging industry with its overwhelming advantages. Soft capsules are becoming a new trend of packaging in the industries of medicine, health products and cosmetics at home and abroad

in recent years, the international community has also attached great importance to the development and research of soft capsules. Now the world has nearly 1000 models of soft capsule manufacturing machines, with an annual output of up to 700billion capsules and more than 3000 varieties. At present, the United States is the largest soft capsule manufacturer in the world, and its sales volume ranks first in the world, followed by Germany and Britain. At present, the global sales of soft capsules is about US $400million, of which nutritious products account for a large proportion, up to more than 70% at most. It has a broad market in developed countries

China also pays more attention to the production and development of soft capsule preparations, and has made great progress. The production scope has also developed from simple western medicine preparations to Chinese patent medicine preparations. At present, 9 traditional Chinese medicine factories have produced soft capsules of traditional Chinese medicine preparations and put them on the market, and some manufacturers have developed soft capsules of nourishing nutrients. In addition, the emergence of daily chemical capsules has also greatly enriched soft capsules