A kind of low hygroscopic colloid bismuth pectin capsule and its preparation process

Abstract

The invention discloses a colloidal bismuth pectin capsule with low hygroscopicity and a preparation process thereof. The preparation uses acrylic resin IV as a coating material and light calcium carbonate as an anti-sticking agent to coat the colloidal bismuth pectin. The obtained Coated pellets are filled with capsule shells, which greatly improves the problem of easy moisture absorption and difficult dispersion of colloidal pectin bismuth preparations in the storage process, and improves the curative effect of the drug; at the same time, there are fewer types of excipients used, and the preparation process is simple and easy for industrialization Big production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a low-hygroscopic capsule containing colloidal bismuth pectin and a preparation process thereof. Background technique [0002] Colloidal bismuth pectin is a new type of colloidal bismuth preparation with strong colloidal properties. It can form a high-viscosity sol in acidic medium and form a firm protective film on the gastric mucosa, thereby enhancing the barrier function of the gastric mucosa. The sol formed by colloidal bismuth pectin in acidic medium is better than any other colloidal bismuth agent. It can be deposited on the cell wall of Helicobacter pylori, causing vacuoles to varying degrees in the bacteria, causing cell wall rupture and inhibiting bacterial enzymes. The activity of bacteria interferes with the metabolism of bacteria, making it more sensitive to the normal defense function of the human body. This product also directly stim...

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Problems solved by technology

[0003] Colloidal bismuth pectin is very easy to absorb moisture, and it is placed under high humidity (25°C 92.5%RH) for 5 days to absorb moisture and increase its weight by 13%, resulting in the sample sticking into agglomerates, poor fluidity, and colloidal stability does not meet the requirements

Due to the strong hygroscopicity of colloidal bismuth pectin, marketed drugs are often difficult to disperse evenly in water. After oral administration, they often cannot quickly achieve good swelling and dispersion in the stomach, and cannot completely cover the ulcer surface, thus greatly reducing the curative effect of this product.

[0004] CN100477999C discloses a kind of colloidal pectin bismuth dispersible tablet, and this invention uses a large amount of disintegrants in order to achieve the expected dispersion effect, thereby further enhancing the hygroscopicity of the preparation, causing further deterioration of the colloidal dispersion uniformity in the storage process, It is unfavorable for it to cover the surface of the gastric mucosa, thereby reducing the efficacy

However, the preparation process includes the preparation of liposome precursors, microwave reaction to form nano-liquid, spray-drying to form nanoparticles, and preparation of granules. The process is complicated and the production cost is high.

Organic solvents such as tetrahydrofuran are used in the preparation process, which is not conducive to labor protection

At the same time, the spray-dried solution is more viscous, and it is easy to block the spray gun during the spraying process, resulting in low production efficiency

CN103142548A discloses a colloidal bismuth pectin capsule. In the colloidal bismuth pectin capsule, micropowdered silica gel and pregelatinized starch are mixed with colloidal bismuth pectin according to a specific ratio, and both micropowdered silica gel and pregelatinized starch are stronger Hygroscopicity, during the storage process, the contents of the capsule often appear columnar and difficult to disintegrate, which is not conducive to the uniform adsorption of drugs on the surface of the gastric mucosa

The preparation process of this method is complicated, and the use of a large amount of auxiliary materials itself reduces the adhesion effect of colloidal pectin bismuth, and the porogen and disintegrant used are all substances with strong hygroscopicity, and the dispersion uniformity becomes significantly worse during storage.

[0005] In addition, there are still some methods to reduce the hygroscopicity of samples by using moisture-proof packaging in the existing marketed products

However, moisture-proof packaging can reduce moisture absorption to a certain extent, but it cannot fundamentally solve the problem

At the same time, moisture-proof packaging increases production costs, and the humidity of the environment must be strictly controlled during the production process

Through a careful search of relevant literature, it is found that the existing technologies have failed to adopt relatively simple and effective means to solve the problems of serious moisture absorption, poor dispersion uniformity, and difficulty in meeting the requirements of colloidal bismuth pectin preparations during storage.

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