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Colloidal pectin bismuth capsule and preparation process thereof

A preparation technology of colloidal bismuth pectin, applied in the direction of capsule delivery, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc. Good, not conducive to labor protection and other issues, to achieve the effect of easy product quality control, easy swallowing, rapid disintegration and uniform dispersion

Active Publication Date: 2019-09-06
浙江得恩德制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation process of this invention 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
[0014] Patent CN 104825419B discloses a low hygroscopicity colloidal bismuth pectin capsule and its preparation process, using acrylic resin as the coating material and light calcium carbonate as the anti-sticking agent to coat the colloidal bismuth pectin, which greatly solves the problem of During the storage of the preparation, it is easy to absorb moisture and form agglomerates. However, due to the large particle size and no disintegrant, the colloidal bismuth pectin is not easy to disperse evenly
[0015] Through a careful search of domestic and foreign literature, it was found that the prior art failed to provide a colloidal bismuth pectin preparation that can disperse rapidly in the gastric acid environment, have good adhesion to the gastric mucosa, and have a simple preparation process

Method used

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  • Colloidal pectin bismuth capsule and preparation process thereof
  • Colloidal pectin bismuth capsule and preparation process thereof
  • Colloidal pectin bismuth capsule and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033]

[0034] Preparation Process:

[0035] (1) colloidal bismuth pectin and croscarmellose sodium are air-pulverized, mixed evenly according to the prescription amount, and set aside;

[0036] (2) Add low-substituted hydroxypropyl cellulose LH-31 into a centrifugal granulator, and slowly spray purified water into it to prepare a blank pellet core;

[0037] (3) Sprinkle the mixed powder prepared in (1) into the blank ball core prepared in (2) at a fixed rate, and spray purified water slowly at the same time. After the mixed powder is added, stop spraying purified water and continue spheronizing for 10 minutes ;

[0038] (4) Dry the pellets prepared in (3) in a fluidized bed, and fill them with capsules.

Embodiment 2

[0040]

[0041] Preparation Process:

[0042] (1) colloidal bismuth pectin and croscarmellose sodium are air-pulverized, mixed evenly according to the prescription amount, and set aside;

[0043] (2) Add low-substituted hydroxypropyl cellulose LH-31 into a centrifugal granulator, and slowly spray purified water into it to prepare a blank pellet core;

[0044] (3) Sprinkle the mixed powder prepared in (1) into the blank ball core prepared in (2) at a fixed rate, and spray purified water slowly at the same time. After the mixed powder is added, stop spraying purified water and continue spheronizing for 20 minutes ;

[0045] (4) Dry the pellets prepared in (3) in a fluidized bed, and fill them with capsules.

Embodiment 3

[0047]

[0048] Preparation Process:

[0049] (1) colloidal bismuth pectin and croscarmellose sodium are air-pulverized, mixed evenly according to the prescription amount, and set aside;

[0050] (2) Add low-substituted hydroxypropyl cellulose LH-31 into a centrifugal granulator, and slowly spray purified water into it to prepare a blank pellet core;

[0051] (3) Sprinkle the mixed powder prepared in (1) into the blank ball core prepared in (2) at a fixed rate, and spray purified water slowly at the same time. After the mixed powder is added, stop spraying purified water and continue spheronizing for 30 minutes ;

[0052] (4) Dry the pellets prepared in (3) in a fluidized bed, and fill them with capsules.

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Abstract

The invention discloses a colloidal pectin bismuth capsule and a preparation process thereof, a capsule content is prepared by coating mixed powder of colloidal pectin bismuth and low-substituted hydroxypropyl cellulose on a low-substituted hydroxypropyl cellulose LH-31 pellet core. The preparation has the advantages of high content density, small capsule and convenience for swallowing by the patient; the preparation is rapidly dispersed in the stomach acid environment, has good adhesion to the gastric mucosa, and has simple preparation process and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a capsule containing colloidal bismuth pectin and a preparation process thereof. Background technique [0002] Gastrointestinal disease is a frequently occurring and common disease in clinical practice, with a high incidence rate, refractory disease, and easy recurrence disease. The treatment drugs include antacids, antacids, mucosal protective agents, antibiotics, etc. Commonly used mucosal protective agents are sucralfate, aluminum hydroxide gel and bismuth preparations. The mechanism of action of bismuth is that in an acidic environment, it can complex proteins to form a protective film to cover the ulcer surface, thereby preventing the stimulation of pepsin, gastric acid and food; it can also form a complex with pepsin to reduce its digestive activity. Form a complex with epidermal growth factor, gather in the lesion, and protect epidermal gro...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/732A61K47/38A61P1/04
CPCA61K9/1652A61K9/1682A61K33/245A61P1/04
Inventor 金春晖潘伟红金鹿鸣王学英
Owner 浙江得恩德制药股份有限公司
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