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Polaprezinc rectum gel as well as preparation method and application thereof

A technology of polyprezinc and rectum, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of polluting clothes, easy leakage, long treatment period, etc., and achieve good dissolution degree of effect

Pending Publication Date: 2020-04-10
吉林省博大伟业制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, currently the commonly used preparations for the rectum include enemas and suppositories. For specific formulations, refer to the polyprezinc rectal administration preparation disclosed in CN108125963A; enemas and suppositories still do not meet the actual needs of ulcerative colitis treatment
A large number of clinical applications have found that enema drugs have a large diffusion area and good clinical efficacy, but there are still three common problems: first, the course of treatment for this type of disease is long, and it is extremely inconvenient for medical staff to use professional equipment for drug administration; First, it cannot stay in the intestine. In order to ensure the duration of drug action, patients are required to lie flat for a long time after administration, and the action time is still limited; third, it is easy to leak and pollute clothes, affecting normal work and life.

Method used

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  • Polaprezinc rectum gel as well as preparation method and application thereof
  • Polaprezinc rectum gel as well as preparation method and application thereof
  • Polaprezinc rectum gel as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1 A polyprezinc rectal gel

[0028] Prescription 1 is as follows:

[0029]

[0030]

[0031] Among them, the particle size distribution of polyprezinc is D90≤30μm, D50≤10μm;

[0032] The preparation method of polyprezinc rectal gel is as follows:

[0033] a. Crush polyprezinc until the particle size distribution of polyprezinc is D90≤40μm and D50≤10μm;

[0034] b. Weigh each raw material according to weight percentage;

[0035] c. Prepare pH 4.5 aqueous solution: adjust with 0.27% citric acid and 0.55% sodium citrate;

[0036] d. Add xanthan gum, carbomer and benzalkonium bromide to the pH 4.5 aqueous solution configured in step c, and stir to dissolve completely;

[0037] e. Add polyprezinc to the solution of step d, stir and mix well, and get it.

Embodiment 2

[0038] Example 2 A polyprezinc rectal gel

[0039] Prescription 2 is as follows:

[0040]

[0041] Among them, the particle size distribution of polyprezinc is D90≤40μm, D50≤10μm;

[0042] The preparation method of polyprezinc rectal gel is as follows:

[0043] a. Crush polyprezinc until the particle size distribution of polyprezinc is D90≤40μm and D50≤10μm;

[0044] b. Weigh each raw material according to weight percentage;

[0045] c. Prepare pH 5.5 aqueous solution: adjust with 0.029% citric acid and 0.20% sodium citrate;

[0046] d. Add xanthan gum, carbomer and benzalkonium bromide to the pH 5.5 aqueous solution configured in step c, and stir to dissolve completely;

[0047] e. Add polyprezinc to the solution of step d, stir and mix well, and get it.

Embodiment 3

[0048] Example 3 A polyprezinc rectal gel

[0049] Prescription 3 is as follows:

[0050]

[0051] Among them, the particle size distribution of polyprezinc is D90≤30μm, D50≤10μm;

[0052] The preparation method of polyprezinc rectal gel is as follows:

[0053] a. Crush polyprezinc until the particle size distribution of polyprezinc is D90≤30μm and D50≤10μm;

[0054] b. Weigh each raw material according to weight percentage;

[0055] c. Preparation of pH 6.8 aqueous solution: adjusted with 0.68% dipotassium hydrogen phosphate and 0.09% sodium hydroxide;

[0056] d. Add xanthan gum, carbomer and benzalkonium bromide to the pH 6.8 aqueous solution configured in step c, and stir to dissolve completely;

[0057] e. Add polyprezinc to the solution of step d, stir and mix well, and get it.

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Abstract

The invention provides polaprezinc rectum gel as well as a preparation method and application thereof. The rectum gel comprises polaprezinc and auxiliary materials; the particle size distribution of the polaprezinc is as follows: D90 is less than or equal to 40 micrometers and D50 is less than or equal to 10 micrometers. The auxiliary materials comprise a suspending aid, a biological adhesive, a preservative and an aqueous solution with the pH value of 4.5-6.8. The polaprezinc rectum gel disclosed by the invention has a very good dissolution rate.

Description

Technical field [0001] The invention belongs to the field of polyprezinc preparations, and particularly relates to a polyprezinc rectal administration gel and a preparation method and application thereof. Background technique [0002] Colon ulcer is an acute or chronic inflammation confined to the colonic mucosa and submucosa. It can be manifested as localized defects and ulcers. It is mostly caused by infection, ischemia, inflammation, tumors and drugs. Its size, shape, depth, The development process is also inconsistent. Due to different causes, the distribution of lesions is different, and some lesions may involve the entire colon. Common diseases mainly include: Ulcerative colitis (UC), Crohn's disease (CD), ischemic bowel disease (Ischemiccolitis), colon tumor (Colonic tumor), drug-induced enteritis and infectious enteritis (Infectiveenteritis), such as Clostridium difficile infection (CDI), Intestinal tuberculosis (IT), Amoebae, Antibiotic-associated diarrhea (AAD), etc. ...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K31/555A61K47/36A61K47/38A61P1/04
CPCA61K9/06A61K9/0031A61K31/555A61K47/36A61K47/38A61P1/04
Inventor 谢文博李晓冬黄晓光李明如
Owner 吉林省博大伟业制药有限公司
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