Kallidinogenase enteric coated tablet and preparation method thereof

A technology of pancreatic kininogenase and enteric-coated tablets, which is applied in the fields of pill delivery, pharmaceutical formulation, peptide/protein composition, etc., and can solve the problem of non-compliance of content uniformity of finished products, non-compliance of content uniformity and unstable drug quality and other issues to achieve the effect of avoiding titer loss, less potency unit loss, and improving content and stability

Inactive Publication Date: 2012-12-12
武陟维尔康生化制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Relevant literature and published patents show that the existing pancreatic kininogenase preparations, especially tablets, tend to lose a lot of potency due to wet granulation in the production process, and the use of blank granulation method tends to make the content uniformity of the finished product If it does not meet the regulations, the potency is easy to decrease, and the water-soluble film coating premix is ​​used in the encapsulation process, and the potency is more likely to be lost a

Method used

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  • Kallidinogenase enteric coated tablet and preparation method thereof
  • Kallidinogenase enteric coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Example 1 Preparation of pancreatic kininogenase tablets

[0032] A pancreatic kininogenase enteric-coated tablet, every 1000 tablets includes the following components:

[0033] Pancreatic kininogenase: 140,000 units

[0034] Starch: 130g

[0035] Microcrystalline Cellulose: 20g

[0036] Sodium carbonate 17g:

[0037] Hypromellose: 8g

[0038] Magnesium Stearate 3g

[0039] Enteric Film Coating Premix (Ahua) 24g

[0040] Preparation:

[0041] 1. Preparation: Grind excipients such as pancreatic kininogenase, starch, microcrystalline cellulose, sodium carbonate, hypromellose, and magnesium stearate through an 80-mesh sieve.

[0042] 2. Prepare blank granules: Mix the weighed auxiliary materials according to the prescription amount, add purified water and stir evenly to make soft materials, pass through a 20-mesh sieve to prepare blank granules. Place the granules in a hot air circulation oven, and dry them with hot air below 50°C. The dried blank granules are size...

Embodiment 2

[0048] Example 2 Preparation of pancreatic kininogenase tablets

[0049] A pancreatic kininogenase enteric-coated tablet, every 1000 tablets includes the following components:

[0050] Pancreatic kininogenase: 90,000 units

[0051] Lactose: 140g

[0052] Microcrystalline Cellulose: 15g

[0053] Sodium Alginate 25g

[0054] Hypromellose: 6g

[0055] Magnesium Stearate 3g

[0056] Enteric film coating premix (Yingmao) 28

[0057] 1. Preparation: Grind excipients such as pancreatic kininogenase, lactose, microcrystalline cellulose, sodium alginate, hypromellose, and magnesium stearate through an 80-mesh sieve.

[0058] 2. Prepare blank granules: Mix the weighed auxiliary materials according to the prescription amount, add purified water and stir evenly to make soft materials, pass through a 20-mesh sieve to prepare blank granules. Place the granules in a hot air circulation oven, and dry them with hot air below 50°C. The dried blank granules are sized with a 20-mesh stainles...

Embodiment 3

[0063] Example 3 Preparation of pancreatic kininogenase tablets

[0064] A pancreatic kininogenase enteric-coated tablet, every 1000 tablets includes the following components:

[0065] Pancreatic kininogenase: 120,000 units

[0066] Lactose: 120g

[0067] Sodium starch glycolate: 18g

[0068] Calcium chloride 27g

[0069] Hypromellose: 7g

[0070] Magnesium Stearate 2g

[0071] Enteric Film Coating Premix (Ahua) 20g

[0072] 1. Preparation: Grind excipients such as pancreatic kininogenase, lactose, sodium starch glycolate, calcium chloride, hypromellose, and magnesium stearate through an 80-mesh sieve.

[0073] 2. Prepare blank granules: Mix the weighed auxiliary materials according to the prescription amount, add purified water and stir evenly to make soft materials, pass through a 20-mesh sieve to prepare blank granules. Place the granules in a hot air circulation oven, and dry them with hot air below 50°C. The dried blank granules are sized with a 20-mesh stainless s...

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Abstract

The invention discloses a kallidinogenase enteric coated tablet which contains kallidinogenase which is used as an active ingredient, and a tablet core contains sodium alga acid or inorganic salt which is taken as a stabilizer. The invention further discloses a preparation method of the kallidinogenase enteric coated tablet, wherein adjuvants are taken as blank particles at first, kallidinogenaseserving as the main active ingredient is then added and is uniformly mixed, the tablet is produced according to a conventional method, and finally, enteric coating is used to coat a premixing agent into enteric film coating. The added stabilizer has the activity of being combined with the kallidinogenase into activating enzyme, so the kallidinogenase is prevented from titer loss during the production process, and the active ingredient input is in accordance with finished product yield. An adhesive has strong adhesive force, large particle adhesive power, and is easily mixed with the kallidinogenase uniformly. The formula has the characteristics of little unit titer loss during the production process and high finished product titer recovery rate; all adjuvants have no interference with thefinished product inspection, the finished product is high in quality, safe and effective.

Description

technical field [0001] The invention relates to a pancreatic kininogenase enteric-coated tablet and a preparation method thereof. Background technique [0002] Pancreatic kininogenase is a peripheral vasodilator with the effect of dilating blood vessels and improving microcirculation. Pancreatic kininogenase acts on kininogen in the body to release kinin, which directly acts on small blood vessels and capillaries, thereby producing a A series of pharmacological effects, such as dilating capillaries, dilating small arteries, etc., can improve the permeability and blood flow of blood vessels while dilating blood vessels; it can regulate blood pressure and reduce myocardial oxygen consumption; it can also promote the secretion of prostate and improve various Organ blood flow. As an internationally recognized microcirculation improving agent, pancreatic kininogenase is an enzyme drug with definite curative effect and mild side effects, suitable for long-term administration, and...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/28A61K38/48A61K47/02A61K47/26A61P9/00
Inventor 刘盛儒王增鑫隗青孙岩王基伟张梅村姚风梅
Owner 武陟维尔康生化制药有限公司
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