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Oral preparation for reducing brinolase, preparation method and uses thereof

An oral preparation, defibrase technology, applied in the field of defibrase oral preparations, can solve problems such as inconvenient use, low bioavailability, and patient pain

Inactive Publication Date: 2008-09-24
深圳市利世隆科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, the defibrase injection preparation has disadvantages. First, the conditions required for the production of the injection are high, and the production cost is high; secondly, the injection brings pain to the patient; moreover, it is inconvenient to use, and the preparation needs to be injected with an appropriate amount before use. It is dissolved in water or saline, so strict aseptic operation and injection are required by skilled persons
Since defibrase itself is a protease, administration of common oral preparations will cause most of defibrase to be degraded in the stomach, and defibrase is also difficult to be absorbed in the stomach, and its bioavailability is very low, so it is difficult to achieve oral administration. purpose of medication

Method used

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  • Oral preparation for reducing brinolase, preparation method and uses thereof
  • Oral preparation for reducing brinolase, preparation method and uses thereof
  • Oral preparation for reducing brinolase, preparation method and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0063] The preparation method of enteric-coated tablet generally includes steps such as granulation, tabletting, and coating.

[0064] The preparation method of enteric-coated capsules usually includes the steps of granulating and encapsulating.

[0065] The preparation method of enteric-coated pellets usually includes: the preparation methods of pellets include coating pot method, centrifugal layering method, spheroid granulation method, emulsification method, extrusion spheronization method, fluidized bed granulation coating, oscillating drop There are differences in the specific operation steps in methods such as preparation methods.

[0066] In another preferred example, the obtained mixture is prepared into microcapsules, and coated into enteric-coated tablets after tableting, or the microcapsules are filled into enteric-coated capsule shells to make enteric-coated capsules, or the microcapsules are made into Enteric-coated pellets.

[0067] Spherical pellet granulator ...

Embodiment 1

[0105] Embodiment 1, preparation of defibrase enteric-coated capsules

[0106] Take defibrase 0.2g (protein weight, specific activity is 2000U / mg protein) and fully mix with carboxymethyl cellulose salt 15g, low-substituted hydroxypropyl cellulose 15g, cross-linked polyvinylpyrrolidone 10g, gelatin 5g, etc., to prepare Form microcapsules, then fully mix the microcapsules with 5 g of microcrystalline cellulose, 25 g of starch, and talcum powder, pack into No. 3 enteric-coated capsules, and prepare 1000 enteric-coated capsules, each capsule containing 0.2 mg of defibrase.

[0107] In this embodiment, multiple batches of capsules were prepared, and the batch numbers 0901, 0902, and 0903 were randomly selected for testing.

Embodiment 2

[0108] Embodiment 2, preparation of defibrase enteric-coated tablets

[0109] Take defibrase 0.2g (specific activity is about 1500U / mg protein) and carboxymethyl cellulose salt 15g, low-substituted hydroxypropyl cellulose 10g, cross-linked polyvinylpyrrolidone 4g, gelatin 5g, etc., fully mix, granulate, Freeze-dried, coated with cellulose acetate phthalate, passed through a 18-24 mesh sieve, and then mixed with 5 g of microcrystalline cellulose, 25 g of starch, 4 g of cross-linked polyvinylpyrrolidone, 4 g of cross-linked sodium carboxymethyl cellulose, Low-substituted-hydroxypropyl cellulose 5g, appropriate amount of magnesium stearate and micropowder silica gel, mixed and pressed into 1000 tablets. Each tablet contains 0.2mg defibrase.

[0110] In this example, multiple batches of enteric-coated tablets were produced, among which batch numbers 1011, 1012, and 1013 were randomly selected for testing.

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Abstract

The invention discloses a novel fiber reducing enzyme oral preparation, which contains enteric dissolved preparation the main component of which is fiber reducing enzyme. The invention also provides the preparation method and the purpose of the fiber reducing enzyme oral preparation. The preparation can be clinically used for treating or preventing diseases such as: (1) acute cerebral infarction, including cerebral thrombosis, cerebral embolism, transient cerebral ischemia attack, and cerebral infarction recrudescence; (2) myocardial infarction, unstable angina, and myocardial infarction recrudescence; (3) vascular disease in limbs, including femoral artery embolism, thromboangitis obliterans, and Raynauds disease; (4) blood in high-viscosity state, hypercoagulability state, and pro-thrombotic state; (5) sudden deafness; (6) pulmonary embolism; etc.

Description

technical field [0001] The invention relates to an oral defibrase preparation, a preparation method and application of the defibrase oral preparation. Background technique [0002] Defibrase is a single component thrombin (Thrombin like) extracted and purified from snake venom. It has similar effects to plasma thrombin, and has the functions of reducing fibrin, antithrombotic, and thrombolytic. Thrombin-like enzyme (ThrombinLikeenzyme) is a product with a certain curative effect named by the World Health Organization (WHO) international non-proprietary drug name. It has arginine esterase and thrombin activity. Due to the difference of snake species, there are many products to come out, such as Ancrod identified and named by WHO and recorded in British Pharmacopoeia, Reptilas (Venoms of Agkistrodon acutus, haemocoagulase) and Batroxobin produced in Japan (Batroxobin, obtained by separating and refining from the venom of the Brazilian spearhead snake subspecies Bothropsmoojen...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/48A61K9/16A61K9/48A61K9/50A61P9/10A61P7/02
Inventor 黄捷张小芳
Owner 深圳市利世隆科技有限公司
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