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Nano calcium carbonate enteric-coated bioadhesive tablets and their preparation method

A nano-calcium carbonate and bioadhesion technology, applied in the field of drugs for the treatment and prevention of lead poisoning, enteric-coated bioadhesive tablets and its preparation, can solve the problems of high cost, no significant repelling and therapeutic effect for patients, and inconvenience in medication

Inactive Publication Date: 2009-09-30
THE SECOND XIANGYA HOSPITAL OF CENT SOUTH UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Its curative effect is definite, but there are obvious disadvantages: 1. Toxic and side effects are big; Medication is inconvenient and the cost is high; 4. Chronic kidney disease and patients with reduced chronic renal clearance rate have poor effect
[0007] Ordinary calcium, including calcium carbonate, has the function of preventing lead poisoning, and its mechanism of action lies in Ca 2+ with Pb 2+ Competitive antagonism of this type of preparation by increasing Ca 2+ Competitively antagonizes Pb for absorption in the upper small intestine 2+ The absorption makes Pb 2+ The amount absorbed into the human body is reduced, and finally achieves the function of preventing lead poisoning. However, it has no significant expulsion and therapeutic effect on patients with high blood lead levels. Therefore, ordinary calcium, including calcium carbonate, cannot be used as a drug for the treatment of lead poisoning

Method used

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  • Nano calcium carbonate enteric-coated bioadhesive tablets and their preparation method
  • Nano calcium carbonate enteric-coated bioadhesive tablets and their preparation method
  • Nano calcium carbonate enteric-coated bioadhesive tablets and their preparation method

Examples

Experimental program
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Effect test

preparation example Construction

[0035] 1) Preparation of tablet core

[0036] Take the prescription amount of nano-calcium carbonate, carbomer, and hydroxypropyl methylcellulose, pulverize and sieve, mix evenly, add binder ethanol aqueous solution, mix and granulate, dry, pass through a 16-mesh sieve for granulation, and obtain bioadhesive Type granules; take the prescription amount of nano-calcium carbonate and microcrystalline cellulose, pulverize and sieve, mix evenly, add the binder hydroxypropyl methylcellulose aqueous solution, mix and granulate, dry, pass through a 16-mesh sieve for granulation, and obtain disintegrating Disintegrating granules; Weigh a certain proportion of bioadhesive granules and disintegrating granules, mix evenly, add 5% sodium carboxymethyl starch and 0.5% magnesium stearate, and press into tablets to obtain nano-calcium carbonate enteric-coated bioadhesive attached chip core;

[0037] 2) Preparation of enteric layer coating

[0038] Dissolve Eudragit L100-55 in ethanol, add t...

experiment example 1

[0042] This experimental example 1 relates to the research on the stability test of the nano-calcium carbonate enteric-coated bioadhesive tablet prepared by the present invention.

[0043] The nano-calcium carbonate enteric-coated bioadhesive sheet prepared by the present invention has been placed for 6 months at a temperature of 40 and a relative humidity of 75%, and the accelerated test shows that its appearance, content, identification and other inspection items have not changed significantly; Calcium carbonate enteric-coated bioadhesive tablets have been placed at room temperature for 6 months, and the results show that their appearance, content, identification and other inspection items have not changed significantly, indicating that the stability of nano-calcium carbonate enteric-coated bioadhesive tablets is good .

experiment example 2

[0045]This experimental example 2 relates to the research on the in vitro release rate of the nano-calcium carbonate enteric-coated bioadhesive tablet prepared by the present invention.

[0046] [Methods] According to the provisions of the Chinese Pharmacopoeia 2005 appendix on the basket method.

[0047] Selection of dissolution medium: artificial gastric juice simulates the conditions in gastric juice, and the pH5.8 buffer simulates the conditions in the environment of duodenal intestinal juice.

[0048] According to the 2005 version of the Chinese Pharmacopoeia basket method, with 500ml of artificial gastric juice, the speed is 120r.min -1 , the temperature is 37±0.5°C, put the tablet into the operating container, immediately start the rotation and start timing, add preheating to 37°C Na after 2h 2 HP0 4 Adjust the pH of the solution to 5.8, continue to stir, sample 5ml at 0.25, 0.5, 1, 2, 3, and 4h, and add 5ml of the same temperature medium at the same time. Add 10 μl ...

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Abstract

The present invention pertains to the technical field of pharmaceutical preparations. The present invention provides a kind of nano calcium carbonate enteric-coated bioadhesive tablets and their preparation method. The enteric-coated bioadhesive tablets contain the following ingredients: a) the tablet core made from nano calcium carbonate and usable minor ingredients; b) the enteric coating layer made from polyacrylic resin enteric coating material and the minor ingredients that can be used as pharmaceuticals. There are two types of tablet cores. One is bioadhesive prescription granule and the other is disintegrating granule. The nano calcium carbonate enteric-coated bioadhesive tablets prepared by the present invention possess the features of positioning, fast disintegration and bioadhesion. The main medicine is not released in stomach. After entering duodenum, the coating layer will be quickly removed. The disintegrating granule in tablet core makes the tablet core disintegrated in a short time, and the bioadhesive granule clings to the upper section of small intestine for a long time and plays a role of interrupting the enterohepatic circulation of lead; in addition, this nano calcium carbonate enteric-coated bioadhesive tablet has very good extraneous releasing effect and stability and may be developed into a new-type lead removing pharmaceutical.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to an enteric-coated bioadhesive tablet of nanometer calcium carbonate and a preparation method thereof, which are used as a medicine for treating and preventing lead poisoning. Background technique [0002] Chronic lead poisoning is an occupational disease and an epidemic in my country at the present stage. The pollution of the environment by modern urbanization and industrialization makes people's blood lead levels generally high. Epidemiological surveys show that more than 100 million children in my country have blood lead levels exceeding the standard, which can cause damage to multiple organs and tissues in the body, mainly including: the central nervous system, hematopoietic system, liver and kidneys, etc., seriously affecting people's health. Physical and mental health, especially the impact on children's physical growth, psychological maturity, intellectual ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/32A61K33/10A61K47/32A61K47/36A61K47/38A61P39/02
Inventor 赵绪元魏科达方平飞肖平徐幸民
Owner THE SECOND XIANGYA HOSPITAL OF CENT SOUTH UNIV
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