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Calcium gluconate oral disintegrating tablet and its preparation process

A technology for calcium gluconate and orally disintegrating tablets is applied in the field of calcium gluconate orally disintegrating tablet preparations, and can solve the problems of heavy economic burden on patients, great pain for patients, allergic reactions or adverse reactions caused by injections and the like.

Active Publication Date: 2005-07-06
COSCI MED TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Oral liquids are inconvenient to carry, and injections are often prone to allergic reactions or adverse reactions. At the same time, injections also have the disadvantages of difficult operation, great pain for patients, high manufacturing and medical costs, and heavy economic burden for patients.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] (1) Prescription

[0034] 1. Raw material - calcium gluconate 100.0g;

[0035] 2. Filling agent - mannitol 100.0g;

[0036] PROSOLV  SMCC 35.0g;

[0037] 3. Disintegrant—croscarmellose sodium 10.0g;

[0038] 4. Glidant—micronized silica gel 2.5g;

[0039] 5. Lubricant - magnesium stearate 2.5g.

[0040] The total weight is 250.0g, and a total of 1000 pieces are made.

[0041] (2) Preparation method

[0042] 1) Take the calcium gluconate raw material and pulverize it, sieve it, and take the granules of 80 mesh to 40 mesh for subsequent use;

[0043] 2) the calcium gluconate and PROSOLV of step 1)  Mix SMCC evenly and set aside;

[0044] 3) Mix mannitol (granular) and croscarmellose sodium evenly;

[0045] 4) Mix the micropowder silica gel and magnesium stearate evenly, then add the materials in step 2) and step 3), and mix evenly;

[0046] 5) Intermediate content detection, after determining the weight of the tablet, it is sent to a tablet press ...

Embodiment 2

[0048] (1) Prescription

[0049] 1. Raw material - calcium gluconate 500.0g;

[0050] 2. Adhesive - polyvinylpyrrolidone K-30 3.0g;

[0051] 3. Filling agent - mannitol 200.0g;

[0052] Microcrystalline cellulose 100.0g;

[0053] 4. Flavoring agent - aspartame 9.0g;

[0054] Orange essence 18.0g;

[0055] 5. Disintegrant—cross-linked polyvinylpyrrolidone 20.0g;

[0056]Croscarmellose 34.0g;

[0057] 6. Glidant—micronized silica gel 8.0g;

[0058] 7. Lubricant—magnesium stearate 8.0g.

[0059] The total weight is 900.0g, and a total of 1000 pieces are made.

[0060] (2) Preparation method

[0061] 1) Dissolve polyvinylpyrrolidone K-30 with 50% ethanol and dilute to a certain concentration for later use;

[0062] 2) Get calcium gluconate and microcrystalline cellulose to granulate with a high-speed mixing and stirring granulator, use the solution in step 1) as a binder, and dry it for subsequent use;

[0063] 3) Mix mannitol, micropowder silica...

Embodiment 3

[0067] (1) Prescription

[0068] 1. Raw material - calcium gluconate 150.0g;

[0069] 2. Coating material - Eudragit  E100 15.0g;

[0070] 3. Filling agent - polysaccharide 175.0g;

[0071] 4. Flavoring agent - aspartame 4.0g;

[0072] Orange essence 8.0g;

[0073] 5. Disintegrant—cross-linked polyvinylpyrrolidone 26.0g;

[0074] Low-substituted hydroxypropyl methylcellulose 14.0g;

[0075] 6. Glidant—micronized silica gel 4.0g;

[0076] 7. Lubricant—magnesium stearate 4.0g.

[0077] The total weight is 400.0g, and a total of 1000 pieces are made.

[0078] (2) Preparation method

[0079] 1) Take Eudragit  E100 is dissolved in more than 95% medicinal ethanol and diluted to a certain concentration for later use;

[0080] 2) Take calcium gluconate and place it in a fluidized bed to boil, spray the above solution at a certain speed for powder coating to obtain calcium gluconate powder-coated granules, and dry them for later use;

[0081] 3) Mi...

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Abstract

The invention relates to a calcium gluconate orally disintegrating tablet which is prepared by using calcium gluconate as raw material, using bulking agent, crumbling agent, flavoring agent, flow aid, and lubricating agent as adjuvant, and using bonding agent clothing sheet material as required, or adding right amount of effervescent agent. The preparing process employs a tablet compressing machine for pelleting.

Description

technical field [0001] The invention relates to a calcium gluconate orally disintegrating tablet preparation for preventing and treating calcium deficiency. Background technique [0002] It can promote the calcification of bones and teeth, maintain the normal excitability of neuromuscular, reduce capillary permeability, and increase the contractility of capillary wall. It is clinically used for the prevention and treatment of calcium deficiency such as tetany, bone hypoplasia, rickets and tuberculosis, calcium salt supplementation for pregnant and lactating women. [0003] The dosage forms of existing calcium gluconate preparations include: injection, oral liquid and common tablet etc. [0004] Due to the dosage form, ordinary tablets need a lot of water to be taken down, which makes it difficult for many elderly people, infants, or patients with difficulty swallowing and water intake, and the elderly, infants and young children are the most in need of calcium supplementati...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/191A61P3/02
Inventor 蒋海松王红喜王锦刚
Owner COSCI MED TECH CO LTD
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