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Warfarin sodium oral cavity dispersion film agent and preparation method thereof

A technology of warfarin sodium and dispersing film, which is applied in the field of medicine, can solve problems such as the difficulty of precise dosage, and achieve the effect of convenient use

Inactive Publication Date: 2018-09-04
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The warfarin sodium orodispersible film designed by the present invention aims at the problem of the difficulty in precise dosage of warfarin sodium that is ubiquitous in the clinical application of warfarin sodium. The new dosage form of farin sodium has a good application prospect

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1: Preparation of a blank orodispersible film.

[0024] Step 1: Prepare the slurry. Weigh 1.5050 g of hypromellose and add it into deionized water, heat and stir with a magnetic stirrer at a constant temperature of 40°C to dissolve it to form a clear and transparent hypromellose solution, and place it at room temperature for later use. Weigh 0.3045 g of glycerol and add 2 mL of deionized water to dissolve it to form an aqueous solution of glycerol. Add the aqueous solution of glycerol into the aqueous solution of hypromellose, and stir evenly to obtain a drug-free slurry.

[0025] Step 2: Degassing. The uniformly stirred drug-free slurry was left to stand at room temperature for 12 hours for degassing treatment.

[0026] Step 3: Coating. The above-mentioned degassed slurry is uniformly coated on a smooth glass plate or a stainless steel plate.

[0027] Step 4: Dry. Place the above-mentioned glass plate or stainless steel plate that has been plated in a bla...

Embodiment 2

[0029] Example 2: Preparation of warfarin sodium orodispersible film.

[0030] Step 1: Prepare the slurry. Weigh 1.5050 g of hypromellose and add it into deionized water, heat and stir with a magnetic stirrer at a constant temperature of 40°C to dissolve it to form a clear and transparent hypromellose solution, and place it at room temperature for later use. Weigh 0.3045 g of glycerol and 0.1680 g of warfarin sodium, add 2 mL of deionized water to dissolve and form a drug-containing solution of glycerol and warfarin sodium. Add the drug-containing solution into the hypromellose aqueous solution and stir evenly to obtain the drug-containing slurry.

[0031] Step 2: Degassing. The uniformly stirred drug-containing slurry was left to stand at room temperature for 12 hours for degassing treatment.

[0032] Step 3: Coating. The above-mentioned degassed slurry is uniformly coated on a smooth glass plate or a stainless steel plate.

[0033] Step 4: Dry. Place the above-mentione...

Embodiment 3

[0035] Example 3: Inspection of disintegration time limit of warfarin sodium orodispersible film.

[0036] Disintegration time limit checks were performed using a tablet disintegrator. Hang the hanging basket on the stainless steel metal bracket of the disintegration instrument. The hanging basket can just submerge the 1000mL beaker filled with 37°C water. The bottom of the beaker is 25mm, the distance that the bracket moves up and down is 55±2mm, and the reciprocating speed is 30-32 times per minute. Take 1×1cm in Example 1-2 respectively 2 The blank film and 6 warfarin sodium orodispersible films were respectively placed in 6 glass tubes of the hanging basket, the elevator was started, and the time for all the 6 films to dissolve was recorded, and three batches of samples were measured.

[0037] The measurement results are: the average disintegration time limit of the blank orodispersible film in Example 1 is 35 s, and the average disintegration time limit of the warfarin ...

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Abstract

The invention discloses a warfarin sodium oral cavity dispersion film agent easy for dose deviding, and a preparation method thereof, which belong to the technical field of medicines. The designed warfarin sodium oral cavity dispersion film agent is prepared from warfarin sodium, a film-forming material and a plasticizer. According to the preparation method provided by the invention, the film agent is prepared through a flow casting method, is smooth and clean in surface, and can be quickly dissolved to release medicine when encountering water, so that the warfarin sodium is favorably orally absorbed. In order to achieve the aim of easiness in dose deviding, scale identification is carried out on a warfarin sodium oral cavity dispersion film, and the dosage can be flexibly adjusted according to the length of the film, so that the use is convenient. Through preparing the warfarin sodium oral cavity dispersion film agent, the defects that dose deviding on a traditional warfarin sodium tablet is not easy and is inaccurate in clinic treatment are overcome, and the warfarin sodium oral cavity dispersion film agent is an oral anticoagulant more suitable for clinic personalized medication.

Description

technical field [0001] The invention relates to a warfarin sodium oral dispersible film and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Warfarin sodium is an oral anticoagulant drug, belonging to class I drugs in the BCS classification, and its oral bioavailability is close to 100%. The mechanism of action of warfarin sodium is to competitively antagonize vitamin K, reducing the synthesis of vitamin K-dependent coagulation factors, thereby exerting its anticoagulant effect. However, the therapeutic window of warfarin sodium is narrow, and insufficient dosage is prone to thromboembolism, which makes anticoagulant therapy fail; overdose can lead to bleeding, which can be life-threatening in severe cases. At the same time, the individual differences in warfarin sodium medication are very large. To achieve the same effect, the difference between high and low doses can be more than 10 times. Therefore, clinically, by...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/37A61K47/38A61P7/02
CPCA61K31/37A61K9/006A61K47/38A61P7/02
Inventor 吴正红马巧芳祁小乐
Owner CHINA PHARM UNIV
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