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Nitroglycerin oral instant film and preparation method thereof

A technology of oral instant film and nitroglycerin, which is applied in the field of nitroglycerin oral instant film preparation and its preparation, can solve the problems of sublingual tablet dissolving time is too long, affecting the compliance of drug treatment, affecting the efficacy of nitroglycerin, and achieving the taste Good, relieves symptoms of angina pectoris, low cost effect

Inactive Publication Date: 2013-04-17
于晓勇
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this type of drug is currently administered in oral tablets, and its disadvantages are: some patients (such as the elderly and children) have difficulty swallowing, which affects the compliance of drug treatment; ordinary tablets dissolve slowly and are absorbed through the digestive tract. The utilization is low; the sublingual tablet also takes too long to dissolve, and the treatment is unstable, which affects the efficacy of nitroglycerin.

Method used

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  • Nitroglycerin oral instant film and preparation method thereof
  • Nitroglycerin oral instant film and preparation method thereof
  • Nitroglycerin oral instant film and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] prescription:

[0018]

[0019]

[0020] The principal agent of this embodiment is nitroglycerin, the polymer film-forming agent is hydroxypropyl cellulose, glycerol is a plasticizer, lactose and xylitol are taste-masking agents, and FD&C edible blue pigment No. 1 is used To increase the appearance aesthetics of the film.

[0021] The preparation process of the present embodiment is carried out through the following steps:

[0022] 1. Add 6.5 kg of high molecular weight hydroxypropyl cellulose and 32.3 kg of low molecular weight hydroxypropyl cellulose in the prescription into 160 kg of 40 ° C water and stir for 2 hours to dissolve;

[0023] 2. Add 40 kg of 40°C water to adjust the viscosity of the aqueous solution to 5300cps;

[0024] 3. Add 22.4 kg lactose, 11.8 kg xylitol, 20 g FD&D edible blue coloring No. 1 in sequence under stirring, and stir for 30 minutes until the solution is uniform and transparent; a mixed solution is obtained;

[0025] 4. Add 760 g ...

Embodiment 2

[0032] prescription:

[0033]

[0034] The preparation process of this embodiment is the same as that of embodiment 1. Make a solid film with a thickness of 25 microns; cut the film into small pieces with a length of 25 mm and a width of 15 mm, and the weight of each film is 50 mg.

Embodiment 3

[0036] prescription:

[0037]

[0038] The preparation process of this embodiment is the same as that of embodiment 1. Make a solid film with a thickness of 25 microns; cut the film into small pieces with a length of 25 mm and a width of 15 mm, and the weight of each film is 50 mg.

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Abstract

The invention discloses a nitroglycerin oral instant film and a preparation method thereof. The instant film comprises nitroglycerin, high-molecular-weight hydroxypropyl cellulose, low-molecular-weight hydroxypropyl cellulose, glycerol, lactose, xylitol and an FD&C (Food, Drug, and Cosmetic) edible blue pigment. The instant film can be dissolved completely in an oral cavity within 5-60 seconds, so that the bioavailability of an effective ingredient, namely nitroglycerin, is improved greatly, and an effect is exerted quickly.

Description

technical field [0001] The invention relates to an oral pharmaceutical preparation for treating cardiovascular diseases and a preparation method thereof, in particular to a nitroglycerin oral instant film preparation and a preparation method thereof. Background technique [0002] Angina pectoris is an early manifestation of heart disease, showing paroxysmal attacks. The typical symptom is squeezing or constricting pain, which gradually disappears within 3 to 5 minutes. Therefore, in order to effectively relieve the pain caused by the attack of angina pectoris, the drugs for treating angina pectoris must take effect quickly. Nitrates, calcium antagonists, natural plant extracts and Chinese patent medicines are commonly used drugs for the treatment of angina pectoris. Among them, nitrates are representative drugs for the prevention and treatment of angina pectoris, with definite curative effects and few side effects. However, this type of drug is currently administered in or...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/21A61K47/38A61P9/10
Inventor 于晓勇
Owner 于晓勇
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