A kind of composition and its preparation method and application

A technology of composition and hydrate, which is applied in the direction of drug combination, pharmaceutical formula, medical preparation of non-active ingredients, etc., can solve the problem of taste masking of the undisclosed dextromethorphan quinidine composition, and achieve the improvement of taste, bitterness and numbing , high safety, and the effect of solving dysphagia

Active Publication Date: 2022-07-19
BEIJING JITAI PHARM TECH CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the above two taste-masking related documents do not disclose the taste-masking of the dextromethorphan quinidine composition.

Method used

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  • A kind of composition and its preparation method and application
  • A kind of composition and its preparation method and application
  • A kind of composition and its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Preparation of binary inclusion complex by grinding method: weigh an appropriate amount of dextromethorphan hydrobromide and quinidine sulfate, respectively add cyclodextrin, add an appropriate amount of purified water, grind, and dry in an oven at 60 °C. The cyclodextrin-saturated ethanol solution was washed, dried in a 60° C. oven again, ground and sieved to obtain dextromethorphan cyclodextrin inclusion complex and quinidine cyclodextrin inclusion complex, respectively.

[0030] The encapsulation efficiency of the obtained inclusion compound was detected, and the taste-masking effect of cyclodextrin was evaluated by artificial taste method. The results are shown in Table 1.

[0031] Artificial taste method: The volunteers did not eat, drink, or chew gum at least 1 hour before the test, and rinsed their mouths with deionized water more than 3 times. The volunteers put the sample in the mouth, spit it out after 10s, rinsed the mouth with deionized water until there was...

Embodiment 2

[0035] Preparation of ternary inclusion compound by grinding method: after weighing dextromethorphan hydrobromide and quinidine sulfate, mix, adopt the preparation method in Example 1 to prepare cyclodextrin, dextromethorphan hydrobromide and quinidine sulfate Dextromethorphan quinidine cyclodextrin inclusion complex in a molar ratio of 3:1:0.236. The encapsulation efficiency of dextromethorphan quinidine inclusion complexes prepared from different cyclodextrins was detected, and the results are shown in Table 2.

[0036]

[0037]The results showed that the encapsulation efficiency of dextromethorphan and quinidine by the ternary inclusion complex was better. Compared with the binary clathrate, the ternary clathrate significantly improved the encapsulation efficiency of dextromethorphan and quinidine. In particular, the ternary inclusion complex of β-cyclodextrin can even increase the encapsulation efficiency of quinidine by more than 10 times.

Embodiment 3

[0039] Aqueous solution method to prepare ternary inclusion complex: weigh an appropriate amount of cyclodextrin into a beaker, add dextromethorphan hydrobromide and quinidine sulfate to make cyclodextrin, dextromethorphan hydrobromide and quinidine sulfate molar The ratio is 3:1:0.236, an appropriate amount of deionized water is added, and the mixture is stirred at 60° C. until the mixture is completely dissolved, and the solution is freeze-dried to obtain a freeze-dried powder. The obtained freeze-dried powder was washed with a saturated ethanol solution of cyclodextrin, filtered and then dried in an oven at 60° C., ground, crushed and sieved to obtain a dextromethorphan quinidine inclusion complex. The encapsulation efficiency of dextromethorphan quinidine inclusion complexes prepared from different cyclodextrins was detected, and the results are shown in Table 3.

[0040]

[0041] The results show that the encapsulation efficiency of dextromethorphan and fenquinidine is...

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Abstract

The invention provides a dextromethorphan quinidine composition, a preparation method and application thereof. By adding cyclodextrin, the bitterness and numbness of dextromethorphan and quinidine are improved, and at the same time, the dextromethorphan and quinidine composition provided by the invention can be easily prepared into various oral preparations that are easy to swallow, which solves the problem of swallowing by patients with nervous system diseases. Difficult questions can greatly improve the medication experience.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a composition comprising a dextromethorphan quinidine inclusion compound, a preparation method and application thereof. Background technique [0002] Dextromethorphan hydrobromide and quinidine sulfate are a combination drug developed by Avanir pharmaceuticals Inc for the treatment of pseudobulbar mood (PBA), which was first approved by the FDA in October 2010. The drug is the first and only drug for the treatment of PBA, also known as emotional incontinence, mainly secondary to neurological diseases such as Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, and stroke. Crying or laughing for the sudden appearance of unconsciousness. [0003] Dextromethorphan and quinidine taste bad, bitter and numb, and are currently marketed as capsules. Patients with neurological diseases often have symptoms such as dysphagia and salivation. Studies have shown...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/69A61K31/485A61K31/4709A61P25/00A61P25/28
CPCA61K47/6951A61K31/485A61K31/4709A61P25/00A61P25/28A61K2300/00
Inventor 赖青海王孝便李海燕王文首赖才达
Owner BEIJING JITAI PHARM TECH CO LTD
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