A kind of doxylamine succinate hydrochloride pyridoxine enteric-coated tablet medicinal composition and preparation method thereof

A technology of pyridoxine hydrochloride and doxylamine succinate, which is applied in the field of medicine, can solve the problems that the release degree can only reach about 50%, the rapid development of drug effect is affected, and the release is slow, so as to avoid adverse reactions. , low cost, good stability

Active Publication Date: 2019-12-31
SICHUAN HAISCO PHARMA CO LTD
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  • Abstract
  • Description
  • Claims
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AI Technical Summary

Problems solved by technology

[0010] The inventors found that the above-mentioned doxylamine succinate hydrochloride enteric-coated tablets of the prior art, when carrying out the dissolution test of pH6.8 phosphate buffer (alkaline stage) after the first 0.1NHCl (acid stage), its The release in the alkali stage is very slow, and the release rate in 1 hour can only reach about 50%. When the dissolution test is carried out directly in the alkali stage without the acid stage, it can be released normally and quickly, and the release rate in 1 hour can reach more than 70%; However, the tablet must pass through the gastric acid environment before entering the neutral environment of the small intestine, which is similar to the above dissolution test process of the first acid stage and then the alkali stage. If the enteric-coated tablet cannot be well dissolved in the alkali stage Dissolution will inevitably affect the rapid development of the drug effect
The possible reason for this situation is that the carboxyl groups of some drugs and enteric-coated materials will be complexed. During the 2-hour soaking process in acid, the infiltration of water will make it difficult for the raw materials inside the tablet core to form complexes with the enteric-coated materials. dissolved substances, thereby affecting the release

Method used

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  • A kind of doxylamine succinate hydrochloride pyridoxine enteric-coated tablet medicinal composition and preparation method thereof
  • A kind of doxylamine succinate hydrochloride pyridoxine enteric-coated tablet medicinal composition and preparation method thereof
  • A kind of doxylamine succinate hydrochloride pyridoxine enteric-coated tablet medicinal composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] The preparation of embodiment 1 doxylamine succinate pyridoxine hydrochloride sheet of the present invention

[0047] 1. Tablet core preparation:

[0048] Prepare raw materials (1000 tablets) according to the following formula:

[0049]

[0050] Preparation steps:

[0051] (1) Dry the starch until the water content is less than 1.5%, and dry the talcum powder until the water content is less than 5% at 80°C;

[0052] (2) pulverize doxylamine succinate and pyridoxine hydrochloride, cross 100 mesh sieves, and set aside;

[0053] (3) mix doxylamine succinate and talcum powder, pass through a 40-mesh sieve to disperse, and mix to obtain the mixture ①;

[0054] (4) Pyridoxine hydrochloride is added to the mixture ①, mixed to obtain the mixture ②;

[0055] (5) The low-substituted hydroxypropyl cellulose was mixed twice with starch equivalent dilution method, then added to the mixture ②, and mixed to obtain the mixture ③;

[0056] (6) Add the remaining starch and the mi...

Embodiment 2

[0078] The preparation of embodiment 2 doxylamine succinate pyridoxine hydrochloride tablet of the present invention

[0079] 1. Tablet core preparation:

[0080] Prepare raw materials (1000 tablets) according to the following formula:

[0081]

[0082] Preparation steps:

[0083] (1) Dry the microcrystalline cellulose PH102 until the water content is less than 3%, and dry the silicon dioxide until the water content is less than 5% at 80°C;

[0084] (2) pulverize doxylamine succinate and pyridoxine hydrochloride, cross 100 mesh sieves, and set aside;

[0085] (3) Mix doxylamine succinate with silicon dioxide, disperse through a 40-mesh sieve, and mix to obtain the mixture ①;

[0086] (4) Pyridoxine hydrochloride is added to the mixture ①, mixed to obtain the mixture ②;

[0087] (5) The sodium carboxymethyl starch is mixed twice with mannitol equivalent dilution method and then added to the mixture ②, mixed to obtain the mixture ③;

[0088] (6) Add the remaining mannito...

Embodiment 3

[0110] Embodiment 3 The preparation of doxylamine succinate pyridoxine hydrochloride tablet of the present invention

[0111] 1. Tablet core preparation:

[0112] Prepare raw materials (1000 tablets) according to the following formula:

[0113]

[0114] Preparation steps:

[0115] (1) Dry the microcrystalline cellulose PH102 until the moisture content is less than 3%, dry the lactose until the moisture content is less than 1.5%, and dry the silica until the moisture content is less than 5% at 80°C;

[0116] (2) pulverize doxylamine succinate and pyridoxine hydrochloride, cross 100 mesh sieves, and set aside;

[0117] (3) Mix doxylamine succinate with silicon dioxide, disperse through a 40-mesh sieve, and mix to obtain the mixture ①;

[0118] (4) Pyridoxine hydrochloride is added to the mixture ①, mixed to obtain the mixture ②;

[0119] (5) The croscarmellose sodium was mixed twice with lactose equivalent dilution method, then added to the mixture ②, and mixed to obtain ...

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Abstract

The invention provides a compound doxylamine succinate-pyridoxine hydrochloride enteric-coated tablet pharmaceutical composition and a preparation method thereof. The composition comprises a tablet core containing doxylamine succinate and pyridoxine hydrochloride, an isolation coating, an enteric coating and other medicinal auxiliary materials. The preparation method has simple processes. The pharmaceutical composition has good stability, is insoluble in the stomach and can be fast released in the intestine so that the problem that the existing pharmaceutical composition has a reduced release rate when entering into an intra-intestinal neutral environment from a gastric acid environment.

Description

technical field [0001] The invention relates to a doxylamine succinate hydrochloride pyridoxine enteric-coated tablet pharmaceutical composition and a preparation method thereof, belonging to the technical field of medicines. Background technique [0002] Morning sickness is a natural reaction during pregnancy. The main symptoms are weakness, depression, dizziness, nausea, nausea, poor appetite, sensitivity or strong reaction to peculiar smell, especially in the early morning or when you just wake up. These symptoms generally occur around the fifth week of pregnancy. After the sixteenth week, most people's morning sickness will gradually reduce until it disappears naturally, but there are also a few pregnant women who have morning sickness throughout pregnancy, which is quite painful. Morning sickness is not only detrimental to the recuperation of pregnant women, but also because most people's appetite is affected during pregnancy, and the nutrition of the fetus comes from t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4415A61K9/36A61K9/32A61P1/08A61K31/4402
Inventor 王淑红汪顺洪任东冯卫刘波
Owner SICHUAN HAISCO PHARMA CO LTD
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