Doxylamine succinate-pyridoxine hydrochloride enteric-coated tablet pharmaceutical 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 rate can only reach about 50%, affect the rapid effect of the drug, and is not easy to dissolve, so as to avoid adverse reactions , low cost, good stability

Active Publication Date: 2017-05-03
SICHUAN HAISCO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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 0.1N HCl (acid stage), It releases very slowly in the alkali stage, and the release rate can only reach about 50% in 1 hour. When the dissolution test is directly carried out 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%. ; but the tablet must go through the gastric acid environment first and then enter the neutral environment of the small intestine, which is similar to the dissolution test process of the first acid stage and then the alkali stage above. 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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  • Doxylamine succinate-pyridoxine hydrochloride enteric-coated tablet pharmaceutical composition and preparation method thereof
  • Doxylamine succinate-pyridoxine hydrochloride enteric-coated tablet pharmaceutical composition and preparation method thereof
  • Doxylamine succinate-pyridoxine hydrochloride enteric-coated tablet pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Example 1 Preparation of doxylamine succinate pyridoxine hydrochloride tablets of the present invention

[0047] 1. Tablet core preparation:

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

[0049]

[0050] Preparation steps:

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

[0052] (2) Crush doxylamine succinate and pyridoxine hydrochloride, pass through a 100-mesh sieve, and set aside;

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

[0054] (4) Add pyridoxine hydrochloride to mixture ① and mix to obtain mixture ②;

[0055] (5) Mix the low-substituted hydroxypropyl cellulose twice with the starch equal dilution method, then add it to the mixture ②, and mix to obtain the mixture ③;

[0056] (6) Add the remaining starch and mixture ③ into the multi-directional motion mixer, rotate at 10 rpm, an...

Embodiment 2

[0078] Example 2 Preparation of doxylamine succinate pyridoxine hydrochloride tablets of the present invention

[0079] 1. Tablet core preparation:

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

[0081]

[0082] Preparation steps:

[0083] (1) Dry the microcrystalline cellulose PH102 at 80°C until the moisture content is less than 3% and silica to the moisture content less than 5%;

[0084] (2) Crush doxylamine succinate and pyridoxine hydrochloride, pass through a 100-mesh sieve, and set aside;

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

[0086] (4) Add pyridoxine hydrochloride to mixture ① and mix to obtain mixture ②;

[0087] (5) Mix the sodium carboxymethyl starch with mannitol equal dilution method twice, then add it to the mixture ②, and mix to obtain the mixture ③;

[0088] (6) Add the remaining mannitol, mixture ③, and microcrystalline cellulose PH102 into the multi-d...

Embodiment 3

[0110] Example 3 Preparation of doxylamine succinate pyridoxine hydrochloride tablets of the present invention

[0111] 1. Tablet core preparation:

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

[0113]

[0114] Preparation steps:

[0115] (1) Dry microcrystalline cellulose PH102 at 80°C to moisture less than 3%, lactose to moisture less than 1.5%, and silicon dioxide to moisture to less than 5%;

[0116] (2) Crush doxylamine succinate and pyridoxine hydrochloride, pass through a 100-mesh sieve, and set aside;

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

[0118] (4) Add pyridoxine hydrochloride to mixture ① and mix to obtain mixture ②;

[0119] (5) Mix the croscarmellose sodium with lactose equal dilution method twice, then add it to the mixture ②, and mix to obtain the mixture ③;

[0120] (6) Add the remaining lactose, mixture ③, and microcrystalline cellulose PH102 to the mu...

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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 pharmaceutical composition of doxylamine succinate pyridoxine hydrochloride enteric-coated tablets and a preparation method thereof, and belongs to the technical field of medicine. Background technique [0002] Morning sickness is a natural reaction during pregnancy. The main symptoms are weakness, depression, dizziness, nausea, nausea, poor appetite, and 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 decrease until it disappears naturally, but there are also a few pregnant women who have morning sickness throughout their pregnancy, which is more painful. Morning sickness is not only not conducive to the recovery of pregnant women, but also because most people's appetite is affected during pregnancy, and the nutrition of the fetus com...

Claims

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Application Information

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Patent Type & Authority Applications(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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