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Composite capsule for stomach intestine and its preparing method and use

A composite, gastrointestinal technology, applied in the directions of capsule delivery, pharmaceutical formulations, and non-active ingredients medical preparations, etc., can solve the problems of reducing the drug load in capsule space, shortening the validity period of drugs, and aggravating gastric or intestinal damage, etc. To achieve the effect of reducing the fluctuation range of blood drug concentration, prolonging drug absorption time, and reducing gastrointestinal damage

Inactive Publication Date: 2008-07-09
连云港长慧医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] At present, there are many oral drug dosage forms, including tablets, capsules, oral liquids, pills, emulsions, etc., but most of the drug release sites are only in the stomach or intestinal tract, which has the following disadvantages: ①Single-point release of drugs will increase the burden on the stomach or intestinal tract. damage, for example, the dosage is 10 mg, and the threshold dose of gastrointestinal adverse reactions is 5 mg, if administered according to the traditional dosage form, the incidence of adverse reactions will inevitably increase; The peak concentration may cause poisoning; ③The drug has a short action time and takes more times; ④It is difficult to determine the administration time in compound preparations, for example, glipizide requires administration 30 minutes before meals, and metformin hydrochloride requires administration at or after meals , when to administer the compound preparation of the two is more reasonable is a difficult problem for conventional preparations
⑤According to traditional methods, it is difficult to make compound preparations for drugs with unstable physical and chemical properties, or drugs that are prone to interactions; ⑥Due to the interaction between compound drugs, the validity period of drugs may be shortened
⑦ Traditional compound preparations introduce many troubles to the quality control of preparations due to the presence of several drugs mixed
Multi-layer capsules, Huweidan capsules, and composite capsules are small capsules inside large capsules. The volume of the capsules is large, and the drug loading capacity in the capsule space is reduced, making it difficult for patients to take them. Moreover, they do not use capsule gastrointestinal coating technology, which makes it impossible to separate the drugs. release in stomach and intestine
Although the volume of the divided drug capsule is small, the capsule gastrointestinal coating technology cannot be applied, and the drug can not be released separately in the stomach and intestinal tract

Method used

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  • Composite capsule for stomach intestine and its preparing method and use
  • Composite capsule for stomach intestine and its preparing method and use
  • Composite capsule for stomach intestine and its preparing method and use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1 Gastrointestinal compound capsule preparation and application method 1

[0031] Capsules made of stomach-soluble materials: Gelatin, titanium dioxide, and coloring agents are used as materials, which are molded and dried in a specific mold after hot melting.

[0032] Enteric capsule: use gelatin as the main material to prepare ordinary capsules, and prepare enteric coating liquid for coating. The specific coating liquid formula is as follows:

[0033] Acrylic resin No. II and Acrylic resin No. III are 2 parts each, castor oil 2 g, diethyl phthalate 2 g, Tween 802 g, and 95% ethanol is added to 100 ml.

[0034] Production process: The stomach-soluble capsules are molded on the mold, and then dipped in the enteric-coating solution for one time, demoulding, incision, fitting, and enteric-coated hollow capsules are formed.

[0035] After obtaining the capsule cap and enteric capsule made of the above-mentioned gastric-soluble materials, the drug is mechanically ...

Embodiment 2

[0036] Embodiment 2 Gastrointestinal compound capsule preparation and application method 2

[0037] Enteric-coated capsules are prepared as follows: weigh 1 part of acrylic resin L-type, 10 parts of medicinal gelatin, and 30 parts of distilled water to prepare a water-soluble glue, add 1% to 2% diethyl phthalate, 1% PVP, After 0.5% pigment, the special capsule mold is dipped in glue once to make the basic capsule. After drying, the capsule is dipped in 8% enteric-coated acrylic resin aqueous solution once again.

[0038] After obtaining the capsule cap and enteric capsule body made of the above-mentioned gastric-soluble materials, the drug is mechanically filled. The main process includes the supply of enteric capsules, the arrangement of the shells of the enteric capsules, the alignment of the direction, and the separation of the shells of the enteric capsules. The enteric-coated capsule is filled with medicine, the shell of the enteric-coated capsule is closed, and the capsu...

Embodiment 3

[0039] Example 3 Danshen dripping pill aspirin gastrointestinal compound capsule preparation.

[0040] Prescription composition:

[0041] Gastric soluble part Danshen dripping pills 6 capsules

[0042] Enteric-coated portion Aspirin 75mg

[0043] Starch 75mg

[0044] Differential Silica Gel 2%

[0045] The production process takes aspirin and starch and mixes them evenly by the method of equal incremental dilution, then uses 5% PVP ethanol solution as the binder, adopts the wet granulation process, granulates, and after drying at 40 degrees, add micropowder silica gel and mix evenly before filling. have to.

[0046] The in vitro dissolution method is determined according to the second method of dissolution determination in appendix XC of the Chinese Pharmacopoeia 2000 edition, and the in vitro dissolution curve: reference Figure 6 :

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PUM

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Abstract

The present invention relates to medicine and its production process, and the composite gastrointestinal capsule is one kind of oral medicine preparation with both stomach releasing medicine component and intestine releasing medicine component. The composite gastrointestinal capsule includes one capsule cap capable of being dissolved inside stomach and holding stomach releasing medicine component, and one capsule body cap capable of being dissolved inside intestine and holding intestine releasing medicine component. The medicine preparation features no mutual action between different medicine components, raised compound medicine preparation stability, located medicine releasing, reduced stimulation on stomach and intestine of some medicine, synergistic medicine action and accurate medicine content.

Description

1. Technical field [0001] The invention relates to a gastrointestinal compound capsule, its preparation method and application. The capsule releases medicines in the stomach and the intestinal tract after oral administration, and the capsule is composed of a capsule cap made of a gastric-soluble material and an enteric-coated capsule. 2. Background technology [0002] At present, there are many oral drug dosage forms, including tablets, capsules, oral liquids, pills, emulsions, etc., but most of the drug release sites are only in the stomach or intestinal tract, which has the following disadvantages: ①Single-point release of drugs will increase the burden on the stomach or intestinal tract. damage, for example, the dosage is 10 mg, and the threshold dose of gastrointestinal adverse reactions is 5 mg, if administered according to the traditional dosage form, the incidence of adverse reactions will inevitably increase; The peak concentration may cause poisoning; ③The drug has...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K47/00A61J3/07
Inventor 林雅军李华陈光亮徐希平
Owner 连云港长慧医药有限公司