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A preparation method of colon targeting preparation

A technology of colon targeting and preparation, which is applied in the direction of pharmaceutical formulations, medical preparations of non-active ingredients, antineoplastic drugs, etc., and can solve the limitations of large-scale industrial production and clinical application, the low probability of colon-dissolving hollow capsule shells, and the production cycle Lengthen and other problems, to achieve the effect of stable coating process, high coating rate and easy operation

Active Publication Date: 2011-12-14
TIANJIN ZHONGXIN PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In actual production, it was found that the commercially available colonic-soluble empty capsules had a low probability of being on the shell, and the medicine would pollute the instrument after filling, which would bring very tedious follow-up work, which not only caused great waste of medicine, but also lengthened the production cycle and increased production. The cost limits the large-scale industrial production and clinical application of this preparation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Prepare liquid hard capsules according to the conventional process: mix artebenolide oil and salad oil evenly, fill in common capsule shells, and adopt sealing material (mixed solution of HPMC5%, PVA11%, ethanol 34%, water 60%) to Seal the joint of the capsule shell to make a liquid hard capsule; prepare a colonic enteric coating solution, the formula of which is composed of acrylic resin S100, 85% ethanol, Tween-80, triethyl citrate and castor oil, each group The percentage by weight of points is: acrylic resin S100 6.5%, 85% ethanol 89.0%, Tween-800.5%, triethyl citrate 3.0%, castor oil 1.0%; Coating is done to obtain the colonic enteric solution liquid hard capsule of the present invention.

[0016] An in vitro dissolution test was carried out on the capsule, and the results were as follows: the dissolution rate was less than 1% in 37°C pH 6.8 artificial intestinal fluid for 3 hours; and more than 90% was dissolved in 37°C pH 7.8 artificial intestinal fluid 1 hour. ...

Embodiment 2

[0018] Preparation of liquid hard capsules according to the conventional process: get 9 parts of zedoary oil, 1 part of tangerine peel oil and 10 parts of olive oil, fully mix and fill in common gelatin capsule shells, and adopt sealing material (HPMC5%, PVA11%, ethanol 34%, water 60%) seal the capsule shell joint, and prepare it into a liquid hard capsule; prepare a colonic enteric coating solution, and its formula is composed of Eutech L, Eutech S, 80% ethanol, diethyl phthalate and talcum powder, the weight percent of each component is: Eudragit L 1.25%, Eudragit S 3.75%, 80% ethanol 93.5%, diethyl phthalate 0.5% and talcum powder 1.0%; The colon enteric solution coating solution coats the liquid hard capsule to obtain the colon enteric solution liquid hard capsule of the present invention.

[0019] The in vitro dissolution test of the capsule was carried out, and the results were as follows: the dissolution in artificial gastric juice at 37°C for 2 hours was less than 1%; ...

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Abstract

A preparation method for a colon-targeting preparation, which uses ordinary capsules, fills colonic administration into the capsules, seals the capsule shell with a sealing material to form a liquid hard capsule, and uses colon The enteric coating solution is used for coating; the colon enteric coating solution is prepared by mixing coating materials, coating solvents and plasticizers; the filling in the capsule can be medicine for treating ulcerative colitis or colon cancer. The advantages of the present invention: the liquid hard capsule is coated with a pH-sensitive coating material to achieve the purpose of targeted release in the colon, and the ordinary gelatin capsule shell is used. Compared with the special colostomy-coated capsule shell of the prior art, the rate of loading is high. The coating process is stable, easy to operate, and suitable for large-scale industrial production; the liquid hard capsule prepared by this method can maintain the color and transparency of the original capsule after coating, and improve patient compliance; the process is simple, no special equipment is required, easy to operate, and low cost. low.

Description

(1) Technical field [0001] The invention relates to the technical field of pharmaceutical manufacturing, in particular to a method for preparing a colon targeting preparation. (2) Background technology [0002] Capsules are a preparation that fills liquid, powder or granular drugs into empty capsules or wraps drugs in a capsule matrix. It is usually divided into two types, hard capsules and soft capsules, and is widely used in clinical practice. Liquid hard capsules are made by filling a certain amount of liquid medicine or semi-solid medicine in hollow capsules. If the hollow capsules are transparent, they are fully transparent liquid hard capsules; Wrapping must be done at the same time. Compared with the hard capsule shell, the water and oxygen transmission rate of the soft capsule is significantly higher, which is not conducive to the storage of the drug; and the rubber skin is prone to dehydration and aging, resulting in unqualified product disintegration. In the 1970...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K47/32A61P35/00A61P1/00
Inventor 潘勤杜凌然
Owner TIANJIN ZHONGXIN PHARMA GRP CO LTD
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