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Preparation of colon-targeted preparation

A colon targeting and preparation technology, which can be used in pharmaceutical formulations, medical preparations with non-active ingredients, antitumor drugs, etc., can solve the limitations of large-scale industrial production and clinical application, low probability of colon dissolving hollow capsule shells, and increased production. Cost and other issues, to achieve the effect of stable coating process, high probability of coating, and easy operation

Active Publication Date: 2008-07-02
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 carried out to obtain the colon 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 ho...

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 Composed of talcum powder, the weight percentage of each component is: Eudragit L1.25%, Eudragit S3.75%, 80% ethanol 93.5%, diethyl phthalate 0.5% and talcum powder 1.0%; Coating the liquid hard capsule with the above-mentioned colon enteric coating liquid can 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 ho...

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Abstract

The invention relates to a preparation method of a colon targeting preparation, which adopts an ordinary capsule, the colon delivered drug is filled in the capsule, the sealing material is used for sealing at the sleeving position of a capsule shell, so as to prepare a liquid hard capsule, and the coating liquid of colon enteric coating is used for coating of the finished liquid hard capsule; the coating liquid of colon enteric coating is prepared by coating material, coating solvent and plasticizer by mixing; the fillers in the capsule can be used as the drug for the treatment of ulcerative colitis or colon cancer. The invention has the advantages that: the invention adopts the pH-sensitive coating material to carry out the coating for the liquid hard capsule, so as to achieve the purpose of colon targeting release; the invention adopts the ordinary gel capsule shell; compared with the prior art of selecting the special colonic-coated capsule shell, the machine using ratio is high, the coating process is stable, the operation is easy, the invention is applicable to the large-scale industrial production; the liquid hard capsule which is prepared by the method can maintain the luster and transparency of the original capsule after the coating, thus improving the patient compliance; the technique is simple, the special equipments are not needed, the operation is easy and the cost is 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 Applications(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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