Vancomycin hydrochloride medicine composition and method for preparing vancomycin hydrochloride medicine composition

The technology of vancomycin hydrochloride and the composition is applied in the field of vancomycin hydrochloride pharmaceutical composition and its preparation, which can solve the problems of limited dosage form of vancomycin hydrochloride, skin flushing, complex components, etc. Widen the use of dosage forms and the effect of simple ingredient distribution

Pending Publication Date: 2017-07-21
YUNG SHIN PHARMA IND KUNSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In the prior art, there have been some reports related to vancomycin hydrochloride preparations. In the report, vancomycin hydrochloride exists as an injection, but the injection needs to be dissolved in water to be prepared into a solution for use, and it causes severe pain during intramuscular injection. Phlebitis can be caused at the injection part during intravenous injection, and characteristic symptoms such as extreme skin flushing and erythema appear on the back of the neck, upper limbs and upper body of the human body during rapid intravenous infusion; Vancomycin hydroch

Method used

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  • Vancomycin hydrochloride medicine composition and method for preparing vancomycin hydrochloride medicine composition
  • Vancomycin hydrochloride medicine composition and method for preparing vancomycin hydrochloride medicine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Vancomycin hydrochloride 30%; matrix 70%; lubricant 0%;

[0033] Wherein the matrix is ​​PEG4000.

[0034] Preparation:

[0035] (1) Vancomycin hydrochloride is sieved with a 200-mesh sieve for subsequent use;

[0036] (2) Melting PEG4000 at 60°C for later use;

[0037] (3) Weighing sieved vancomycin hydrochloride and molten PEG4000 according to the formula dosage, and mixing the above two materials weighed to obtain a mixture of raw and auxiliary materials;

[0038] (4) sieving the raw and auxiliary material mixture obtained in step (3) with a 200-mesh sieve to obtain raw and auxiliary material granules;

[0039] (5) filling the mixture of raw and auxiliary materials obtained in step (4) into the hard capsule shell to prepare a hard capsule preparation.

[0040] The results of performance testing of the vancomycin hydrochloride composition prepared in this specific example are as follows in Table 1:

[0041] Table 1

[0042] instrument time Dissoluti...

Embodiment 2

[0044] Vancomycin hydrochloride 40%; matrix 58%; lubricant 2%;

[0045] Wherein the matrix is ​​stearic acid, and the lubricant is sodium stearyl fumarate.

[0046] Preparation:

[0047] (1) Vancomycin hydrochloride is sieved with a 100-mesh sieve for subsequent use;

[0048] (2) Melting poloxamer 188 at 40°C for later use;

[0049] (3) Weighing sieved vancomycin hydrochloride, fused poloxamer 188 and sodium stearyl fumarate according to the dosage of the formula, and mixing the above three materials weighed to obtain a mixture of raw and auxiliary materials;

[0050] (4) filling the mixture of raw and auxiliary materials obtained in step (3) into the soft capsule shell to prepare a soft capsule preparation.

[0051] The vancomycin hydrochloride composition performance testing result is as follows table 2:

[0052] Table 2

[0053] instrument time Dissolution SOTAX AT 7smart / Tianjin University Radio Factory ZRS-8G 45min 87.6％

Embodiment 3

[0055] Vancomycin hydrochloride 42%; matrix 50%; lubricant 8%;

[0056] Wherein the matrix is ​​PEG6000, and the lubricant is magnesium stearate.

[0057] Preparation:

[0058] (1) Vancomycin hydrochloride is sieved with 80 mesh sieves for subsequent use;

[0059] (2) Melt PEG6000 at 50°C for later use;

[0060] (3) Weighing sieved vancomycin hydrochloride and melted PEG6000 according to the formula dosage, and mixing the above two materials weighed to obtain a mixture of raw and auxiliary materials;

[0061] (4) sieving the raw and auxiliary material mixture obtained in step (3) with a 24-mesh sieve to obtain raw and auxiliary material granules;

[0062] (5) Put the raw and auxiliary material granules obtained in step (4) and the lubricant magnesium stearate into a mixing device and mix for 10 minutes to obtain drug mixed granules;

[0063] (6) Compressing the drug mixed granules obtained in step (5) into tablets.

[0064] The vancomycin hydrochloride composition perform...

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Abstract

The invention discloses a vancomycin hydrochloride medicine composition and a method for preparing the same. The vancomycin hydrochloride medicine composition comprises 10-60% of vancomycin hydrochloride, 30-90% of matrixes and 0-10% of lubricants, and preferably comprises 30-40% of vancomycin hydrochloride, 50-70% of matrixes and 2-8% of lubricants. The matrixes are one or two types of PEG (polyethylene glycol) 1000-6000, stearic acid and poloxamer 188, and the lubricants are one or two types of micro-powder silica gel, talc powder, sodium stearyl fumarate, sodium dodecyl sulfate and magnesium stearate. The vancomycin hydrochloride medicine composition can be in one of dosage forms of soft capsules, hard capsules and tablets. The vancomycin hydrochloride medicine composition and the method have the advantages that components in the vancomycin hydrochloride medicine composition are easily matched with one another, and medicines are high in stability; hot melting technologies are adopted in the method for preparing the vancomycin hydrochloride medicine composition, processes for producing the vancomycin hydrochloride medicine composition are simple, can be implemented conveniently and quickly, are stable and can be scaled up advantageously, and service dosage forms of the vancomycin hydrochloride can be broadened.

Description

technical field [0001] The invention relates to a vancomycin hydrochloride pharmaceutical composition and a preparation method thereof, belonging to the technical field of pharmaceutical preparations and preparation methods thereof. Background technique [0002] Pseudomembranous colitis is caused by Clostridium difficile (Clostridium difficile), which infects more than 700,000 people in the United States every year. Once "Clostridium difficile" infects the lining of the large intestine, the toxin it produces can cause Severe diarrhea, large intestine inflammation and even death, and the infection rate of this strain has been increasing year by year, and in recent years, it often occurs in hospitals, nursing centers, communities and other places. Currently the only treatment for pseudomembranous colitis is oral vancomycin hydrochloride recommended by the FDA. [0003] The mechanism of action of vancomycin hydrochloride is to exert a quick-acting bactericidal effect by inhibi...

Claims

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Application Information

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IPC IPC(8): A61K38/14A61K47/10A61K47/12A61K47/20A61P31/04A61P1/00
CPCA61K38/14A61K47/10A61K47/12A61K47/20
Inventor 刘佳刘祥伟王清平马毛迎徐梦琪吴嘉义王珊珊左霜高刘芳陶劭颖刘正斌吴苗卓嘉和李芳全
Owner YUNG SHIN PHARMA IND KUNSHAN
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