CN103127515A - Traditional Chinese medicine cataplasm matrix composition and preparation method thereof - Google Patents

Traditional Chinese medicine cataplasm matrix composition and preparation method thereof Download PDF

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Publication number
CN103127515A
CN103127515A CN2011103722097A CN201110372209A CN103127515A CN 103127515 A CN103127515 A CN 103127515A CN 2011103722097 A CN2011103722097 A CN 2011103722097A CN 201110372209 A CN201110372209 A CN 201110372209A CN 103127515 A CN103127515 A CN 103127515A
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Prior art keywords
parts
add
standby
chinese medicine
polyvinyl alcohol
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Chinese (zh)
Inventor
朱志宏
卜振军
杨静
阳海
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Hunan Jiudian Pharmaceutical Co Ltd
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Hunan Jiudian Pharmaceutical Co Ltd
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Abstract

The invention provides a traditional Chinese medicine cataplasm matrix composition and a preparation method thereof. The traditional Chinese medicine cataplasm prepared by the matrix composition of the invention is easy to coat, large in drug loading capacity, suitable for repeated uncovering and covering, convenient for use by patients, good in transdermal effect, and easy to bring into play of drug effect.

Description

A kind of Chinese medicine catablasm base material composition and method of making the same
Invention field
The present invention relates to base composition of a kind of Chinese medicine patcher and preparation method thereof, belong to the field of Chinese medicines.
Background technology
Domestic commercially available traditional plaster externally applied ointment, mostly use natural rubber as cream base now.But because all containing the different in nature vegetable protein of sensitization in natural rubber, thus easily bring out skin allergy or cause skin irritation, and produce tearing pain when peeling off.In addition, the tradition rubber plaster needs to use large petrol as solvent in preparation process, the volatile medicine that has therapeutical effect when adopting the most gasoline of stoving process volatilization also will run off thereupon, another traditional plaster drug loading is less, transdermal effect is poor, can't repeatedly take off subsides and wait shortcomings to affect curative effect.
Along with the development of medicinal industry, pharmaceutical preparation is constantly progressive, and cataplasma replaces traditional plaster gradually.And Chinese patent medicine further developing due to preparation level, also gradually adopt this exterior-applied formulation of cataplasma, and Chinese medicine is due to the reason of the aspects such as preparation technology, extract consumption as effective therapeutic component is all larger, and the drug loading that how to make Chinese medicine patcher obviously increases and viscosity is better, and the inventor has carried out relevant research to catablasm base material.A kind of drug loading is large, transdermal effect good in order to provide better, slow at the uniform velocity the delivery system of release, the inventor is through a large amount of practical studies, develops a kind of substrate that can prepare Chinese medicine patcher after the Chinese medicine extract with therapeutical effect that is applicable to add.
Summary of the invention
Purpose of the present invention aims to provide a kind of aqueous gel base composition that contains sodium polyacrylate and sodium carboxymethyl cellulose.Described base composition is prepared from by the component of following weight portion proportioning:
5~15 parts of carbomers
1~5 part of xanthan gum
3~20 parts of polyvinyl alcohol
0.5~3 part of colloidal state aluminium hydroxide
5~25 parts of 1,2-PDs
8~30 parts of glycerol
1~5 part of azone
0.5~3 part of Borneolum Syntheticum.
Wherein, carbomer and xanthan gum are adhesive agent, and polyvinyl alcohol not only can improve the denseness of the front substrate of cataplasma agent molding, and improve adhesion; Add the colloidal state aluminium hydroxide as cross-linking agent, can not only strengthen the drug release ability, more can strengthen the drug loading of Chinese medicine patcher; The promoter that azone and Borneolum Syntheticum absorb as percutaneous, the speed of accelerating Drug Percutaneous Absorption can strengthen the amount of Drug Percutaneous Absorption simultaneously; Add 1,2-PD and glycerol as wetting agent, more be conducive to make Chinese medicine patcher to keep for a long time necessary moisture, thereby improve patient's compliance.
In order to reach better effect, described base composition is prepared from by the component of following weight portion proportioning:
7~12 parts of carbomers
2~3 parts of xanthan gum
10~15 parts of polyvinyl alcohol
1.2~2 parts of colloidal state aluminium hydroxide
12~18 parts of 1,2-PDs
15~25 parts of glycerol
2~4 parts of azones
1.2~2 parts of Borneolum Syntheticums.
In order to reach optimum efficiency, described base composition is prepared from by the component of following weight portion proportioning:
10 parts of carbomers
2.5 parts of xanthan gum
12 parts of polyvinyl alcohol
1.5 parts of colloidal state aluminium hydroxide
15 parts of 1,2-PDs
20 parts of glycerol
3 parts of azones
1.5 parts of Borneolum Syntheticums.
In order to make base composition of the present invention have better performance, also can add appropriate pH adjusting agent, pH adjusting agent is selected from organic acid or mineral acid, comprises a kind of in malic acid, tartaric acid, phosphoric acid, citric acid, dilute hydrochloric acid or their mixture, optimization citric acid.The weight portion of described citric acid is preferably 0.1~3 part, is more preferably 0.5~2 part, most preferably is 1 part.
Another object of the present invention aims to provide a kind of preparation method of above-mentioned Chinese medicine catablasm base material compositions.Described method comprises the steps:
A, carbomer and glycerol are fully stirred, add appropriate water-soluble swollen, standby;
B, polyvinyl alcohol is added appropriate water dissolution, then add the abundant stirring and evenly mixing of xanthan gum, swelling, standby;
C, with steps A and B gained material mix homogeneously and fully stir mediate after, slowly add the colloidal state aluminium hydroxide and stir into, standby;
D, step C gained gelling material is slowly at the uniform velocity added 1,2-PD, azone and Borneolum Syntheticum, namely get base composition of the present invention.
The more preferably preparation method of base composition of the present invention comprises the steps:
A, carbomer and glycerol are fully stirred, add appropriate water-soluble swollen, standby;
B, polyvinyl alcohol is added appropriate water dissolution, then add the abundant stirring and evenly mixing of xanthan gum, swelling, standby;
C, with steps A and B gained material mix homogeneously and fully stir mediate after, slowly add the colloidal state aluminium hydroxide and stir into, standby;
D, step C gained gelling material is slowly at the uniform velocity added 1,2-PD, azone, citric acid and Borneolum Syntheticum, namely get base composition of the present invention.
The best preparation method of base composition of the present invention comprises the steps:
A, take 10 parts of carbomers, 2.5 parts of xanthan gum, 12 parts of polyvinyl alcohol, 1.5 parts of colloidal state aluminium hydroxide, 15 parts of 1,2-PDs, 20 parts of glycerol, 3 parts of azones, 1 part of citric acid, 1.5 parts of Borneolum Syntheticums.
B, carbomer and glycerol are fully stirred, add appropriate water-soluble swollen 20 hours, standby;
C, polyvinyl alcohol is added appropriate water dissolution, then add the abundant stirring and evenly mixing of xanthan gum, swelling is about 18 hours, and is standby;
D, step B and C gained material mix homogeneously are placed in kneader, control temperature at 37~43 ℃, and fully stir mediate after, slowly add the colloidal state aluminium hydroxide and stir into gelling material, standby;
E, step D gained gelling material is warming up to 50 ℃ after, slowly at the uniform velocity add 1,2-PD, azone, citric acid and Borneolum Syntheticum, namely get base composition of the present invention.
Above-mentioned Chinese medicine catablasm base material compositions adds Chinese medicine extract or the last non-woven fabrics of coating of Chinese medicinal powder with therapeutical effect, and the cutting section can be prepared into Chinese medicine patcher.
The every consumption per day of Chinese medicine catablasm base material compositions of the present invention is 2~10g, 1~2 time on the one.
In order to verify that Chinese medicine catablasm base material compositions of the present invention and preparation technology thereof are much better than traditional natural rubber cream and preparation technology thereof, the inventor to two kinds of handicraft products in the situation that add the same medicine component with gas chromatography determination its volatile ingredient, measure with each time point accumulation transit dose, assay method and result are as follows:
1, instrument and reagent
Japan Shimadzu GC-10A gas chromatograph, fid detector.
Reference substance: salicylic acid methanol and Camphora are middle inspection and provide.
2, chromatographic condition
Macrogol 2000 is fixative, and coating concentration is 10%, glass column: long 2 meters; The gas flow of fid detector (ml/min): nitrogen 50, hydrogen 50 and air 500.
3, method and result
The preparation of reference substance solution: precision measures methyl salicylate reference substance 0.2ml respectively, then precision takes Borneolum Syntheticum reference substance 1mg, Camphora reference substance 1mg, is placed in the 10ml volumetric flask, adds ethyl acetate and is diluted to scale, shakes up, and get final product.
The preparation of need testing solution: get substrate ointment of the present invention, each a slice of natural rubber substrate ointment, press the cutting of Franz diffusion cell dispenser mouth, Franz diffusion cell opposite side is put into 8ml diffusion liquid, in 37 ± 2 ℃ of temperature controls, again collecting absorption liquid 0.5,2,4,8 interval times, and use ethyl acetate extraction, merge, move in the 1ml volumetric flask, standby.
Sample tests: get above-mentioned sample liquid, the accurate 2 μ l that draw, calculate its content by external standard method respectively, and result is as follows:
The medicine volatile ingredient transit dose measurement result table of base composition of the present invention and natural rubber substrate
Figure 2011103722097100002DEST_PATH_IMAGE002
The result demonstration under identical experiment condition, is compared with the diffusibility of traditional rubber plaster, and the gel that adopts base composition of the present invention to make is much better than traditional rubber plaster; And the substrate diffusibility of the present invention that adds pH adjusting agent obviously is better than the substrate of the present invention of the pH adjusting agent that do not add.
The specific embodiment:
Embodiment 1:
Carbomer 200g, xanthan gum 50g, polyvinyl alcohol 250g, colloidal state aluminium hydroxide 30g, 1,2-PD 300g, glycerol 400g, azone 60g, Borneolum Syntheticum 30g; Carbomer and glycerol are fully stirred, add appropriate water-soluble swollen 20 hours, standby; Separately polyvinyl alcohol is added appropriate water dissolution, then add xanthan gum abundant stirring and evenly mixing to the polyvinyl alcohol glue, swelling is about 18 hours, and is standby; With above-mentioned two kinds of mixture mix homogeneously and after fully stirring kneading, slowly add the colloidal state aluminium hydroxide and stir into gelling material at last; Slowly at the uniform velocity add wherein again 1,2-PD, azone and Borneolum Syntheticum, namely get base composition of the present invention.
At last above-mentioned gained base composition is added Chinese medicine extract or the Chinese medicinal powder with therapeutical effect, coat after mix homogeneously on the backing base materials such as non-woven fabrics or separated type material, cutting, section can be prepared into aqueous gel 100 of the present invention and paste.
Embodiment 2:
Carbomer 200g, xanthan gum 50g, polyvinyl alcohol 250g, colloidal state aluminium hydroxide 30g, 1,2-PD 300g, glycerol 400g, azone 60g, citric acid 20g and Borneolum Syntheticum 30g; Carbomer and glycerol are fully stirred, add appropriate water-soluble swollen 20 hours, standby; Separately polyvinyl alcohol is added appropriate water dissolution, then add xanthan gum abundant stirring and evenly mixing to the polyvinyl alcohol glue, swelling is about 18 hours, and is standby; With above-mentioned two kinds of mixture mix homogeneously and after fully stirring kneading, slowly add the colloidal state aluminium hydroxide and stir into gelling material at last; Slowly at the uniform velocity add wherein again 1,2-PD, azone, citric acid and Borneolum Syntheticum, namely get base composition of the present invention.
At last above-mentioned gained base composition is added Chinese medicine extract or the Chinese medicinal powder with therapeutical effect, coat after mix homogeneously on the backing base materials such as non-woven fabrics or separated type material, cutting, section can be prepared into aqueous gel 100 of the present invention and paste.
Embodiment 3:
Carbomer 225g, xanthan gum 75g, polyvinyl alcohol 300g, colloidal state aluminium hydroxide 45g, 1,2-PD 375g, glycerol 450g, azone 75g, citric acid 45g and Borneolum Syntheticum 45g; Carbomer and glycerol are fully stirred, add appropriate water-soluble swollen 24 hours, standby; Separately polyvinyl alcohol is added appropriate water dissolution, then add xanthan gum abundant stirring and evenly mixing to the polyvinyl alcohol glue, swelling is about 15 hours, and is standby; With above-mentioned two kinds of mixture mix homogeneously and after fully stirring kneading, slowly add the colloidal state aluminium hydroxide and stir into gelling material at last; Slowly at the uniform velocity add wherein again 1,2-PD, azone, citric acid and Borneolum Syntheticum, namely get base composition of the present invention.
At last above-mentioned gained base composition is added Chinese medicine extract or the Chinese medicinal powder with therapeutical effect, coat after mix homogeneously on the backing base materials such as non-woven fabrics or separated type material, cutting, section can be prepared into aqueous gel 100 of the present invention and paste.
Embodiment 4:
Carbomer 200g, xanthan gum 40g, polyvinyl alcohol 120g, colloidal state aluminium hydroxide 20g, 1,2-PD 200g, glycerol 320g, azone 40g, citric acid 4g and Borneolum Syntheticum 20g; Carbomer and glycerol are fully stirred, add appropriate water-soluble swollen 21 hours, standby; Separately polyvinyl alcohol is added appropriate water dissolution, then add xanthan gum abundant stirring and evenly mixing to the polyvinyl alcohol glue, swelling is about 18 hours, and is standby; With above-mentioned two kinds of mixture mix homogeneously and after fully stirring kneading, slowly add the colloidal state aluminium hydroxide and stir into gelling material at last; Slowly at the uniform velocity add wherein again 1,2-PD, azone, citric acid and Borneolum Syntheticum, namely get base composition of the present invention.
At last above-mentioned gained base composition is added Chinese medicine extract or the Chinese medicinal powder with therapeutical effect, coat after mix homogeneously on the backing base materials such as non-woven fabrics or separated type material, cutting, section can be prepared into aqueous gel 100 of the present invention and paste.
Embodiment 5:
Carbomer 210g, xanthan gum 60g, polyvinyl alcohol 300g, colloidal state aluminium hydroxide 35g, 1,2-PD 360g, glycerol 450g, azone 60g and Borneolum Syntheticum 35g; Carbomer and glycerol are fully stirred, add appropriate water-soluble swollen 24 hours, standby; Separately polyvinyl alcohol is added appropriate water dissolution, then add xanthan gum abundant stirring and evenly mixing to the polyvinyl alcohol glue, swelling is about 18 hours, and is standby; With above-mentioned two kinds of mixture mix homogeneously and after fully stirring kneading, slowly add the colloidal state aluminium hydroxide and stir into gelling material at last; Slowly at the uniform velocity add wherein again 1,2-PD, azone and Borneolum Syntheticum, namely get base composition of the present invention.
At last above-mentioned gained base composition is added Chinese medicine extract or the Chinese medicinal powder with therapeutical effect, coat after mix homogeneously on the backing base materials such as non-woven fabrics or separated type material, cutting, section can be prepared into aqueous gel 100 of the present invention and paste.
Embodiment 6:
Carbomer 240g, xanthan gum 60g, polyvinyl alcohol 300g, colloidal state aluminium hydroxide 40g, 1,2-PD 360g, glycerol 500g, azone 80g, citric acid 10g and Borneolum Syntheticum 40g; Carbomer and glycerol are fully stirred, add appropriate water-soluble swollen 16~24 hours, standby; Separately polyvinyl alcohol is added appropriate water dissolution, then add xanthan gum abundant stirring and evenly mixing to the polyvinyl alcohol glue, swelling is about 15~20 hours, and is standby; With above-mentioned two kinds of mixture mix homogeneously and after fully stirring kneading, slowly add the colloidal state aluminium hydroxide and stir into gelling material at last; Slowly at the uniform velocity add wherein again 1,2-PD, azone, citric acid and Borneolum Syntheticum, namely get base composition of the present invention.
At last above-mentioned gained base composition is added Chinese medicine extract or the Chinese medicinal powder with therapeutical effect, coat after mix homogeneously on the backing base materials such as non-woven fabrics or separated type material, cutting, section can be prepared into aqueous gel 100 of the present invention and paste.

Claims (10)

1. Chinese medicine catablasm base material compositions, it is characterized in that described base composition is prepared from by the component of following weight portion proportioning: 5~15 parts of carbomers, 1~5 part of xanthan gum, 3~20 parts of polyvinyl alcohol, 0.5~3 part of colloidal state aluminium hydroxide, 5~25 parts of 1,2-PDs, 8~30 parts of glycerol, 1~5 part of azone, 0.5~3 part of Borneolum Syntheticum.
2. base composition according to claim 1, it is characterized in that described compositions is prepared from by the component of following weight portion proportioning: 7~12 parts of carbomers, 2~3 parts of xanthan gum, 10~15 parts of polyvinyl alcohol, 1.2~2 parts of colloidal state aluminium hydroxide, 12~18 parts of 1,2-PDs, 15~25 parts of glycerol, 2~4 parts of azones, 1.2~2 parts of Borneolum Syntheticums.
3. base composition according to claim 1, it is characterized in that described compositions is prepared from by the component of following weight portion proportioning: 10 parts of carbomers, 2.5 parts of xanthan gum, 12 parts of polyvinyl alcohol, 1.5 parts of colloidal state aluminium hydroxide, 15 parts of 1,2-PDs, 20 parts of glycerol, 3 parts of azones, 1.5 parts of Borneolum Syntheticums.
4. according to right 1 to the 3 described Chinese medicine catablasm base material compositions of any one, it is characterized in that described compositions also can add pH adjusting agent.
5. Chinese medicine catablasm base material compositions according to right 4, is characterized in that described compositions pH adjusting agent is selected from organic acid or mineral acid, comprises a kind of in malic acid, tartaric acid, phosphoric acid, citric acid, dilute hydrochloric acid or their mixture, optimization citric acid; Described citric acid weight portion is preferably 0.1~3 part, is more preferably 0.5~2 part, most preferably is 1 part.
6. the preparation method of the described Chinese medicine catablasm base material compositions of claims 1 to 3 any one, is characterized in that described method comprises the steps:
A, carbomer and glycerol are fully stirred, add appropriate water-soluble swollen, standby;
B, polyvinyl alcohol is added appropriate water dissolution, then add the abundant stirring and evenly mixing of xanthan gum, swelling, standby;
C, with steps A and B gained material mix homogeneously and fully stir mediate after, slowly add the colloidal state aluminium hydroxide and stir into, standby;
D, step C gained gelling material is slowly at the uniform velocity added 1,2-PD, azone and Borneolum Syntheticum, namely get base composition of the present invention.
7. the preparation method of the described Chinese medicine catablasm base material compositions of claim 5, is characterized in that described method comprises the steps:
A, carbomer and glycerol are fully stirred, add appropriate water-soluble swollen, standby;
B, polyvinyl alcohol is added appropriate water dissolution, then add the abundant stirring and evenly mixing of xanthan gum, swelling, standby;
C, with steps A and B gained material mix homogeneously and fully stir mediate after, slowly add the colloidal state aluminium hydroxide and stir into, standby;
D, step C gained gelling material is slowly at the uniform velocity added 1,2-PD, azone, citric acid and Borneolum Syntheticum, namely get base composition of the present invention.
8. the preparation method of base composition claimed in claim 7, is characterized in that described method comprises the steps:
A, take 10 parts of carbomers, 2.5 parts of xanthan gum, 12 parts of polyvinyl alcohol, 1.5 parts of colloidal state aluminium hydroxide, 15 parts of 1,2-PDs, 20 parts of glycerol, 3 parts of azones, 1 part of citric acid, 1.5 parts of Borneolum Syntheticums;
B, carbomer and glycerol are fully stirred, add appropriate water-soluble swollen 16~24 hours, standby;
C, polyvinyl alcohol is added appropriate water dissolution, then add the abundant stirring and evenly mixing of xanthan gum, swelling is about 15~20 hours, and is standby;
D, with step B and C gained material mix homogeneously and fully stir mediate after, slowly add the colloidal state aluminium hydroxide and stir into gelling material, standby;
E, step D gained gelling material is slowly at the uniform velocity added 1,2-PD, azone, citric acid and Borneolum Syntheticum, namely get base composition of the present invention.
9. the preparation method of base composition claimed in claim 8, is characterized in that described method comprises the steps:
A, take 10 parts of carbomers, 2.5 parts of xanthan gum, 12 parts of polyvinyl alcohol, 1.5 parts of colloidal state aluminium hydroxide, 15 parts of 1,2-PDs, 20 parts of glycerol, 3 parts of azones, 1 part of citric acid, 1.5 parts of Borneolum Syntheticums;
B, carbomer and glycerol are fully stirred, add appropriate water-soluble swollen 20 hours, standby;
C, polyvinyl alcohol is added appropriate water dissolution, then add the abundant stirring and evenly mixing of xanthan gum, swelling is about 18 hours, and is standby;
D, step B and C gained material mix homogeneously are placed in kneader, control temperature at 37~43 ℃, and fully stir mediate after, slowly add the colloidal state aluminium hydroxide and stir into gelling material, standby;
E, step D gained gelling material is warming up to 50 ℃ after, slowly at the uniform velocity add 1,2-PD, azone, citric acid and Borneolum Syntheticum, namely get base composition of the present invention.
10. the described Chinese medicine catablasm base material compositions of claim 1 to 8 any one, is characterized in that described compositions adds the Chinese medicine ingredients with therapeutical effect to be prepared into Chinese medicine patcher.
CN2011103722097A 2011-11-22 2011-11-22 Traditional Chinese medicine cataplasm matrix composition and preparation method thereof Pending CN103127515A (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1647803A (en) * 2004-01-20 2005-08-03 北京东方凯恩医药科技有限公司 Chinese medicine composition plaster for external anti-inflammation and analgetics
CN1846703A (en) * 2006-02-13 2006-10-18 程定超 Vagina administration mifepristone prepn and its composition and prepn process
CN1965814A (en) * 2006-11-03 2007-05-23 昆明制药集团股份有限公司 Cataplasma of bulleyaconitine A

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1647803A (en) * 2004-01-20 2005-08-03 北京东方凯恩医药科技有限公司 Chinese medicine composition plaster for external anti-inflammation and analgetics
CN1846703A (en) * 2006-02-13 2006-10-18 程定超 Vagina administration mifepristone prepn and its composition and prepn process
CN1965814A (en) * 2006-11-03 2007-05-23 昆明制药集团股份有限公司 Cataplasma of bulleyaconitine A

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
梁秉文: "《中药经皮给药制剂技术》", 30 April 2006 *
赵斌等: "中药巴布剂亲水性基质的研究进展", 《中华中医药学刊》 *

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