CN102058702A - Fructus evodiae and coptis chinensis hydrogel bapu paste preparation process and substrate - Google Patents
Fructus evodiae and coptis chinensis hydrogel bapu paste preparation process and substrate Download PDFInfo
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- CN102058702A CN102058702A CN2009102373496A CN200910237349A CN102058702A CN 102058702 A CN102058702 A CN 102058702A CN 2009102373496 A CN2009102373496 A CN 2009102373496A CN 200910237349 A CN200910237349 A CN 200910237349A CN 102058702 A CN102058702 A CN 102058702A
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- coptis chinensis
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Abstract
The invention discloses a fructus evodiae and coptis chinensis hydrogel bapu paste as well as a preparation method and a substrate prescription thereof. The bapu paste is prepared from an extracted obtained by extracting and refining fructus evodiae, coptis chinensis and elecampane and a proper substrate and is used for treating digestive system diseases, such as gastral cavity and hypochondrium pain, belching acid regurgitation, heat defecation, gastric ulcer, and the like. The fructus evodiae and coptis chinensis hydrogel bapu paste is changed from a fructus evodiae and coptis chinensis tablet into a bapu dosage, has no acrimony or irritability, and is an external preparation for treating digestive diseases by transdermal medicament delivery. The preparation method comprises the following steps of: extracting volatile oil from fructus evodiae and elecampane by using a steam distilling method; refluxing medicament residues retained after volatile oil is extracted for three times with 5 times of 80 percent of ethanol; recycling the ethanol from extract liquid into an extract with the relative density of 1.15 to 1.40 for standby; refluxing a coptis chinensis drinking tablet for three times with 5 times of 70 percent of ethanol; recycling the ethanol till the relative density is 1.15 to 1.40; adding boil water with equal amount with medicaments, stirring, filtering during heat and adding 10 percent of hydrochloric acid into filter liquid for adjusting pH value to 1.6 to 2.0; pumping and filtering; washing the extract to neutrality with a small amount of cold distilled water; combining a coptis chinensis extract with the fructus evodiae and elecampane extract; concentrating to an extract with the relative density of 1.15 to 1.40 and adding the substrate to obtain the fructus evodiae and coptis chinensis bapu paste.
Description
Technical field
The present invention relates to a kind of abdominal and hypochondriac pain that can be used for treating, belch acid regurgitation, stool diarrhea of heat type, the cataplasma of the percutaneous dosing exterior-applied formulation of digestive system disease such as gastric ulcer-make in flakes by cornel.The present invention be more particularly directed to the preparation technology and the matrix formulations of this medicine.
Background technology
Prescriptions of Chinese medicine of the present invention derive from the 5th of the Chinese medicine ministry standard cornel in flakes, former dosage form is a tablet.Cornel is mainly used to treat digestive tract disease in flakes clinically, is used for gastric ulcer mostly.The present invention changes cornel into cataplasma in flakes according to the traditional Chinese medical science " inner disease outer treat " theory, the percutaneous dosing treatment traditional Chinese medical science " gastric abscess " disease.
The external use plaster that Chinese medicine patcher is made up of water-soluble high-molecular material.At first occur the seventies in Japan.Early stage cataplasma is a mud shape cataplasma, because medication chemistry Development of Materials, selectable high molecular polymer is provided, develop into the typing cataplasma, that is: medicine is mixed with the substrate of water-soluble high-molecular substance, coat on the backing of non-woven fabrics, surface coverage polyethylene or polypropylene film, be cut into different size by instructions for use, in the plastic bag of packing into, sealing is preserved.The typing cataplasma is because easy to use, ixoderm skin not, and the skin allergy of no rubber plaster, and moisture retention is preferably arranged, keratodermatitis is softened, thereby help the Transdermal absorption of medicine.
Cataplasma has plurality of advantages, compares with peroral dosage form, and no liver first-pass effect is not subjected to the influence of gastrointestinal tract degraded, the bioavailability height; Compare with injection, easy to use, no pain; Compare with ointment, dosage is accurate, and absorption area is fixed, so blood drug level is stable; Compare with rubber-emplastrum, the sensitization that viscosifier such as no Colophonium may cause is little to skin irritation.Product development at present is used for the treatment of the pain that arthritis, soft tissue injury, hyperosteogeny diseases cause more, compare with traditional Chinese medicine patch unguentum, the polymer-based material in the cataplasma can absorb and carry the Chinese medicine extract that comprises multiple water solublity and liposoluble constituent better and give " gelation " molding.Therefore, cataplasma has advantages such as the medicine carrying capacity is big, the transdermal performance is good, dosage is accurate, absorption area is little, blood drug level is stable, the comfortable convenience of use.
Present Chinese medicine patcher has been limited to the patch of local therapeutic effects substantially, and the transdermal delivery system of inner disease outer treat yet there are no launch.Meanwhile, Chinese medicine patcher also ubiquity viscosity deficiency, poor stability, long shortcoming of production cycle, therefore, the invention provides " inner disease outer treat " emplastrum kind that a kind of topical plays general action.
Summary of the invention
The objective of the invention is to diseases such as application skins based upon bidding drug treatment gastric ulcer, gastric acid are many, stomach discomfort, the gastrointestinal of avoiding long-term oral administration to bring does not accommodate the destruction to medicine, and medicine of a kind of safe, effective, nonirritant, hypersensitive percutaneous dosing treatment digestive system disease and preparation method thereof is provided.
Cornel of the present invention function in flakes cures mainly: the pathogenic fire purging pain relieving is used for abdominal and hypochondriac pain, belch acid regurgitation, diseases such as stool diarrhea of heat type, gastric ulcer.Monarch drug in the Rhizoma Coptidis side of being.Its bitter in the mouth, cold in nature, the effect of heat clearing and damp drying, eliminating fire and detoxication is arranged.The effective constituent that mainly contains of Rhizoma Coptidis is an isoquinoline alkaloid, comprises berberine (berberine), coptisine (coptisine), jateorhizine (jatrorrhizine), palmatine (palmatine) etc.Fructus Evodiae is rutaceae Fructus Evodiae or the dry almost ripe fruit of dredging the hair Fructus Evodiae.Its flavor is real, bitter, hot in nature, dispersing cold for relieving pain, stopping nausea and vomiting by lowering the adverse flow of QI, supporing yang antidiarrheal effect are arranged, mainly contain fat-soluble biological bases rutaecarpin (evodiamine), rutaecarpine (rutaecarpine), obaculactone (evodin), organic acid and volatile oil and become to grade.Rhizoma Coptidis is a bitter and cold medicines, and Fructus Evodiae contains a large amount of volatile oil, for reducing oral administration gastrointestinal tract is produced stimulation.Extract and the suitable substrate adjuvant of medicine of respectively distinguishing the flavor of during the present invention will write out a prescription made the hydrogel crust cloth cream of percutaneous dosing.
The present invention is by following scheme implementation:
Cornel of the present invention connects hydrogel crust cloth cream, be with the Rhizoma Coptidis in the prescription, Fructus Evodiae, the Radix Aucklandiae through extract, refining, make extractum, mixes with suitable substrate adjuvant again, make hydrogel and cling to cloth cream.
The preparation method of cornel Lian Babu cream of the present invention, concrete steps are as follows:
1. Fructus Evodiae, Radix Aucklandiae decoction pieces extract volatile oil with steam distillation, and volatile oil device is in addition preserved; Carry the aqueous solution behind the oil, be evaporated to relative density 1.08-1.12, doubly measure 95% ethanol precipitation with 1.5-3, filter, filtrate is continued to employ; Fructus Evodiae, the Radix Aucklandiae extract medicinal residues behind the volatile oil with 5 times of alcohol refluxs of measuring 70%-95% 3 times; Extracting solution and filtrate merge, and reclaim ethanol to (relative density 1.15-1.40), and is standby.
2. take by weighing the Rhizoma Coptidis decoction pieces, with the alcohol reflux 3 times of 5 times of amount 50-80%, each 1.5 hours; Filter merging filtrate, reclaim ethanol between the relative density (1.15-1.40), the boiling water of adding and medical material equivalent, stir, filtered while hot, filtrate adds 10% hydrochloric acid accent PH to 1.6-2.0, cold preservation 12 hours, sucking filtration, extract is extremely neutral with a little washing of cold distilled water.With Rhizoma Coptidis extract and Fructus Evodiae, costol extract, Fructus Evodiae, Radix Aucklandiae water extract-alcohol precipitation liquid merge, and are evaporated to relative density 1.20-1.40, mixing, cornel connect extractum.
3. gained extractum adds transdermal penetrating agent, nertralizer etc.At last with gained extractum again with substrate by 1: the mixed of 4-20, stir refining and 10-120 minute, coating, press mold, cutting, packing promptly gets cornel and connects hydrogel and cling to cloth cream.
Substrate of the present invention can be to be mixed by weight by following natural and synthetic high molecular polymer:
Preparation technology of the present invention is:
A. carbomer, gelatin, magnificent glue, arabic gum are used 2-12 part G ﹠ W 10-30 part respectively, heat 40-70 ℃ of swelling, mix homogeneously.
B. polyvinyl alcohol, sodium carboxymethyl cellulose add 4-80 ℃ of dissolving of 2-10 part water heating and swelling, mixing.
C. sodium polyacrylate adds the dispersion of 1-10 part glycerol, adds the dissolving of water 1-8 part.
D. aluminum glycinate or aluminium potassium sulfate, EDTA-2Na add the dissolving of water 2-10 part
The E.A component is mixed with the B component, adds the D component again, and mix with the C component back that stirs, and makes crust cloth cream base in 20-120 minute, cornel is connected extractum again and mixes with substrate, adds volatile oil at last.Stirred 20-120 minute, and can even make crust cloth cream by cornel.
The present invention has significant curative effect through pharmacodynamic experiment research:
Cornel Lian Babu cream is to the influence of experimental rat gastric ulcer: from the ulcer incidence rate, each administration group all is lower than vehicle group; Ulcer suppresses percentage rate and is dose dependent.This shows that oral cornel connects powder and external cornel and connects cataplasma the experimental rat gastric ulcer is all had certain therapeutical effect;
Show with pepsin output result of the test: oral cornel connects powder and the external cornel connects the pepsin output that cataplasma can increase experimental rat gastric ulcer model animal, improve pH value, reduce gastric acidity, increase the gastric juice volume, reduce the stimulation of gastric acid, the experimental rat gastric ulcer is played certain therapeutical effect gastric mucosa;
Experiment adopts proinflammatory agent intersection dish to cause scorching rat foot claw swelling model, with the positive medicine of commercially available diclofenac, investigate the resist inflammation on repercussive function of cornel Lian Babu cream, the result shows: middle dosage group can obviously reduce toes swelling degree, improve the toes inhibitory rate of intumesce, action time is longer, small dose group also can reduce toes swelling degree, improve the toes inhibitory rate of intumesce, but action time, middle dosage group was short, and results suggest external cornel connects that the swelling of rat toes has significantly resist inflammation on repercussive function due to the cataplasma on Carrageenan;
Experiment is to turn round the body number of times, and absorbance is an index, is the antiinflammatory positive drug with the Aspirin Enteric-coated Tablets, and YUANHU ZHITONG PIAN is the antalgic and inflammation relieving positive drug, turns round topic and permeability experiment by mice, investigates the scorching effect in anti-pain, town of cornel Lian Babu cream.The result shows: each group compares with vehicle group, and the body number of times of turning round of positive drug YUANHU ZHITONG PIAN group is starkly lower than vehicle group, and significant differences (P＜0.001) is arranged; Oral even cornel group and 1.5g crude drug/kg group all has significant difference (P＜0.05); 6.0g crude drug/kg group has than significant difference (P＜0.01); 12.0g crude drug/kg group has significant differences (P＜0.001).
This shows that what connect that the 6.0g crude drug/kg of cornel cataplasma and inflammatory exudation that 12.0g crude drug/kg group can obviously reduce the abdominal cavity and pain causes turns round the body number of times, and mice is had certain anti-inflammatory and analgesic effect by the abdominal cavity inflammation that chemical stimulation causes.
The pharmacodynamic experiment result of study shows that cornel Lian Babu cream has the obvious suppression gastric ulcer, antalgic and inflammation relieving and repercussive effect, and the pharmacological action that proves cornel Lian Babu cream is effective.
Cornel Lian Babu cream nonirritant of the present invention and anaphylaxis:
Adopt cornel to connect cataplasma and give rabbit intact skin and damaged skin single and multiple dosing, dosage is 7 * 10cm
2/ only/time.The result shows, single-dose, and irritant reaction such as erythema, edema all do not appear in intact skin and damaged skin group, and the average product score value is 0; Successive administration, intact skin treated animal and damaged skin group there is no erythema or edema, and the average product score value is 0;
Therefore, cornel connects cataplasma to rabbit intact skin, the equal nonirritant of damaged skin.
Cornel connects cataplasma by 17.5cm
2/ only, the guinea pig skin sensitization contact is contacted administration with exciting.After the administration, body weight gain of Cavia porcellus and matched group be no significant difference relatively.Overview index Non Apparent Abnormality, anaphylaxis does not appear in skin.And positive control drug 2, the 4-dinitro-chloro-benzene obviously causes the guinea pig skin anaphylaxis.Experimental results show that: cornel connects the anaphylaxis that cataplasma can not cause guinea pig skin.
The specific embodiment
Embodiment:
Connect extractum by following prepared cornel:
1. Fructus Evodiae, Radix Aucklandiae decoction pieces extract volatile oil with steam distillation, and volatile oil device is in addition preserved; Carry the aqueous solution behind the oil, be evaporated to relative density 1.08-1.12, doubly measure 95% ethanol precipitation with 1.5-3, filter, filtrate is continued to employ; Fructus Evodiae, the Radix Aucklandiae extract medicinal residues behind the volatile oil with 5 times of alcohol refluxs of measuring 70%-95% 3 times; Extracting solution and filtrate merge, and reclaim ethanol to (relative density 1.15-1.40), and is standby.
2. take by weighing the Rhizoma Coptidis decoction pieces, with the alcohol reflux 3 times of 5 times of amount 50-80%, each 1.5 hours; Filter merging filtrate, reclaim ethanol between the relative density (1.15-1.40), the boiling water of adding and medical material equivalent, stir, filtered while hot, filtrate adds 10% hydrochloric acid accent PH to 1.6-2.0, cold preservation 12 hours, sucking filtration, extract is extremely neutral with a little washing of cold distilled water.With Rhizoma Coptidis extract and Fructus Evodiae, costol extract, Fructus Evodiae, Radix Aucklandiae water extract-alcohol precipitation liquid merge, and are evaporated to relative density 1.20-1.40, mixing, cornel connect extractum.
The substrate preparation:
A. carbomer, gelatin, magnificent glue, arabic gum are used 20 parts of 10 parts of G ﹠ Ws respectively, heat 50 ℃ of swellings, mix homogeneously.
B. polyvinyl alcohol, sodium carboxymethyl cellulose add 70 ℃ of dissolvings of 8 parts of water heating and swelling, mixing.
C. sodium polyacrylate adds 6 parts of glycerol dispersions, adds 6 parts of dissolvings of water.
D. aluminum glycinate or aluminium potassium sulfate, EDTA-2Na add 8 parts of dissolvings of water
The E.A component is mixed with the B component, adds the D component again, and mix with the C component back that stirs, made crust cloth cream base in 40 minutes, again cornel is connected extractum and mix, add volatile oil at last and stirred 40 minutes with substrate, coating, press mold, cutting, packing promptly can be made into cornel and connect hydrogel crust cloth cream.
Claims (3)
1. one kind can be used for treating abdominal and hypochondriac pain, belch acid regurgitation, stool diarrhea of heat type, the Chinese medicine patcher of digestive system disease such as gastric ulcer.It is characterized in that it is made by Fructus Evodiae, Rhizoma Coptidis, Radix Aucklandiae extract and substrate, it is characterized in that: this substrate is to be made of by weight mixing following natural or synthetic high molecular polymer:
2. 1 described cornel Lian Babu cream according to claim is to make as follows:
A. carbomer, gelatin, magnificent glue, arabic gum are used 2-12 part G ﹠ W 10-30 part respectively, heat 40-70 ℃ of swelling, mix homogeneously.
B. polyvinyl alcohol, sodium carboxymethyl cellulose add 2-10 part water dissolution and swelling, mixing.
C. sodium polyacrylate adds the dispersion of 1-10 part glycerol, adds 2-10 part water dissolution
D. aluminum glycinate or aluminium potassium sulfate, EDTA-2Na add the dissolving of water 2-10 part
The E.A component is mixed with the B component, adds the D component again, and mix with the C component back that stirs, and makes in 20-120 minute and to cling to cloth cream base matter.
3. cornel Lian Babu cream according to claim 1 is made by Rhizoma Coptidis, Fructus Evodiae, Radix Aucklandiae extract and above-mentioned substrate, it is characterized in that: Fructus Evodiae, Radix Aucklandiae decoction pieces extract volatile oil with steam distillation; Carry medicinal residues behind the volatile oil with the alcohol reflux of 70%-95% 3 times; Reclaim ethanol to relative density 1.15-1.40 extractum; The alcohol reflux of Rhizoma Coptidis usefulness 50-80% 3 times, alcohol extract reclaims ethanol to relative density 1.15-1.40, the boiling water of adding and medical material equivalent, stir, filtered while hot, filtrate adds 10% hydrochloric acid accent PH to 1.3-1.8, cold preservation 12 hours is filtered, and extract is extremely neutral with a little washing of cold distilled water.Rhizoma Coptidis extract and Fructus Evodiae, Radix Aucklandiae extract are merged, and water-bath is concentrated into relative density 1.20-1.45 extractum, cornel is connected extractum again and mixes with substrate, adds volatile oil at last.Stirred 20-120 minute, and promptly got cornel through coating, press mold, cutting and connect hydrogel crust cloth cream.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2009102373496A CN102058702A (en) | 2009-11-16 | 2009-11-16 | Fructus evodiae and coptis chinensis hydrogel bapu paste preparation process and substrate |
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| CN2009102373496A CN102058702A (en) | 2009-11-16 | 2009-11-16 | Fructus evodiae and coptis chinensis hydrogel bapu paste preparation process and substrate |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102871988A (en) * | 2011-07-13 | 2013-01-16 | 日东电工株式会社 | Jelly-form preparation and method for producing jelly-form preparation |
| CN102988545A (en) * | 2012-10-08 | 2013-03-27 | 卞毓平 | Preparation method and application of Yulian tablet |
-
2009
- 2009-11-16 CN CN2009102373496A patent/CN102058702A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102871988A (en) * | 2011-07-13 | 2013-01-16 | 日东电工株式会社 | Jelly-form preparation and method for producing jelly-form preparation |
| CN102988545A (en) * | 2012-10-08 | 2013-03-27 | 卞毓平 | Preparation method and application of Yulian tablet |
| CN102988545B (en) * | 2012-10-08 | 2013-12-25 | 黄涵 | Preparation method and application of Yulian tablet |
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Open date: 20110518 |