CN100333720C - Compound analgesic agent - Google Patents
Compound analgesic agent Download PDFInfo
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- CN100333720C CN100333720C CNB2005100232122A CN200510023212A CN100333720C CN 100333720 C CN100333720 C CN 100333720C CN B2005100232122 A CNB2005100232122 A CN B2005100232122A CN 200510023212 A CN200510023212 A CN 200510023212A CN 100333720 C CN100333720 C CN 100333720C
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- radix notoginseng
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Abstract
The present invention relates to a compound analgesic agent which belongs to the medicine technical field. The compound analgesic agent comprises an antisticking layer, a hydrophilic gel layer and a back lining layer, wherein the hydrophilic gel layer is composed of a medicine and base materials and is characterized in that the medicine is a compound formula composed of lidocaine hydrochloride and notoginseng, and the notoginseng adopts superfine powder of notoginseng, or ethanol extract products of notoginseng or panax notoginseng saponins; the base materials comprise the components: gelatin, sodium carboxymethylcellulose, polyvinylpyrrolidone, polyacrylic acids with unequal neutralization degrees, sorbitol, kaoline, glycerol, propanediol, ethanol, ethylparaben, disodium edetate, calcium hydroxide, tartaric acid, etc. The compound analgesic agent of the present invention is used for alleviating the pain of traumatic injury, the painful swelling of blood stasis and the neuropathic pain after herpes and operations, and the compound analgesic agent has a favorable effect on the alleviation of pain.
Description
Technical field:
The present invention relates to medical technical field, is a kind of analgesic agent of being made by drug salts lidocaine hydrochloride and notoginseng.
Background technology:
Lidocaine hydrochloride is to imitate local anesthetic in the amide-type commonly used clinically, has that local anesthetic action is fast and strong, penetration power reaches advantages such as timeliness is long greatly, is considered to a kind of ideal local anaesthetics.External at present having through 5% lidocaine patch of skin administration got permission listing (trade name LIDODERM
), characteristics such as have that whole body blood drug level is low, medicine concentrates on agents area and systemic adverse reactions is few are widely used in the neuropathic pain behind pain relieving, the especially herpes zoster of peripheral neuralgia.Domestic also have some about the research of transdermal permeation of lidocaine report [Cheng Yuhui etc. the research of local anesthetic transdermal permeation of lidocaine. Acta Pharmaceutica Sinica, 1995; 30 (8): 615-620], but still do not have lidocaine patch product development success.
Radix Notoginseng is the most frequently used clinically a kind of Chinese medicine, multiple external preparation such as red medicine plaster, shaolin plaster for rheumatism and wound, YUNNAN BAIYAO cream have been widely used in as main component, effect with dissipating blood stasis hemostasis, subduing swelling and relieving pain, and having effects such as antiinflammatory, antiviral, external curing traumatic injury, swelling and pain due to blood stasis etc. have good result.Though the more existing reports of the research that relevant Radix Notoginseng externally applied transdermal absorbs, comprise the Notoginseng Root Transdermal absorption [Cai Qingshun etc. the research of Notoginseng Root Transdermal absorption. Jiangxi College of Traditional Chinese Medicine journal, 2002; 14 (4): 9-10], panax notoginseng cataplasma development [Yi Jun etc. the selection of Percutaneous absorption enhancer in the panax notoginseng cataplasma. ACAD J GCP, 2000; 16 (2): 91-93] etc., but be traditional compound Chinese medicinal preparation, have not yet to see Radix Notoginseng and the Chinese medicine and western medicine Bastian-Bruns agent product of lidocaine hydrochloride composition or relevant report.
Summary of the invention:
The invention provides a kind of Chinese medicine and western medicine compound analgesic agent of forming by Radix Notoginseng and lidocaine hydrochloride.
Lidocaine hydrochloride can be alleviated the symptom of various acute and chronic pain rapidly; Radix Notoginseng then plays the effect of dissipating blood stasis hemostasis, subduing swelling and relieving pain, and has effects such as antiinflammatory, antiviral.Both are formed compound recipe be developed into a kind of novel analgesic agent, can obtain than using the better therapeutic effect of single component.
Compound analgesic agent of the present invention comprises three layers of backing layer, hydrophilic gel layer and adherent layers.The hydrophilic gel layer is made up of medicine and substrate, and its Chinese medicine is the compound recipe of being made up of lidocaine hydrochloride and Radix Notoginseng.Radix Notoginseng is selected from superfines, and (particle diameter is less than 10 μ m, female seven pharmaceutcal corporation, Ltds of Yunnan mountain of papers), Radix Notoginseng total arasaponins (Pharmaceutical branch company of Yunnan Radix Stephaniae Sinicae (Radix Stephaniae Dielsianae) Group Co.,Ltd) or Radix Notoginseng ethanol extraction, wherein the preparation method of Radix Notoginseng ethanol extraction is: Radix Notoginseng powder is broken into coarse powder (20～40 order), press the percolation (appendix IO of Chinese Pharmacopoeia version in 2000) under fluid extract and the extractum item, after making solvent dipping 24h with 75% ethanol, with per kilogram per minute 1～3ml speed percolation slowly, collection is equivalent to the percolate of 10 times of amounts of Radix Notoginseng, and drying promptly.Substrate comprises framework material, wetting agent, antiseptic, chelating agent, cross-linking agent, cross-linked evocating agent, also can contain Percutaneous absorption enhancer and cross-linked inhibitor.Polyacrylic acid that framework material is not waited by gelatin, sodium carboxymethyl cellulose, polyvinylpyrrolidone, sorbitol, degree of neutralization and Kaolin or zinc oxide are formed, wherein polyvinylpyrrolidone is selected from models such as K30, K90 or K90D, and the polyacrylic acid that degree of neutralization does not wait is selected from models such as NP-600, NP-700 or PAS 7S; Wetting agent is glycerol and propylene glycol, antiseptic is selected from methyl hydroxybenzoate, ethyl hydroxybenzoate, propyl hydroxybenzoate, chelating agent is a disodium edetate, cross-linking agent is selected from calcium hydroxide, aluminium hydroxide, calcium chloride, aluminum chloride, cross-linked evocating agent is selected from tartaric acid, citric acid, Percutaneous absorption enhancer is selected from methyl salicylate, Mentholum, Camphora, Oleum Terebinthinae, eucalyptus oil, azone etc., and cross-linked inhibitor is an ethanol.The ratio of each component is: 2～5 parts of lidocaine hydrochlorides; 2～10 parts of Radix Notoginseng superfines, or 0.2～1 part of Radix Notoginseng ethanol extraction, or 0.2～1 part of Radix Notoginseng total arasaponins; 1～2 part in gelatin; 2～4 parts of sodium carboxymethyl cellulose; 2～4 parts of polyvinylpyrrolidones; 1～3 part of the polyacrylic acid that degree of neutralization does not wait; 1～5 part of Kaolin or zinc oxide; 15～30 parts of sorbitol; 2～10 parts of glycerol, 5～15 parts of propylene glycol; 0.05～0.1 part of antiseptic; 0.04～0.1 part of disodium edetate; 0.1～0.5 part of cross-linking agent; 0.05～0.25 part of cross-linked evocating agent; 20～40 parts of purified water; The consumption of Percutaneous absorption enhancer is no more than 10% of hydrophilic gel layer; The cross-linked inhibitor consumption of ethanol is no more than hydrophilic gel layer 10%.
The preparation method of cataplasma of the present invention is:
1, preparation (I) phase solution: gelatin is added the abundant swelling of water by said ratio, sorbitol, disodium edetate, cross-linking agent, Kaolin or zinc oxide, lidocaine hydrochloride, Radix Notoginseng superfines or Radix Notoginseng ethanol extraction or Radix Notoginseng total arasaponins are added in the gelatin, fully stir, dissolve, get (I) phase solution;
2, preparation (II) phase solution: antiseptic is dissolved in the propylene glycol, polyacrylic acid, sodium carboxymethyl cellulose, polyvinylpyrrolidone, ethanol and Percutaneous absorption enhancer that adding glycerol, degree of neutralization do not wait, swelling routinely, mix homogeneously, (II) phase solution;
3, (1) phase solution is crossed 80 mesh sieves, with (II) solution mixing mutually, gradation adds 10% aqueous solution of cross-linked evocating agent, stirs, and is laid on the non-woven fabrics then, and 50 ℃ were dried by the fire 4～8 hours, covered adherent layer, cut into 7 * 10cm
2Cataplasma, pack.
Through the clinical comparison test, lidocaine hydrochloride cataplasma treatment group effective percentage is 65%, especially neuropathic pain after the herpes is had remarkable result; Panax notoginseng cataplasma treatment group effective percentage is 82%, and is apparent in view to traumatic injury, swelling and pain due to blood stasis effect; The compound analgesic agent treatment group effective percentage that lidocaine hydrochloride of the present invention and Radix Notoginseng are formed reaches 92%, not only remarkable to traumatic injury, swelling and pain due to blood stasis effect, and to after the herpes, postoperative chronic, intractable neuropathic pain also has remarkable result, has advantages such as rapid-action, that effect is held time long and untoward reaction is few; Show that compound analgesic agent analgesic effect of the present invention obviously is better than single cataplasma with Radix Notoginseng or lidocaine hydrochloride.
The specific embodiment:
Embodiment 1 compound analgesic agent
Prescription and proportioning:
Lidocaine hydrochloride 2.5g Radix Notoginseng superfines 3g
Gelatin 1g sodium carboxymethyl cellulose 2g
Polyvinylpyrrolidone K90 3g sorbitol 19g
Polyacrylic acid NP700 1g Kaolin 5g
Propylene glycol 10g glycerol 5g
Ethanol 5g ethyl hydroxybenzoate 0.08g
Disodium edetate 0.04g calcium hydroxide 0.25g
Tartaric acid 0.125g purified water 30ml
Preparation method is:
1, preparation (I) phase solution: gelatin is added the abundant swelling of water by said ratio, 60 ℃ of water-bath dissolvings down, sorbitol, disodium edetate, calcium hydroxide, Kaolin, lidocaine hydrochloride and Radix Notoginseng superfines are added in the gelatin, fully stir, dissolve, get (I) phase solution;
2, ethyl hydroxybenzoate is dissolved in the propylene glycol, adds glycerol, polyacrylic acid NP700, sodium carboxymethyl cellulose, polyvinylpyrrolidone K90, ethanol, swelling, mix homogeneously gets (II) phase solution;
3, (I) phase solution is crossed 80 mesh sieves, with (II) solution mixing mutually, gradation adds 10% aqueous tartaric acid solution, stirs, and is laid on 500cm then
2On the non-woven fabrics, 50 ℃ were dried by the fire 4 hours, covered adherent layer, cut into 7 * 10cm
2Cataplasma, pack.
Embodiment 2 compound analgesic agents
Prescription and proportioning:
Lidocaine hydrochloride 5g Radix Notoginseng ethanol extraction 0.6g
Gelatin 1g sodium carboxymethyl cellulose 2g
Polyvinylpyrrolidone K90 3g sorbitol 19g
Polyacrylic acid NP700 2g Kaolin 5g
Propylene glycol 10g glycerol 5g
Ethanol 5g ethyl hydroxybenzoate 0.08g
Disodium edetate 0.04g calcium hydroxide 0.4g
Citric acid 0.2g methyl salicylate 2.0g
Purified water 30ml
Preparation method is:
1, preparation (I) phase solution: gelatin is added the abundant swelling of water by said ratio, 60 ℃ of water-bath dissolvings down, sorbitol, disodium edetate, calcium hydroxide, Kaolin, lidocaine hydrochloride and Radix Notoginseng ethanol extraction are added in the gelatin, fully stir, dissolve, get (I) phase solution;
2, ethyl hydroxybenzoate is dissolved in the propylene glycol, adds glycerol, polyacrylic acid NP700, sodium carboxymethyl cellulose, polyvinylpyrrolidone K90, ethanol, methyl salicylate, swelling, mix homogeneously gets (II) phase solution;
3, (I) phase solution is crossed 80 mesh sieves, with (II) solution mixing mutually, gradation adds 10% aqueous solution of citric acid, stirs, and is laid on 500cm then
2On the non-woven fabrics, 50 ℃ were dried by the fire 6 hours, covered adherent layer, cut into 7 * 10cm
2Cataplasma, pack.
Embodiment 3 compound analgesic agents
Prescription and proportioning:
Lidocaine hydrochloride 2.5g Radix Notoginseng superfines 5g
Gelatin 2g sodium carboxymethyl cellulose 2g
Polyvinylpyrrolidone K30 2g sorbitol 19g
Polyacrylic acid NP600 2g Kaolin 5g
Propylene glycol 10g glycerol 5g
Ethanol 5g methyl hydroxybenzoate 0.08g
Disodium edetate 0.04g calcium hydroxide 0.4g
Citric acid 0.2g Mentholum 2.0g
Purified water 30ml
Preparation method is:
1, preparation (I) phase solution: gelatin is added the abundant swelling of water by said ratio, 60 ℃ of water-bath dissolvings down, sorbitol, disodium edetate, calcium hydroxide, Kaolin, lidocaine hydrochloride and Radix Notoginseng superfines are added in the gelatin, fully stir, dissolve, get (I) phase solution;
2, methyl hydroxybenzoate, Mentholum are dissolved in the propylene glycol, add glycerol, polyacrylic acid NP600, sodium carboxymethyl cellulose, polyvinylpyrrolidone K30, ethanol, swelling, mix homogeneously gets (II) phase solution;
3, (I) phase solution is crossed 80 mesh sieves, with (II) solution mixing mutually, gradation adds 10% aqueous solution of citric acid, stirs, and is laid on 500cm then
2On the non-woven fabrics, 50 ℃ were dried by the fire 8 hours, covered adherent layer, cut into 7 * 10cm
2Cataplasma, pack.
Embodiment 4 compound analgesic agents
Prescription and proportioning:
Lidocaine hydrochloride 5g Radix Notoginseng total arasaponins 1g
Gelatin 1g sodium carboxymethyl cellulose 2g
Polyvinylpyrrolidone K90 3g sorbitol 19g
Polyacrylic acid NP600 1g Kaolin 5g
Propylene glycol 10g glycerol 5g
Ethanol 5g ethyl hydroxybenzoate 0.08g
Disodium edetate 0.04g calcium chloride 0.4g
Tartaric acid 0.2g azone 2.0g
Purified water 30ml
Preparation method is:
1, preparation (I) phase solution: gelatin is added the abundant swelling of water by said ratio, 60 ℃ of water-bath dissolvings down, sorbitol, disodium edetate, calcium chloride, Kaolin, lidocaine hydrochloride and Radix Notoginseng ethanol extraction are added in the gelatin, fully stir, dissolve, get (I) phase solution;
2, ethyl hydroxybenzoate, azone are dissolved in the propylene glycol, add glycerol, polyacrylic acid NP600, sodium carboxymethyl cellulose, polyvinylpyrrolidone K90, ethanol, swelling, mix homogeneously gets (II) phase solution;
3, (I) phase solution is crossed 80 mesh sieves, with (II) solution mixing mutually, gradation adds 10% aqueous tartaric acid solution, stirs, and is laid on 500cm then
2On the non-woven fabrics, 50 ℃ were dried by the fire 4 hours, covered adherent layer, cut into 7 * 10cm
2Cataplasma, pack.
Claims (7)
1, a kind of compound analgesic agent, comprise backing layer, hydrophilic gel layer and adherent layer, the hydrophilic gel layer is made up of medicine and substrate, it is characterized in that medicine is the compound recipe of being made up of lidocaine hydrochloride and Radix Notoginseng, wherein Radix Notoginseng is selected from Radix Notoginseng superfines, Radix Notoginseng ethanol extraction or Radix Notoginseng total arasaponins; Substrate comprises framework material, wetting agent, antiseptic, chelating agent, cross-linking agent, cross-linked evocating agent, framework material is by gelatin, sodium carboxymethyl cellulose, polyvinylpyrrolidone, the polyacrylic acid that degree of neutralization does not wait, sorbitol, and on the high mountain range or zinc oxide form, wherein polyvinylpyrrolidone is selected from K30, K90 or K90D, the polyacrylic acid that degree of neutralization does not wait is selected from NP-600, NP-700 or PAS 7S, wetting agent is glycerol and propylene glycol, antiseptic is selected from methyl hydroxybenzoate, ethyl hydroxybenzoate, propyl hydroxybenzoate, chelating agent is a disodium edetate, cross-linking agent is selected from calcium hydroxide, aluminium hydroxide, calcium chloride, aluminum chloride, cross-linked evocating agent is selected from tartaric acid, citric acid; Proportioning is: 2～5 parts of lidocaine hydrochlorides; 2～10 parts of Radix Notoginseng superfines, or 0.2～1 part of Radix Notoginseng ethanol extraction, or 0.2～1 part of Radix Notoginseng total arasaponins; 1～2 part in gelatin; 2～4 parts of sodium carboxymethyl cellulose; 2～4 parts of polyvinylpyrrolidones; 1～3 part of the polyacrylic acid that degree of neutralization does not wait; 1～5 part of Kaolin or zinc oxide; 15～30 parts of sorbitol; 2～10 parts of glycerol, 5～15 parts of propylene glycol; 0.05～0.1 part of antiseptic; 0.04～0.1 part of disodium edetate; 0.1～0.5 part of cross-linking agent; 0.05～0.25 part of cross-linked evocating agent; 20～40 parts of purified water.
2, by the described compound analgesic agent of claim 1, it is characterized in that also containing in the substrate Percutaneous absorption enhancer, Percutaneous absorption enhancer is selected from methyl salicylate, Mentholum, Camphora, Oleum Terebinthinae, eucalyptus oil, azone, and consumption is no more than 10% of hydrophilic gel layer weight.
3, by claim 1 or 2 described compound analgesic agents, it is characterized in that also adding in the substrate cross-linked inhibitor ethanol with the delayed cross-linking response speed, consumption is no more than 10% of hydrophilic gel layer weight.
4, by the described compound analgesic agent of claim 3, it is characterized in that the prescription of hydrophilic gel layer and proportioning are: lidocaine hydrochloride 2.5g, Radix Notoginseng superfines 3g, gelatin 1g, sodium carboxymethyl cellulose 2g, polyvinylpyrrolidone K903g, sorbitol 19g, polyacrylic acid NP7001g, Kaolin 5g, propylene glycol 10g, glycerol 5g, ethanol 5g, ethyl hydroxybenzoate 0.08g, disodium edetate 0.04g, calcium hydroxide 0.25g, tartaric acid 0.125g, purified water 30ml.
5, by the described compound analgesic agent of claim 3, it is characterized in that the prescription of hydrophilic gel layer and proportioning are: lidocaine hydrochloride 5g, Radix Notoginseng ethanol extraction 0.6g, gelatin 1g, sodium carboxymethyl cellulose 2g, polyvinylpyrrolidone K903g, sorbitol 19g, polyacrylic acid NP7002g, Kaolin 5g, propylene glycol 10g, glycerol 5g, ethanol 5g, methyl salicylate 2g, ethyl hydroxybenzoate 0.08g, disodium edetate 0.04g, calcium hydroxide 0.4g, citric acid 0.2g, purified water 30ml.
6, by the described compound analgesic agent of claim 3, it is characterized in that the prescription of hydrophilic gel layer and proportioning are: lidocaine hydrochloride 2.5g, Radix Notoginseng superfines 5g, gelatin 2g, sodium carboxymethyl cellulose 2g, polyvinylpyrrolidone K302g, sorbitol 19g, polyacrylic acid NP6002g, Kaolin 5g, propylene glycol 10g, glycerol 5g, ethanol 5g, methyl hydroxybenzoate 0.08g, disodium edetate 0.04g, calcium hydroxide 0.4g, citric acid 0.2g, Mentholum 2.0g, purified water 30ml.
7, by the described compound analgesic agent of claim 3, it is characterized in that the prescription of hydrophilic gel layer and proportioning are: lidocaine hydrochloride 5g, Radix Notoginseng total arasaponins 1g, gelatin 1g, sodium carboxymethyl cellulose 2g, polyvinylpyrrolidone K90 3g, sorbitol 19g, polyacrylic acid NP6001g, Kaolin 5g, propylene glycol 10g, glycerol 5g, ethanol 5g, ethyl hydroxybenzoate 0.08g, disodium edetate 0.04g, calcium chloride 0.4g, tartaric acid 0.2g, azone 2.0g, purified water 30ml.
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| CNB2005100232122A CN100333720C (en) | 2005-01-11 | 2005-01-11 | Compound analgesic agent |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100232122A CN100333720C (en) | 2005-01-11 | 2005-01-11 | Compound analgesic agent |
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| CN1679520A CN1679520A (en) | 2005-10-12 |
| CN100333720C true CN100333720C (en) | 2007-08-29 |
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| CNB2005100232122A Expired - Fee Related CN100333720C (en) | 2005-01-11 | 2005-01-11 | Compound analgesic agent |
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Cited By (1)
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|---|---|---|---|---|
| WO2023154047A1 (en) * | 2022-02-10 | 2023-08-17 | Glaxosmithkline Consumer Healthcare Holdings (Us) Llc | Rapid relief spray |
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| CN101879250B (en) * | 2010-06-25 | 2012-10-31 | 安舒贴(天津)外用制剂科技有限公司 | Arthralgia relief gel paste and preparation method |
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| CN102018696B (en) * | 2010-11-22 | 2013-07-03 | 北京泰德制药股份有限公司 | Skin external preparation containing lidocaine or pharmaceutical salt thereof |
| CN102716487B (en) * | 2011-03-29 | 2016-03-09 | 兰州大学 | Ginsenoside-Rd Transdermal absorption penetration enhancer and application thereof |
| CN104274859B (en) * | 2014-10-17 | 2016-08-24 | 云南白药集团无锡药业有限公司 | A kind of hydrocolloid containing Radix Notoginseng total arasaponins is applied ointment or plaster and preparation method thereof |
| CN105854072A (en) * | 2016-04-19 | 2016-08-17 | 上海昌颌医药科技有限公司 | Medical gel and method for preparing medical treatment gel paster for external use through medical gel |
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| CN108404082B (en) * | 2018-04-24 | 2022-05-17 | 湖南九典制药股份有限公司 | Compound traditional Chinese medicine preparation with effects of promoting blood circulation and relieving pain and preparation method thereof |
| CN110522816A (en) * | 2019-10-21 | 2019-12-03 | 健民药业集团股份有限公司 | A kind of cow-bezoar infantile umbilical paste and preparation method thereof |
| CN113398101B (en) * | 2021-07-30 | 2022-06-28 | 温州医科大学附属眼视光医院 | Compound lidocaine gel patch |
| CN113907952A (en) * | 2021-08-31 | 2022-01-11 | 长沙海润生物技术有限公司 | Non-stick dressing and preparation method thereof |
| AU2021463815A1 (en) * | 2021-09-09 | 2024-02-01 | Andros Pharmaceuticals Co., Ltd. | Topical anesthetic agent-clay composite compositions |
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