CN105535519A - Preparation method of compound rhizoma corydalis film coating agent for local pain relieving - Google Patents

Preparation method of compound rhizoma corydalis film coating agent for local pain relieving Download PDF

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CN105535519A
CN105535519A CN201610094113.1A CN201610094113A CN105535519A CN 105535519 A CN105535519 A CN 105535519A CN 201610094113 A CN201610094113 A CN 201610094113A CN 105535519 A CN105535519 A CN 105535519A
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liniment
rhizoma corydalis
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filmogen
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穆滨
郑东友
吴琳华
杨波
何林
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HARBIN KANGLONG PHARMACEUTICAL CO Ltd
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Abstract

The invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a preparation method of a compound rhizoma corydalis film coating agent for local pain relieving. The preparation method comprises the following steps of 1 raw material medicine processing, 2 supercritical carbon dioxide extracting and 3 film coating agent preparing. The compound rhizoma corydalis film coating agent for local pain relieving is prepared from the following raw material medicines and pharmaceutically acceptable auxiliary materials, wherein the raw material medicines comprise, by weight, 1-10 parts of rhizoma corydalis, 1-10 parts of trogopterus dung and 1-30 parts of common bletilla tubers, and the pharmaceutically acceptable auxiliary materials comprise, by weight, 2-20 parts of a film forming material, 3-18 parts of volatile organic solvent and 2-8 parts of a plasticizer. According to the preparation method of the compound rhizoma corydalis film coating agent for local pain relieving, the dissolution efficiency of the effective constituents is high, and destruction to the effective constituents is little; the prepared film coating agent is short in film forming time, does not has the skin irritation, has the anti-inflammatory action and has the better treatment effect on diseases such as rheumatism ostealgia prone to relapse.

Description

A kind of preparation method of local analgesia compound recipe Rhizoma Corydalis liniment
Technical field
The invention belongs to technical field of traditional Chinese medicine preparation, be specifically related to a kind of preparation method of local analgesia compound recipe Rhizoma Corydalis liniment.
Background technology
Rhizoma Corydalis is the dry tuber of papaveraceae plant corydalis, pain relieving common medicine, and forefathers praise highly as " specially controlling upper and lower all pains all over the body ".Rhizoma Corydalis acrid in the mouth, hardship, warm in nature; Return liver, spleen channel; Have invigorate blood circulation, circulation of qi promoting, pain relieving effect.No matter have a headache, breast stomachache, hypochondriac pain, menstrual pain, arthralgia, traumatic injury pain, all genus coagulation of QI-blood cause, and belong to pure pain character, all can apply, speed of producing effects and property is not dry strong, good analgesic effect.Clinically morely be used for the treatment of gynecological's dysmenorrhoea, join Radix Angelicae Sinensis, the Radix Paeoniae Alba (or Radix Paeoniae Rubra), as the essential drugs of the various dysmenorrhoea for the treatment of, then with disease compatibility.Containing 15 kinds of alkaloids in Rhizoma Corydalis, so far as is known, wherein more important is tetrahydropalmatine, Chou prime and A prime.But at present oral medicine aspect is mainly rested on to the utilization of Rhizoma Corydalis.
Liniment is one of exterior-applied formulation of percutaneous dosing.It is contacted with local skin by medicine, and through horny layer, diffuse transmission skin, is then entered a kind of administering mode of human circulation by capillary absorbance.As a kind of medicine for external use, liniment has plurality of advantages: (1) due to its using skin as administration channel, medicine can go directly affected part and avoid the impact of liver and gastrointestinal " first pass effect ", utilization ratio of drug is high, the infringement to stomach, liver can be reduced, avoid the degraded of oral medicine in gastrointestinal and inactivation simultaneously; (2) can medicine be inputted in body speed on demand, maintain constant effective blood drug concentration, avoid the blood drug level peak valley phenomenon that oral administration etc. causes, reduce toxicity; (3) easy to use, can interruption of the administration at any time; (4) preparation technology is simple, and material of need not mounting, do not need special machine equipment, production cost is low.
Report in prior art in the preparation of liniment is more.Such as, Chinese patent application " mulation for analgesia smearing agent and preparation technology thereof " (application number: CN99112620.3A) discloses a kind of Pigmentum agent, utilizes concentration to be that the ethanol extraction of 70-95% obtains by components such as Radix aconiti szechenyiani, Rhizoma Corydalis, Oletum Trogopterori, Borneolum Syntheticum and Moschus.This liniment has strong and lasting anti-inflammatory analgesic effect.Chinese patent " a kind of reducing swelling and alleviating pain liniment and preparation method thereof " (Authorization Notice No.: CN1315521C) disclose a kind of by the Radix Aucklandiae, Radix Saposhnikoviae, Herba Schizonepetae, Herba Asari, Cortex Acanthopancis, Ramulus Cinnamomi, Radix Achyranthis Bidentatae, Rhizoma Chuanxiong, Radix Cynanchi Paniculati, the Radix Angelicae Dahuricae, Rhizoma Curcumae, Radix seu Caulis Parabarii, DALUOSAN, Camphora, Mentholum 20 simply crude drug ethanol percolation obtain extract, then mix with suitable liniment adjuvant and the liniment made.Chinese patent " a kind of liniment for the treatment of burn and scald and preparation method thereof " (Authorization Notice No.: CN101869668B) disclosed liniment is then Radix Et Rhizoma Rhei, Cortex Phellodendri, the Pseudobulbus Bletillae (Rhizoma Bletillae), decocting cooking method obtains after the Radix Angelicae Dahuricae and Radix Sanguisorbae mixing extract with by supercritical CO 2extraction extracts the Herba Lysimachiae foenum-graeci quintessence oil obtained, and liniment adjuvant mixes.This liniment has good stability, absorbs rapid-action, bioavailability advantages of higher, can be used for reducing swelling and alleviating pain, osteopatia sprain, the symptoms such as rheumatic ostalgia.
But the liniment occurred clinically at present, problems such as always there is unsatisfactory shortcoming: the poor water resistance of film, mechanical strength and toughness deficiency cause film easily to chap, film formation time is long causes therapeutic effect not good enough.
Summary of the invention
In order to enrich Rhizoma Corydalis dosage form, solve the problems such as poor water resistance, mechanical strength and toughness that in prior art, liniment exists are not enough, film formation time is long, an object of the present invention is to provide a kind of local analgesia compound recipe Rhizoma Corydalis liniment.
Another object of the present invention is to provide the method preparing above-mentioned local analgesia compound recipe Rhizoma Corydalis liniment.
In order to realize foregoing invention object, a technical scheme of the present invention provides a kind of local analgesia compound recipe Rhizoma Corydalis liniment, by weight, it is made up of following crude drug and pharmaceutically acceptable adjuvant: wherein, described crude drug comprises Rhizoma Corydalis 1-10 part, Oletum Trogopterori 1-10 part, Pseudobulbus Bletillae (Rhizoma Bletillae) 1-30 part; Described pharmaceutically acceptable accessory package contains filmogen 2-20 part, volatile organic solvent 3-18 part, plasticizer 2-8 part.
Preferably, described filmogen is PVAC polyvinylalcohol or its modified structure, with one or more in polyvinyl formal-acetal, polyvinyl alcohol contracting first butyraldehyde, carbomer, vinylpyrrolidone, acrylic resin, sodium carboxymethyl cellulose, collodion, chitin, chitosan or derivatives thereof, alginate, ethyl cellulose, Bletilla glucomannan and zein, wherein, PVAC polyvinylalcohol is one or more in PVA0588, PVA1788 and PVA124; The modified structure of described PVAC polyvinylalcohol carries out structurally-modified by this area routine techniques means to polyvinyl alcohol, such as, to the etherification modified structure of PVAC polyvinylalcohol, preferably, utilizes epoxychloropropane to carry out etherification modified to polyvinyl alcohol.
Further preferably, described filmogen is the combination of PVAC polyvinylalcohol or its modified structure and polyvinyl formal-acetal or polyvinyl alcohol contracting first butyraldehyde, such as, is the combination of PVA124 and polyvinyl formal-acetal.
Still more preferably, in described filmogen, the weight ratio of PVAC polyvinylalcohol or its modified structure and polyvinyl formal-acetal or polyvinyl alcohol contracting first butyraldehyde is 1:(0.1-0.7).
In technique scheme of the present invention, the volatile organic solvent in described liniment plays the effect of dissolved substance and filmogen.Described volatile organic solvent is one or more in dehydrated alcohol, acetone, ethyl acetate, ether and absolute methanol.
Preferably, the volatile organic solvent in liniment provided by the invention is dehydrated alcohol or ether.
In technique scheme of the present invention, the plasticizer in described liniment, for improving the toughness of film, can avoid the pharmaceutical film breach because the External Force Actings such as motion cause and even the situation that therapeutic process is interrupted that comes off.Described plasticizer is one or more in glycerol, propylene glycol, diethyl phthalate, dibutyl phthalate, glyceryl triacetate, sorbitol and mannitol.
Preferably, the plasticizer in liniment provided by the invention is one or more in glycerol, propylene glycol and mannitol.
Preferably, local analgesia compound recipe Rhizoma Corydalis liniment of the present invention, by weight, it is made up of following crude drug and pharmaceutically acceptable adjuvant: wherein, and described crude drug comprises Rhizoma Corydalis 1-4 part, Oletum Trogopterori 1-4 part, Pseudobulbus Bletillae (Rhizoma Bletillae) 1-7 part; Described pharmaceutically acceptable accessory package contains filmogen 3-13 part, volatile organic solvent 5-15 part, plasticizer 2-6 part.
Another technical scheme of the present invention provides a kind of preparation method of above-mentioned local analgesia compound recipe Rhizoma Corydalis liniment, and the method comprises the steps:
1) process of preparing Chinese medicine of crude drug:
1. the Rhizoma Corydalis of formulation weight part is taken, take solid-to-liquid ratio as 1:(3-8) ratio to be placed in by ethanol water, acetic acid aqueous solution and gallic acid with weight ratio be 1:(0.5-5): the mixed liquor that the ratio of (0.01-0.03) forms, supersound process 5-9h under 30-55 DEG C of condition, drain rear drying, pulverize, cross 10-50 mesh sieve, obtain fumitory coarse powder;
2. the Oletum Trogopterori of formulation weight part is taken, take solid-to-liquid ratio as 1:(3-8) ratio to be placed in by ethanol water, acetic acid aqueous solution and triethylamine with weight ratio be 1:(0.5-5): the mixed liquor that the ratio of (0.01-0.03) forms, supersound process 5-9h under 30-55 DEG C of condition, drain rear drying, pulverize, cross 10-50 mesh sieve, obtain Oletum Trogopterori coarse powder
Wherein the volumetric concentration of ethanol water is 75-95%, and the volumetric concentration of acetic acid aqueous solution is 40-60%;
2) carbon dioxide supercritical fluid extraction
1. take the Pseudobulbus Bletillae (Rhizoma Bletillae) of formulation weight part, dry, pulverize, cross 10-50 mesh sieve, obtain Pseudobulbus Bletillae (Rhizoma Bletillae) coarse powder;
2. by described Rhizoma Corydalis, Oletum Trogopterori and Pseudobulbus Bletillae (Rhizoma Bletillae) coarse powder are placed in extraction kettle, Co 2 supercritical fluid is inputted in extraction kettle, be 8-16MPa in extracting pressure, extraction temperature is 32-50 DEG C, the flow velocity of carbon dioxide is extract under 10-30kg/h condition, supercritical extract 1 and supercritical extraction regenerant 1 is obtained after extraction 1-3h, wherein, entrainer 1 is methanol: acetone: strong aqua ammonia take weight ratio as 1:(0.1-0.5): the mixture of the ratio composition of (0.01-0.05), entrainer 1 and Rhizoma Corydalis, the weight ratio of Oletum Trogopterori and Pseudobulbus Bletillae (Rhizoma Bletillae) coarse powder mixture is 1:(20-100),
3. by supercritical extraction regenerant 1 extracting pressure be 16-35MPa, extraction temperature is 32-50 DEG C, the flow velocity of carbon dioxide carries out secondary supercritical extraction under being 10-30kg/h condition, supercritical extract 2 is obtained after extraction 3-5h, wherein, entrainer 2 is ethanol: normal hexane: ethyl acetate: acetic acid=1:(0.1-0.5): (1-5): the mixture of (0.1-0.5), entrainer 2 is 1:(20-100 with the weight ratio of supercritical extraction regenerant 1);
4. supercritical extract 1 and 2 is mixed, obtain supercritical extract;
3) preparation of liniment
1. the filmogen of formulation weight part, volatile organic solvent and plasticizer is taken;
2. in described supercritical extract, add volatile organic solvent and the filmogen aqueous solution of formulation weight part, be heated to dissolve completely, more at room temperature add the plasticizer of formulation weight part, dilute standardize solution with pure water.
Preferably, described filmogen can be the combination of PVA124 and polyvinyl formal-acetal, in this case, the compound method of described filmogen aqueous solution is: PVA124 and polyvinyl formal-acetal are placed in the swelling 10-14h of pure water at 25-45 DEG C, is then (2-20) with pure water with solid-to-liquid ratio: (50-60) is heated to dissolve completely at 80-95 DEG C after mixing.
Described filmogen for other combine time, adopt similar method to dissolve.
Preferably, drying mode of the present invention is the one in hot blast vacuum drying, microwave drying and belt vacuum drying, and more preferably belt vacuum is dry, and wherein baking temperature is 50-70 DEG C, and vacuum is 10-25MPa.
Wherein, Oletum Trogopterori be vertebrate, Mammalia, Rodentia, flying squirrel section, trogopterus xanthipes Milne-Edwards and belong to the dry feces of animal together.Oletum Trogopterori sweet in the mouth, warm in nature.Modern pharmacological research shows, main containing compositions such as retinoid material, catechol, benzoic acid, goreishic acid, uracil, m-hydroxybenzoic acid, protocatechuic acid, hypoxanthine, allantoin in Oletum Trogopterori, it is a kind of well drug for invigorating blood circulation and eliminating stasis, there is promoting blood circulation to remove blood stasis, the effect of parch to black hemostasis.Clinical be mainly used in treatment trusted subordinate congestion pain, dysmenorrhea, blood stasis amenorrhea, puerperal abdominalgia with blood stasis; External can treat traumatic injury, Serpentis, insect bite wound.Zoopery confirms, it also has the effect alleviating smooth muscle spasm more significantly; Inhibitory action in various degree is all had in addition to tubercule bacillus and various skin fungus.Record in Compendium of Material Medica: " Oletum Trogopterori, also, abnormal smells from the patient is all thick, the yin aspect of yin for liver channel of foot-Jueyin medicine.Therefore enter blood system.The main blood of liver, therefore can disorders of blood be controlled, loose blood and blood and only all pains.”
The Pseudobulbus Bletillae (Rhizoma Bletillae) has another name called Pseudobulbus Bletillae (Rhizoma Bletillae), for the dry tuber of the orchid family Pseudobulbus Bletillae (Rhizoma Bletillae) platymiscium Pseudobulbus Bletillae (Rhizoma Bletillae), main containing Bletilla glucomannan, Anthraquinones, bibenzyl, luxuriant and rich with fragrance class, join luxuriant and rich with fragrance class, join luxuriant and rich with fragrance ethers, the material such as phenanthro-pyran, bibenzyl glucose glycoside (militarine), Bletilla glucomannan has certain vicidity, plays certain auxiliary filming function.Pseudobulbus Bletillae (Rhizoma Bletillae) bitter in the mouth, sweet, puckery, cold nature, returns lung, liver, stomach warp, has good astringing to arrest bleeding, effect of detumescence and promoting granulation.According to preliminary observation, its hemostasis principle, for making hemagglutination, forms artificial thrombosis, can be used for the haematemesis for the treatment of hemoptysis, traumatic hemorrhage, sore swollen toxin, chapped skin etc.Along with the research of modern pharmacology deepens continuously, find that it has obvious inhibitory action to tubercule bacillus, tumor cell etc.
Concoct, refer to be that raw material is prepared in the process of medicine the clean system, cutting or the big gun that carry out and processed process, to reach taste masking, to reduce the objects such as toxicity, medicament curative effect enhancement, the stripping of enhancing effective ingredient with Chinese herbal medicine.
To the process of preparing Chinese medicine of Rhizoma Corydalis, adopt processed with vinegar more, vinegar boils and steaming with vinegar.Experimental result shows, in the Rhizoma Corydalis extract after processed with vinegar, the content of total alkaloids raises.In concocting process, in ethanol (wine), acetic acid (vinegar) simultaneous situation, (structure is trihydroxybenzoic acid to add a small amount of gallic acid, there is the character of phenol and carboxylic acid, clinical research shows that it has antibacterial, antivirus action), be aided with supersound process, be more conducive to the stripping of effective ingredient.
To the process of preparing Chinese medicine of Oletum Trogopterori, the vinegar wine that adopts is processed more.Oletum Trogopterori extract after the process of preparing Chinese medicine reaches the object of taste masking, and can strengthen the effect of promoting blood circulation and stopping pain.In concocting process, in ethanol (wine), acetic acid (vinegar) simultaneous situation, add a small amount of organic base-triethylamine, effectively can promote the stripping of active component, and triethylamine boiling point low (89 DEG C), is easy to removing.
PVAC polyvinylalcohol is a kind of conventional filmogen, due to the polyhydroxy group in molecule, it has good water solublity, but also make the liniment good hygroscopicity that obtains and poor water resistance simultaneously, if adopt on its basis and be mixed into membrane material, while the filming performance ensureing liniment, the resistance to water of corresponding liniment can also be improved.
Local analgesia compound recipe Rhizoma Corydalis liniment provided by the invention has good mechanical property, and not easy fracture, ensure that drug effect effectively, and compared with prior art (comparative example 2), film formation time is short; And not there is skin irritation, there is antiinflammatory action, for easy recurrent disease, as rheumatic ostalgia has good therapeutic effect.
The preparation method of local analgesia compound recipe Rhizoma Corydalis liniment provided by the invention, first crude drug Rhizoma Corydalis and Oletum Trogopterori are concocted, in concocting process, add organic acid (gallic acid), alkali (triethylamine), the dissolution efficiency of effective ingredient is high; Adopt the supercritical extraction that extraction efficiency is high, without the need to high temperature, little to the destruction of effective ingredient; In addition, utilize the mixed solvent with opposed polarity to make entrainer, can farthest extract the material with opposed polarity.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is further elaborated.These embodiments are only for purpose of explanation, and do not limit the scope of the invention and essence.
Embodiment 1
A kind of local analgesia compound recipe Rhizoma Corydalis liniment, by weight, it is made up of following crude drug and pharmaceutically acceptable adjuvant: wherein, and described crude drug comprises Rhizoma Corydalis 4 parts, Oletum Trogopterori 4 parts, the Pseudobulbus Bletillae (Rhizoma Bletillae) 7 parts; Described pharmaceutically acceptable accessory package contains the combination (weight ratio is 1:0.1) 13 parts of PVA124 and polyvinyl formal-acetal, dehydrated alcohol 18 parts, glycerol 8 parts.
Prepare the method for above-mentioned liniment, it is as follows that the method comprising the steps of:
1) process of preparing Chinese medicine of crude drug:
1. the Rhizoma Corydalis of formulation weight part is taken, take solid-to-liquid ratio as the mixed liquor that the ratio of the 1:3 ratio that to be placed in by ethanol water, acetic acid aqueous solution and gallic acid take weight ratio as 1:0.5:0.01 forms, supersound process 6h under 30 DEG C of conditions, drain rear belt vacuum dry, wherein baking temperature is 55 DEG C, and vacuum is 10MPa, pulverizes, cross 10 mesh sieves, obtain fumitory coarse powder;
2. the Oletum Trogopterori of formulation weight part is taken, take solid-to-liquid ratio as the mixed liquor that the ratio of the 1:3 ratio that to be placed in by ethanol water, acetic acid aqueous solution and triethylamine take weight ratio as 1:0.5:0.01 forms, supersound process 6h under 55 DEG C of conditions, drain final vacuum hot air drying, wherein baking temperature is 60 DEG C, and vacuum is 10MPa, pulverize, cross 10 mesh sieves, obtain Oletum Trogopterori coarse powder
Wherein the volumetric concentration of ethanol water is 95%, and the volumetric concentration of acetic acid aqueous solution is 40%, and triethylamine is for analyzing alcohol;
2) carbon dioxide supercritical fluid extraction
1. take the Pseudobulbus Bletillae (Rhizoma Bletillae) of formulation weight part, vacuum hot-air dry, wherein baking temperature is 70 DEG C, and vacuum is 25MPa, pulverizes, and crosses 10 mesh sieves, obtains Pseudobulbus Bletillae (Rhizoma Bletillae) coarse powder;
2. described Rhizoma Corydalis, Oletum Trogopterori and Pseudobulbus Bletillae (Rhizoma Bletillae) coarse powder are placed in extraction kettle, Co 2 supercritical fluid is inputted in extraction kettle, extracting pressure be 8MPa, extraction temperature is 33 DEG C, the flow velocity of carbon dioxide extracts under being 12kg/h condition, supercritical extract 1 and supercritical extraction regenerant 1 is obtained after extraction 3h, wherein, entrainer 1 is methanol: acetone: strong aqua ammonia take weight ratio as the mixture of 1:0.1:0.05, and entrainer 1 is 1:20 with the weight ratio of Rhizoma Corydalis, Oletum Trogopterori and Pseudobulbus Bletillae (Rhizoma Bletillae) coarse powder mixture;
3. by supercritical extraction regenerant 1 extracting pressure be 35MPa, extraction temperature is 50 DEG C, the flow velocity of carbon dioxide carries out secondary supercritical extraction under being 30kg/h condition, supercritical extract 2 is obtained after extraction 5h, wherein, entrainer 2 is ethanol: normal hexane: ethyl acetate: the mixture of acetic acid=1:0.1:5:0.5, and entrainer 2 is 1:20 with the weight ratio of supercritical extraction regenerant 1;
4. supercritical extract 1 and 2 is mixed, obtain supercritical extract;
3) preparation of liniment
1. PVA124 and polyvinyl formal-acetal, dehydrated alcohol and the glycerol of formulation weight part is taken;
2. in above-mentioned supercritical extract, add dehydrated alcohol and PVA124 and polyvinyl formal-acetal aqueous solution, be heated to dissolve completely, more at room temperature add glycerol, be diluted to 100mL standardize solution with pure water.
Embodiment 2
A kind of local analgesia compound recipe Rhizoma Corydalis liniment, by weight, it is made up of following crude drug and pharmaceutically acceptable adjuvant: wherein, and described crude drug comprises Rhizoma Corydalis 10 parts, Oletum Trogopterori 1 part, the Pseudobulbus Bletillae (Rhizoma Bletillae) 7 parts; Described pharmaceutically acceptable accessory package contains epoxychloropropane modified PVA124 and zein (weight ratio is 4:1) 10 parts, dehydrated alcohol 10 parts, propylene glycol 5 parts,
Wherein, the process conditions of epoxychloropropane modified PVA124 are: solvent is dimethyl sulfoxide, etherifying agent is epoxychloropropane, the mol ratio of epoxychloropropane and polyvinyl alcohol is 1.5:1.0, and etherification temperature is 65 DEG C, and the response time is 6h, specifically can refer to " polyvinyl alcohol etherification modified and analysis of Influential Factors " (Kang Yong etc., " Shanghai Plastic ", the 4th phase in 2015, P45-48).
Prepare the method for above-mentioned liniment, it is as follows that the method comprising the steps of:
1) process of preparing Chinese medicine of crude drug:
1. the Rhizoma Corydalis of formulation weight part is taken, take solid-to-liquid ratio as the mixed liquor that the ratio of the 1:8 ratio that to be placed in by ethanol water, acetic acid aqueous solution and gallic acid take weight ratio as 1:5:0.03 forms, supersound process 9h under 55 DEG C of conditions, 70 DEG C of dryings after draining, pulverize, cross 50 mesh sieves, obtain fumitory coarse powder;
2. the Oletum Trogopterori of formulation weight part is taken, take solid-to-liquid ratio as the mixed liquor that the ratio of the 1:8 ratio that to be placed in by ethanol water, acetic acid aqueous solution and triethylamine take weight ratio as 1:5:0.03 forms, supersound process 9h under 55 DEG C of conditions, 70 DEG C of dryings after draining, pulverize, cross 50 mesh sieves, obtain Oletum Trogopterori coarse powder
Wherein the volumetric concentration of ethanol water is 75%, and the volumetric concentration of acetic acid aqueous solution is 60%, and the mass concentration of triethylamine is 99%;
2) carbon dioxide supercritical fluid extraction
1. take the Pseudobulbus Bletillae (Rhizoma Bletillae) of formulation weight part, dry, pulverize, cross 50 mesh sieves, obtain Pseudobulbus Bletillae (Rhizoma Bletillae) coarse powder;
2. described Rhizoma Corydalis, Oletum Trogopterori and Pseudobulbus Bletillae (Rhizoma Bletillae) coarse powder are placed in extraction kettle, Co 2 supercritical fluid is inputted in extraction kettle, extracting pressure be 20MPa, extraction temperature is 50 DEG C, the flow velocity of carbon dioxide extracts under being 30kg/h condition, supercritical extract 1 and supercritical extraction regenerant 1 is obtained after extraction 2h, wherein, entrainer 1 is methanol: acetone: strong aqua ammonia take weight ratio as the mixture of 1:0.5:0.05, and entrainer 1 is 1:50 with the weight ratio of Rhizoma Corydalis, Oletum Trogopterori and Pseudobulbus Bletillae (Rhizoma Bletillae) coarse powder mixture;
3. by supercritical extraction regenerant 1 extracting pressure be 35MPa, extraction temperature is 50 DEG C, the flow velocity of carbon dioxide carries out secondary supercritical extraction under being 20kg/h condition, supercritical extract 2 is obtained after extraction 5h, wherein, entrainer 2 is ethanol: normal hexane: ethyl acetate: the mixture of acetic acid=1:0.5:1:0.1, and entrainer 2 is 1:100 with the weight ratio of supercritical extraction regenerant 1; 4. supercritical extract 1 and 2 is mixed, obtain supercritical extract;
3) preparation of liniment
1. etherification modified dose of the PVA124 of above-mentioned formulation weight part, zein, dehydrated alcohol and propylene glycol is taken;
2. in above-mentioned supercritical extract, add dehydrated alcohol and PVA124 etherification modified dose of aqueous solution, be heated to dissolve completely, more at room temperature add propylene glycol, be diluted to 100mL standardize solution with pure water.
Embodiment 3
A kind of local analgesia compound recipe Rhizoma Corydalis liniment, by weight, it is made up of following crude drug and pharmaceutically acceptable adjuvant: wherein, and described crude drug comprises Rhizoma Corydalis 1 part, Oletum Trogopterori 10 parts, the Pseudobulbus Bletillae (Rhizoma Bletillae) 30 parts; Described pharmaceutically acceptable accessory package contains PVA124 and chitin (weight ratio is 5:1) 20 parts, ethyl acetate 5 parts, absolute methanol 13 parts, sorbitol 4 parts, 4 parts, mannitol.
The preparation method of this liniment is with embodiment 1.
Comparative example 1
A kind of local analgesia compound recipe Rhizoma Corydalis liniment, by weight, it is made up of following crude drug and pharmaceutically acceptable adjuvant: wherein, and described crude drug comprises Rhizoma Corydalis 4 parts, Oletum Trogopterori 4 parts, the Pseudobulbus Bletillae (Rhizoma Bletillae) 7 parts; Described pharmaceutically acceptable accessory package contains PVA12413 part, dehydrated alcohol 18 parts, glycerol 8 parts.
The preparation method of this liniment is with embodiment 1.
Comparative example 2
Crude drug prescription:
Radix Aucklandiae 47g, Radix Saposhnikoviae 47g, Herba Schizonepetae 47g, Herba Asari 47g, Cortex Acanthopancis 47g, Ramulus Cinnamomi 47g, Radix Achyranthis Bidentatae 47g, Rhizoma Chuanxiong 47g, Radix Cynanchi Paniculati 47g, Radix Angelicae Dahuricae 70g, Rhizoma Curcumae 47g, Radix seu Caulis Parabarii 70g, DALUOSAN 100g, Radix Ardisiae punctatae 70g, Radix Zanthoxyli 100g, Caulis Fibraureae 95g, Fructus Gardeniae 100g, Rhizoma Sparganii 70g, Lignum Aquilariae Resinatum 32.5g, Camphora 55g, Mentholum 55g
The preparation method of active component: above 20 simply, except Camphora, outside Mentholum, 19 tastes such as all the other Radix Aucklandiae are ground into 20 orders, according to the percolation (Chinese Pharmacopoeia version in 2000 annex I 0) under fluid extract and extractum item, use 53% ethanol as solvent, flood after 28 hours, with the speed of 3mL per minute slowly percolation, collection is filtered liquid 5000g, be evaporated to the extractum that relative density is 1.3 (80 DEG C), get Camphora, Mentholum and above-mentioned extractum mix, obtain active component 180g for subsequent use, by extracted active component 180g, add polyvinyl formal-acetal 20g, limit edged stirs, to all dissolving, add 70% ethanol again to 3500g, obtain product.(concrete with reference to Chinese patent CN1315521C " a kind of reducing swelling and alleviating pain liniment and preparation method thereof " embodiment 1)
Below performance test is carried out to the liniment that embodiment 1-3 and comparative example 1-2 prepares.
The preparation of film: each 2mL of liniment that Example 1-3 and comparative example 1-2 is obtained respectively, is applied to 5 × 10cm 2on glass plate, ambient temperatare is put, and dry formation film also records film formation time.
1.1 hot strength method of testings
Obtained film is cut into strip, carries out stretching experiment, wherein, rate of extension is 8mm/min, and elongation at break computing formula is: ε=△ L b/ L 0* 100%, wherein, ε is film elongation at break, %; Δ L bfor the elongation in gauge length when film ruptures, mm; L 0for film gauge length, mm.
Test result is as shown in table 1 below,
The mechanical property of the liniment of the liniment that table 1 embodiment 1-3 and comparative example 1-2 obtains
As can be seen from Table 1, the elongation at break of the liniment provided by embodiment of the present invention 1-3 is all better than the elongation at break of liniment obtained in comparative example 1 and 2, and wherein, the mechanical property of liniment obtained in embodiment 1 is best, elongation at break is 95%, and fracture strength is 38MPa.
The Evaluation on Appearance Quality of 1.2 liniment
Carry out Evaluation on Appearance Quality to liniment obtained in embodiment 1-3 and comparative example 1-2, comprise film formation time, color and luster, film property, stretchability, pliability, quality, wherein, evaluation criterion is as shown in table 2,
Table 2. liniment appearance character standards of grading
The each 2mL of liniment obtained in extraction embodiment 1-3 respectively, is evenly applied to 5 × 10cm of formed objects respectively 2glass plate on, 37 DEG C of observations, take identical evaluation methodology to mark, evaluation result is as shown in table 3:
As can be seen from Table 3, the film formation time of the liniment provided by embodiment of the present invention 1-3 is all short than comparative example 1 and 2, and pliability and film property are all obviously better than comparative example 1 and 2.
1.3 the test of pesticide effectiveness
1.3.1 skin allergy test
Get Cavia porcellus 30, be divided into 3 groups, often organize 10, shaved off by guinea pig back diamond wool, every side scope medicine 4cm × 2cm, during application, skin of unhairing should without breakage.Respectively with normal saline 2mL/ only (blank group), the obtained liniment 2.0mL/ of embodiment 1 only, and 1%2,4-dinitrochlorobenzene 0.2mL/ only, is applied to district of losing hair or feathers on the left of each treated animal, continues 6h, in the 7th day, 14 days respectively repeat 1 time, within the 28th day, will be coated with unconcerned agent and 1%2,4-dinitrochlorobenzene with same method and be applied to right side and to lose hair or feathers district, tested material is removed after exciting 6h, observe 24,48,72h skin allergy situation.There is not erythema and edema in the animal of blank group and liniment.Result shows, the liniment that the embodiment of the present invention 1 provides to mouse skin without anaphylaxis.
1.3.2 Skin Irritation Test
Intact skin prepares and damaged skin prepares same skin allergy test.Liniment 2mL obtained for embodiment 2 is applied to intact skin and damaged skin rabbit left dorsal depilation district, the coating of depilation district, right side is with the normal saline of area, and often organize 10,24h is administered once, continuous 7 days.The liniment that removing man rabbit back is residual, after observing drug withdrawal there is not erythema and edema in local application position, and result shows, the liniment that the embodiment of the present invention 2 provides is to rabbit no skin irritation.
1.3.3 the inhibitory action of on Carrageenan pedal swelling
Healthy male Wistar rat 50,200-220g, male and female half and half, be divided into 5 groups at random, use respectively outside liniment obtained in 0.9% normal saline (blank group) and embodiment 1,2,3 and comparative example 2 and put administration on the skin, put 6 every day on the skin, put 3 days continuously on the skin, after last administration 30 minutes, cause swollen with 1% carrageenin in rat hindleg subcutaneous injection, every rat 0.2mL, cause the swollen front volume measuring the sufficient sole of the foot with improvement volumetric method, cause swollen rear survey per hour once sufficient sole of the foot volume, continuous 6 times, cause swollen rear rat paw edema result as table 4:
The liniment on Carrageenan that table 4 embodiment 1-3 and comparative example 2 obtain causes the impact of rat paw edema
Experimental result shows, the liniment that embodiment of the present invention 1-3 provides significantly can suppress the rat paw edema rate caused by carrageenin.
1.3.4 to the therapeutic effect of rheumatic ostalgia
Rheumatism, full name is " rheumatism ".It comprises all erosion musculoskeletal systems and involves the comprehensive connective tissue disease of a class of whole body, as strong in joint, muscle, flesh, synovial bursa etc.It mainly with pain, swelling for main manifestations, be " obstinate disease " that be difficult to capture, be called " not dead cancer " by world medical circle.
The present embodiment randomly draws 300 routine rheumatic ostalgia patients, Qi Zhongnan, female half and half, and in age 22-65 year, course of disease 30-50 days, is divided into 5 groups by above-mentioned patient, and blank group, matched group and test group, often organize each 60 people.Wherein, test group: smear the liniment that the embodiment of the present invention 1,2,3 provides respectively; Blank group: smear the normal saline of 0.9%; Matched group: the liniment provided by comparative example 2 is provided.Be each 12g, every day 3 times; Smear medicine one week, in 7 days, 28 days, observe when 56 days and record experimental result,
Efficacy assessment standard: cure, when referring to 7 days, pain disease obviously alleviates or disappears, and without recurrence 56 days time;
Effective, when referring to 7 days, above-mentioned clinical symptoms has alleviating or improving to a certain degree, and has alleviating or improving to a certain degree without above-mentioned clinical symptoms when recurrence or 7 days 56 days time, and recurrence 56 days time;
Invalid, when referring to 7 days, above-mentioned clinical symptoms is without improvement or DeGrain.Statistical result is as shown in table 5.
The liniment that table 5 embodiment 1-3 and comparative example 2 obtain is to the therapeutic effect of rheumatic ostalgia
As can be seen from Table 5, have good therapeutic effect by liniment provided by the invention to rheumatic ostalgia, effective percentage can reach 85%.
Only illustratively, scope of the present invention is not limited thereto above-described embodiment.It is apparent for modifying to one skilled in the art, and the present invention is only by the restriction of claims scope.

Claims (10)

1. a local analgesia compound recipe Rhizoma Corydalis liniment, by weight, it is made up of following crude drug and pharmaceutically acceptable adjuvant: wherein, and described crude drug comprises Rhizoma Corydalis 1-10 part, Oletum Trogopterori 1-10 part, Pseudobulbus Bletillae (Rhizoma Bletillae) 1-30 part; Described pharmaceutically acceptable accessory package contains filmogen 2-20 part, volatile organic solvent 3-18 part, plasticizer 2-8 part.
2. according to the liniment described in claim 1, wherein, described filmogen is PVAC polyvinylalcohol or its modified structure, and one or more in polyvinyl formal-acetal, polyvinyl alcohol contracting first butyraldehyde, carbomer, vinylpyrrolidone, acrylic resin, sodium carboxymethyl cellulose, collodion, chitin, chitosan or derivatives thereof, alginate, ethyl cellulose, Bletilla glucomannan and zein.
3. according to the liniment described in claim 2, wherein, described PVAC polyvinylalcohol is one or more in PVA0588, PVA1788 and PVA124.
4. according to the liniment described in claim 2, wherein, described filmogen is the combination of PVAC polyvinylalcohol or its modified structure and polyvinyl formal-acetal or polyvinyl alcohol contracting first butyraldehyde; Preferably, in filmogen, the weight ratio of PVAC polyvinylalcohol or its modified structure and polyvinyl formal-acetal or polyvinyl alcohol contracting first butyraldehyde is 1:(0.1-0.7).
5. according to the liniment described in claim 1, wherein, described volatile organic solvent is dehydrated alcohol or ether.
6. according to the liniment described in claim 1, wherein, described plasticizer is one or more in glycerol, propylene glycol and mannitol.
7. according to the liniment described in claim 1, by weight, it is made up of following crude drug and pharmaceutically acceptable adjuvant: wherein, and described crude drug comprises Rhizoma Corydalis 1-4 part, Oletum Trogopterori 1-4 part, Pseudobulbus Bletillae (Rhizoma Bletillae) 1-7 part; Described pharmaceutically acceptable accessory package contains filmogen 3-13 part, volatile organic solvent 5-15 part, plasticizer 2-6 part.
8. a preparation method for the liniment according to any one of claim 1-7, the method comprises the steps:
1) process of preparing Chinese medicine of crude drug:
1. the Rhizoma Corydalis of formulation weight part is taken, take solid-to-liquid ratio as 1:(3-8) ratio to be placed in by ethanol water, acetic acid aqueous solution and gallic acid with weight ratio be 1:(0.5-5): the mixed liquor that the ratio of (0.01-0.03) forms, supersound process 5-9h under 30-55 DEG C of condition, drain rear drying, pulverize, cross 10-50 mesh sieve, obtain fumitory coarse powder;
2. the Oletum Trogopterori of formulation weight part is taken, take solid-to-liquid ratio as 1:(3-8) ratio to be placed in by ethanol water, acetic acid aqueous solution and triethylamine with weight ratio be 1:(0.5-5): the mixed liquor that the ratio of (0.01-0.03) forms, supersound process 5-9h under 30-55 DEG C of condition, drain rear drying, pulverize, cross 10-50 mesh sieve, obtain Oletum Trogopterori coarse powder
Wherein the volumetric concentration of ethanol water is 75-95%, and the volumetric concentration of acetic acid aqueous solution is 40-60%;
2) carbon dioxide supercritical fluid extraction
1. take the Pseudobulbus Bletillae (Rhizoma Bletillae) of formulation weight part, dry, pulverize, 10-50 mesh sieve, obtain Pseudobulbus Bletillae (Rhizoma Bletillae) coarse powder;
2. described Rhizoma Corydalis, Oletum Trogopterori and Pseudobulbus Bletillae (Rhizoma Bletillae) coarse powder are placed in extraction kettle, Co 2 supercritical fluid is inputted in extraction kettle, 8-16MPa, extraction temperature be 32-50 DEG C, the flow velocity of carbon dioxide extracts under being 10-30kg/h condition, supercritical extract 1 and supercritical extraction regenerant 1 is obtained after extraction 1-3h, wherein, entrainer 1 is methanol: acetone: strong aqua ammonia take weight ratio as 1:(0.1-0.5): the mixture of (0.01-0.05), entrainer 1 is 1:(20-100 with the weight ratio of Rhizoma Corydalis, Oletum Trogopterori and Pseudobulbus Bletillae (Rhizoma Bletillae) coarse powder mixture);
3. by supercritical extraction regenerant 1 extracting pressure be 16-35MPa, extraction temperature is 32-50 DEG C, the flow velocity of carbon dioxide carries out secondary supercritical extraction under being 10-30kg/h condition, supercritical extract 2 is obtained after extraction 3-5h, wherein, entrainer 2 is ethanol: normal hexane: ethyl acetate: acetic acid=1:(0.1-0.5): (1-5): the mixture of (0.1-0.5), entrainer 2 is 1:(20-100 with the weight ratio of supercritical extraction regenerant 1);
4. supercritical extract 1 and 2 is mixed, obtain supercritical extract;
3) preparation of liniment
1. the filmogen of formulation weight part, volatile organic solvent and plasticizer is taken;
2. in described supercritical extract, add volatile organic solvent and the filmogen aqueous solution of formulation weight part, be heated to dissolve completely, more at room temperature add the plasticizer of formulation weight part, dilute standardize solution with pure water.
9. according to Claim 8 described in preparation method, wherein, described filmogen is the combination of PVA124 and polyvinyl formal-acetal, the compound method of filmogen aqueous solution is: PVA124 and polyvinyl formal-acetal are placed in the swelling 10-14h of pure water at 25-45 DEG C, is then (2-20) with pure water with solid-to-liquid ratio: (50-60) is heated to dissolve completely at 80-95 DEG C after mixing.
10. according to Claim 8 described in preparation method, wherein, described drying mode is the one in hot blast vacuum drying, microwave drying and belt vacuum drying, and more preferably belt vacuum is dry, wherein baking temperature is 50-70 DEG C, and vacuum is 10-25MPa.
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