CN1695642A - Compound gel of goldenlarch bark preparation method - Google Patents

Compound gel of goldenlarch bark preparation method Download PDF

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Publication number
CN1695642A
CN1695642A CN 200410014912 CN200410014912A CN1695642A CN 1695642 A CN1695642 A CN 1695642A CN 200410014912 CN200410014912 CN 200410014912 CN 200410014912 A CN200410014912 A CN 200410014912A CN 1695642 A CN1695642 A CN 1695642A
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cortex pseudolaricis
gel
ethanol
propylene glycol
tincture
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童玉新
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Abstract

A compound golden larch bark gel is prepared from golden larch bark tincture, benzoic acid salicylic acid, carbomer, ethanol, propanediol, glycerine and polyethanediol 400 through sequential mixing and sterilizing.

Description

Compound recipe Cortex Pseudolaricis gel and preparation method thereof
Technical field
The present invention relates to a kind of gel preparation, exactly is a kind of compound recipe Cortex Pseudolaricis gel and preparation technology thereof.
Background technology
Tinea manus and pedis is a commonly encountered diseases in the dermatosis, frequently-occurring disease accounts for Dermatology Clinic case about 5%~20%, and the medicine for the treatment of tinea diseases such as the tinea manuum, tinea pedis, tinea corporis at present is a lot,, Compound Flavescent Sophora and Salicylic Acid Powders once clean as beri-beri powder, tinea pedis etc. mostly are powder, water preparation or tincture.Water preparation needs the long-time affected part of soaking; Powder loses easily and needs sometimes to transfer and applies, so the patient uses inconvenience; The tincture poor stability, big to the zest of skin, the patient uses uncomfortable, is difficult to accept, and transports, carries inconvenience simultaneously.
Summary of the invention
The objective of the invention is by bioadhesion technology and percutaneous dosing technology, provide a kind of drug loading big, energy long period and site of action tight adhesion, good biocompatibility, help the absorption of medicine, little to skin irritation, good stability, transportation, easy to carry has horny layer softening and the compound recipe Cortex Pseudolaricis gel that suppresses epidermis mycete, fungus and itching-relieving action.
A kind of compound recipe Cortex Pseudolaricis gel is characterized in that its ingredient is that Cortex Pseudolaricis extracts extractum, salicylic acid, benzoic acid, and gel-type vehicle is a carbomer, also contains solvent, wetting agent.
Described compound recipe Cortex Pseudolaricis gel is characterized in that it is the ethanol extraction extractum of 10% Cortex Pseudolaricis tincture that Cortex Pseudolaricis extracts extractum, and wherein principal agent salicylic acid and benzoic acid also have the antiseptical function, solvent is an ethanol, propylene glycol, or propylene glycol, ethanol, PEG400, wetting agent is a glycerol.
Described compound recipe Cortex Pseudolaricis gel is characterized in that the composition by weight of each material medicine is:
10% Cortex Pseudolaricis tincture 400~500
Benzoic acid 80~200
Salicylic acid 30~90 carbomers 40~50
Propylene glycol 350~500 ethanol 150~350
Glycerol 20~40.
Described compound recipe Cortex Pseudolaricis gel is characterized in that the composition by weight of each material medicine is:
10% Cortex Pseudolaricis tincture 400~500
Benzoic acid 80~200
Salicylic acid 30~90 carbomers 40~50
Propylene glycol 150~250 ethanol 150~350
Glycerol 20~40 PEG400s 220~240.
Described compound recipe Cortex Pseudolaricis gel is characterized in that the composition by weight of each material medicine is:
10% Cortex Pseudolaricis tincture 440 (being used as medicine after being condensed into extractum)
Benzoic acid 131.9
Salicylic acid 65.9 carbomers 45
Propylene glycol 200 ethanol 300
Glycerol 30 PEG400s 230.
The preparation method of described compound recipe Cortex Pseudolaricis gel is characterized in that:
(1) percolation extracts Cortex Pseudolaricis, gets the Cortex Pseudolaricis tincture coarse powder with 80% soak with ethanol 48 hours, and percolation speed is 3ml/min.kg, and percolate is 10% Cortex Pseudolaricis tincture, again Cortex Pseudolaricis tincture is reclaimed ethanol, is concentrated into relative density and is 1.25~1.30 extractum;
(2) take by weighing carbomer, add Polyethylene Glycol 400 or propylene glycol and stir, make carbomer gel;
(3), add Cortex Pseudolaricis extractum, benzoic acid, salicylic acid successively and stir, with the carbomer gel mixing with ethanol, mixed with propylene glycol;
(4) add glycerol and stir evenly, get product.
The Cortex Pseudolaricis main chemical compositions is native chaste tree formic acid, native chaste tree acetic acid, native chaste tree propanoic acid etc. for the diterpene acids comprises, triterpenes comprises the acid of golden larch furan, betulic acid, native chaste tree glycosides, β-paddy steroid acid etc.Salicylic acid is a 2 hydroxybenzoic acid, is white trickle acicular crystal or white crystalline powder, odorless or odorless almost, and it is little sweet to distinguish the flavor of, and aqueous solution shows acid reaction, and is easily molten in ethanol or ether, dissolves slightly soluble in chloroform, slightly soluble in water in boiling water.Benzoic acid is white scale or acicular crystal or the crystalline powder that mercerising is arranged, light weight, odorless or little smelly; Little in hot-air have a volatility, and aqueous solution shows acid reaction, and is easily molten in ethanol, chloroform or ether, dissolves slightly soluble in water in boiling water.
The present invention, carries out percolation and extracts as solvent with 80% ethanol, when percolation speed is 3ml/min.kg, and the solid content height, comparatively suitable.Select carbomer as gel-type vehicle, simultaneously, reduce the ethanol content in the gel in the preparation as far as possible, make it to obtain stabilizing gel, and drug loading is big, energy long period and site of action tight adhesion, good biocompatibility, help medicine and pass through Transdermal absorption, little to skin irritation, transportation, easy to carry has horny layer softening and suppresses epidermis mycete, fungus and itching-relieving action, be used for dermatosis good effects such as the tinea manuum, tinea pedis and tinea corporis, the patient uses comfortable.
The preparations shaping Journal of Sex Research
1, choice of base: select carbomer as gel-type vehicle, carbomer is as water-soluable gel substrate commonly used, prepares easy to use, and cheap and easy to get.
2, the selection of solvent system: salicylic acid, benzoic acid slightly soluble and be soluble in ethanol in water, Cortex Pseudolaricis extractum all can dissolve in ethanol and propylene glycol, by of the comparison of different solvents system, be solvent system so select ethanol-propylene glycol-PEG400 to shaping influence.Glycerol plays moisture-keeping function in gel, consumption adds 3% routinely.
3, the optimization of pharmaceutical formulation: the orthogonal design scheme by three factors, three levels is carried out trial test, at first the carbomer consumption is carried out trial test, find that consumption is all right in the molding of 4-5%, the gained gel consistency is moderate, thereby the carbomer consumption is decided to be 4%, 4.5%, 5%.The consumption of ethanol and propylene glycol determines that by solubility test each medicine and other adjuvant of organizing solvent adds (the carbomer consumption is 4.5%) by above-mentioned basic recipe;
Skin irritation test
24 of healthy white rabbit, body weight 2.1~2.4kg, male and female half and half, female unpregnancy are selected in experiment for use.Each rabbit experiment antedorsal spinal column both sides depilation, the about 70cm of every side 2, wherein 12 in depilation district rub with emery paper to skin transudate is arranged till, cause the local skin breakage.After 24 hours, be divided into two and organize (damaged skin group and intact skin group) greatly: damaged skin and intact skin all are divided into two groups again then: wherein 6 rabbit are in coated side, depilation district, the left side of rabbit Cortex Pseudolaricis gel 5g in the damaged skin group, and depilation district in right side is coated with gel vehicle 5g and compares; 6 rabbit are in depilation district, the left side of rabbit coated side Cortex Pseudolaricis tincture 2ml in addition, and depilation district in right side is coated with gel vehicle 5g and compares, and cover again with immobilization with adhesive tape with the nonirritant gauze outward.6 rabbit are in coated side, depilation district, the left side of rabbit Cortex Pseudolaricis gel 5g in the intact skin group, and depilation district in right side is coated with gel vehicle 5g and compares; 6 rabbit are in depilation district, the left side of rabbit coated side Cortex Pseudolaricis tincture 2ml in addition, and depilation district in right side is coated with gel vehicle 5g and compares, and cover again with immobilization with adhesive tape with the nonirritant gauze outward.24 hours flush away medicines after the administration are pressed with method and dosage again and are continued administration, and continuous 7 days.Back 24 hours flush away medicines after the last administration, and after removing medicine, observed administration both sides skin conditions in 30-60 minute, 24 hours, 48 hours, compound recipe Cortex Pseudolaricis gel and vehicle group are to intact skin and damaged skin as a result, and the compound recipe Cortex Pseudolaricis tincture does not all have obvious irritation to intact skin; And compound recipe Cortex Pseudolaricis tincture has tangible irritant reaction to damaged skin, mainly shows as: animal pain after the administration and scream, agitation, successive administration is after 7 days, the administration local skin is rough, and erythema and edema are arranged.
Allergic experiment
24 of healthy albino guinea-pigs, body weight 250~300g, male and female half and half, female unpregnancy are selected in experiment for use.Be divided into 3 groups at random by body weight and sex, first group is compound recipe Cortex Pseudolaricis gel group, and second group is the gel vehicle group, the 3rd group of positive matched group (give positive sensitization medicine, promptly 2,4-dinitrochlorobenzene).Each is organized Cavia porcellus and tests preceding 24 hours all in the depilation of guinea pig back both sides, the about 3 * 3cm of the every side of unhairing district scope.
Sensitization contact: get compound recipe Cortex Pseudolaricis gel 1.0g and be coated in depilation district, Cavia porcellus left side, cover, continue 6 hours with non-stimulated immobilization with adhesive tape again with one deck oilpaper and two layers of gauze.Every animal sub-cage rearing.The next day once, amount to three times.The blank group is applied with excipient, positive controls with 1% 2,4-dinitrochlorobenzene 0.2ml sensitization, method is the same.
Excite contact: after last sensitization 14 days, 0.1g was applied to depilation district, guinea pig back right side with compound recipe Cortex Pseudolaricis gel, positive control with 0.1%2,4-dinitrochlorobenzene 0.2ml.Remove after 6 hours and tried thing, observe at once, observed the skin allergy situation then in 24,48,72 hours once more.
The result shows: compound recipe Cortex Pseudolaricis gel and gel vehicle treated animal, observe 72 hours after removing medicine always, anaphylaxis all do not occur, two groups of sensitization rates are 0%, and the sensitization rate of positive controls (2,4 dinitrochlorobenzene) is 80% (model success).So the external of compound recipe Cortex Pseudolaricis gel does not have irritated reaction to skin.
Acute toxicity testing
Get 60 of healthy guinea pigs, body weight 180~210g, male and female half and half, female unpregnancy.Under every Mus waking state, lose hair or feathers (3 * 8cm) respectively in the both sides, back, form the depilation district, be divided into three groups (excipient matched group and compound recipe Cortex Pseudolaricis gel high and low dose groups) then, and till to the part sepage being arranged with silicon carbide paper friction in depilation district, every group of right side (formation damaged skin), then in both sides depilation district externally coated compound Cortex Pseudolaricis gel 5g/kg (concentration is respectively 1.21g and 0.242g crude drug/g gel) and gel vehicle 5g/kg, cover with one deck oilpaper and two layers of gauze, continue 4 hours with non-stimulated immobilization with adhesive tape again.The topical dressings person of coming off, administration again.Gave once totally three times every 4 hours.The last administration was removed binder after 24 hours, cleaned local left drug with warm saline, observed the response situation of Cavia porcellus at once, observed continuously 7 days.Should observe the color and the activity that nonirritant and animal are arranged, hair color, defecation, appetite etc. of each guinea pig skin every day, and record there are non-toxic reaction and dead animal number.Routine is raised with condition.Result: observed continuously 7 days, and do not find tangible whole body toxicity, also do not have animal dead.Experimental result shows: compound recipe Cortex Pseudolaricis gel is given Cavia porcellus intact skin and damaged skin external maximum concentration (clinical people's consumption 5 times) maximum dosage-feeding (totally three times), observes a week, does not find tangible whole body toxicity, does not also have animal dead.
The preparations shaping Journal of Sex Research that the present invention carries out, the skin irritation test, allergic experiment and acute toxicity testing prove gel preparation determined curative effect of the present invention, and zest is little, and good stability has no side effect.
Usage and consumption: external, be applied to the affected part, 1~2 time on the one, medication continued for 1~2 week.
The specific embodiment
Embodiment 1
Raw material weight component of the present invention is
10% Cortex Pseudolaricis tincture 400ml benzoic acid, 80 grams
Salicylic acid 30 gram carbomers 40 grams
Propylene glycol 150 gram ethanol 150 grams
Glycerol 20 gram PEG400s 220 grams
The method of preparation is:
(1) the chaste tree skin that fetches earth is ground into coarse powder, with the percolation under the tincture item, do solvent impregnated 48 hours with 80% ethanol after, percolation slowly, percolation speed is 3ml/min.kg, collects percolate, obtain 10% Cortex Pseudolaricis tincture, reclaim ethanol, be concentrated into relative density and be 1.25~1.30 extractum;
(2) take by weighing carbomer by above-mentioned weight, add Polyethylene Glycol 400 and stir, make carbomer gel;
(3) with ethanol, mixed with propylene glycol, add above-mentioned Cortex Pseudolaricis extractum, benzoic acid, salicylic acid successively and stir, admixing medical solutions;
(4) above-mentioned admixing medical solutions and the carbomer gel behind flowing steam sterilization are merged mixing, add glycerol again and stir evenly, make semi-finished product, after sterilize, inspect by random samples back mechanization fill.
Embodiment 2
Raw material weight component of the present invention is
10% Cortex Pseudolaricis tincture 500ml benzoic acid, 200 grams
Salicylic acid 90 gram carbomers 50 grams
Propylene glycol 250 gram ethanol 350 grams
Glycerol 40 gram PEG400s 240 grams
The method of preparation is:
(1) the chaste tree skin that fetches earth is ground into coarse powder, with tincture item percolation down, do solvent impregnated 48 hours with 80% ethanol after, percolation slowly, the collection percolate obtains 10% Cortex Pseudolaricis tincture, recovery ethanol is concentrated into relative density and is 1.25~1.30 extractum;
(2) take by weighing carbomer by above-mentioned weight, add Polyethylene Glycol 400 and stir, make carbomer gel;
(3) with ethanol, mixed with propylene glycol, add above-mentioned Cortex Pseudolaricis extractum, benzoic acid, salicylic acid successively and stir, admixing medical solutions;
(4) above-mentioned admixing medical solutions and the carbomer gel behind flowing steam sterilization are merged mixing, add glycerol again and stir evenly, make semi-finished product, after sterilize, inspect by random samples back mechanization fill.
Embodiment 3
Raw material weight component of the present invention is
10% Cortex Pseudolaricis tincture 440ml benzoic acid, 131.9 grams
Salicylic acid 65.9 gram carbomers 45 grams
Propylene glycol 200 gram ethanol 300 grams
Glycerol 30 gram PEG400s 230 grams
The method of preparation is:
(1) the chaste tree skin that fetches earth is ground into coarse powder, with tincture item percolation down, do solvent impregnated 48 hours with 80% ethanol after, percolation slowly, the collection percolate, recovery ethanol is concentrated into relative density and is 1.25~1.30 extractum;
(2) take by weighing carbomer by above-mentioned weight, add Polyethylene Glycol 400 and stir, make carbomer gel;
(3) with ethanol, mixed with propylene glycol, add above-mentioned Cortex Pseudolaricis extractum, benzoic acid, salicylic acid successively and stir, admixing medical solutions;
(4) above-mentioned admixing medical solutions and the carbomer gel behind flowing steam sterilization are merged mixing, add glycerol again and stir evenly, make semi-finished product, after sterilize, inspect by random samples back mechanization fill.
Embodiment 4
Raw material weight component of the present invention is
10% Cortex Pseudolaricis tincture 400ml benzoic acid, 80 grams
Salicylic acid 30 gram carbomers 40 grams
Propylene glycol 370 gram ethanol 150 grams
Glycerol 20 grams
The method of preparation is:
(1) the chaste tree skin that fetches earth is ground into coarse powder, with the percolation under the tincture item, do solvent impregnated 48 hours with 80% ethanol after, percolation slowly, percolation speed is 3ml/min.kg, collects percolate, obtain 10% Cortex Pseudolaricis tincture, reclaim ethanol, be concentrated into relative density and be 1.25~1.30 extractum;
(2) take by weighing carbomer by above-mentioned weight, add an amount of propylene glycol and stir, make carbomer gel;
(3) with the mixed with propylene glycol of ethanol, surplus, add above-mentioned Cortex Pseudolaricis extractum, benzoic acid, salicylic acid successively and stir, admixing medical solutions;
(4) above-mentioned admixing medical solutions and the carbomer gel behind flowing steam sterilization are merged mixing, add glycerol again and stir evenly, make semi-finished product, after sterilize, inspect by random samples back mechanization fill.

Claims (6)

1, a kind of compound recipe Cortex Pseudolaricis gel is characterized in that its ingredient extracts extractum, salicylic acid, benzoic acid by Cortex Pseudolaricis and form, and gel-type vehicle is a carbomer, also contains solvent, wetting agent.
2, compound recipe Cortex Pseudolaricis gel according to claim 1 is characterized in that Cortex Pseudolaricis extractum is that 10% Cortex Pseudolaricis tincture reclaims gained behind the ethanol, and its solvent is propylene glycol, ethanol, or propylene glycol, ethanol, PEG400, and wetting agent is a glycerol.
3, compound recipe Cortex Pseudolaricis gel according to claim 2 is characterized in that the composition by weight of each material medicine is:
10% Cortex Pseudolaricis tincture 400~500
Benzoic acid 80~200
Salicylic acid 30~90 carbomers 40~50
Propylene glycol 350~500 ethanol 150~350
Glycerol 20~40.
4, compound recipe Cortex Pseudolaricis gel according to claim 2 is characterized in that the composition by weight of each material medicine is:
10% Cortex Pseudolaricis tincture 400~500
Benzoic acid 80~200
Salicylic acid 30~90 carbomers 40~50
Propylene glycol 150~250 ethanol 150~350
Glycerol 20~40 PEG400s 220~240.
5, compound recipe Cortex Pseudolaricis gel according to claim 2 is characterized in that the composition by weight of each material medicine is:
10% Cortex Pseudolaricis tincture 440 (being used as medicine after being condensed into extractum)
Benzoic acid 131.9
Salicylic acid 65.9 carbomers 45
Propylene glycol 200 ethanol 300
Glycerol 30 PEG400s 230.
6, according to the preparation method of the described compound recipe Cortex Pseudolaricis of one of claim 2 to 5 gel, it is characterized in that:
(1) percolation extracts Cortex Pseudolaricis, gets the Cortex Pseudolaricis coarse powder with 80%7 alcohol immersions 48 hours, and percolation speed is 3ml/min.kg, and percolate is 10% Cortex Pseudolaricis tincture, again Cortex Pseudolaricis tincture is reclaimed ethanol, is concentrated into relative density and is 1.25~1.30 extractum;
(2) take by weighing carbomer, add Polyethylene Glycol 400 or propylene glycol and stir, make carbomer gel;
(3), add Cortex Pseudolaricis extractum, benzoic acid, salicylic acid successively and stir, with the carbomer gel mixing with ethanol, mixed with propylene glycol;
(4) add glycerol and stir evenly, get product.
CN 200410014912 2004-05-13 2004-05-13 Compound gel of goldenlarch bark preparation method Pending CN1695642A (en)

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101396431B (en) * 2007-09-30 2012-02-22 童玉新 Bitongning gel and its preparing method
CN102441030A (en) * 2010-10-09 2012-05-09 安徽科创中药天然药物研究所有限责任公司 Compound medicine for treating fungus infection diseases, its preparation method and quality control technology
CN103494891A (en) * 2013-09-24 2014-01-08 韦成旺 Traditional Chinese medicine composition for treating dermatoses and preparation method thereof
CN104546954A (en) * 2014-12-04 2015-04-29 余秀民 Compound cortex pseudolaricis cool and refreshing ointment
CN105920103A (en) * 2016-06-23 2016-09-07 施建有 External spray for treating dermatophytosis and preparation method thereof
CN107441127A (en) * 2017-09-01 2017-12-08 骆凌翔 The compound effacement emulsion of suppression oxygen orientation medicine transdermal chronic disease one again
CN107789374A (en) * 2017-10-27 2018-03-13 李创华 A kind of extracting method of corter pseudolaricis active material
CN111821349A (en) * 2020-07-14 2020-10-27 郑州维谊生物科技有限公司 Foot skin antibacterial liquid and preparation method thereof
CN111991431A (en) * 2020-08-26 2020-11-27 陈广生 A liniment for treating alopecia areata and its preparation method

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101396431B (en) * 2007-09-30 2012-02-22 童玉新 Bitongning gel and its preparing method
CN102441030A (en) * 2010-10-09 2012-05-09 安徽科创中药天然药物研究所有限责任公司 Compound medicine for treating fungus infection diseases, its preparation method and quality control technology
CN103494891A (en) * 2013-09-24 2014-01-08 韦成旺 Traditional Chinese medicine composition for treating dermatoses and preparation method thereof
CN103494891B (en) * 2013-09-24 2016-01-20 韦成旺 One treats dermopathic Chinese medicine composition and preparation method thereof
CN104546954A (en) * 2014-12-04 2015-04-29 余秀民 Compound cortex pseudolaricis cool and refreshing ointment
CN105920103A (en) * 2016-06-23 2016-09-07 施建有 External spray for treating dermatophytosis and preparation method thereof
CN107441127A (en) * 2017-09-01 2017-12-08 骆凌翔 The compound effacement emulsion of suppression oxygen orientation medicine transdermal chronic disease one again
CN107789374A (en) * 2017-10-27 2018-03-13 李创华 A kind of extracting method of corter pseudolaricis active material
CN111821349A (en) * 2020-07-14 2020-10-27 郑州维谊生物科技有限公司 Foot skin antibacterial liquid and preparation method thereof
CN111991431A (en) * 2020-08-26 2020-11-27 陈广生 A liniment for treating alopecia areata and its preparation method

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