CN104173377B - Method for producing calamine pastes - Google Patents
Method for producing calamine pastes Download PDFInfo
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- CN104173377B CN104173377B CN201410448202.2A CN201410448202A CN104173377B CN 104173377 B CN104173377 B CN 104173377B CN 201410448202 A CN201410448202 A CN 201410448202A CN 104173377 B CN104173377 B CN 104173377B
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- calamina
- impalpable powder
- calamine
- zinc oxide
- combination
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Abstract
The invention discloses a method for producing calamine pastes. The method for producing calamine pastes comprises the steps of (1) sterilizing calamine fine powder, zinc oxide fine powder and paste matrix; (2) mixing; (3) mixing with a bacteriostatic agent; and (4) filling to obtain finished products. The calamine pastes produced according to the method have the advantage of good homogeneity, and calamine pastes of different performances are obtained by adjusting the components and proportions of polyethylene glycol in the paste matrix.
Description
Technical field
The present invention relates to a kind of production method of Calamina unguentum, be specially a kind of production method of calamine Ointment, especially a kind of production method containing the calamine Ointment of thymol or resorcinol, belongs to medical manufacture field.
Background technology
Calamina is carbonate mineral calcite race smithsonite, main containing zinc carbonate.After excavating, clean, dry, except roguing stone.This product character is block aggregation, in irregular bulk, and canescence or pale red.Surface mealiness, matt, uneven, porous, like cellular.Body is light, frangible.Odorless, taste is micro-puckery.Function cures mainly: removing toxic substances improving acuity of vision and removing nebula, the antipruritic sore of removing dampness.For conjunctival congestion and swelling pain, marginal blepharitis, nebula film bulbar conjunctiva polyp, ulcer being unable to heal, pus is dripping, eczema, skin pruritus.
The modal dosage form of Calamina is lotion, be through calcining, grinding to form fine powder by the Calamina of natural recovery, or fly to obtain Calamina impalpable powder through water again, be equipped with glycerol grinding and be mixed with suspendible lotion in stirring to open with water after paste dress, Calamine Lotion has long clinical practice, in treatment skin pruritus, ulcer, redness etc., have good effect.
But Calamine Lotion has takes inconvenience, not easily preserves, and stability of suspension is not good, and medicated powder is difficult to the defect staying affected part.
In prior art, the research about Calamina novel form mainly concentrates on semi-solid preparation, makes emulsifiable paste, ointment or gel by Calamina.
(the Zhu Changhui such as Zhu Changhui, Deng, the preparation of Calamina dimethicone emulsifiable paste and assay, Liaoning University of TCM's journal, 2008, 10(4), 139-140) propose Calamina dimethicone emulsifiable paste and preparation method thereof, its prescription Calamina 100g, polysorbate 80 10g, dimethicone 180g, polyoxyethylene (15) base alkyl Pilus Caprae seu Ovis alcohol ether 15g, liquid paraffin 90g, glycerol 150g, octadecanol 110g, ethyl hydroxybenzoate 1g, purified water adds to 1000g, concrete preparation method is: by polysorbate 80, polyoxyethylene 15 base alkyl Pilus Caprae seu Ovis alcohol ether, glycerol, ethyl hydroxybenzoate, purified water is heated to 85 DEG C as aqueous phase, be incubated for subsequent use, dimethicone, octadecanol, liquid paraffin heat fused, as oil phase, are incubated for subsequent use, oil phase is added in aqueous phase, stirring and emulsifying, Calamina water flies, and adds in emulsion, stirs with mulser, is cooled to cream and get final product.
Chinese patent CN 102397292A proposes a kind of preparation method of Calamina emulsifiable paste, be specially: prescription is Calamina 18%-20%, white vaseline 16%, stearic acid 4%, monoglyceride 5%, ethyl hydroxybenzoate solution 1%, Tween 80 2%, peregal A-20 1%, glycerol 11%, triethanolamine 2%, distilled water 38%-40%, method is: 1. primary response device be three can the rustless steel container of agitating heating, Calamina grinds powder, send in the first rustless steel container, add glycerol and stir as pastel.2. white vaseline, stearic acid, monoglyceride are sent into the second rustless steel container, be heated to about 80 DEG C, make mixture reach molten condition, stir.] 3. Tween 80, peregal A-20, triethanolamine, distilled water are sent into the 3rd rustless steel container, be heated to about 80 DEG C, stir after dissolving, now add ethyl hydroxybenzoate solution and maintain the temperature at about 80 DEG C, stirring.4. the material in the second rustless steel container is added slowly in the 3rd rustless steel container, limit edged stirs, and when temperature is reduced to 60 DEG C, is also added by the first rustless steel container pastel in the 3rd rustless steel container, continue to be stirred to condensation, after sterilization, namely packaging obtains Calamina emulsifiable paste finished product.
But prior art exists some defects for the preparation of Calamina unguentum, Calamina unguentum is caused still to be difficult to the status of alternative Calamine Lotion.Calamine stone and oxide powder and zinc cannot be uniformly dispersed in the paste substrate of fine and close thickness, thus have impact on drug effect.
Summary of the invention
The object of the invention is to, provide a kind of production method of Calamina unguentum, solve the defect that existing Calamina unguentum production method exists, namely calamine stone and oxide powder and zinc are difficult to finely dispersed problem in paste substrate.
Further, in the production method of Calamina unguentum of the present invention, also use a kind of ointment base combination with variable performance, the calamine Ointment of different application scope can be made by described substrate combination.
For realizing this goal of the invention, applicant proposed following technical scheme, comprising step: 1) by Calamina impalpable powder, zinc oxide impalpable powder, paste substrate sterilizing separately; 2) mix; 3) mix with antibacterial again; 4) fill obtains finished product;
The prescription of described Calamina unguentum is by weight:
Calamina impalpable powder 50-150 part,
Zinc oxide impalpable powder 50-100 part,
Antibacterial 0.01-5 part,
Single glycerol distearate 50-60 part
Mixed fatty glycerides 20-80 part
Sodium lauryl sulphate 20-60 part
Oleum Arachidis hypogaeae semen 20-50 part
Liquid Macrogol-650 parts
Water is appropriate, makes total amount to 1000 parts;
Described Calamina impalpable powder is flown through water by pharmaceutical grade calamine stone, cross No. 8 medicine sieves obtains;
Described zinc oxide impalpable powder is flown through calcining, water by pharmaceutical grade zinc oxide, crosses No. 8 medicine sieves and obtains;
Described antibacterial comprises one or more the combination in resorcinol, thymol, methyl hydroxybenzoate, ethyl hydroxybenzoate, propyl hydroxybenzoate, butyl hydroxybenzoate, Benzalkonii Chloridum, benzalkonium bromide, sorbic acid.
Further, described paste substrate is mixed by aqueous phase and oil phase and forms, aqueous phase is the combination of Polyethylene Glycol and sodium lauryl sulphate, oil phase is the combination of single glycerol distearate, mixed fatty glycerides and Oleum Arachidis hypogaeae semen, described Polyethylene Glycol is one or more the combination of molecular weight from 200 to 4000, uses this substrate will obtain Calamina emulsifiable paste.
Concrete, the preparation of Calamina emulsifiable paste can according to following scheme implementation:
1) by Calamina impalpable powder, zinc oxide impalpable powder, paste substrate sterilizing separately;
2) drop in container by single glycerol distearate of recipe quantity, mixed fatty glycerides, heating makes fusing, and keep the Oleum Arachidis hypogaeae semen adding recipe quantity under stirring, insulated and stirred obtains oil phase, for subsequent use; By the Polyethylene Glycol of recipe quantity, heat fused, adds sodium lauryl sulphate, in 70 DEG C of insulated and stirred 30min, under agitation drops into Calamina impalpable powder and the zinc oxide impalpable powder of recipe quantity, stirs and be mixed to get aqueous phase; Afterwards oil phase is dropped in the aqueous phase under stirring, fully stirring, mixing, emulsifying, insulation;
3) mix with antibacterial again;
4) fill obtains finished product.
Because calamine stone and oxide powder and zinc are oil, water-insoluble, it cannot be uniformly dispersed by conventional ointment production method in paste substrate.In the present invention, first common calamine stone and oxide powder and zinc are changed into impalpable powder by applicant, it is made to possess homodisperse possibility, recycling Polyethylene Glycol series is substrate, adopt oil phase and the emulsifying agent of special ratios, Calamina impalpable powder and zinc oxide impalpable powder can be adsorbed by oil droplets, thus can be dispersed in polyethylene glycol medium.
In this scheme, Polyethylene Glycol can be molecular weight from 200 to 4000 any one or multiple combination, all can obtain Calamina emulsifiable paste of good performance.Applicant finds through repetition test, and the requirement according to the different applications to calamine Ointment can be selected the kind of Polyethylene Glycol and consumption.Low molecular poly accounts for proportion is larger, and the paste substrate hydrophilic obtained is better.The Polyethylene Glycol of high molecular accounts for proportion is larger, and the paste substrate lipophile obtained is better.By the performance regulating the ratio of Polyethylene Glycol can change the Calamina emulsifiable paste that the present invention obtains, thus the symptom of reply different situations.
Such as:
1. w(PEG400): w(Macrogol 4000)=1:3-4, be applicable to make and can stick with paste on wound, play the calamine Ointment of certain iris action;
2. w(Macrogol 200): w(cetomacrogol 1000): w(Macrogol 2000)=4-6:1-2:1, be applicable to make the calamine Ointment with certain absorption wound seepage function.
On the basis of such scheme, a preferred scheme is, antibacterial selects one in thymol, resorcinol or combination.Adding of resorcinol or thymol, effectively can kill the surviving microorganisms in ointment, the invasion of microorganism can also be suppressed simultaneously after ointment Kaifeng, also play the disinfective action to wound in addition, the best results when thymol and resorcinol consumption mass ratio are 1:2-3.The fragrant odour of resorcinol and thymol, effectively can improve the medication compliance of patient.
In this programme, to the method for calcinating of pharmaceutical grade zinc oxide, can be that commercially available pharmaceutical grade zinc oxide is sent into Muffle furnace, in 350 DEG C of preheating 30min, be warming up to 1025 DEG C of calcinings 2.5h, afterwards furnace cooling with the time of 30min afterwards.
The conventional maneuver that described " water flies " is Chinese medicine processing, those skilled in the art can describe from any one the knowledge obtaining this part the textbook of the science of Chinese drug processing.
Beneficial effect of the present invention is:
1. use the solution of the present invention that calamine stone and oxide powder and zinc can be made to be dispersed in unguentum medium uniformly, the raising of uniformity is conducive to the performance of drug effect, also makes ointment good looking appearance.
2. Polyethylene Glycol series is introduced ointment base, considerably increase the flexibility ratio of preparation, the unguentum of different applications can be derived.
Detailed description of the invention
Further illustrate the present invention program below by way of several embodiment, it should be noted that following examples not any type of further restriction to the present invention program.
Embodiment 1
The prescription of Calamina unguentum is by weight:
Calamina impalpable powder 50g,
Zinc oxide impalpable powder 50g,
Ethyl hydroxybenzoate 0.01g,
Single glycerol distearate 45g;
Mixed fatty glycerides 40g;
Sodium lauryl sulphate 30g
Oleum Arachidis hypogaeae semen 50g;
Macrogol 200 400g;
Cetomacrogol 1000 200g;
Macrogol 2000 100g;
Add water 1000g.
Operating procedure is:
1) in jerrycan, spread into 50g Calamina impalpable powder out 0.5-1cm left and right thickness with 50g zinc oxide impalpable powder, at 150 DEG C, sterilizing 4h, for subsequent use;
Get each component of paste substrate sterilizing 4h at 150 DEG C for subsequent use;
2) drop in container by mono-for 45g glycerol distearate, 200g mixed fatty glycerides, heating makes fusing, and add 50g Oleum Arachidis hypogaeae semen under keeping stirring in 85 DEG C, insulated and stirred obtains oil phase, for subsequent use; By Macrogol 200 400g, cetomacrogol 1000 100g, Macrogol 2000 100g mix, heat fused, then add sodium lauryl sulphate 30g, in 70 DEG C of insulated and stirred 30min, under agitation drop into Calamina impalpable powder and zinc oxide impalpable powder, stir and be mixed to get aqueous phase; Afterwards oil phase dropped in the aqueous phase under stirring, fully stir, mix, emulsifying, insulation;
3) ethyl hydroxybenzoate 0.01g is dropped into above-mentioned emulsion, supply weight to 1000g with water while stirring, be fully uniformly mixed;
4) fill becomes 50, obtains finished product.
Embodiment 2
The prescription of Calamina unguentum is by weight:
Calamina impalpable powder 150g;
Zinc oxide impalpable powder 50g;
Resorcinol 5g;
Single glycerol distearate 40g;
Mixed fatty glycerides 30g;
Sodium lauryl sulphate 55g;
Oleum Arachidis hypogaeae semen 30g;
Macrogol 600 340g;
Macrogol 4000 460g;
Add water 1000g.
Except prescription difference, preparation method is with embodiment 1.
Embodiment 3
The prescription of Calamina unguentum is by weight:
Calamina impalpable powder 100g;
Zinc oxide impalpable powder 100g;
Thymol 0.5g;
Resorcinol 1.5g;
Single glycerol distearate 60g;
Mixed fatty glycerides 80g;
Sodium lauryl sulphate 60g;
Oleum Arachidis hypogaeae semen 25g;
Macrogol 200 300g
Cetomacrogol 1000 100g;
Macrogol 2000 50g;
Add water 1000g.
Except prescription difference, preparation method is with embodiment 1.
Embodiment 4
The prescription of Calamina unguentum is by weight:
Calamina impalpable powder 100g;
Zinc oxide impalpable powder 100g;
Benzalkonii Chloridum 0.02g;
Single glycerol distearate 55g;
Mixed fatty glycerides 65g;
Sodium lauryl sulphate 35g;
Oleum Arachidis hypogaeae semen 25g;
PEG400 150g;
Macrogol 4000 600g;
Add water 1000g.
Except prescription difference, preparation method is with embodiment 1.
Embodiment 5
The prescription of Calamina unguentum is by weight:
Calamina impalpable powder 100g;
Zinc oxide impalpable powder 50g;
Thymol 0.5g;
Single glycerol distearate 55g;
Mixed fatty glycerides 70g;
Sodium lauryl sulphate 25g;
Oleum Arachidis hypogaeae semen 25g;
PEG400 200g;
Macrogol 4000 600g;
Add water 1000g.
Except prescription difference, preparation method is with embodiment 1.
Comparative example 1
Implement to obtain Calamina emulsifiable paste finished product according to the method that CN 102397292A embodiment 1 is contained.
Comparative example 2
Calamina dimethicone emulsifiable paste finished product is prepared according to " preparation of Calamina dimethicone emulsifiable paste and assay " contained preparation method;
Embodiment 6 powder body disperses homogeneity inspection in substrate
Each 3 of Example 1-5, fill finished product, often props up and longitudinally cuts open, afterwards the horizontal quartering, is divided into top, middle and upper part, middle and lower part, 4 pieces, bottom mastic, accurately weighs.Add water respectively and make stromatolysis, add moderate amount of sulfuric acid just to dissolve to Calamina and Zinc oxide powder, add the oily components in q. s. methylene chloride extraction substrate, use separatory funnel separatory, collect combining water layer, with ammonia-ammonium chloride for buffer (pH=10), the disodiumedetate of 0.05mol/L is volumetric solution, and C.I. 14645. is that indicator titration becomes pure blue to solution from aubergine and is terminal.Calculate zinc (in ZnO) content in each sample, be listed as follows:
Can clearly find out from the test result of the present embodiment, the calamine Ointment using the embodiment 1-5 of the present invention program to obtain has extraordinary dispersion homogeneity.
Claims (3)
1. a production method for Calamina unguentum, comprises step: 1) by Calamina impalpable powder, zinc oxide impalpable powder, paste substrate sterilizing separately; 2) mix; 3) mix with antibacterial again; 4) fill obtains finished product, it is characterized in that, the prescription of described Calamina unguentum is by weight:
Described Calamina impalpable powder is flown through water by pharmaceutical grade calamine stone, cross No. 8 medicines sieve, dry heat sterilization after obtain; Described zinc oxide impalpable powder is flown through calcining, water by pharmaceutical grade zinc oxide, crosses No. 8 medicine sieves, obtains after dry heat sterilization;
Described antibacterial is selected from one or more the combination in resorcinol, thymol, methyl hydroxybenzoate, ethyl hydroxybenzoate, propyl hydroxybenzoate, butyl hydroxybenzoate, Benzalkonii Chloridum, benzalkonium bromide, sorbic acid;
Described paste substrate is mixed by aqueous phase and oil phase and forms, aqueous phase is the combination of Polyethylene Glycol and sodium lauryl sulphate, oil phase is the combination of single glycerol distearate, mixed fatty glycerides and Oleum Arachidis hypogaeae semen, described Polyethylene Glycol is one or more the combination of molecular weight from 200 to 4000, uses this substrate will obtain Calamina emulsifiable paste;
Described step 2) mixing, it is characterized in that, first the Calamina impalpable powder of recipe quantity and zinc oxide impalpable powder are dispersed in aqueous phase, again oil phase are poured in aqueous phase under stirring.
2. method according to claim 1, is characterized in that, described antibacterial is the combination of thymol and resorcinol, and mass ratio is 1:2-3.
3. a calamine Ointment, is characterized in that being prepared by the method described in claim 1-2 any one.
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| CN201410448202.2A CN104173377B (en) | 2014-09-04 | 2014-09-04 | Method for producing calamine pastes |
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| CN201410448202.2A CN104173377B (en) | 2014-09-04 | 2014-09-04 | Method for producing calamine pastes |
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| CN104173377B true CN104173377B (en) | 2015-07-01 |
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Effective date of registration: 20190107 Address after: 410331 No. 167 Kangping Road, Liuyang Economic and Technological Development Zone, Changsha City, Hunan Province Patentee after: Hunan Er-Kang Pharmaceutical Co., Ltd. Address before: 410331 Hunan Erkangxiang Pharmaceutical Co., Ltd., Changsha National Biological Industrial Base, Changsha City, Hunan Province Patentee before: HUNAN ERKANG XIANGYAO PHARMACEUTICAL CO., LTD. |