CN104189004A - Production method of calamine lotion - Google Patents
Production method of calamine lotion Download PDFInfo
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- CN104189004A CN104189004A CN201410448157.0A CN201410448157A CN104189004A CN 104189004 A CN104189004 A CN 104189004A CN 201410448157 A CN201410448157 A CN 201410448157A CN 104189004 A CN104189004 A CN 104189004A
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Abstract
The invention discloses a production method of a calamine lotion. The method comprises the steps of grinding calamine superfine powder and zinc oxide superfine through a wet method and mixing at a mass ratio of 1: (0.3-3), cleaning, preparing liquid, stirring and filling to obtain a finished product. Through the scheme disclosed by the invention, the finished product has advantages that the stability of suspension liquid is good and microorganisms are effectively controlled.
Description
Technical field
The present invention relates to a kind of production method of Calamine Lotion, be specifically related to use calamine stone, zinc oxide to mix through wet grinding, be mixed with the method for Calamine Lotion, belong to medical manufacture field.
Background technology
Calamine Lotion is long conventional medicine for external use of a kind of clinical practice time, has the effect of convergence and protection skin, is applicable to the acute itching skin disease such as urticaria, miliaria.
Calamine Lotion compound method is more, and modal is by Calamina 50g, zinc oxide 150g and glycerol 50ml, adds water appropriate, grinds, then adds water and make into 1000ml, mixes, and obtains.But the Calamine Lotion obtaining by this tradition compound method has the defect that suspendability is poor, stability is not good.
Chinese patent CN 1157183 C provide a kind of scheme that solves Calamine Lotion stability, on the basis of original prescription, add the xanthan gum of 0.01%-5%.This scheme preferably resolves the defect that Calamine Lotion can not be long placed in, stability of suspension is poor that traditional compound method obtains, but the xanthan gum adding is to be fermented through Xanthomonas campestris by saccharide, the outer microbial polysaccharide of born of the same parents producing, is used for adding to the larger potential safety hazard of existence in the external-use lotion that contacts inflammation skin.
Chinese patent CN 102813674A discloses the compound method of another kind of Calamine Lotion, described lotion every 100 milliliters containing 150 grams of Calaminas, 50 grams of zinc oxide, 50 milliliters, 10 grams Mentholums of glycerol and 30 ml gentamicin injection, surplus is purified water.This patented technology declares, above medicine is prescription together, can strengthen antipruritic and antibacterial action, to causing each viroid of itching skin disease to have collaborative the inhibition and killing action, thereby effectively eases the pain, accelerates treatment process.Broad ectrum antibiotic gentamycin add the bacteria breed that can suppress solution, yet, adding of gentamycin makes this Calamine Lotion no longer be suitable for all groups, its by banned for gentamycin anaphylaxis person, simultaneously, gentamycin has ototoxicity to a certain degree, has limited on the contrary the clinical application of Calamine Lotion.
Chinese patent CN 102379897 A also disclose a kind of compound method of Calamine Lotion, it is raw material that described Calamine Lotion be take calamine stone 1.6%, oxide powder and zinc 0.6%, glycerol 5%, Polysorbate 0.01%, bromo geramine 0.01%, distilled water 92.78%, by following steps, obtain finished product: 1, in capacity is the rustless steel container of 500 liters, first add the distilled water that accounts for total amount 75% volume, again temperature is raise, add surfactant Polysorbate, bromo geramine, and then add glycerol, stir.2, with nylon plastic(s) mesh bag dress zinc oxide and calamine stone, gradation washes in above solution, (nylon plastic(s) mesh bag density is 3# screen cloth eye).3, more remaining distilled water is added, stir energetically.4, product is sent into disinfect box sterilization, after sterilization, subpackage obtains finished product.This patented technology is declared, use the Calamine Lotion of this method preparation, exquisite quality, delaminating deposition speed is slow, stores for a long time prevented from caking, during preparation, saves time, Polysorbate and bromo geramine are surfactant, having stronger emulsification, is also effectively external antibacterial, to improving pharmaceutical effectiveness, has played good action.Yet this technology adopts nylon plastic(s) mesh bag as the screen cloth of medicated powder, is difficult to obtain the powder body of exquisite quality, also cannot in suitability for industrialized production, apply simultaneously, promote among a small circle in can only be between hospital preparation; Meanwhile, finished product integral body is sent into disinfect box, also cannot obtain good sterilization effect.
In sum, prior art fail thoroughly to solve that Calamine Lotion suspension stability is poor, microbial limit is controlled difficult problem.
Summary of the invention
The object of the invention is to, solution Calamine Lotion suspension stability is poor, microbial limit is controlled difficult problem.For realizing the object of the invention, applicant has proposed following technical scheme.
First, the invention provides a kind of improved prescription of calamine Lotion, the mass ratio that is specially Calamina impalpable powder and zinc oxide impalpable powder is 1:0.3-3.In addition, also contain the glycerol of 0.8-1.3 times of quality of medicated powder gross mass, and appropriate pure water is mixed with the suspension of 20%-25% total mass concentration.
Further, the suspending agent that described Calamine Lotion also can add the total suspension quality of 2%-5% is to improve performance.
Described suspending agent is selected from one or more in carrageenin, mannitol, Macrogol 200, PEG400, chitosan.
Mechanism research about suspending agent thinks, the mechanism one of suspending agent is the stickiness that has increased disperse medium, thereby reduces the speed of particle sedimentation; The 2nd, carry identical charges with particle, rely on charge repulsion to make microgranule in solvent, keep stable suspersion.Applicant, when suspending agent is studied, unexpected finds that chitosan also has certain suspending effect, especially at chitosan, during with certain proportion mixing coupling, has produced unexpected excellent results with Macrogol 200.This combination is applied to have no in suspending agent report as stabilizing agent.
Secondly, the invention provides a kind of improved Calamine Lotion compound method, comprising:
(1) by commercially available pharmaceutical grade Zinc oxide powder after calcining, water flies to concoct and obtains zinc oxide impalpable powder; Commercially available pharmaceutical grade calamine stone after flying to concoct, water is obtained to Calamina impalpable powder;
(2) by Calamina impalpable powder and the zinc oxide impalpable powder ratio of 1:0.3-3 in mass ratio, add abrasive media, through wet grinding, mixing;
(3) with appropriate abrasive media, clean mixed-powder for several times, filter;
(4) to the mixed-powder after cleaning, add the glycerol of 0.8-1.3 times of quality to carry out premix, then add appropriate aquesterilisa, high-speed stirred 30min is mixed with the suspension of 20%-25% total mass concentration;
(5) suspension obtains finished product through clean fill, sealing.
Further, described wet grinding medium can be the aqueous solution of water, one or more alcohol, alcohol, further, is preferably alcohol, is selected from one or more the combination in ethanol, isopropyl alcohol, propylene glycol; Further, most preferably be isopropyl alcohol: the mixed solution of propylene glycol=1:0.3-1.5 volume ratio.
Further, when described dosing is stirred, also can add the suspending agent of the total suspension quality of 2%-5%; Further, described suspending agent is selected from one or more mixing in carrageenin, mannitol, Macrogol 200, PEG400, chitosan, most preferably is chitosan: Macrogol 200 is with the mixture of 1:2.2-2.5 mass ratio.
Zinc oxide impalpable powder can be obtained by such method: commercially available pharmaceutical grade zinc oxide is placed in Muffle furnace, be warming up to after 550 ℃, in 30min, be warming up to 1050 ℃ and keep 2h, afterwards furnace cooling, take out material, beat that powder, water fly, No. 8 standard medicines of mistake sieve and get final product.
Calamina impalpable powder is to be obtained by such method: commercially available pharmaceutical grade calamine stone water is flown, crosses No. 8 standard medicines and sieve and get final product.
In technique scheme, " water flies " is the conventional means of Chinese medicine processing, and those skilled in the art can arrive and implement at any textbook learning of describing Chinese medicine processing.
Beneficial effect of the present invention is:
1. via technical scheme disclosed by the invention, can prepare the Calamine Lotion that microorganism is qualified, suspension stability is good;
2. in terms of existing technologies, the present invention does not add other antibiotic or extra disinfectant, when guaranteeing fungistatic effect, has reduced application risk;
3. the Calamine Lotion that uses superfine powder configuration to obtain, its powder body is fine and smooth, good hand touch, bioavailability is good, and effect is more remarkable.
The specific embodiment
By several specific embodiments, further illustrate the present invention program below, it should be noted that all non-any type of further restrictions to the present invention program of following any example.
Embodiment 1
Prescription:
Calamina impalpable powder 50g;
Zinc oxide impalpable powder 15g;
Medicinal glycerin 50g.
Calamina impalpable powder 50g and zinc oxide impalpable powder 15g are dropped into mortar, add appropriate aquesterilisa moistening, grind, during note supplementing moisture content, keep powder body moistening, to be ground be thick after, add aquesterilisa and clean, filter.Adding afterwards 50g medicinal glycerin, be uniformly mixed and be thick, add the suspension that appropriate aquesterilisa high-speed stirred 30min is mixed with 20% mass concentration, is finished product.
Embodiment 2
Prescription:
Calamina impalpable powder 50g;
Zinc oxide impalpable powder 150g;
Medicinal glycerin 50g.
Calamina impalpable powder 50g and zinc oxide impalpable powder 150g are dropped into mortar, add appropriate aquesterilisa moistening, grind, during note supplementing moisture content, keep powder body moistening, to be ground be thick after, add aquesterilisa and clean, filter.Adding afterwards 50g medicinal glycerin, be uniformly mixed and be thick, add the suspension that appropriate aquesterilisa high-speed stirred 30min is mixed with 25% mass concentration, is finished product.
Embodiment 3
Prescription:
Calamina impalpable powder 50g;
Zinc oxide impalpable powder 100g;
Medicinal glycerin 50g.
Calamina impalpable powder 50g and zinc oxide impalpable powder 100g are dropped into mortar, add appropriate aquesterilisa moistening, grind, during note supplementing moisture content, keep powder body moistening, to be ground be thick after, add aquesterilisa and clean, filter.Adding afterwards 50g medicinal glycerin, be uniformly mixed and be thick, add the suspension that appropriate aquesterilisa high-speed stirred 30min is mixed with 25% mass concentration, is finished product.
Embodiment 4
Prescription:
Calamina impalpable powder 50kg;
Zinc oxide impalpable powder 100kg;
Medicinal glycerin 50kg.
Calamina impalpable powder 50kg and zinc oxide impalpable powder 100kg are dropped into mortar, add ethanol moistening, grind, during note supplementing ethanol, keep powder body moistening, to be ground be thick after, add ethanol and clean, filter.Adding afterwards 50kg medicinal glycerin, be uniformly mixed and be thick, add the suspension that appropriate aquesterilisa high-speed stirred 30min is mixed with 25% mass concentration, is finished product.
Embodiment 5
Prescription:
Calamina impalpable powder 50g;
Zinc oxide impalpable powder 100g;
Medicinal glycerin 50g.
Calamina impalpable powder 50g and zinc oxide impalpable powder 100g are dropped into mortar, add isopropyl alcohol moistening, grind, during note supplementing isopropyl alcohol, keep powder body moistening, to be ground be thick after, add isopropyl alcohol and clean, filter.Adding afterwards 50g medicinal glycerin, be uniformly mixed and be thick, add the suspension that appropriate aquesterilisa high-speed stirred 30min is mixed with 25% mass concentration, is finished product.
Embodiment 6
Prescription:
Calamina impalpable powder 50g;
Zinc oxide impalpable powder 150g;
Medicinal glycerin 40g.
Calamina impalpable powder 50g and zinc oxide impalpable powder 100g are dropped into mortar, by isopropyl alcohol: propylene glycol volume ratio is that 1:0.3 is configured to abrasive media, add appropriate this abrasive media and make powder body moistening, grind, note to supplement during this time abrasive media, keep powder body moistening, to be ground be thick after, add abrasive media and clean, filter.Adding afterwards 40g medicinal glycerin, be uniformly mixed and be thick, add the suspension that appropriate aquesterilisa high-speed stirred 30min is mixed with 23% mass concentration, is finished product.
Embodiment 7
Prescription:
Calamina impalpable powder 50kg;
Zinc oxide impalpable powder 150kg;
Medicinal glycerin 40kg.
Calamina impalpable powder 50kg and zinc oxide impalpable powder 100kg are dropped into mortar, by isopropyl alcohol: propylene glycol volume ratio is that 1:1.5 is configured to abrasive media, add appropriate this abrasive media and make powder body moistening, grind, note to supplement during this time abrasive media, keep powder body moistening, to be ground be thick after, add abrasive media and clean, filter.Adding afterwards 40kg medicinal glycerin, be uniformly mixed and be thick, add the suspension that appropriate aquesterilisa high-speed stirred 30min is mixed with 23% mass concentration, is finished product.
Embodiment 8
Prescription:
Calamina impalpable powder 50kg;
Zinc oxide impalpable powder 150kg;
Medicinal glycerin 65kg.
Calamina impalpable powder 50kg and zinc oxide impalpable powder 100kg are dropped into mortar, by isopropyl alcohol: propylene glycol volume ratio is that 1:1.1 is configured to abrasive media, add appropriate this abrasive media and make powder body moistening, grind, note to supplement during this time abrasive media, keep powder body moistening, to be ground be thick after, add abrasive media and clean, filter.Adding afterwards 65kg medicinal glycerin, be uniformly mixed and be thick, add the suspension that appropriate aquesterilisa high-speed stirred 30min is mixed with 23% mass concentration, is finished product.
Embodiment 9
While stirring except dosing, also added outside the Macrogol 200 of 2% total suspension quality, all the other are with embodiment 1.
Embodiment 10
While stirring except dosing, also added outside the mannitol of 5% total suspension quality, all the other are with embodiment 2.
Embodiment 11
While stirring except dosing, also added outside the carrageenin of 4.5% total suspension quality, all the other are with embodiment 3.
Embodiment 12
While stirring except dosing, also added outside 5% total suspension quality chitosan, all the other are with embodiment 4.
Embodiment 13
While stirring except dosing, outside the compositions of the chitosan-Macrogol 200 that has also added 2% total suspension quality with the mixing of 1:2.2 mass ratio, all the other are with embodiment 6.
Embodiment 14
While stirring except dosing, outside the compositions of the chitosan-Macrogol 200 that has also added 3.5% total suspension quality with the mixing of 1:2.5 mass ratio, all the other are with embodiment 7.
Embodiment 15
While stirring except dosing, outside the compositions of the chitosan-Macrogol 200 that has also added 3.3% total suspension quality with the mixing of 1:2.23 mass ratio, all the other are with embodiment 8.
Comparative example 1
Described in Chinese patent CN 1157183 C embodiment, implement, obtain finished product.
Comparative example 2
According to implementing described in Chinese patent CN 102379897 A embodiment 1, obtain finished product.
Embodiment 16 suspension sedimentation volumns are than test
Assay method: suspensoid is put in graduated cylinder, mixes, the height of measuring the front suspension of sedimentation is H0, after sedimentation face no longer changes, after survey sedimentation, the height of sedimentation face is Hu.Its sedimentation volumn is F=(Hu/H0) * 100% than F.For suspension, sedimentation volumn is than larger, and suspension is more stable.
By above result, can clearly be found out, the Calamine Lotion obtaining according to technical solution of the present invention, its stability of suspension is more excellent than existing commercially available prod under long-term standing condition, and the scheme of having added suspending agent has obtained better effect under the standing condition of short-term.
Embodiment 17 limit test of microbe
Microbial limit test according to two > > appendix XI J of < < Chinese Pharmacopoeia version in 2010 carries out.Standard regulation, for other local administration preparations, microbial limit is that every 1g, 1ml or 10cm2 must not cross 100cfu, it is that every 1g, 1ml or 10cm2 must not cross 100cfu that yeast and mold is counted limit, and staphylococcus aureus, Pseudomonas aeruginosa limit are that every 1g, 1ml or 10cm2 must not detect.Get embodiment 1 ~ 15, commercially available prod, each 10ml of comparative example's 1 ~ 2 product, check in accordance with the law, result is as follows:
Claims (6)
1. a production method for Calamine Lotion, comprise by Calamina impalpable powder and zinc oxide impalpable powder in mass ratio 1:0.3-3 through wet grinding, mix, cleaning, dosing stirring, fill obtain finished product, it is characterized in that,
To be Zinc oxide powder fly to concoct through calcining, water described zinc oxide impalpable powder obtains,
To be calamine stone fly to concoct through water described Calamina impalpable powder obtains,
The medium that described wet grinding is used is the sterile water solution of aquesterilisa, one or more mixed alkoxide solutions or alcohol,
It is by the medicated powder cleaning up that described dosing is stirred, the glycerol premix that interpolation and medicated powder mass ratio are 1:0.8-1.3, then add appropriate aquesterilisa, high-speed stirred 30min is mixed with the suspension of 20%-25% total mass concentration.
2. method according to claim 1, is characterized in that, the medium that described wet grinding is used is alcohol, is selected from one or more the combination in ethanol, isopropyl alcohol, propylene glycol.
3. method according to claim 2, is characterized in that, the medium that described wet grinding is used for isopropyl alcohol and mixed with propylene glycol liquid, its volume ratio be isopropyl alcohol: propylene glycol=1:0.3-1.5.
4. according to the method described in claim 1-3 any one, it is characterized in that, when described dosing is stirred, also can add the suspending agent of the total suspension quality of 2%-5%.
5. method according to claim 4, is characterized in that, described suspending agent is selected from one or more mixing in carrageenin, mannitol, Macrogol 200, PEG400, chitosan.
6. method according to claim 5, is characterized in that, described suspending agent is chitosan and Macrogol 200, and its mass ratio is 1:2.2-2.5.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410448157.0A CN104189004B (en) | 2014-09-04 | 2014-09-04 | A kind of production method of Calamine Lotion |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410448157.0A CN104189004B (en) | 2014-09-04 | 2014-09-04 | A kind of production method of Calamine Lotion |
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| CN104189004A true CN104189004A (en) | 2014-12-10 |
| CN104189004B CN104189004B (en) | 2016-08-17 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104940137A (en) * | 2015-06-02 | 2015-09-30 | 湖南尔康湘药制药有限公司 | Preparation method of calamine lotion |
| CN106139226A (en) * | 2016-08-30 | 2016-11-23 | 苏州美迪斯医疗运动用品股份有限公司 | A kind of medical sponge and preparation method thereof |
| CN106137978A (en) * | 2016-08-19 | 2016-11-23 | 西藏甘露藏药股份有限公司 | A kind of preparation method of mineral drug powder particles agent |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1337226A (en) * | 2001-09-24 | 2002-02-27 | 中国人民解放军军事医学科学院放射医学研究所林仲武 | Calamine lotion |
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2014
- 2014-09-04 CN CN201410448157.0A patent/CN104189004B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1337226A (en) * | 2001-09-24 | 2002-02-27 | 中国人民解放军军事医学科学院放射医学研究所林仲武 | Calamine lotion |
Non-Patent Citations (2)
| Title |
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| 张亚敏: "水飞法之浅析", 《中医药信息》 * |
| 张玉梅等: "关于改进炉甘石洗剂处方的商榷", 《西北药学杂志》 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104940137A (en) * | 2015-06-02 | 2015-09-30 | 湖南尔康湘药制药有限公司 | Preparation method of calamine lotion |
| CN104940137B (en) * | 2015-06-02 | 2019-03-01 | 湖南尔康制药股份有限公司 | A kind of preparation method of calamine lotion |
| CN106137978A (en) * | 2016-08-19 | 2016-11-23 | 西藏甘露藏药股份有限公司 | A kind of preparation method of mineral drug powder particles agent |
| CN106139226A (en) * | 2016-08-30 | 2016-11-23 | 苏州美迪斯医疗运动用品股份有限公司 | A kind of medical sponge and preparation method thereof |
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| Publication number | Publication date |
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| CN104189004B (en) | 2016-08-17 |
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Effective date of registration: 20181227 Address after: 410331 Liuyang Economic and Technological Development Zone No. 167, 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. |
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