CN104940137B - A kind of preparation method of calamine lotion - Google Patents
A kind of preparation method of calamine lotion Download PDFInfo
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- CN104940137B CN104940137B CN201510293822.8A CN201510293822A CN104940137B CN 104940137 B CN104940137 B CN 104940137B CN 201510293822 A CN201510293822 A CN 201510293822A CN 104940137 B CN104940137 B CN 104940137B
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- calamine
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- zinc oxide
- deflocculant
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Abstract
The present invention provides a kind of preparation methods of calamine lotion, specifically includes the following steps: mixed grinding, cleaning, with liquid stirring, filling finished product, have stability of suspension good using present invention product obtained, it is lasting to suspend, microorganism is effectively controlled, and applies the used time without sand type.
Description
Technical field
The present invention relates to a kind of preparation method of calamine lotion, more particularly to using calamine, zinc oxide it is super
Fine powder stirs the method that calamine suspension is made with liquid, belongs to pharmaceutical manufacturing field through dry grinding.
Background technique
The main ingredient of calamine lotion is calamine, zinc oxide, is a kind of clinical application time longer external preparation for skin
Chemical drugs preparation, pink colour suspension.Have the function of restraining and protecting skin, is suitable for the severe pruritus such as nettle rash, prickly heat
Skin disease.
The preparation of calamine is mainly external-use lotion, is after calamine, zinc oxide are broken into fine powder, to add suitable quantity of water and glycerol
It is tuned into solid suspension, needs to shake up before each use, and takes and is applied to affected part in right amount.The traditional preparation method of calamine lotion be by
Calamine 150g, zinc oxide 50g, glycerol 50ml, and grind with certain purified water, are diluted with water to 1000ml, mix to get
Calamine lotion.But though the calamine lotion that this method is prepared has the advantage that helps himself freely to, due to suspension itself
Intrinsic property, be long placed in rear suspension liquid system can make because of the electrostatic interaction between gravity and powder medicinal powder therein occur to reunite and
Sedimentation, even if being shaken up for several times before use every time, it is also difficult to impalpable powder is uniformly dispersed again, leads to each dosage disunity,
Error is larger.Meanwhile the calamine stone reunited due to particle volume increase so that declined bioavailability of oral administration and influence drug effect.
In addition, the drug of suspending agent state applies the sense of used time grittiness, long after storage the defects of precipitation precipitating, easily agglomeration.
Chinese patent CN 1157183C then discloses the component of calamine lotion, and 0.01%- is added on original prescription
5% xanthan gum.The invention solves the defect that calamine lotion suspension stability is poor, cannot be long placed in, but added xanthan gum
It is a kind of carbohydrate, the complex polysaccharide generated through xanthomonas campestris fermentation is used as easily causing in topical lotion thin
Bacterium infection, there are biggish security risks.
Chinese patent CN102379897A also discloses a kind of preparation method of calamine lotion, which is firstly added always
The distilled water of 75% volume is measured, temperature rises to 40 DEG C, and 0.01% surfactant Polysorbate of total amount and 0.01% new clean that is added
It goes out, 5% glycerol, stirs evenly, then with nylon plastic(s) mesh bag by 1.6% calamine stone, 0.6% oxide powder and zinc is in 500 liters
In rustless steel container, the above solution is washed by several times, then remaining distilled water is added, stirred evenly energetically, product feeding is disappeared
Malicious case disinfection, packing obtains finished product after disinfection.Although the calamine lotion delaminating deposition speed of this method preparation is slower, storage long is not
Easily agglomeration, but the technology uses nylon plastic(s) mesh bag, it is difficult to the powder of quality exquisiteness is obtained, the painting used time can generate sand type,
And it is easy to fall off after drying.
Summary of the invention
To overcome drawbacks described above present in existing calamine lotion, the invention discloses a kind of preparations of calamine lotion
Method, to solve the above problems.
Firstly, in the present invention calamine lotion preparation method, specifically includes the following steps: mixed grinding, cleaning, match liquid
Stirring, filling finished product, it is characterised in that: the calamine and zinc oxide is superfine powder, and mixed grinding is dry using being put into
Method grinding, described matching joined Colloidal microcrystalline cellulose, deflocculant, glycerol, lubricant mixture as mixed in liquid stirring
Outstanding stabilizer, then plus suitable solvent in stirring into suspension in high-speed mixer, being configured to mass concentration is 30% -50%
Suspension.
Further, preparation method of the present invention specifically includes the following steps:
(1) calamine and zinc oxide are prepared into superfine powder through airslide disintegrating mill；
(2) calamine and zinc oxide Ultramicro-powder 3-10:1 in mass ratio are mixed through dry grinding；
(3) it is cleaned repeatedly repeatedly using alcohol-water mixture；
(4) Colloidal microcrystalline cellulose, deflocculant, glycerol, lubricant mixture are added into deionized water and high-speed mixer
It is stirred, prepares the suspension that mass concentration is 30% -50%；
(5) filling to obtain finished product.
Further, calamine and zinc oxide ultra-fine powder of the present invention average diameter≤10 μm.
Further, Colloidal microcrystalline cellulose in the Suspension stabilisers being added with liquid stirring in preparation method of the present invention: anti-
Flocculant: glycerol: lubricant=1:0.2-0.5:0.9-1.2:0.01-0.05.
Further, it cleans required alcohol and is selected from one of ethyl alcohol, glycerine, isopropanol or a variety of mixing.
Further, it is the mixed liquor of isopropanol and glycerine with alcohol selected by liquid, volume ratio is isopropanol: glycerine=
1:3-10。
Further, the deflocculant is selected from one of citrate, tartrate, phosphate or a variety of mixing,
The combination of preferably citric acid salt and tartrate, mass ratio are (1-10): (1-20), the group of preferably citric acid sodium and potassium tartrate
It closes.
Further, the lubricant is selected from one of magnesium stearate, hydrogenated vegetable oil, polyethylene glycol or a variety of mixed
It closes.
Colloidal microcrystalline cellulose is suspending agent in above-mentioned suspension stabilizer, and citrate is deflocculant, glycerol and tristearin
Sour magnesium is lubricant.Colloidal microcrystalline cellulose is since crystallite partial size is small, so each powder is filled with a large amount of crystallite.Containing big
The product for measuring small dispersion can reduce sinking speed, increase the stability of dispersion, eliminate the hard packing of fallout particulate；Citron
Hydrochlorate is deflocculant, in suspension due to be suspended for surface free group presence or adsorbent solution in ion and band
There is the ion of identical charges, while counter ion is distributed in around it.When containing a large amount of solia particles in suspension, often easily agglutination
It is not easy to topple at the paste of stiff, appropriate deflocculant, which is added, can increase its mobility, and citrate is because it has
Good dissolubility and thermal stability are comparatively ideal stabilizers in suspension, and safe and nontoxic, pollution-free.Glycerol is one
Kind lubricant, has stronger hygroscopicity, can absorb the moisture in air, and skin is made to keep wet.Magnesium stearate is drug
In common auxiliary material, be mainly used as lubricant, antiplastering aid and glidant, be added into calamine lotion, so that suspended particulate
With good mobility and compressibility, the painting used time can reduce sand type.And it is mixed by suspension stabilizer of the present invention
The ratio of object is closed, the stablizing effect for being directly added into the mix suspending stabilizer is significantly larger than each suspension stabilizer and is individually added into.
Beneficial effect
(1) calamine and zinc oxide of the present invention are all made of superfine powder, i.e., diameter≤10 μm, powder is molten
Solution property increases substantially, and has stronger adsorptivity and strong penetrability, can be good at effectively mentioning through skin histology
High bioavilability, significant effect.
(2) use suspension stabilizer mixed for Colloidal microcrystalline cellulose, deflocculant, glycerol, lubricant in the present invention program
Object is closed, suspension stability can be effectively improved, can effectively save suspended state, and good dispersion again, improves and produces
The quality and its effect of product.
(3) present invention prize calamine and zinc oxide are mixed by dry grinding, and process is relatively simple, are saved many wet
The follow-up work that method needs, while it is lower with production cost to consume energy.
(4) calamine lotion of the present invention program preparation, good hand touch apply the used time without sand type.
Specific embodiment
The present invention program is further illustrated below by way of several specific embodiments, it should be understood that any one following
Embodiment is not any type of limitation of the invention further.
Embodiment 1
Calamine 150kg, zinc oxide 500kg are prepared into superfine powder through airslide disintegrating mill, and diameter is 3 μm, and the two is passed through
Dry grinding mixing, and multipass is cleaned using isopropanol 10L and glycerine 30L mixing repeatedly, Colloidal microcrystalline fiber is then added
Element, potassium citrate and sodium tartrate mixture (mass ratio 1:1), glycerol, magnesium stearate=1:0.2:0.9:0.01 mix suspending
Stabilizer is configured to the suspension that concentration is 30%-50%, finally filling to obtain finished product.
Embodiment 2
Calamine 150kg, zinc oxide 500kg are prepared into superfine powder through airslide disintegrating mill, and diameter is 5 μm, and the two is passed through
Dry grinding mixing, and multipass is cleaned using isopropanol 10L and glycerine 50L mixing repeatedly, Colloidal microcrystalline fiber is then added
Element, potassium dihydrogen phosphate, glycerol, magnesium stearate=1:0.3:1.0:0.03 mix suspending stabilizer, being configured to concentration is 30%-50%
Suspension, last filling finished product.
Embodiment 3
Calamine 150kg, zinc oxide 500kg are prepared into superfine powder through airslide disintegrating mill, and diameter is 8 μm, and the two is passed through
Dry grinding mixing, and multipass is cleaned using isopropanol 10L and glycerine 80L mixing repeatedly, Colloidal microcrystalline fiber is then added
Element, sodium tartrate, glycerol, magnesium stearate=1:0.3:1.0:0.05 mix suspending stabilizer, being configured to concentration is 30%-50%'s
Suspension, it is finally filling to obtain finished product.
Embodiment 4
Calamine 150kg, zinc oxide 500kg are prepared into superfine powder through airslide disintegrating mill, and diameter is 10 μm, and the two is passed through
Dry grinding mixing, and multipass is cleaned using isopropanol 10L and glycerine 100L mixing repeatedly, Colloidal microcrystalline fiber is then added
Element, potassium citrate, glycerol, magnesium stearate=1:0.3:1.2:0.03 mix suspending stabilizer, being configured to concentration is 30%-50%'s
Suspension, it is finally filling to obtain finished product.
Comparative example
Calamine 150kg, zinc oxide 500kg are prepared into superfine powder through airslide disintegrating mill, and diameter is 8 μm, and the two is passed through
Dry grinding mixing, and multipass is cleaned using isopropanol 10L and glycerine 50L mixing repeatedly, Colloidal microcrystalline fiber is then added
The suspension stabilizer of plain 10kg is configured to the suspension that concentration is 30%-50%, finally filling to obtain finished product.
5 suspension of embodiment settles solvent than test
Test method: suspension is put into graduated cylinder, is mixed, and the height of suspension is H before measurement settles0, in sedimentation face
After no longer changing, the height in face is settled as H after surveying sedimentationu.Its sedimentation volumn ratio F is F=(Hu/ H0) × 100%.For suspending
Liquid, sedimentation solvent ratio is bigger, and suspension is more stable.
From the foregoing, it will be observed that the calamine lotion of the present invention program preparation, the stability of suspension is in the condition stood for a long time
It is lower more excellent than comparative example product.It can be seen that being added to mixing suspension stabilizer can be good at improving the stabilization of suspension
Property, make it be kept for the suspended state time more long under static conditions.
6 limit test of microbe of embodiment
It is carried out according to the microbial decolorization of " Chinese Pharmacopoeia " 2010 editions second annex XI J.Standard regulation is right
In other local administration preparations, microbial limit is every 1g, 1ml or 10cm2It must not exceed 100cfu, yeast and mold number limit
Degree is every 1g, 1ml or 10cm2It must not exceed 100cfu, staphylococcus aureus, pseudomonas aeruginosa are every 1g, 1ml or 10cm2
It must not detect.Example 1-4, commercial product, each 10ml of comparative example product, check in accordance with the law, as a result as follows:
Claims (5)
1. a kind of preparation method of calamine lotion, specifically includes the following steps: mixed grinding, cleaning, with liquid stirring, filling
Finished product, it is characterised in that: superfine powder first is made in calamine and zinc oxide, then mixes dry grinding, described stirs with liquid
In joined Colloidal microcrystalline cellulose, deflocculant, glycerol, lubricant mixture as Suspension stabilisers, then it is plus suitable molten
Agent in stirring into suspension in high-speed mixer, be configured to mass concentration be 30%-50% suspension, wherein calamine and
Zinc oxide ultra-fine powder mass ratio 3-4:1, deflocculant are selected from one of citrate, tartrate, phosphate or a variety of mixed
It closes；Lubricant is magnesium stearate, with Colloidal microcrystalline cellulose in the Suspension stabilisers being added in liquid stirring: deflocculant: glycerol:
Lubricant ratio=1:0.2-0.5:0.9-1.2:0.01-0.05.
2. preparation method according to claim 1, it is characterised in that the following steps are included:
(1) calamine and zinc oxide are prepared into superfine powder through airslide disintegrating mill；
(2) calamine and zinc oxide ultra-fine powder are mixed through dry grinding in mass ratio；
(3) it is cleaned repeatedly repeatedly using alcohol-water mixture；
(4) deionized water and high-speed mixer is added to carry out Colloidal microcrystalline cellulose, deflocculant, glycerol, lubricant mixture
The suspension that mass concentration is 30%-50% is prepared in stirring；
(5) filling to obtain finished product.
3. preparation method according to claim 1, which is characterized in that the calamine and zinc oxide ultra-fine powder is averaged
Diameter≤10 μm.
4. preparation method according to claim 2, which is characterized in that alcohol in step (3) is selected from ethyl alcohol, glycerine, different
One of propyl alcohol or a variety of mixing.
5. the preparation method according to claim 4, which is characterized in that with alcohol selected by liquid be the mixed of isopropanol and glycerine
Liquid is closed, volume ratio is isopropanol: glycerine=1:3-10.
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Citations (4)
| 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 |
| US6479058B1 (en) * | 1999-09-02 | 2002-11-12 | Mccadden Michael E. | Composition for the topical treatment of poison ivy and other forms of contact dermatitis |
| CN102379897A (en) * | 2010-08-30 | 2012-03-21 | 殷峰林 | Preparation method of calamine lotion |
| CN104189004A (en) * | 2014-09-04 | 2014-12-10 | 湖南尔康湘药制药有限公司 | Production method of calamine lotion |
-
2015
- 2015-06-02 CN CN201510293822.8A patent/CN104940137B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6479058B1 (en) * | 1999-09-02 | 2002-11-12 | Mccadden Michael E. | Composition for the topical treatment of poison ivy and other forms of contact dermatitis |
| 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 |
| CN102379897A (en) * | 2010-08-30 | 2012-03-21 | 殷峰林 | Preparation method of calamine lotion |
| CN104189004A (en) * | 2014-09-04 | 2014-12-10 | 湖南尔康湘药制药有限公司 | Production method of calamine lotion |
Non-Patent Citations (2)
| Title |
|---|
| 对炉甘石洗剂处方的一点改进;陈世龄;《西北药学杂志》;19971231;第12卷(第6期);参见全文 |
| 混悬剂用助悬剂的研究进展;丁波等;《中国现代药物应用》;20110228;第5卷(第3期);参见第231-232页第1栏,第233页第5栏 |
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| TA01 | Transfer of patent application right |
Effective date of registration: 20190201 Address after: 410331 No. 167 Kangping Road, Liuyang Economic and Technological Development Zone, Changsha City, Hunan Province Applicant after: Hunan Er-Kang Pharmaceutical Co., Ltd. Address before: 410331 Hunan Erkangxiang Pharmaceutical Co., Ltd., Changsha National Biological Industrial Base, Changsha City, Hunan Province Applicant before: HUNAN ERKANG XIANGYAO PHARMACEUTICAL CO., LTD. |
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