CN103919750B - Calamina effervescent tablet and preparation method thereof - Google Patents
Calamina effervescent tablet and preparation method thereof Download PDFInfo
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- CN103919750B CN103919750B CN201410183983.7A CN201410183983A CN103919750B CN 103919750 B CN103919750 B CN 103919750B CN 201410183983 A CN201410183983 A CN 201410183983A CN 103919750 B CN103919750 B CN 103919750B
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- calamina
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Abstract
The invention discloses a kind of Calamina effervescent tablet and preparation method thereof.Described Calamina effervescent tablet is external effervescent tablet, comprises following composition: calamine stone, citric acid, sodium bicarbonate, micropowder silica gel, polyvidone, glycerol.Above-mentioned material is granulated after premix, granulate, obtains Calamina effervescent tablet at the environment lower sheeting of low humidity.These product have to be convenient to store, and be beneficial to use, effervescent effect has good visual effect, is of value to patient and selects, and the calamine lotion simultaneously obtained is matching while using, avoids the defect that traditional Calamine Lotion is long placed in rotten precipitation.
Description
Technical field
The invention discloses a kind of Calamina effervescent tablet and preparation method thereof, relate to art of pharmaceutical industry.
Background technology
Calamina is carbonate mineral calcite race smithsonite, main containing zinc carbonate (ZnCO
3), also containing small amounts calcium (CaO), magnesium oxide (MgO), ferrum oxide (Fe2O3), manganese oxide (MnO).After excavating, clean, dry, except roguing stone, pulverize, there is removing toxic substances improving acuity of vision and removing nebula, effect of the antipruritic sore of removing dampness.
Calamina is one of medicine that department of dermatologry is conventional; generally be mixed with lotion or unguentum; external can suppress local aureus growth; can detoxify, removing dampness, antipruritic, sore; kind control swell and ache, ulcer being unable to heal, eczema; the diseases such as skin pruritus, as anticorrosion, convergence, the protective agent treatment scytitis or surface injury of moderate.The preparation of Calamina is mainly external-use lotion, is after Calamina is broken into fine powder, adds suitable quantity of water and glycerol furnishing solid suspension, each use before need to shake up, and get and be applied to affected part in right amount.
Traditional Calamine Lotion is the water slurry of Calamina, random advantage is taken although have, but due to the intrinsic property of suspension itself, after being long placed in, suspension system can make medicated powder wherein occur to reunite and sedimentation because of the electrostatic interaction between gravity and powder, even if before using each, shake for several times, also be difficult to superfine medicated powder to be again uniformly dispersed, cause each dosage disunity.Meanwhile, the calamine stone of having reunited increases due to particle volume, makes declined bioavailability of oral administration and affects drug effect.In addition, the medicine being in suspending agent state is easy mould growth afterwards in Kaifeng, makes medicine contaminated and loses efficacy, even threatening the safety of medicine.
Generally speaking, Calamina unguentum is compared with Calamine Lotion, and without significant difference in therapeutic effect, but unguentum tool has the following advantages: drug distribution is even, and easily grasp dosage during use, medicine is easily stranded in affected part, does not need to repeatedly use.Calamina can prepare multiple unguentum, and as compound calamine ointment, calamine Ointment, Calamina emulsifiable paste etc., formula and preparing process are also different.But more or less there is the shortcomings such as production cost is high, drug effect slow, use is inconvenient.
Chinese patent CN103239475A discloses a kind of processing procedure and Calamina dispersible tablet of Calamina, and its dispersible tablet is the preparation be prepared from by the supplementary material of following weight proportion: Calamina processed product 726 parts, cross-linked methyl sodium cellulosate 36-39 part, sodium carboxymethyl cellulose 7-8 part.But still there is apt to deteriorate, easy sedimentation in said preparation, is unfavorable for low etc. the many defects of the inconsistent and bioavailability of the dosage of preserving and causing after medicated powder reunion sedimentation.
Summary of the invention
For overcoming the above-mentioned defect existed in existing Calamina preparation, the invention discloses a kind of Calamina effervescent tablet to solve the problem.
First, Calamina effervescent tablet of the present invention, is characterized in that being made up of calamine stone, acid source disintegrating agent, alkali source disintegrating agent, fluidizer and binding agent.
Further, Calamina effervescent tablet of the present invention is made up of following component:
Calamine stone 60-80%;
Acid source disintegrating agent 1-25%;
Alkali source disintegrating agent 1-25%;
Fluidizer 0.5-5%;
Binding agent 0.5-5%.
Described acid source disintegrating agent is selected from one in citric acid, tartaric acid, fumaric acid, adipic acid or malic acid or combination, described alkali source disintegrating agent is selected from one in sodium carbonate, sodium bicarbonate, potassium bicarbonate or combination, described fluidizer is colloidal silica, magnesium stearate, described binding agent is one in glycerol, water, polyvinylpyrrolidone, ethanol or combination, and the monolithic of described Calamina effervescent tablet is heavily 0.5-2g.
Secondly, present invention also offers a kind of preparation method of Calamina effervescent tablet.This part invention is realized by following scheme:
(1) raw materials used proportioning is:
Calamine stone 60-80 part,
Acid source disintegrating agent 1-25 part,
Alkali source disintegrating agent 1-25 part,
Fluidizer 0.5-5 part,
Binding agent 0.5-5 part;
And make as follows:
A () premix: be split into two halves by load weighted calamine stone, mixes with acid source disintegrating agent, alkali source disintegrating agent respectively, in the process of mixing, add binding agent;
B () is granulated: be dispersed in respectively in the ethanol solution of 10% polyvinylpyrrolidone by obtain in step a two mixture and carry out non-water granulation, crosses 50 mesh sieves, obtains acid source granule and alkali source granule in 60 DEG C of dry 4h;
(c) granulate: always mix after the acid source granule obtained in step (b) and alkali source granule are crossed 40 mesh sieves, always do time as 20min-90min;
D () tabletting: after granulate always mixes, adds fluidizer, send into tabletting machine and obtain finished product;
Described acid source disintegrating agent is selected from one in citric acid, tartaric acid, fumaric acid, adipic acid or malic acid or combination, described alkali source disintegrating agent is selected from one in sodium carbonate, sodium bicarbonate, potassium bicarbonate or combination, described fluidizer is colloidal silica, magnesium stearate, described binding agent is one in glycerol, water, polyvinylpyrrolidone or combination, and the Calamina effervescent blade of gained is heavily 0.5-2g.
In the implementation process of such scheme, should notice that the humidity of operating environment must not, higher than 30%, be good with 15-25%.The advantage of this programme is, acid source and alkali source disintegrating agent is mixed with calamine stone respectively, and adopts non-water environment to granulate, and effectively avoids bronsted lowry acids and bases bronsted lowry and ionizes in the process of preparation because meeting water thus neutralization reaction occurs, the preparation failure caused.
Specific embodiment
The present invention is further illustrated below by way of several specific embodiment.Should be appreciated that following embodiment is not limitation of the invention further, those skilled in the art are fully understanding that the adjustment that basis of the present invention is carried out embodiment is also within protection scope of the present invention.
Embodiment 1
(1) raw materials used proportioning is:
Calamine stone 600g,
Citric acid 150g,
Sodium bicarbonate 180g,
Colloidal silica 50g,
Water 20g;
Above-mentioned raw materials makes 1000, and every sheet is containing calamine stone 0.6g.
Step is as follows:
(a) premix: the calamine stone of 600g is split into two halves, mix with 150g citric acid, 180g sodium bicarbonate respectively, in the process of mixing, 8g water is added in the mixture of calamine stone and citric acid, in the mixture of calamine stone and sodium bicarbonate, add 12g water, mix homogeneously obtains two mixture;
B () is granulated: be dispersed in respectively in the ethanol solution of 10% polyvinylpyrrolidone by obtain in step a two mixture and carry out non-water granulation, crosses 50 mesh sieves, obtains acid source granule and alkali source granule in 60 DEG C of dry 4h;
(c) granulate: after the acid source granule obtained in step (b) and alkali source granule are crossed 40 mesh sieves respectively, always mix, the time is 30min;
D () tabletting: after granulate, adjustment tabletting parameter is added 50g colloidal silica feeding tabletting machine and is obtained finished product, the heavy 1g of sheet.
Embodiment 2
(1) raw materials used proportioning is:
Calamine stone 750g,
Tartaric acid 80g,
Sodium bicarbonate 120g,
Magnesium stearate 30g,
Polyvinylpyrrolidone 20g;
Above-mentioned raw materials makes 500, and every sheet is containing calamine stone 1.5g.
Step is as follows:
(a) premix: the calamine stone of 750g is split into two halves, mix with 80g tartaric acid, 120g sodium bicarbonate respectively, in the process of mixing, 10g polyvinylpyrrolidone water is added in calamine stone and tartaric mixture, in the mixture of calamine stone and sodium bicarbonate, add 10g polyvinylpyrrolidone, mix homogeneously obtains two mixture;
B () is granulated: be dispersed in respectively in the ethanol solution of 10% polyvinylpyrrolidone by obtain in step a two mixture and carry out non-water granulation, crosses 50 mesh sieves, obtains acid source granule and alkali source granule in 60 DEG C of dry 4h;
(c) granulate: after the acid source granule obtained in step (b) and alkali source granule are crossed 40 mesh sieves respectively, always mix, the time is 60min;
D () tabletting: after granulate, adjustment tabletting parameter, sends material into tabletting machine after adding 30g magnesium stearate and obtains finished product, the heavy 2g of sheet.
Embodiment 3
(1) raw materials used proportioning is:
Calamine stone 700g,
Fumaric acid 150g,
Sodium bicarbonate 90g,
Colloidal silica 20g,
Glycerol 20g;
Polyvinylpyrrolidone 20g
Above-mentioned raw materials makes 2000, and every sheet is containing calamine stone 0.35g.
Step is as follows:
(a) premix: the calamine stone of 700g is split into two halves, mix with 150g fumaric acid, 90g sodium bicarbonate respectively, in the process of mixing, 20g polyvinylpyrrolidone is added in the mixture of calamine stone and fumaric acid, in the mixture of calamine stone and sodium bicarbonate, add 20g glycerol, mix homogeneously obtains two mixture;
B () is granulated: be dispersed in respectively in the ethanol solution of 10% polyvinylpyrrolidone by obtain in step a two mixture and carry out non-water granulation, crosses 50 mesh sieves, obtains acid source granule and alkali source granule in 60 DEG C of dry 4h;
(c) granulate: the acid source granule obtained in step (b) and alkali source granule are mixed, after mixing granulate crosses 40 mesh sieves respectively, always mix, the time is 90min;
D () tabletting: after granulate, adjustment tabletting parameter, sends material into tabletting machine after adding 20g colloidal silica and obtains finished product, the heavy 0.5g of sheet.
Comparative example 1
Calamina dispersible tablet 1000 (every sheet is containing calamine stone 0.726g) is prepared, for use according to CN103239475A description embodiment 4.
Embodiment 4
The product obtained by embodiment 1-4, checks dispersing uniformity, stability of suspension and In Vitro Bacteriostasis ability respectively.
Dispersing uniformity checks with reference to [dispersing uniformity] described method in Chinese Pharmacopoeia version in 2010 two annex IA, the Calamina dispersible tablet that the Calamina effervescent tablet obtained embodiment 1-3, embodiment 4 obtain, check in accordance with the law, and record from beginning disintegrate to disperse complete required time.
Stability of suspension checks each 6 of Example 1-4 product, is placed in 100ml15-25 DEG C of water, fully leaves standstill after shake 3min, observes and record suspension Apparent character, judge whether to occur layering, sedimentation every 5min.
In Vitro Bacteriostasis ability test
(1) the accurate staphylococcus aureus of antibacterial culturing label taking, standard E. coli, staphylococcus aureus, staphylococcus epidermidis, escherichia coli, Salmonella, pseudomonas aeruginosa strains are a little, in inoculation nutrient broth medium, cultivate 18h for 37 DEG C;
(2) quadracycline positive control solution preparation take quadracycline standard substance 50mg, add sterilized water and be made into 5g/L in right amount, with sterilized water dilution and standardize solution be 0.05 μ g/mL as positive control solution, for subsequent use;
(3) Nutrient agar after 20mL fusing is got in bacteriostatic activity test pours 9cm culture dish into, treat that it solidifies, be spread evenly across on the nutrient agar panel solidified with liquid-transfering gun absorption 0.1mL bacterium liquid, make a call to 4 holes with aseptic steel pipe, cover corresponding region marking pen at culture dish and divide and No. 1-4, numbering; A kind of experimental bacteria of every block flat board coating.
(4) each 6 of Example 1-4 product, obtained medicinal liquid after beaker adds 250ml15-25 DEG C of sterilized water jolting 3min respectively, after standing 0min, 10min, 20min, 30min, medicinal liquid 0.05ml is drawn respectively from 2cm under liquid level, the hole of culture dish is injected by the order of numbering in (3), draw the sterilized water 0.05ml that configuration medicinal liquid is used simultaneously, inject another culture dish of the same type as blank; Draw positive control solution 0.05ml again and inject another culture dish of the same type as positive control; Sample time and zone number correspond to: 0min---and No. 1; 10min---No. 2; 20min---No. 3; 30min---No. 4.
Antibacterial circle diameter is measured and record with ruler after all culture dishs are cultivated 24h in 37 DEG C.
Above-mentioned experimental result is as follows:
Table 1 dispersing uniformity check result
The inspection of table 2 stability of suspension
Table 3 In Vitro Bacteriostasis capacity experimental
Can significantly be found out by above test result, according to the Calamina effervescent tablet that the present invention program obtains, compared with prior art dispersible tablet, disintegrate more rapidly, suspend more lasting, dispersion evenly, also can keep stronger bacteriostasis even if be long placed in, there is obvious advantage and significant progress.
Claims (2)
1. a Calamina effervescent tablet, is characterized in that being made up of following component:
Calamine stone 60-80%;
Acid source disintegrating agent 1-25%;
Alkali source disintegrating agent 1-25%;
Fluidizer 0.5-5%;
Binding agent 0.5-5%;
And make as follows:
A () premix: be split into two halves by load weighted calamine stone, mixes with acid source disintegrating agent, alkali source disintegrating agent respectively, in the process of mixing, add binding agent;
B () is granulated: be dispersed in respectively in the ethanol solution of 10% polyvinylpyrrolidone by obtain in step a two mixture and carry out non-water granulation, crosses 50 mesh sieves, obtains acid source granule and alkali source granule in 60 DEG C of dry 4h;
(c) granulate: always mix after the acid source granule obtained in step (b) and alkali source granule are crossed 40 mesh sieves, always do time as 20min-90min;
D () tabletting: after granulate always mixes, adds fluidizer, send into tabletting machine and obtain finished product;
Described acid source disintegrating agent is selected from one in citric acid, tartaric acid, fumaric acid, adipic acid or malic acid or combination, described alkali source disintegrating agent is selected from one in sodium carbonate, sodium bicarbonate, potassium bicarbonate or combination, described fluidizer is colloidal silica, magnesium stearate, described binding agent is one in glycerol, polyvinylpyrrolidone or combination, and the monolithic of described Calamina effervescent tablet is heavily 0.5-2g.
2. Calamina effervescent tablet according to claim 1, is characterized in that comprising following component:
Calamine stone 75%;
Tartaric acid 8%;
Sodium carbonate 12%;
Magnesium stearate 3%;
Polyvinylpyrrolidone 2%;
The sheet of described Calamina effervescent tablet is heavily 2g.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410183983.7A CN103919750B (en) | 2014-05-04 | 2014-05-04 | Calamina effervescent tablet and preparation method thereof |
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| CN201410183983.7A CN103919750B (en) | 2014-05-04 | 2014-05-04 | Calamina effervescent tablet and preparation method thereof |
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| CN103919750B true CN103919750B (en) | 2016-02-17 |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101352526A (en) * | 2008-03-24 | 2009-01-28 | 阳瑞鸿 | Dendrobium effervescing agent |
| CN101352457A (en) * | 2008-03-24 | 2009-01-28 | 阳瑞鸿 | Cordyceps sinensis effervescing agent |
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2014
- 2014-05-04 CN CN201410183983.7A patent/CN103919750B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101352526A (en) * | 2008-03-24 | 2009-01-28 | 阳瑞鸿 | Dendrobium effervescing agent |
| CN101352457A (en) * | 2008-03-24 | 2009-01-28 | 阳瑞鸿 | Cordyceps sinensis effervescing agent |
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Effective date of registration: 20190108 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. |
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