CN103638013A - Viaminate vitamin E cream - Google Patents
Viaminate vitamin E cream Download PDFInfo
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- CN103638013A CN103638013A CN201310615592.3A CN201310615592A CN103638013A CN 103638013 A CN103638013 A CN 103638013A CN 201310615592 A CN201310615592 A CN 201310615592A CN 103638013 A CN103638013 A CN 103638013A
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Abstract
The invention belongs to the field of chemical medicines, and particularly relates to a viaminate vitamin E cream. The cream is prepared from the following raw materials: 0.1-0.5 part of viaminate, 0.3-0.8 part of vitamin E, 5-10 parts of stearic acid, 5-10 parts of glyceryl monostearate, 0.5-4 parts of wool fat, 0.5-2 parts of albolene, 10-20 parts of glycerin, 0.5-2 parts of sodium dodecyl sulfate, 0.01-0.1 part of preservative and the balance of water based on 100 parts in total. The viaminate vitamin E cream provided by the invention has good quality stability and can quickly permeate into skin and stay for relatively long time; moreover, the viaminate vitamin E cream is convenient to use and avoids adverse reaction, thereby deserving clinical popularization and application.
Description
Technical field
The invention belongs to chemicals field, be specifically related to a kind of Viaminate dimension E emulsifiable paste.
Background technology
Acne is a kind of chronic inflammatory disease dermatoses of pilosebaceous unit, is mainly apt to occur in teenager, very large to teen-age psychology and social influence, but often can naturally alleviate or fully recover after adolescence.It is feature that pleomorphism skin lesion such as being apt to occur in facial acne, pimple, pustule, tuberosity is take in clinical manifestation.
Viaminate is used for the treatment of various acnes, abnormal cutaneous keratinization, and ichthyosis, psoriasis (psoriasis), lichen class dermatosis, mucosal disease and connective tissue disease etc. are also had to certain curative effect.Vitamin E, represents remarkable antioxidation and the challenge to the age.Vitamin E can be effectively to free radical resisting, LPO inhibitor, eliminating chloasma; The activity of restraint of tyrosinase, generates thereby reduce melanin.And Viaminate dimension E emulsifiable paste, as a kind of local topical medicine of acne treatment, not only has the effect for the treatment of, also the skin of damaged is had to certain restitution, be a kind of good effect medicine of comprehensive Acne treatment.
Summary of the invention
The object of the invention is to provide a kind of steady quality, eutherapeutic Viaminate dimension E emulsifiable paste.
For achieving the above object, the present invention adopts following technical scheme:
A kind of Viaminate dimension E emulsifiable paste, in weight portion, described emulsifiable paste is made by the following raw material of 100 parts of total amounts: Viaminate 0.1-0.5 part, 0.3 part-0.8 part of vitamin E, stearic acid 5-10 part, glyceryl monostearate 5-10 part, lanoline 0.5-4 part, white vaseline 0.5-2 part, glycerol 10-20 part, sodium lauryl sulphate 0.5-2 part, antiseptic 0.01-0.1 part, surplus is water.
Preferably, in weight portion, described emulsifiable paste is made by the following raw material of 100 parts of total amounts: 0.3 part of Viaminate, 0.5 part of vitamin E, 7.0 parts of stearic acid, 7.0 parts of glyceryl monostearates, 2.0 parts of lanolines, 1.0 parts of white vaseline, 15 parts of glycerol, 1.0 parts of sodium lauryl sulphates, 0.05 part of antiseptic, surplus is water.
Preparation method, comprises the steps:
1) prepare water: in proportion water raw material glycerol, sodium lauryl sulphate, antiseptic and water are dropped in water tank, be heated to 80 ± 5 ℃, stir 20-30min to after being uniformly dissolved, standby;
2) prepare oil phase: in proportion oil phase raw material stearic acid, glyceryl monostearate, lanoline and white vaseline are added in oil phase tank, be warming up to 70 ± 5 ℃, after oil phase raw materials melt, stir 20-30min and continue to be warmed up to 80 ± 5 ℃, evenly rear standby;
3) prepare emulsifiable paste: above-mentioned water raw material, oil phase raw material are proceeded in emulsion tank, 80 ± 5 ℃ of insulated and stirred 25-35min, under the condition that vacuum is 0.03 ± 0.02Mpa in emulsion tank, stir 20-30min, then homogenizing 15-25min, cool the temperature to 50 ± 5 ℃, add Viaminate, vitamin E, continue homogenizing 30-45min, be cooled to 33 ± 5 ℃, embedding and get final product.
Viaminate dimension E emulsifiable paste of the present invention, contained Viaminate is vitamin A derivative, has the differentiation of promotion epithelial cell and comes off, regulates and prevent keratinization and the effect that suppresses sebum secretion, also has the effect of antiinflammatory, inhibition propionibacterium acnes; Vitamin E has the effect of anti-oxidation protection skin.
Not only quality stability is good for Viaminate of the present invention dimension E emulsifiable paste, and can rapid permeability skin and retain the long period, and medication is convenient, has no adverse reaction, and clinic is applied.
The specific embodiment
Embodiment 1
A kind of Viaminate dimension E emulsifiable paste, following raw material by total amount 100g is made: Viaminate 0.1g, vitamin E 0.3g, stearic acid 5g, glyceryl monostearate 5g, lanoline 0.5g, white vaseline 0.5g, glycerol 10g, sodium lauryl sulphate 0.5g, antiseptic 0.01g, surplus is purified water.Wherein, antiseptic is specially ethyl hydroxybenzoate.
Preparation method, comprises the steps:
1) prepare water: in proportion water raw material glycerol, sodium lauryl sulphate, antiseptic and purified water are dropped in water tank, be heated to 75 ℃, stir 30min to after being uniformly dissolved, standby;
2) prepare oil phase: in proportion oil phase raw material stearic acid, glyceryl monostearate, lanoline and white vaseline are added in oil phase tank, be warming up to 65 ℃, after oil phase raw materials melt, open agitator and stir 30min and continue to be warmed up to 75 ℃, evenly rear standby;
3) prepare emulsifiable paste: above-mentioned water raw material, oil phase raw material are proceeded in emulsion tank, open rubbing board agitator, 75 ℃ of insulated and stirred 35min, under the condition that vacuum is 0.01Mpa in emulsion tank, stir 30min, then homogenizing 25min, cools the temperature to 45 ℃, add Viaminate (crossing 100 mesh sieves), vitamin E, continue homogenizing 45min, be cooled to 28 ℃, embedding and get final product.
Embodiment 2
A kind of Viaminate dimension E emulsifiable paste, following raw material by total amount 100g is made: Viaminate 0.2g, vitamin E 0.5g, stearic acid 6g, glyceryl monostearate 6g, lanoline 1g, white vaseline 1g, glycerol 14g, sodium lauryl sulphate 1g, antiseptic 0.04g, surplus is purified water.Wherein, antiseptic is specially methyl hydroxybenzoate.
Preparation method, comprises the steps:
1) prepare water: in proportion water raw material glycerol, sodium lauryl sulphate, antiseptic and purified water are dropped in water tank, be heated to 80 ℃, stir 25min to after being uniformly dissolved, standby;
2) prepare oil phase: in proportion oil phase raw material stearic acid, glyceryl monostearate, lanoline and white vaseline are added in oil phase tank, be warming up to 70 ℃, after oil phase raw materials melt, open agitator and stir 25min and continue to be warmed up to 80 ℃, evenly rear standby;
3) prepare emulsifiable paste: above-mentioned water raw material, oil phase raw material are proceeded in emulsion tank, open rubbing board agitator, 80 ℃ of insulated and stirred 30min, under the condition that vacuum is 0.03Mpa in emulsion tank, stir 25min, then homogenizing 20min, cools the temperature to 50 ℃, add Viaminate (crossing 100 mesh sieves), vitamin E, continue homogenizing 40min, be cooled to 33 ℃, embedding and get final product.
Embodiment 3
A kind of Viaminate dimension E emulsifiable paste, following raw material by total amount 100g is made: Viaminate 0.3g, vitamin E 0.5g, stearic acid 7.0g, glyceryl monostearate 7.0g, lanoline 2.0g, white vaseline 1.0g, glycerol 15g, sodium lauryl sulphate 1.0g, antiseptic 0.05g, surplus is purified water.Wherein, antiseptic is specially sodium benzoate.
Preparation method, comprises the steps:
1) prepare water: in proportion water raw material glycerol, sodium lauryl sulphate, antiseptic and purified water are dropped in water tank, be heated to 80 ℃, stir 30min to after being uniformly dissolved, standby;
2) prepare oil phase: in proportion oil phase raw material stearic acid, glyceryl monostearate, lanoline and white vaseline are added in oil phase tank, be warming up to 70 ℃, after oil phase raw materials melt, open agitator and stir 30min and continue to be warmed up to 80 ℃, evenly rear standby;
3) prepare emulsifiable paste: above-mentioned water raw material, oil phase raw material are proceeded in emulsion tank, open rubbing board agitator, 80 ℃ of insulated and stirred 30min, under the condition that vacuum is 0.04Mpa in emulsion tank, stir 30min, then homogenizing 25 min, cool the temperature to 50 ℃, add Viaminate (crossing 100 mesh sieves), vitamin E, continue homogenizing 45min, be cooled to 30 ℃, embedding and get final product.
Embodiment 4
A kind of Viaminate dimension E emulsifiable paste, following raw material by total amount 100g is made: Viaminate 0.5g, vitamin E 0.8g, stearic acid 10g, glyceryl monostearate 10g, lanoline 4g, white vaseline 2g, glycerol 20g, sodium lauryl sulphate 2g, antiseptic 0.1g, surplus is purified water.Wherein, antiseptic is specially ethyl hydroxybenzoate.
Preparation method, comprises the steps:
1) prepare water: in proportion water raw material glycerol, sodium lauryl sulphate, antiseptic and purified water are dropped in water tank, be heated to 85 ℃, stir 20min to after being uniformly dissolved, standby;
2) prepare oil phase: in proportion oil phase raw material stearic acid, glyceryl monostearate, lanoline and white vaseline are added in oil phase tank, be warming up to 75 ℃, after oil phase raw materials melt, open agitator and stir 20min and continue to be warmed up to 85 ℃, evenly rear standby;
3) prepare emulsifiable paste: above-mentioned water raw material, oil phase raw material are proceeded in emulsion tank, open rubbing board agitator, 85 ℃ of insulated and stirred 25min, under the condition that vacuum is 0.05Mpa in emulsion tank, stir 20min, then homogenizing 15min, cools the temperature to 55 ℃, add Viaminate (crossing 100 mesh sieves), vitamin E, continue homogenizing 30min, be cooled to 38 ℃, embedding and get final product.
Reliable and stable in order to verify drug quality of the present invention, the Viaminate dimension E emulsifiable paste that applicant produces embodiment 1-4 has carried out relevant experimental study, specific as follows:
1, test objective
This programme is mainly described the implementation plan that Viaminate dimension E stability of cream is investigated, and for the continuous stability of product, investigates plan, and the data of study on the stability are provided.
The existing storage requirement of Viaminate dimension E cream products is shady and cool preservation.Now carry out temperature and be no more than the investigation of 20 ° of C conditions long-time stability of lower 30 months, determine that Viaminate dimension E cream products can, under the storage requirement indicating, meet the requirements of quality standard.
2, investigation condition
Carry out temperature and be no more than 20 ° of long-time stability investigations under C storage requirement.At 0 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months and 36 months points, sample is carried out to Detection of Stability.
When long-time stability are investigated, Viaminate dimension E cream products packaging material are all consistent with the existing packing of product with form, adopt aluminium-plastic pipe packing.
3, investigation project and test plan
According to each study on the stability, require to carry out the sampling of Viaminate dimension E cream products sample.After sampling, sample is placed under corresponding experiment condition.
While putting in the test plan fixed time, specified quantity sample is taken out, relevant item is tested according to correlation method.After having tested, complete in time report.
4, investigation project and method of testing, stability criterion
The sample being packaged in described interior packaging material (aluminium-plastic pipe) is tested, according to the sampling plan of each checkpoint, got respective numbers sample.
According to following method of testing and quality standard, the relevant item of sample is measured.
After sample sampling, should in one week, measure.
Table 1: method of testing and respective standard
Owing to considering that discriminating in quality standard, loading amount, microbial limit item index result are more stable, during study on the stability, only in the time of 18 months, check discriminating, loading amount, microbial limit item, do not check At All Other Times.
Viaminate dimension E emulsifiable paste of the present invention is tested by following quality standard:
Particularly, projects method of testing is as follows:
Differentiate: (1) gets this product 1g, adds chloroform 3ml, stir Viaminate dimension E emulsifiable paste is dissolved, filter, in filtrate, add solution (mass ratio, the Butter of antimony.: chloroform=1:3) 1ml, aobvious brownish red, crossfades into aubergine of Butter of antimony..(2) get Viaminate and vitamin E reference substance, add respectively dehydrated alcohol and make the reference substance solution that approximately contains 0.3mg and 0.5mg in every 1ml, separately get content of vitamin E and measure the need testing solution under item, according to content of vitamin E, measure the method test under item, in chromatogram, the retention time of two main peaks of need testing solution should be consistent with the retention time at corresponding reference substance peak in reference substance solution respectively.
Loading quantity inspection: get 5 of test samples, remove enclosing cover, clean its outer wall respectively, to be dried after, accurately weighed its weight, removes content, after container is cleaned and is dried respectively, distinguish again the weight of accurately weighed empty, obtain the loading amount and average loading amount of each container contents, should be up to specification.
Limit test of microbe: check according to microbial limit test (two appendix XI J of Chinese Pharmacopoeia version in 2010), bacterial population, yeast and mold number all must not be crossed 100cfu/g; Staphylococcus aureus, Pseudomonas aeruginosa all every 1g must not detect.
Assay:
The operation of Viaminate lucifuge.Get the content under the qualified item of content uniformity, mix, precision takes in right amount (being approximately equivalent to Viaminate 10mg), puts in beaker, adding chloroform 3ml stirs, with the about 70ml of dehydrated alcohol, moved in 100ml measuring bottle, jolting 20 minutes, makes to dissolve, with dehydrated alcohol, be diluted to scale, shake up, filter, get subsequent filtrate as need testing solution.Precision measures need testing solution 2ml, puts in 50ml measuring bottle, with dehydrated alcohol, is diluted to scale, mix, according to ultraviolet visible spectrophotometry (two appendix IV A of Chinese Pharmacopoeia version in 2010), at the wavelength place of 370nm, measure trap, by the absorptance (E of C29H37NO3
) be 1420 calculating.
Vitamin E is according to high performance liquid chromatography (two appendix V D of Chinese Pharmacopoeia version in 2010).
Chromatographic condition and system suitability octadecylsilane chemically bonded silica are filler; Methanol is mobile phase; Detection wavelength is 285nm; Number of theoretical plate calculates and should be not less than 1000 by vitamin E peak.
The operation of algoscopy lucifuge.Precision takes this product appropriate (being approximately equivalent to vitamin e1 0mg), puts in 20ml measuring bottle, adds dehydrated alcohol 10ml ultrasonic dissolution, adds dehydrated alcohol to scale, shakes up, and filters.Precision measures subsequent filtrate 10 μ l, and injection liquid chromatography, records chromatogram; Another precision takes vitamin E reference substance, be measured in the same method, by external standard method with calculated by peak area.
5, stability test data statistics
The results are shown in Table 2.
Table 2: Viaminate dimension E stability of cream test data statistics
In order to verify that medicine of the present invention has good therapeutic effect, applicant has carried out correlation test research, specific as follows:
Case selection
1, case inclusion criteria and exclusion standard: the patient who enters anthology research must meet following whole standard: 18-35 year, male or female; Clinical definite acne, lesion degree meets Pillsbury classification method I, II grade standard; Not oral or external curing acne medicine in 4 weeks; All patient's voluntary participations are also signed Informed Consent Form.Do not meet above-mentioned requirements, all not as observing case.
2, method
(1) Therapeutic Method: give embodiment 3 Viaminate dimension E emulsifiable paste, every night 1 medicine of external.Before treatment, record observation index, respectively at further consultation in 3,6 weeks, observe and record skin lesion type, number, have no adverse reaction.
(2) curative effect determinate standard: before therapeutic index=(the rear total skin lesion number of total skin lesion number-treatment before treatment)/treatment, total skin lesion counts * 100%.Cure: therapeutic index >=90%; Effective: 60%≤therapeutic index < 90%; Take a turn for the better: 20%≤therapeutic index < 60%; Invalid: therapeutic index < 20%.Effective number of cases=healing number of cases+effective number of cases.
3, curative effect
All cases all complete the course for the treatment of in accordance with regulations.The 3rd week and the 6th week cure rate are respectively 41.9% and 60.2%, and total effective rate is respectively 66.1% and 94.6%.Concrete outcome is in Table 3.
Table 3: curative effect statistical table
4, conclusion
This test application Viaminate dimension E cream for treating 186 routine acnes, its cure rate is 60.2%, effective percentage reaches 94.6%, wherein best to the curative effect of hoary hair's acne, is secondly blackhead.Show that Viaminate dimension E emulsifiable paste can rapid permeability skin and retain the long period, and medication is convenient, has no adverse reaction, clinic is applied.
Claims (2)
1. a Viaminate is tieed up E emulsifiable paste, it is characterized in that, in weight portion, described emulsifiable paste is made by the following raw material of 100 parts of total amounts: Viaminate 0.1-0.5 part, 0.3 part-0.8 part of vitamin E, stearic acid 5-10 part, glyceryl monostearate 5-10 part, lanoline 0.5-4 part, white vaseline 0.5-2 part, glycerol 10-20 part, sodium lauryl sulphate 0.5-2 part, antiseptic 0.01-0.1 part, surplus is water.
2. Viaminate as claimed in claim 1 is tieed up E ointment, it is characterized in that, in weight portion, described emulsifiable paste is made by the following raw material of 100 parts of total amounts: 0.3 part of Viaminate, 0.5 part of vitamin E, 7.0 parts of stearic acid, 7.0 parts of glyceryl monostearates, 2.0 parts of lanolines, 1.0 parts of white vaseline, 15 parts of glycerol, 1.0 parts of sodium lauryl sulphates, 0.05 part of antiseptic, surplus is water.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310615592.3A CN103638013A (en) | 2013-11-28 | 2013-11-28 | Viaminate vitamin E cream |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310615592.3A CN103638013A (en) | 2013-11-28 | 2013-11-28 | Viaminate vitamin E cream |
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| CN103638013A true CN103638013A (en) | 2014-03-19 |
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| CN201310615592.3A Pending CN103638013A (en) | 2013-11-28 | 2013-11-28 | Viaminate vitamin E cream |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110927078A (en) * | 2018-09-19 | 2020-03-27 | 杭州和合医学检验实验室有限公司 | Method for detecting vitamin A in blood |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN301195751S (en) * | 2009-09-27 | 2010-05-12 | 天津药业集团新郑股份有限公司 | Packing box (Vitamin and Vitamin e Cream) |
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- 2013-11-28 CN CN201310615592.3A patent/CN103638013A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN301195751S (en) * | 2009-09-27 | 2010-05-12 | 天津药业集团新郑股份有限公司 | Packing box (Vitamin and Vitamin e Cream) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110927078A (en) * | 2018-09-19 | 2020-03-27 | 杭州和合医学检验实验室有限公司 | Method for detecting vitamin A in blood |
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Application publication date: 20140319 |