CN102370947B - External preparation with effects of diminishing inflammation, relieving itching, disinfecting and sterilizing and preparation method thereof - Google Patents
External preparation with effects of diminishing inflammation, relieving itching, disinfecting and sterilizing and preparation method thereof Download PDFInfo
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Abstract
The invention belongs to the field of medicine and particularly relates to an external preparation with the effects of diminishing inflammation, relieving itching, disinfecting and sterilizing and a preparation method thereof. The invention needs to solve the technical problems of carrying out improvement aiming at a Binghuangfule ointment and enhancing the curative effect and the compliance of a patient. The external preparation comprises the following bulk drugs proportioned by weight: 20 to 68 parts of rhubarb, 1 to 40 parts of turmeric, 1 to 10 parts of baikal skullcap root, 3 to 10 parts of licorice, 20 to 40 parts of sulfur, 0.1 to 6.5 parts of borneol and 0.1 to 4.5 parts of menthol; and the improvement is characterized in the extraction method of the bulk drugs. The preparation method of the external preparation comprises the following steps: (A) extracting the rhubarb, the turmeric, the baikal skullcap root and the licorice by using water or alcohol so as to obtain an extract for standby application; and (B) preparing the external preparation by the extract, the sulfur, the borneol, the menthol and acceptable auxiliary materials in pharmacy according to a conventional method in the pharmacy. The preparation process of the external preparation disclosed by the invention is simple and convenient, the operation is easy, and the external preparation obtained by preparation has an obvious curative effect in clinic and is better than an ointment; and moreover, the external preparation does not taint clothing, and the compliance of the patient is good.
Description
Technical field
The invention belongs to field, be specifically related to there is antiinflammatory, the external preparation of antipruritic and disinfection effect and preparation method thereof.
Background technology
Neurodermatitis, eczema, tinea pedis, psoriasis etc. be take common, the frequently-occurring disease that skin pruritus is cardinal symptom.Treat the external preparation such as ointment, emulsifiable paste and disinfectant preparation that the medicine of above-mentioned disease is made more, take antipruritic as main.
China Patent Publication No. CN1939522A, application number 200510107769.4, treat dermopathic external preparation and preparation method thereof: disclosing a kind of is the dermopathic external preparation for the treatment of of active drug composition by natural drug Radix Et Rhizoma Rhei, Rhizoma Curcumae Longae, sulfur, Radix Scutellariae, Radix Glycyrrhizae, Borneolum Syntheticum, Mentholum, it is that Radix Et Rhizoma Rhei, Rhizoma Curcumae Longae, sulfur, Radix Scutellariae, Radix Glycyrrhizae are pulverized or decocted with water, filter, concentrated, after dry extract powder, add external medicine preparation acceptable to assist adding ingredient with Borneolum Syntheticum and the Mentholum of porphyrize, mix homogeneously and get final product.
In applying clinically, the rarely seen ointment of making of marketed drugs, the happy ointment of the yellow skin of ice, has heat clearing and damp drying, promoting blood circulation by removing wind, the effect of itch stopping and diminish inflammation.Be used for the skin pruritus that damp-heat accumulation or heat in blood wind-dryness cause; Neurodermatitis, warm rash and because of various funguses, antibacterial, infected by microbes, cause the itching skin disease such as hands, foot, tinea corporis and psoriasis.But find in application process, ointment is easily infected with clothes, be difficult to clean, after smearing and normal skin colouring discrimination obvious, although therapeutic effect is remarkable, because smearing rear inconvenience, plain, patient's poor compliance.
Invention human desires is improved the defect of the yellow happy ointment of skin of ice patient's poor compliance in clinical practice.
Summary of the invention
Technical problem solved by the invention is to improve for the happy ointment of the yellow skin of ice, improves curative effect and patient's compliance.
For solving the technology of the present invention problem, be achieved through the following technical solutions: improve the extracting method of the happy ointment of the yellow skin of existing ice, and be made into suitable external preparation.
Particularly, this external preparation does not change the effect of the yellow skin happy ointment of ice itself, still has antiinflammatory, antipruritic and disinfection effect.The weight proportion of its crude drug is: Radix Et Rhizoma Rhei 20-68 part, Rhizoma Curcumae Longae 1-40 part, Radix Scutellariae 1-10 part, Radix Glycyrrhizae 3-10 part, sulfur 20-40 part, Borneolum Syntheticum 0.1-6.5 part, Mentholum 0.1-4.5 part.
In order to guarantee curative effect of medication, the weight proportion of crude drug is preferred: Radix Et Rhizoma Rhei 30-40 part, Rhizoma Curcumae Longae 20-30 part, Radix Scutellariae 3-7 part, Radix Glycyrrhizae 3-7 part, sulfur 20-25 part, Borneolum Syntheticum 0.1-3.5 part, Mentholum 1.5-3.5 part.
Through checking, when the optimum weight proportioning of crude drug is 1.8 parts of 30 parts of Radix Et Rhizoma Rhei, 20 parts, Rhizoma Curcumae Longae, 4 parts of Radix Scutellariaes, 4 parts, Radix Glycyrrhizae, 20 parts of sulfurs, 2 parts of Borneolum Syntheticums, Mentholum, curative effect is the most stable, definite.
Improvement of the present invention is: the extracting method of crude drug of the present invention, and its preparation method is as follows:
A, by after Radix Et Rhizoma Rhei, Rhizoma Curcumae Longae, Radix Scutellariae, Radix Glycyrrhizae water or alcohol extraction, obtain extracting solution, standby;
B, extracting solution, sulfur, Borneolum Syntheticum, Mentholum and pharmaceutically acceptable adjuvant are prepared to external preparation according to conventional method pharmaceutically.
Wherein, in crude drug, Rhizoma Curcumae Longae, for containing volatile ingredient, when water or alcohol extraction, needs to collect its volatile oil standby.
The extraction conditions of Rhizoma Curcumae Longae is: adds 6-12 times of water gaging and extracts, and collect volatile oil, and Rhizoma Curcumae Longae extracting liquid filtering, concentrated, standby.
Further, amount of water is preferred: add 10 times of water gagings and extract.
Further, concentrated is that Rhizoma Curcumae Longae extracting solution is concentrated into density 50-60 ℃ time is 1.00～1.20.
Further, extraction conditions is: extraction time 1-2 time, each 1-2 hour.
Further, the preferred 2-4 hour of volatile oil acquisition time.
Be that preferred version is: Rhizoma Curcumae Longae adds 10 times of water gagings extracts, extraction time 1-2 time, each 1-2 hour, collects volatile oil, standby; Rhizoma Curcumae Longae extracting liquid filtering, is concentrated into density in the time of 50-60 ℃ and is 1.00～1.20, standby.
For improving extraction efficiency, extract after curcuma powder can being broken into granule.
In crude drug, Radix Scutellariae, Radix Glycyrrhizae, Radix Et Rhizoma Rhei be not containing volatile ingredient, therefore adopt following methods to extract: add 6-12 times of water gaging or ethanol extraction, and extracting liquid filtering, concentrated, standby.
Further, preferred 70-90%.v/v ethanol extraction.
Further, preferably extraction time is 1-2 time, each 1-2 hour.
Further, preferably concentratedly refer to that it is 1.00～1.20 that extracting solution is concentrated into density 50-60 ℃ time.
Be that preferred version is: Radix Scutellariae, Radix Glycyrrhizae, Radix Et Rhizoma Rhei add 6-12 and doubly measure 60-90%.v/v ethanol extraction, extraction time 1-2 time, each 1-2 hour, extracting liquid filtering, is concentrated into density in the time of 50-60 ℃ and is 1.00～1.20, standby.As extract twice, and add for the first time 10 times of amount 75-90%.v/v ethanol, extract 2 hours, add for the second time 6 times of amount 60-75%.v/v ethanol, extract 1 hour.
For improving extraction efficiency, extract after can or being ground into granule by Radix Scutellariae, Radix Glycyrrhizae, Radix Et Rhizoma Rhei section.
Crude drug sulfur is used further to preparation after should pulverizing, and is preferably ground into impalpable powder.
Adopt said extracted method to process after crude drug, can be made into ointment, gel, liniment, varnish, tincture, aerosol, ointment.Especially be suitable for and make the gel that substrate is water-soluable gel substrate.
Water-soluable gel substrate is generally polyacrylic acid (commodity are called carbomer, and following polyacrylic acid is referred to as carbomer), tragacanth, gelatin, starch, cellulose derivative, carbopol, sodium alginate etc. and adds water, glycerol, propylene glycol etc. and make.
(1) when take carbomer as water-soluble base, its prescription ratio is: in every 1000g gel, contain carbomer 5-15g, solubilizing agent (can adopt poloxamer etc., preferred tween, especially preferably Tween 80) 1-3g, glycerol 40-60g, surplus is water (preferably purified water).
In above-mentioned prescription, in order to increase viscosity, and the stability of raising medicine, can also increase solubilizing agent and antiseptic, its prescription ratio is: in every 1000g gel, contain carbomer 5-15g, solubilizing agent 1-3g, glycerol 40-60g, antiseptic 0.5-1.5g, surplus is water (preferably purified water).
When adopting, take carbomer during as water-soluble base, described solubilizing agent is tween, and prescription ratio is: carbomer 5-15g, tween 1-3g, glycerol 40-60g, antiseptic 0.5-1.5g in every 1000g gel, surplus is water (preferably purified water).
Optimizing prescriptions ratio is: carbomer 10g, tween 2g, glycerol 50g, antiseptic 1g in every 1000g gel, surplus is water (preferably purified water).
(2) when take cellulose derivative as water-soluable gel substrate, prescription ratio is: in every 1000g gel, contain cellulose-derived (preferably carboxymethyl cellulose sodium) 50-150g, glycerol 100-400g, surplus is water (preferably purified water).
If add antiseptic and solubilizing agent, prescription ratio is: in every 1000g gel, contain cellulose derivative (preferably carboxymethyl cellulose sodium) 50-150g, glycerol 100-400g, antiseptic 0.5-1.5g, surplus is water (preferably purified water).Its prescription ratio is further preferred: in every 1000g gel, contain cellulose derivative (preferably carboxymethyl cellulose sodium) 100g, glycerol 250g, antiseptic 0.5-1.5g, surplus is water (preferably purified water).
In above-mentioned prescription, antiseptic can adopt ethyl hydroxybenzoate, benzoic acid, sodium benzoate, parabens, sorbic acid, phenols and derivant thereof, chlorobutanol, benzyl alcohol, quaternary ammonium salt, imidazolidinyl urea.Preferred ethyl hydroxybenzoate.
Concrete, the preparation method of gel of the present invention is:
A, weighting raw materials in proportion: the contained crude drug of every 1000g gel is comprised of Radix Et Rhizoma Rhei 20-68g, Rhizoma Curcumae Longae 1-40g, Radix Scutellariae 1-10g, Radix Glycyrrhizae 3-10g, sulfur 20-40g, Borneolum Syntheticum 0.1-6.5g, Mentholum 0.1-4.5g;
Take carbomer during as water-soluble base, in prescription ratio, take each component, standby: carbomer 5-15g, tween 1-3g, glycerol 40-60g, antiseptic 0.5-1.5g in every 1000g gel, surplus is water (preferably purified water);
When C, Rhizoma Curcumae Longae water or alcohol extraction, collect its volatile oil, extracting solution A is concentrated, and volatile oil and extracting solution A are standby;
D, by after Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Glycyrrhizae water or alcohol extraction, obtain extracting solution B, standby;
E, pulverizing sulfur;
F, Borneolum Syntheticum, Mentholum, antiseptic are dissolved in to organic solvent, obtain mixture A, standby;
G, carbomer add water-soluble swollen, add successively after tween, extracting solution A, extracting solution B, mixture A, glycerol, sulfur, mix homogeneously, mend and add water to 1000g;
H, adjust pH to 6.5～7.0.
If take cellulose derivative during as water-soluable gel substrate, preparation method is:
A, weighting raw materials in proportion: the contained crude drug of every 1000g gel is comprised of Radix Et Rhizoma Rhei 20-68g, Rhizoma Curcumae Longae 1-40g, Radix Scutellariae 1-10g, Radix Glycyrrhizae 3-10g, sulfur 20-40g, Borneolum Syntheticum 0.1-6.5g, Mentholum 0.1-4.5g;
B, take cellulose derivative during as water-soluable gel substrate, in prescription ratio, take each component, standby: in every 1000g gel, contain cellulose derivative (preferably carboxymethyl cellulose sodium) 50-150g, glycerol 100-400g, surplus is water (preferably purified water);
When C, Rhizoma Curcumae Longae water or alcohol extraction, collect its volatile oil, extracting solution A is concentrated, and volatile oil and extracting solution A are standby;
D, by after Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Glycyrrhizae water or alcohol extraction, obtain extracting solution B, standby;
E, pulverizing sulfur;
F, cellulose derivative (preferably carboxymethyl cellulose sodium) and glycerol are ground well, heating swelling, after a few hours, adds water to 1000ml;
G, extracting solution A, extracting solution B are dissolved in suitable quantity of water, and sulfur, Borneolum Syntheticum, Mentholum and glycerol are ground well, and mix with substrate.
To sum up, the preparation technology of gel of the present invention is easy, easy to operate, and the gel preparing is evident in efficacy clinically, excellent compared with ointment, and is not infected with medicated clothing, good patient compliance.
The specific embodiment
By specific description of embodiments of the present invention, illustrate but do not limit the present invention below.
Although the happy ointment of the yellow skin of ice is evident in efficacy aspect treatment dermatitis, wet disease, because the happy ointment of the yellow skin of ice is plain after smearing, be easily infected with medicated clothing in application, not too by extensive patients, accepted.
External preparation of the present invention is by changing material treatment process and the product forms of the happy ointment of the yellow skin of field ice, but above-mentioned change does not reduce its effect, still has antiinflammatory, antipruritic and disinfection effect.The weight proportion of its crude drug is: Radix Et Rhizoma Rhei 20-68 part, Rhizoma Curcumae Longae 1-40 part, Radix Scutellariae 1-10 part, Radix Glycyrrhizae 3-10 part, sulfur 20-40 part, Borneolum Syntheticum 0.1-6.5 part, Mentholum 0.1-4.5 part.
The preferred weight proportion of crude drug is preferred: Radix Et Rhizoma Rhei 30-40 part, Rhizoma Curcumae Longae 20-30 part, Radix Scutellariae 3-7 part, Radix Glycyrrhizae 3-7 part, sulfur 20-25 part, Borneolum Syntheticum 0.1-3.5 part, Mentholum 1.5-3.5 part.
Further, the preferred optimum weight proportioning of crude drug is: when 1.8 parts of 30 parts of Radix Et Rhizoma Rhei, 20 parts, Rhizoma Curcumae Longae, 4 parts of Radix Scutellariaes, 4 parts, Radix Glycyrrhizae, 20 parts of sulfurs, 2 parts of Borneolum Syntheticums, Mentholum, curative effect is the most stable, definite.
One, one of the present invention's improvement is the extracting method of crude drug, and its preparation method is as follows:
A, by after Radix Et Rhizoma Rhei, Rhizoma Curcumae Longae, Radix Scutellariae, Radix Glycyrrhizae water or alcohol extraction, obtain extracting solution, standby;
B, extracting solution, sulfur, Borneolum Syntheticum, Mentholum and pharmaceutically acceptable adjuvant are prepared to external preparation according to conventional method pharmaceutically.
Wherein, in crude drug, Rhizoma Curcumae Longae, for containing volatile ingredient, when water or alcohol extraction, needs to collect its volatile oil standby.
The extraction conditions of Rhizoma Curcumae Longae is: adds 6-12 times of water gaging and extracts, and collect volatile oil, and Rhizoma Curcumae Longae extracting liquid filtering, concentrated, standby.Wherein preferred process mode has: (1) amount of water preferably adds 10 times of water gagings and extracts.(2) concentrated is that Rhizoma Curcumae Longae extracting solution is concentrated into density 50-60 ℃ time is 1.00～1.20.(3) extraction conditions is extraction time 1-2 time, each 1-2 hour.
Be that preferred version is: Rhizoma Curcumae Longae adds 10 times of water gagings extracts, extraction time 1-2 time, each 1-2 hour, collects volatile oil, standby; Rhizoma Curcumae Longae extracting liquid filtering, is concentrated into density in the time of 50-60 ℃ and is 1.00～1.20, standby.For improving extraction efficiency, extract after also curcuma powder can being broken into granule.
Owing to containing the volatile oil of 7% left and right in Rhizoma Curcumae Longae, it is one of important effective ingredient.First carry out volatile oil and collect, avoid losing in leaching process.Volatile oil acquisition time is too short, extract not exclusively, overlong time, power consumption is large, and man-hour is long, and cost is high, therefore inventor investigates the extraction of Rhizoma Curcumae Longae volatile ingredient, with volatile oil determination apparatus, at official hour, measure, the meansigma methods of oil mass is got in experiment in triplicate (medical materials in the different places of production), the results are shown in Table 1.
Table 1 Rhizoma Curcumae Longae is extracted the meansigma methods of volatile oil different time
Above result shows: being extracted in 3～4 hours and substantially extracting completely of volatile oil, and the amount of volatile oil increases less from 3 hours, and institute's work consuming duration, energy consumption is many, therefore extract and be advisable for 2 hours, 1～2 hour can be shortened, and 90.5% (0.76/0.84=90.5%) of volatile oil total amount can be extracted.Therefore Rhizoma Curcumae Longae volatile oil acquisition time should be controlled at 2-4 hour, preferably 2 hours.
In crude drug, Radix Scutellariae, Radix Glycyrrhizae, Radix Et Rhizoma Rhei be not containing volatile ingredient, therefore adopt following methods to extract: add 6-12 times of water gaging or ethanol extraction, and extracting liquid filtering, concentrated, standby.Wherein preferred process mode has: (1) is 70-90%.v/v ethanol extraction preferably.(2) preferred extraction time is 1-2 time, each 1-2 hour.(3) preferably concentratedly refer to that it is 1.00～1.20 that extracting solution is concentrated into density 50-60 ℃ time.
Be that preferred version is: Radix Scutellariae, Radix Glycyrrhizae, Radix Et Rhizoma Rhei add 6-12 and doubly measure 60-90%.v/v ethanol extraction, extraction time 1-2 time, each 1-2 hour, extracting liquid filtering, is concentrated into density in the time of 50-60 ℃ and is 1.00～1.20, standby.As extract twice, and add for the first time 10 times of amount 75-90%.v/v ethanol, extract 2 hours, add for the second time 6 times of amount 60-75%.v/v ethanol, extract 1 hour.For improving extraction efficiency, extract after can or being ground into granule by Radix Scutellariae, Radix Glycyrrhizae, Radix Et Rhizoma Rhei section.
Crude drug sulfur is used further to preparation after should pulverizing, and is preferably ground into impalpable powder.
Two, two of the present invention's improvement variations that are dosage form.
Adopt one of improvement extracting method to process after crude drug, can be made into ointment, gel, liniment, varnish, tincture, aerosol, ointment.Especially be suitable for and make the gel that substrate is water-soluable gel substrate, make into after gel, patient Geng Yi accepts.The common carbomer of water-soluable gel substrate, tragacanth, gelatin, starch, cellulose derivative, carbopol, sodium alginate etc. add water, glycerol, propylene glycol etc. and make.
The preferred carbomer of the present invention is water-soluble base, its prescription ratio is: in every 1000g gel, contain carbomer 5-15g, solubilizing agent (can adopt poloxamer etc., preferred tween, especially preferably Tween 80) 1-3g, glycerol 40-60g, surplus is water (preferably purified water).
Can also cellulose derivative be water-soluable gel substrate, prescription ratio be: in every 1000g gel, contain cellulose-derived (preferably carboxymethyl cellulose sodium) 50-150g, glycerol 100-400g, surplus is water (preferably purified water).
Following gel prepare example.
Embodiment 1
Prescription:
Radix Et Rhizoma Rhei 30g, Rhizoma Curcumae Longae 20g, Radix Scutellariae 4g, Radix Glycyrrhizae 4g, sulfur 20g, Borneolum Syntheticum 2g, Mentholum 1.8g;
Substrate: carbomer 10g, Tween 80 2g, glycerol 50g, ethyl hydroxybenzoate 1g, surplus is water.
Method for making:
A, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Glycyrrhizae, Rhizoma Curcumae Longae, be ground into granule, adds for the first time 10 times of water gagings and decoct 2 hours, adds for the second time 6 times of water gagings and decoct 1 hour, filters, and merges decocting liquid, is concentrated into 1.05～1.10 (55 ℃), standby;
B, pulverizing sulfur become fine powder;
C, Borneolum Syntheticum, Mentholum, ethyl hydroxybenzoate dissolve with ethanol, obtain mixture A, standby
D, carbomer add water-soluble swollen, add successively after Tween 80, steps A gained concentrate, mixture A, glycerol, sulfur, mix homogeneously, mend and add water to 1000g;
E, adjust pH to 6.5～7.0, obtain.
Embodiment 2
Prescription:
Radix Et Rhizoma Rhei 68g, Rhizoma Curcumae Longae 40g, Radix Scutellariae 10g, Radix Glycyrrhizae 10g, sulfur 20g, Borneolum Syntheticum 6.5g, Mentholum 4.5g;
Substrate: carbomer 15g, Tween 80 3g, glycerol 50g, ethyl hydroxybenzoate 1.5g, surplus is water.
Method for making:
A, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Glycyrrhizae, Rhizoma Curcumae Longae, be ground into granule, adds for the first time 12 times of water gagings and decoct 2 hours, adds for the second time 8 times of water gagings and decoct 1 hour, filters, and merges decocting liquid, is concentrated into 1.05～1.10 (60 ℃), standby;
B, pulverizing sulfur become impalpable powder;
C, Borneolum Syntheticum, Mentholum, ethyl hydroxybenzoate dissolve with ethanol, obtain mixture A, standby
D, carbomer add water-soluble swollen, add successively after Tween 80, steps A gained concentrate, mixture A, glycerol, sulfur, mix homogeneously, mend and add water to 1000g;
E, adjust pH to 6.5～7.0, obtain.
Embodiment 3
Prescription:
Radix Et Rhizoma Rhei 30g, Rhizoma Curcumae Longae 20g, Radix Scutellariae 4g, Radix Glycyrrhizae 3g, sulfur 40g, Borneolum Syntheticum 2g, Mentholum 1.8g;
Substrate: carbomer 15g, Tween 80 3g, glycerol 50g, sodium benzoate 1.5g, surplus is water.
Method for making:
A, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Glycyrrhizae, Rhizoma Curcumae Longae, be ground into granule, adds for the first time 10 times of water gagings and decoct 2 hours, adds for the second time 6 times of water gagings and decoct 1 hour, filters, and merges decocting liquid, is concentrated into 1.05～1.10 (55 ℃), standby;
B, pulverizing sulfur become fine powder;
C, Borneolum Syntheticum, Mentholum, sodium benzoate dissolve with ethanol, obtain mixture A, standby
D, carbomer add water-soluble swollen, add successively after Tween 80, steps A gained concentrate, mixture A, glycerol, sulfur, mix homogeneously, mend and add water to 1000g;
E, adjust pH to 6.5～7.0, obtain.
Embodiment 4
Prescription:
Radix Et Rhizoma Rhei 30g, Rhizoma Curcumae Longae 20g, Radix Scutellariae 4g, Radix Glycyrrhizae 10g, sulfur 30g, Borneolum Syntheticum 2g, Mentholum 1.8g;
Substrate: carbomer 10g, Tween 80 2g, glycerol 50g, sorbic acid 1g, surplus is water.
Method for making:
A, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Glycyrrhizae, Rhizoma Curcumae Longae, be ground into granule, adds for the first time 10 times of water gagings and decoct 2 hours, adds for the second time 6 times of water gagings and decoct 1 hour, filters, and merges decocting liquid, is concentrated into 1.05～1.10 (55 ℃), standby;
B, pulverizing sulfur become fine powder;
C, Borneolum Syntheticum, Mentholum, sorbic acid dissolve with ethanol, obtain mixture A, standby
D, carbomer add water-soluble swollen, add successively after Tween 80, steps A gained concentrate, mixture A, glycerol, sulfur, mix homogeneously, mend and add water to 1000g;
E, adjust pH to 6.5～7.0, obtain.
Embodiment 5
Prescription:
Radix Et Rhizoma Rhei 40g, Rhizoma Curcumae Longae 20g, Radix Scutellariae 4g, Radix Glycyrrhizae 7g, sulfur 20g, Borneolum Syntheticum 2g, Mentholum 1.8g;
Substrate: carbomer 10g, Tween 80 2g, glycerol 50g, sorbic acid 1g, surplus is water.
Method for making:
A, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Glycyrrhizae, Rhizoma Curcumae Longae, be ground into granule, adds for the first time 10 times of water gagings and decoct 2 hours, adds for the second time 6 times of water gagings and decoct 1 hour, filters, and merges decocting liquid, is concentrated into 1.05～1.10 (55 ℃), standby;
B, pulverizing sulfur become fine powder;
C, Borneolum Syntheticum, Mentholum, sorbic acid dissolve with ethanol, obtain mixture A, standby
D, carbomer add water-soluble swollen, add successively after Tween 80, steps A gained concentrate, mixture A, glycerol, sulfur, mix homogeneously, mend and add water to 1000g;
E, adjust pH to 6.5～7.0, obtain.
Embodiment 6
Prescription:
Radix Et Rhizoma Rhei 30g, Rhizoma Curcumae Longae 20g, Radix Scutellariae 4g, Radix Glycyrrhizae 4g, sulfur 20g, Borneolum Syntheticum 2g, Mentholum 1.8g;
Substrate: carbomer 10g, Tween 80 2g, glycerol 50g, ethyl hydroxybenzoate 1g, surplus is water.
Method for making:
A, curcuma powder are broken into granule, add 10 times of water gagings and extract 2 hours and collect volatile oil, and silk filters, and filtrate is concentrated into 1.05～1.10 (55 ℃), standby;
B, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Glycyrrhizae, be ground into granule, add for the first time 10 times of amount 85%v/v ethanol extractions 2 hours, add for the second time 6 times of amount 75%v/v ethanol extractions 1 hour, filter, merge, be concentrated into 1.05～1.10 (55 ℃), standby;
C, pulverizing sulfur become impalpable powder;
D, Borneolum Syntheticum, Mentholum, ethyl hydroxybenzoate dissolve with ethanol, obtain mixture A, standby
E, carbomer add water-soluble swollen, add successively after Tween 80, steps A and B gained concentrate, mixture A, glycerol, sulfur, mix homogeneously, mend and add water to 1000g;
F, adjust pH to 6.5～7.0, obtain.
Embodiment 7
Prescription:
Radix Et Rhizoma Rhei 40g, Rhizoma Curcumae Longae 20g, Radix Scutellariae 4g, Radix Glycyrrhizae 7g, sulfur 20g, Borneolum Syntheticum 2g, Mentholum 1.8g;
Substrate: carbomer 10g, Tween 80 2g, glycerol 50g, sodium benzoate 1g, surplus is water.
Method for making:
A, curcuma powder are broken into granule, add 10 times of water gagings and extract 2 hours and collect volatile oil, and silk filters, and filtrate is concentrated into 1.05～1.10 (55 ℃), standby;
B, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Glycyrrhizae, be ground into granule, add for the first time 10 times of amount 85%v/v ethanol extractions 2 hours, add for the second time 6 times of amount 75%v/v ethanol extractions 1 hour, filter, merge, be concentrated into 1.05～1.10 (55 ℃), standby;
C, pulverizing sulfur become impalpable powder;
D, Borneolum Syntheticum, Mentholum, sodium benzoate dissolve with ethanol, obtain mixture A, standby
E, carbomer add water-soluble swollen, add successively after Tween 80, steps A and B gained concentrate, mixture A, glycerol, sulfur, mix homogeneously, mend and add water to 1000g;
F, adjust pH to 6.5～7.0, obtain.
Embodiment 8
Prescription:
Radix Et Rhizoma Rhei 30g, Rhizoma Curcumae Longae 20g, Radix Scutellariae 4g, Radix Glycyrrhizae 7g, sulfur 20g, Borneolum Syntheticum 6.5g, Mentholum 4.5g;
Substrate: carbomer 10g, Tween 80 2g, glycerol 50g, sodium benzoate 1g, surplus is water.
Method for making:
A, curcuma powder are broken into granule, add 10 times of water gagings and extract 2 hours and collect volatile oil, and silk filters, and filtrate is concentrated into 1.05～1.10 (55 ℃), standby;
B, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Glycyrrhizae, be ground into granule, add for the first time 10 times of amount 85%v/v ethanol extractions 2 hours, add for the second time 6 times of amount 75%v/v ethanol extractions 1 hour, filter, merge, be concentrated into 1.05～1.10 (55 ℃), standby;
C, pulverizing sulfur become impalpable powder;
D, Borneolum Syntheticum, Mentholum, sodium benzoate dissolve with ethanol, obtain mixture A, standby
E, carbomer add water-soluble swollen, add successively after Tween 80, steps A and B gained concentrate, mixture A, glycerol, sulfur, mix homogeneously, mend and add water to 1000g;
F, adjust pH to 6.5～7.0, obtain.
Embodiment 9
Prescription:
Radix Et Rhizoma Rhei 30g, Rhizoma Curcumae Longae 20g, Radix Scutellariae 10g, Radix Glycyrrhizae 4g, sulfur 20g, Borneolum Syntheticum 2g, Mentholum 1.8g;
Substrate: carbomer 10g, Tween 80 2g, glycerol 50g, sorbic acid 1g, surplus is water.
Method for making:
A, curcuma powder are broken into granule, add 10 times of water gagings and extract 2 hours and collect volatile oil, and silk filters, and filtrate is concentrated into 1.05～1.10 (55 ℃), standby;
B, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Glycyrrhizae, be ground into granule, add for the first time 10 times of amount 85%v/v ethanol extractions 2 hours, add for the second time 6 times of amount 75%v/v ethanol extractions 1 hour, filter, merge, be concentrated into 1.05～1.10 (55 ℃), standby;
C, pulverizing sulfur become impalpable powder;
D, Borneolum Syntheticum, Mentholum, sorbic acid dissolve with ethanol, obtain mixture A, standby
E, carbomer add water-soluble swollen, add successively after Tween 80, steps A and B gained concentrate, mixture A, glycerol, sulfur, mix homogeneously, mend and add water to 1000g;
F, adjust pH to 6.5～7.0, obtain.
Embodiment 10
Prescription:
Radix Et Rhizoma Rhei 30g, Rhizoma Curcumae Longae 20g, Radix Scutellariae 5g, Radix Glycyrrhizae 4g, sulfur 20g, Borneolum Syntheticum 2g, Mentholum 1.8g;
Substrate: sodium carboxymethyl cellulose 60g, glycerol 150g, sorbic acid 1g, surplus are water.
Method for making:
A, curcuma powder are broken into granule, add 10 times of water gagings and extract 2 hours and collect volatile oil, and silk filters, and filtrate is concentrated into 1.05～1.10 (55 ℃), standby;
B, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Glycyrrhizae, be ground into granule, add for the first time 10 times of amount 85%v/v ethanol extractions 2 hours, add for the second time 6 times of amount 75%v/v ethanol extractions 1 hour, filter, merge, be concentrated into 1.05～1.10 (55 ℃), standby;
C, pulverizing sulfur become impalpable powder;
D, sodium carboxymethyl cellulose and glycerol are ground well, heating swelling, after a few hours, adds sorbic acid, adds water to 1000ml;
E, steps A and B gained extracting solution are dissolved in suitable quantity of water, sulfur, Borneolum Syntheticum, Mentholum and glycerol are ground well, mix with substrate.
Embodiment 11
Prescription:
Radix Et Rhizoma Rhei 30g, Rhizoma Curcumae Longae 20g, Radix Scutellariae 10g, Radix Glycyrrhizae 7g, sulfur 20g, Borneolum Syntheticum 6.5g, Mentholum 4.5g;
Substrate: sodium carboxymethyl cellulose 60g, glycerol 150g, chlorobutanol 1g, surplus are water.
Method for making:
A, curcuma powder are broken into granule, add 10 times of water gagings and extract 2 hours and collect volatile oil, and silk filters, and filtrate is concentrated into 1.05～1.10 (55 ℃), standby;
B, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Glycyrrhizae, be ground into granule, add for the first time 10 times of amount 85%v/v ethanol extractions 2 hours, add for the second time 6 times of amount 75%v/v ethanol extractions 1 hour, filter, merge, be concentrated into 1.05～1.10 (55 ℃), standby;
C, pulverizing sulfur become impalpable powder;
D, sodium carboxymethyl cellulose and glycerol are ground well, heating swelling, after a few hours, adds chlorobutanol, adds water to 1000ml;
E, steps A and B gained extracting solution are dissolved in suitable quantity of water, sulfur, Borneolum Syntheticum, Mentholum and glycerol are ground well, mix with substrate.
Embodiment 12
Prescription:
Radix Et Rhizoma Rhei 30g, Rhizoma Curcumae Longae 20g, Radix Scutellariae 10g, Radix Glycyrrhizae 3g, sulfur 40g, Borneolum Syntheticum 2g, Mentholum 1.8g;
Substrate: sodium carboxymethyl cellulose 100g, glycerol 250g, chlorobutanol 1g, surplus are water.
Method for making:
A, curcuma powder are broken into granule, add 10 times of water gagings and extract 2 hours and collect volatile oil, and silk filters, and filtrate is concentrated into 1.05～1.10 (55 ℃), standby;
B, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Glycyrrhizae, be ground into granule, add for the first time 10 times of amount 85%v/v ethanol extractions 2 hours, add for the second time 6 times of amount 75%v/v ethanol extractions 1 hour, filter, merge, be concentrated into 1.05～1.10 (55 ℃), standby;
C, pulverizing sulfur become impalpable powder;
D, sodium carboxymethyl cellulose and glycerol are ground well, heating swelling, after a few hours, adds chlorobutanol, adds water to 1000ml;
E, steps A and B gained extracting solution are dissolved in suitable quantity of water, sulfur, Borneolum Syntheticum, Mentholum and glycerol are ground well, mix with substrate.
One, Experimental agents:
1, by the prescription of embodiment 1 and 7 and method for making, two batches of gels have been prepared respectively, hereinafter to be referred as gel embodiment 1, gel embodiment 7.
2, the happy ointment of the yellow skin of commercial ice.
Two, case distributes and grouping situation:
Selected case is clinical clarifying a diagnosis as subacute eczema, chronic eczema, contact dermatitis, neurodermatitis, tinea manus and pedis all, uses at random gel or emulsifiable paste, contrast therapy effect.Grouping situation is asked for an interview table 1.
Table 1 clinical case distributes and grouping
| Subacute eczema | Chronic eczema | Contact dermatitis | Neurodermatitis | Tinea manus and pedis | Virus infected herpes | |
| Gel embodiment 1 | 40 examples | 60 examples | 20 examples | 30 examples | 30 examples | 30 examples |
| Gel embodiment 7 | 40 examples | 60 examples | 20 examples | 30 examples | 30 examples | 30 examples |
| The happy ointment of the yellow skin of ice | 40 examples | 60 examples | 20 examples | 30 examples | 30 examples | 30 examples |
Three, Therapeutic Method and observation of curative effect
1, Therapeutic Method
In gel embodiment group, morning, noon and afternoon every day each with 1 corresponding medicine painting, put on the skin in affected part, gel smoothens in affected part, ointment need gently be rubbed to drug absorption, 1～3 week was 1 course for the treatment of, during medication without other external used medicines.
2, observation of curative effect
Clinical indexes and score erythema, pimple, infiltration or lichenization, keratinization desquamation, pruritus etc.During each assessment, by 4 grades of point systems, undertaken: 0=without, 1=is slight, 2=moderate, 3=severe.
Therapeutic evaluation: integrated value computing formula is: total mark * 100% before (the rear integration of integration-treatment before integrated value=treatment)/treatment.
Cure: integrated value reduces > 95%;
Effective: integrated value reduces 61%～95%;
Take a turn for the better: integrated value reduces 20%～60%;
Invalid: integrated value reduces < 20%.
Four, therapeutic outcome, in Table 2-4.
Table 2 gel embodiment 1 treatment dermatitis, eczema dermatosis clinical efficacy
Table 3 gel embodiment 7 treatment dermatitis, eczema dermatosis clinical efficacy
The happy Ointment in Treatment dermatitis of the yellow skin of table 4 ice, eczema dermatosis clinical efficacy
Visible by above-mentioned clinical statistics data: gel embodiment 1 and gel embodiment 7 total effective rates are all better than the happy ointment of the yellow skin of ice; Two gels are when treatment subacute eczema, contact dermatitis, and total effective rate can improve 3-5 percentage point.
And patient is more prone to use gel in use, as long as because gel smoothens, can not be infected with medicated clothing yet, it is light yellow or transparent that color is, and smears rear color not obvious, very do not affect attractive in appearance.And ointment also needs massage until absorb after smearing, otherwise ointment can be infected with medicated clothing, and ointment color is darker, after smearing and skin color contrast obvious, affect attractive in appearance.
Gel of the present invention can be realized therapeutical effect and have advantage that effective percentage is high and the characteristic of gel and the substrate of employing have compared with Important Relations.First, gel becomes to grade to form (thin film) (protective layer) protection wound surface at used time carbomer, cellulose matrix, and totally clean, patient's compliance is strong, is beneficial to the normal use of medicine; Secondly, the effective ingredient in medicine, because organic solvent volatilizees, is detained in carbomer, cellulose matrix composition, plays slow releasing function, guarantees the stable of blood drug level, is beneficial to medicine and plays a role, and improves curative effect.
To sum up, the invention provides a kind of gel with antiinflammatory, antipruritic and disinfection effect, apply the dermatosiss such as this gel treatment subacute eczema, chronic eczema, contact dermatitis, neurodermatitis, tinea manus and pedis, virus infected herpes, evident in efficacy, good patient compliance, for clinical practice provides a kind of brand-new selection.
Claims (5)
1. the gel with antiinflammatory, antipruritic and disinfection effect, the weight proportion of its crude drug is: Radix Et Rhizoma Rhei 30g, Rhizoma Curcumae Longae 20g, Radix Scutellariae 4g, Radix Glycyrrhizae 4g, sulfur 20g, Borneolum Syntheticum 2g, Mentholum 1.8g; Substrate: carbomer 10g, Tween 80 2g, glycerol 50g, ethyl hydroxybenzoate 1g, surplus is water, it is characterized in that: it is to prepare by the following method:
A, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Glycyrrhizae, Rhizoma Curcumae Longae, be ground into granule, adds for the first time 10 times of water gagings and decoct 2 hours, adds for the second time 6 times of water gagings and decoct 1 hour, filters, and merges decocting liquid, is concentrated into 55 ℃ of relative densities and is 1.05～1.10, standby;
B, pulverizing sulfur become fine powder;
C, Borneolum Syntheticum, Mentholum, ethyl hydroxybenzoate dissolve with ethanol, obtain mixture A, standby;
D, carbomer add water-soluble swollen, add successively after Tween 80, steps A gained concentrate, mixture A, glycerol, sulfur, mix homogeneously, mend and add water to 1000g;
E, adjust pH to 6.5～7.0, obtain.
2. the preparation method with the gel of antiinflammatory, antipruritic and disinfection effect claimed in claim 1, is characterized in that:
The weight proportion of crude drug is: Radix Et Rhizoma Rhei 30g, Rhizoma Curcumae Longae 20g, Radix Scutellariae 4g, Radix Glycyrrhizae 4g, sulfur 20g, Borneolum Syntheticum 2g, Mentholum 1.8g; Substrate: carbomer 10g, Tween 80 2g, glycerol 50g, ethyl hydroxybenzoate 1g, surplus is water;
Preparation method is as follows:
A, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Glycyrrhizae, Rhizoma Curcumae Longae, be ground into granule, adds for the first time 10 times of water gagings and decoct 2 hours, adds for the second time 6 times of water gagings and decoct 1 hour, filters, and merges decocting liquid, is concentrated into 55 ℃ of relative densities and is 1.05～1.10, standby;
B, pulverizing sulfur become fine powder;
C, Borneolum Syntheticum, Mentholum, ethyl hydroxybenzoate dissolve with ethanol, obtain mixture A, standby;
D, carbomer add water-soluble swollen, add successively after Tween 80, steps A gained concentrate, mixture A, glycerol, sulfur, mix homogeneously, mend and add water to 1000g;
E, adjust pH to 6.5～7.0, obtain.
3. the gel with antiinflammatory, antipruritic and disinfection effect, the weight proportion of its crude drug is: Radix Et Rhizoma Rhei 40g, Rhizoma Curcumae Longae 20g, Radix Scutellariae 4g, Radix Glycyrrhizae 7g, sulfur 20g, Borneolum Syntheticum 2g, Mentholum 1.8g; Substrate: carbomer 10g, Tween 80 2g, glycerol 50g, sodium benzoate 1g, surplus is water, it is characterized in that: it is to prepare by the following method:
A, curcuma powder are broken into granule, add 10 times of water gagings and extract 2 hours and collect volatile oil, and silk filters, and filtrate is concentrated into 55 ℃ of relative densities and is 1.05～1.10, standby;
B, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Glycyrrhizae, be ground into granule, add for the first time 10 times of amount 85%v/v ethanol extractions 2 hours, add for the second time 6 times of amount 75%v/v ethanol extractions 1 hour, filter, merge, be concentrated into 55 ℃ of relative densities and be 1.05～1.10, standby;
C, pulverizing sulfur become impalpable powder;
D, Borneolum Syntheticum, Mentholum, sodium benzoate dissolve with ethanol, obtain mixture A, standby;
E, carbomer add water-soluble swollen, add successively after Tween 80, steps A and B gained concentrate, mixture A, glycerol, sulfur, mix homogeneously, mend and add water to 1000g;
F, adjust pH to 6.5～7.0, obtain.
4. the preparation method with the gel of antiinflammatory, antipruritic and disinfection effect claimed in claim 3, is characterized in that:
The weight proportion of crude drug is:
Radix Et Rhizoma Rhei 40g, Rhizoma Curcumae Longae 20g, Radix Scutellariae 4g, Radix Glycyrrhizae 7g, sulfur 20g, Borneolum Syntheticum 2g, Mentholum 1.8g; Substrate: carbomer 10g, Tween 80 2g, glycerol 50g, sodium benzoate 1g, surplus is water;
Preparation method is as follows:
A, curcuma powder are broken into granule, add 10 times of water gagings and extract 2 hours and collect volatile oil, and silk filters, and filtrate is concentrated into 55 ℃ of relative densities and is 1.05～1.10, standby;
B, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Glycyrrhizae, be ground into granule, add for the first time 10 times of amount 85%v/v ethanol extractions 2 hours, add for the second time 6 times of amount 75%v/v ethanol extractions 1 hour, filter, merge, be concentrated into 55 ℃ of relative densities and be 1.05～1.10, standby;
C, pulverizing sulfur become impalpable powder;
D, Borneolum Syntheticum, Mentholum, sodium benzoate dissolve with ethanol, obtain mixture A, standby;
E, carbomer add water-soluble swollen, add successively after Tween 80, steps A and B gained concentrate, mixture A, glycerol, sulfur, mix homogeneously, mend and add water to 1000g;
F, adjust pH to 6.5～7.0, obtain.
5. the purposes of the gel with antiinflammatory, antipruritic and disinfection effect described in claim 1 or 3 any one in the medicine of preparation treatment virus infected herpes.
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| CN201110346212.1A CN102370947B (en) | 2010-11-05 | 2011-11-04 | External preparation with effects of diminishing inflammation, relieving itching, disinfecting and sterilizing and preparation method thereof |
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| CN201010533772.3 | 2010-11-05 | ||
| CN201110346212.1A CN102370947B (en) | 2010-11-05 | 2011-11-04 | External preparation with effects of diminishing inflammation, relieving itching, disinfecting and sterilizing and preparation method thereof |
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| CN101361951A (en) * | 2008-09-19 | 2009-02-11 | 西藏芝芝药业有限公司 | Skin external preparation with anti-inflammation, itching-relieving and disinfection and sterilization function and preparation method thereof |
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Address after: Lhasa City, Tibet autonomous region 850000 Lhasa economic and Technological Development Zone space mulberry road southeast, southwest Tajielu Patentee after: Tibet Hairong tanggo Pharmaceutical Co. Ltd. Address before: 850000 Lhasa, Tibet autonomous region, No. 54, No. Patentee before: Tibet Zhizhi Pharmacy Group Co., Ltd. |