CN1943676A - Lyrate nightshade gelatin and its preparation method and use - Google Patents
Lyrate nightshade gelatin and its preparation method and use Download PDFInfo
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- CN1943676A CN1943676A CN 200610122432 CN200610122432A CN1943676A CN 1943676 A CN1943676 A CN 1943676A CN 200610122432 CN200610122432 CN 200610122432 CN 200610122432 A CN200610122432 A CN 200610122432A CN 1943676 A CN1943676 A CN 1943676A
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Abstract
This invention relates to the field of medical preparations, revealing a Lyrate nightshade gelatin and its preparation method and use. Performance and quality of the gelatin processed by the method of this invention is table. Compared with the common used external applied soft creams, the lyrate nightshade gelatin has many strong points: easy outspreading of its coated cloth, easy absorbed, fast action, without greasiness. Animal test results indicate that the gelatin can be used effectively to treat eczema and fungal skin disease. Toxin tests show that the gelatin is clinically safe. It can be safely and effectively externally used to treat chromic moist symptom, dermatistis, mycodermatitis. In the lyrate nightshade gelatin of this invention, the abstract from lyrate is 0.5-20%, gelatin matrix 1.5-30%, transdermal accelerant 0.05-8.0%, the moisture remaining agent 1.0-20%, the antiseptic 0.15-8.0% of the weight of the gelatin.
Description
Technical field
The present invention relates to Chinese medicine and natural medicinal formulations field, relate in particular to Herba Solani Lyrati extract gel and its production and application.
Technical background
Herba Solani Lyrati (Solanum lyratum Thunb) is equal congener with bittersweet (S.cathayanum C.Y.Wu etS.C.Huang), the identical and Chang Gongsheng of growing environment, two kind of plant Chang Tongyong.The Herba Solani Lyrati herb contains alkaloid; Contain steroid alkaloid in the bittersweet stem, as lycopene alkali (Tomatidenoi), solasonine (Solasodine), soladulcine (Soladulcidine) etc.Herba Solani Lyrati and bittersweet contained steroid alkaloid and saponin all have antibacterial activity, and wherein the effect of tomatidine is stronger, have antiinflammatory, antiallergic, antipruritic and immunosuppressive action; Extract adds different adjuvants and makes the treatment that gel can be used for eczema and dermatomycosis, alternative cortisone; These product can promote the raising of domestic medical level, have very important social meaning and economic implications.
We still belong to the first time as the single drug development research at home with Herba Solani Lyrati extract, Chinese patent " a kind of preparation method of plant of Solanaceae Herba Solani Lyrati extract ", application number is 200410051623.8, disclose the Herba Solani Lyrati extract preparation method first, Herba Solani Lyrati extract gel preparation preparation method does not see that report is arranged at present.
Summary of the invention
The purpose of this invention is to provide a kind of Herba Solani Lyrati extract external preparation---Herba Solani Lyrati extract gel and preparation method thereof.
Another object of the present invention is the application of open Herba Solani Lyrati extract gel treatment eczema and dermatomycosis.
Purpose of the present invention can reach by following measure:
Herba Solani Lyrati extract gel of the present invention contains Herba Solani Lyrati extract and gel-type vehicle as active medicinal matter.Wherein gel-type vehicle is pharmaceutically commonly used, as one or both the mixture in carbomer U-21, polyvinylpyrrolidone, Polyethylene Glycol, polyvinyl alcohol, methylcellulose, ethyl cellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose, hypromellose, sodium carboxymethyl cellulose, gelatin, the sodium alginate with any mixed, one or both the mixture in preferred carbomer, sodium carboxymethyl cellulose, hydroxypropyl cellulose, polyvinyl alcohol, the polyvinylpyrrolidone with any mixed.
Other adjuvants of gel of the present invention can further contain transdermal enhancer, wetting agent, pH regulator agent, antiseptic etc.
Transdermal enhancer can be one or more mixture with any mixed in the transdermal enhancers such as sulfoxide class, pyrrolones, azone and analog, fatty acid and ester thereof, surfactant, alcohols, polyalcohols, terpenes, amide-type, cyclodextrin, aminoacid and ester thereof, macrocyclic compound, organic acid, phospholipid, as one or more mixture with any mixed in ethanol, propylene glycol, laurocapram, the oleic acid etc.
Wetting agent is one or both mixture with any mixed in glycerol, propylene glycol, Polyethylene Glycol, sorbitol, the maltose alcohol.
The pH regulator agent is triethanolamine, ethylenediamine, lauryl amine, ammonia spirit, sodium bicarbonate, sodium hydroxide or potassium hydroxide etc.
Antiseptic is one or both mixture with any mixed in ethanol, chlorocresol, thimerosal, sorbic acid, potassium sorbate, benzoic acid, sodium benzoate, chlorobutanol, Buddhist nun's paper tinsel tortoise beetle ester, ethylparaben, the Buddhist nun's paper tinsel gold propyl ester.
Herba Solani Lyrati extract gel of the present invention, wherein the weight of Herba Solani Lyrati extract accounts for 0.1~30.0% of gel weight, and preferred 0.5~20.0%; The weight of gel-type vehicle accounts for 5~40.0% of gel weight, and preferred 1.5~30.0%%; The weight of transdermal enhancer accounts for 0.1~30.0% of gel weight, and preferred 0.05~8.0%; The weight of wetting agent accounts for 2.0~35.0% of gel weight, and preferred 1.0~20.0%; The weight of antiseptic accounts for 0.15~20.0% of gel weight, and preferred 0.15~8.0%; The weight of stabilizing agent accounts for 0.008~0.2% of gel weight, and preferred 0.01~0.075%.
Herba Solani Lyrati extract gel of the present invention adopts following preparation technology:
A, with the Herba Solani Lyrati extract of formula ratio, add an amount of dissolved in distilled water;
B, the wetting agent of formula ratio is added suitable quantity of water, stirring and dissolving;
C, take by weighing an amount of transdermal enhancer, add distilled water, heating in water bath, the dissolving back is standby;
D, mix above-mentioned solution, add pigment toning, standardize solution; An amount of to its adding gel-type vehicle, stirring and dissolving adds antiseptic again, adds pH regulator agent adjust pH to 6.8-7.8, stirs evenly, and weighs, and adds distilled water to gross weight, packing, finished product.
Even according to the prepared Herba Solani Lyrati extract gel of the present invention exquisite quality.
Investigated the influence of factors such as light, heat (40 ℃, 60 ℃), low temperature to gel stability of the present invention, the result shows that every index there is no significant change, shows gel steady quality of the present invention.
Below by the animal test results of Herba Solani Lyrati extract gel of the present invention and active component Herba Solani Lyrati extract thereof, further specify the application of the present invention in preparation treatment eczema and dermatomycosis medicine.
Animal acute toxicity experiment shows that the Herba Solani Lyrati extract gel is nontoxic substantially, also is safe even enter human body by skin absorbs, and clinical external can be provided.Behind each medicine group percutaneous coating administration 24h, dispel and tried to observe behind the thing, 1h, 24h, 48h, 72h to the observed on the 7th, it is good that each organizes ordinary circumstance, the skin and hair smoothness, the no change of eye and mucosa is breathed normal, physical agility, movable normal, strong-limbed is not seen other poisoning manifestations, weight increase, all survival; Compare basically identical with the blank group.
Body weight change n=10 before and after table 1 administration
Group | Dosage | Number of animals | 0d(X±SD) | 7d(X±SD) | Gradient (%) * |
Blank group high dose intact skin group high dose damaged skin group low dosage intact skin group low dosage damaged skin group | 4ml 4ml 4ml 1ml 1ml | 10 10 10 10 10 | 300.9±5.6 302.1±5.8 301.7±7.5 298.2±8.7 302.3±7.8 | 354.6±6.7 356.8±11.4 352.5±9.7 351.2±12.4 354.7±8.6 | +17.8 +18.1 +16.8 +17.8 +17.3 |
*Show with administration before relatively ,+show increase.
Every day, secondary was applied to the guinea pig skin administration 24 hours by Cmax and volume, was equivalent to every Cavia porcellus medication 4ml, observed continuously seven days, did not see obvious acute toxic reaction, Cavia porcellus weight increase, all Cavia porcellus survivals.
This product long term toxicity test proves, in administration phase and convalescent period (2 weeks of drug withdrawal) animal generally in order, main hematological indices, biochemical indexes, urinalysis index etc. all belong to normal range, with blank group no difference of science of statistics relatively; Dissect the main organs naked eyes and do not see that obvious visible pathologic changes.Therefore, to use under clinical dosage be safe to this product.
Be subjected to reagent thing, blank substrate to repeat contact in the experiment of this product skin allergy by guinea pig skin, observe the reaction of body immune system on skin, all animals there is no erythema, edema and systemic anaphylaxis as a result, weight increase, with blank basically identical relatively, show that this product do not have anaphylactic reaction to body.
Pharmacology of this product and toxicological test show, the Herba Solani Lyrati extract gel has tangible antiinflammatory, antipruritic, repercussive effect, and the part strain had inhibitory action, as Pseudomonas aeruginosa, staphylococcus aureus, colon bacillus, Salmonella, Candida albicans; Body is not had anaphylactic reaction, and to the skin nonirritant, it is safe using under clinical dosage, and the Herba Solani Lyrati extract gel can be applied to clinical thus.
Gel of the present invention is compared with exterior-applied formulation ointment commonly used, tangible advantage is arranged: characteristics with water-soluble base, easily launch coating, be coated on the skin and can form clear films, adhesive force is strong, coating back skin is comfortable, do not have unhappy sense, effective with the skin coupling, no greasy feeling can be washed, act on rapidly etc., so gel is more suitable for the dermatosis patient local topical.
The specific embodiment
Be that the basis describes the present invention in detail below with embodiments of the invention, but the present invention is not limited to this.
Embodiment 1:
Prescription | Every (g) | 1000 (g) |
Herba Solani Lyrati extract | 0.1 | 100 |
Carbopol U-21 | 1.2 | 1200 |
Tween 80 | 0.75 | 750 |
Glycerol | 3.0 | 3000 |
Buddhist nun's paper tinsel tortoise beetle ester | 0.05 | 50 |
Oleum menthae | 0.0075 | 7.5 |
Triethanolamine | 0.2 | 200 |
Marennin I | 0.015 | 15 |
Distilled water adds to | 15 | 15000 |
Preparation method is as follows:
A, with the Herba Solani Lyrati extract of formula ratio, add an amount of dissolved in distilled water;
B, the glycerol of formula ratio and formula ratio tween 80 are mixed stirring and dissolving;
C, precision take by weighing Oleum menthae, add distilled water, heating in water bath, and the dissolving back is standby;
D, mix above-mentioned solution, add marennin I toning, standardize solution.It is an amount of to add carbopol U-21, and stirring and dissolving adds antiseptic Buddhist nun paper tinsel tortoise beetle ester again, adds about triethanolamine adjust pH to 6.8, stirs evenly, and weighs, and adds distilled water to gross weight, packing, finished product.
Embodiment 2:
Prescription | Every (g) | 1000 (g) |
Herba Solani Lyrati extract | 2.0 | 2000 |
Sodium carboxymethyl cellulose | 2.2 | 2200 |
Glycerol | 2.0 | 2000 |
Marennin I | 0.015 | 15 |
Laurocapram | 0.08 | 80 |
Potassium sorbate | 0.15 | 150 |
10% sodium hydroxide solution | In right amount | In right amount |
Distilled water adds to | 15 | 15000 |
Preparation method:
A, with the Herba Solani Lyrati extract of formula ratio, add an amount of dissolved in distilled water;
B, the glycerol of formula ratio is added suitable quantity of water, stirring and dissolving;
C, precision take by weighing laurocapram, add distilled water, heating in water bath, and the dissolving back is standby;
D, mix above-mentioned solution, add marennin I toning, standardize solution.It is an amount of to add sodium carboxymethyl cellulose, and stirring and dissolving adds potassium sorbate preservative again, adds about 10% sodium hydroxide solution adjust pH to 6.8, stirs evenly, and weighs, and adds distilled water to gross weight, packing, finished product.
Embodiment 3:
Prescription | Every (g) | 1000 (g) |
Herba Solani Lyrati extract | 0.2 | 200 |
Carbopol U-21 | 0.15 | 150 |
Marennin I | 0.015 | 15 |
Propylene glycol | 1.5 | 1500 |
Triethanolamine | 0.2 | 200 |
Dehydrated alcohol | 1.5 | 1500 |
Oleic acid | 1.5 | 1500 |
Ethylparaben | 0.008 | 8 |
Distilled water | 9.917 | 9917 |
Gross weight | 15 | 15000 |
Preparation method is as follows:
A, with the Herba Solani Lyrati extract of formula ratio, add an amount of dissolved in distilled water;
B, formula ratio dehydrated alcohol add suitable quantity of water, stir;
C, formula ratio oleic acid is dissolved in an amount of distilled water, the formula ratio ethylparaben is dissolved in the formula ratio propylene glycol, mixing both;
D, mix above-mentioned solution, add the marennin toning, standardize solution.It is an amount of to add carbopol U-21, and stirring and dissolving adds the antiseptic ethylparaben again, adds about triethanolamine adjust pH to 6.8, stirs evenly, and weighs, and adds distilled water to gross weight, packing, finished product.
Embodiment 4: the bacteriostatic test of Lyrate nightshade gelatin
Become the Herba Solani Lyrati coagulant liquid of series concentration during test with blank substrate modulation Herba Solani Lyrati extract formulations prepared from solutions, with corresponding culture medium dilute thereafter, its Herba Solani Lyrati extract ultimate density is respectively 50,25,12.5,6.25,3.12 and 1.56mg/ml, tests and the viewing test result.The results are shown in following table.
Herba Solani Lyrati gel bacteriostatic test result
Medicine (mg/ml) | 100 | 50 | 25 | 12. 5 | 6.2 5 | 3.1 2 | 1.5 6 | Blank substrate | Negative control | The bacterial strain contrast |
Staphylococcus aureus | -- | + + | + + | + + | + + | + + | + + | + + | -- | ++ |
Escherichia coli | -- | + + | + + | + + | + + | + + | + + | + + | -- | ++ |
Salmonella | -- | + + | + + | + + | + + | + + | + + | + + | -- | ++ |
Pseudomonas aeruginosa | -- | -- | -- | -- | -- | -- | -- | -- | -- | ++ |
Candida albicans | -- | -- | + + | + + | + + | + + | + + | + + | -- | ++ |
The result shows that the Herba Solani Lyrati gel is 100mg/ml to the minimum inhibitory concentration (MIC) of staphylococcus aureus, escherichia coli, salmonella, Candida albicans in the above test organisms; At 1.56mg/ml and above concentration Pseudomonas aeruginosa is had obvious bacteriostasis, blank substrate has strong inhibitory action to Pseudomonas aeruginosa.
Embodiment 5: the guinea pig skin long term toxicity test
Get body weight 190~230g healthy rat, male and female half and half accurately take by weighing embodiment 1 gained gel sample, give Cavia porcellus intact skin and damaged skin respectively with high (1.0ml/ only), low (0.5ml/ only) two dosage, every day 1 time, continuous 90 days (drug withdrawal is one day weekly).In administration phase and convalescent period (2 weeks of drug withdrawal) animal generally in order, main hematological indices, biochemical indexes, urinalysis index etc. all belong to normal range, with blank group no difference of science of statistics relatively; Dissect the main organs naked eyes and do not see that obvious visible pathologic changes.Therefore, to use under clinical dosage be safe to this product.
Claims (5)
1, a kind of Lyrate nightshade gelatin is characterized in that, said preparation comprises active component Herba Solani Lyrati extract and gel-type vehicle.
2, gel according to claim 1, it is characterized in that wherein said gel-type vehicle can be one or both mixture with any mixed in carbomer U-21, polyvinylpyrrolidone, Polyethylene Glycol, polyvinyl alcohol, methylcellulose, ethyl cellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose, hypromellose, sodium carboxymethyl cellulose, gelatin, the sodium alginate; Transdermal enhancer can be one or more mixture with any mixed in sulfoxide class, pyrrolones, azone and analog thereof, fatty acid and ester thereof, surfactant, alcohols, polyalcohols, terpenes, amide-type, cyclodextrin, aminoacid and ester thereof, macrocyclic compound, organic acid or the phospholipid transdermal enhancer; Wetting agent can be one or both mixture with any mixed in glycerol, interior glycol, Polyethylene Glycol, sorbitol, the maltose alcohol; Antiseptic can be one or both mixture with any mixed in ethanol, chlorocresol, thimerosal, sorbic acid, potassium sorbate, benzoic acid, sodium benzoate, chlorobutanol, methyl hydroxybenzoate, ethyl hydroxybenzoate, the propylparaben; The pH regulator agent can be triethanolamine, ethylenediamine, lauryl amine, ammonia spirit, sodium bicarbonate, sodium hydroxide or potassium hydroxide.
3, gel according to claim 2, it is characterized in that, wherein the weight of Herba Solani Lyrati extract accounts for 0.5~20.0% of gel weight, the weight of gel-type vehicle accounts for 1.5~30.0% of gel weight, the weight of transdermal enhancer accounts for 0.05~8.0% of gel weight, the weight of wetting agent accounts for 1.0~20.0% of gel weight, and the weight of antiseptic accounts for 0.15~8.0% of gel weight.
4, gel according to claim 3, its feature also are to use following prepared:
A, with the Herba Solani Lyrati extract of formula ratio, add an amount of dissolved in distilled water;
B, the wetting agent of formula ratio is added suitable quantity of water, stirring and dissolving;
C, take by weighing an amount of transdermal enhancer, add distilled water, heating in water bath, the dissolving back is standby;
D, mix above-mentioned solution, add pigment toning, standardize solution; An amount of to its adding gel-type vehicle, stirring and dissolving adds antiseptic again, adds pH regulator agent adjust pH to 6.8-7.8, stirs evenly, and weighs, and adds distilled water to gross weight, packing, finished product.
5, a kind of gel as claimed in claim 1 is characterized in that, can be applied to treat chronic eczema and dermatomycosis.
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CN113273716A (en) * | 2021-05-19 | 2021-08-20 | 深圳市真味生物科技有限公司 | Atomized liquid gel and preparation process thereof |
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2006
- 2006-09-27 CN CN 200610122432 patent/CN1943676A/en active Pending
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
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CN104547005A (en) * | 2015-01-29 | 2015-04-29 | 张维芬 | Composite astragalus polysaccharide transdermal gel preparation for treating psoriasis and preparation method thereof |
CN105997848A (en) * | 2016-07-02 | 2016-10-12 | 青海民族大学 | Tangut anisodus radix and musk gel and preparation method thereof |
CN107913316A (en) * | 2017-10-13 | 2018-04-17 | 山东中医药大学附属医院 | A kind of horse Huang tincture compound extract gelling agent and preparation method thereof |
CN109289095A (en) * | 2018-11-23 | 2019-02-01 | 淮海工学院 | A kind of colonoscopy gelling agent of saliferous lidocaine hydrochloride and preparation method thereof |
CN109289095B (en) * | 2018-11-23 | 2021-03-26 | 淮海工学院 | Enteroscope gel containing lidocaine hydrochloride and preparation method thereof |
CN113273716A (en) * | 2021-05-19 | 2021-08-20 | 深圳市真味生物科技有限公司 | Atomized liquid gel and preparation process thereof |
CN113273716B (en) * | 2021-05-19 | 2022-05-03 | 深圳市真味生物科技有限公司 | Atomized liquid gel and preparation process thereof |
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