CN104027298A - Lentinan gelata and preparation method thereof - Google Patents
Lentinan gelata and preparation method thereof Download PDFInfo
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- CN104027298A CN104027298A CN201410176857.9A CN201410176857A CN104027298A CN 104027298 A CN104027298 A CN 104027298A CN 201410176857 A CN201410176857 A CN 201410176857A CN 104027298 A CN104027298 A CN 104027298A
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Abstract
The invention relates to a lentinan gelata and a preparation method thereof. The lentinan gelata is an external gelata prepared by mixing lentinan with a proper gel matrix. The invention also relates to the preparation method of the gelata. The lentinan gelata is safe, and can promote the rapid restoration of skin wounds.
Description
Technical field
The present invention relates to a kind of have regulate immunity, promote the gel that skin trauma is repaired, the exterior-applied gel of making after specifically lentinan being mixed with suitable gel-type vehicle, the invention still further relates to the preparation method of this gel.
Background technology
Lentinan is a kind of immunostimulant extracting the sporophore (cap, lamella and stem) from Lentinus Edodes, kinds of tumors is had to stronger inhibitory action, to Chemical Carcinogenesis agent, virus, lure cancer agent to have preventive effect, particularly effective for micrometastasis after operation.It is by irritating the immune system of body, to make the immunologic function of body be restored and improve, and by the resistance of body itself, removes to kill tumor cell.Indirectly, side effect is little in effect, uses safety.
The constituent structure report of relevant lentinan is a lot of, but clear and definite structure is relevant with immunity, only has beta glucan material, its molecular weight is 40～800,000, primary structure is that β-D-(1-3) glucose is main chain, the glucosan that β-(1-6) glucose is side chain, and biological activity is relevant with triple helical chain structure.Lentinan also has immunoregulatory effect.Its similar a kind of host immune reinforcing agent of effect, can stimulate maturation, the Differentiation and proliferation of key cells, improves host's organism balance, reaches and recovers or improve the reactivity effect of host cell to lymphokine, hormone and other bioactie agent.Lentinan all has therapeutical effect to infection such as parasite, mycete, antibacterials, can treat mycobacterium tuberculosis infection, schistosoma mansoni infection, schistosoma japonicum infection and sharp Man protozoan infection.Scald and destroy the skin natural cover for defense, disturbance of blood circulation or forfeiture hemoperfusion, local malnutrition, general immunity power declines, for bacterial invasion is created good condition.Simultaneously large area occurs after scalding that body's immunity is disorderly, and systemic inflammatory response is unbalance, and therefore very easily accompanying infection and death of patient be necessary to regulate the immunologic function of body in treatment scald.At present, the lentinan medicine of listing is the dosage forms such as injection or oral tablet, capsule both at home and abroad, and indication is antitumor or hepatitis, without external type medicine, goes on the market.Therefore, develop a kind of novelly, safe, and can promote that the lentinan exterior-applied gel of skin trauma reparation is very necessary.
By Li Baoqing, horse Yuquan is published in the clinical practice > > (Periodical Classification: medical science is comprehensive of the interim article < < lentinan of < < Hebei medicine > > volume 3 March 34 in 2006, domestic number of the edition: CN13-1090/R) from the antitumor action of lentinan, tumor is put, the increasing treatment effect of chemotherapy, therapeutical effect to multi-infection, the aspects such as therapeutical effect of the viral diseases such as chronic hepatitis B have been carried out very comprehensively introducing to the clinical practice of lentinan, the use of lentinan only only limits to intravenous injection, oral, and do not mention external.
By Zhao Jiming, the progress > > ([middle figure classification number] R96[Document code] A[article numbering] 1672-5085 (2011) 38-0312-03) that Pu Yanchun is published in the interim article < < lentinan of the healthy digest > > in < < China and foreign countries 2011 the 38th has introduced the chemical constitution of lentinan, the extraction of physicochemical property and lentinan, Isolation and purification method, and the immunoregulation effect to lentinan, anti-tumor activity, antiviral activity, and blood sugar lowering and effect for reducing fat are set forth, lentinan is looked forward in clinical practice and health-product market, lentinan is in the application for the treatment of on skin trauma there is no clear and definite pointing out.
Chinese patent application publication No. CN101732336A, Shen Qing Publication day is that the patent of invention of on 06 16th, 2010 discloses a kind of antiparasitic external preparation, it comprises as the active component of anthelmintic and at least one polysaccharides of traditional Chinese medicine, be contained in the carrier of being convenient to body surface administration and described active component medicin spreading, the described active component as anthelmintic is commercial medicine avilamycin at least one one group of Macrolide material producing from streptomycete fermentation, doractin, eprinomectin and plug draw rhzomorph, or by the synthetic derivant ivermectin of this class material, described polysaccharide is glucosan, xyloglucan, heparin, pectin, chitosan, lycium barbarum polysaccharide, lentinan, one or more in Hericium Erinaceus Polysaccharide etc., this invention is produced effects rapidly for driving away parasite, determined curative effect, without obvious toxic-side effects.Although this application discloses the technical scheme that polysaccharides of traditional Chinese medicine (comprising lentinan) is applied to external preparation, but, this external preparation is a kind of antiparasitic external preparation, use is to liking domestic animal, the one group of Macrolide material producing from streptomycete fermentation of take is main component, does not relate to the medicine for external use for the treatment of the skin traumas such as human body scald.
Summary of the invention
The object of the present invention is to provide a kind of can directly spreading upon on the wound surface causing because of scald, ulcer, eczema etc., can regulate immunity, promotion repair in trauma, anti-bacteria to infect, easy to use, be convenient to clean the lentinan gel having no side effect.
The technical solution used in the present invention is:
A lentinan gel, this gel is made by following raw material:
Gel-type vehicle (mass percent):
Thickening agent 0.1～10 wetting agent 0.1～20 antiseptic 0.1～3
Stabilizing agent 0.1～10 purified water is 57～99.6
Lentinan raw material (purity is greater than 96%, and weight average molecular weight is 40～800,000): 0.1 microgram～200 microgram/every gram of gel-type vehicle.
Described thickening agent is Carboxymethyl cellulose sodium, methylcellulose, Polyethylene Glycol, chitosan, and concentration is respectively 0.6～6%.
Described wetting agent is glycerol, propylene glycol, and concentration is respectively 0.1～10%.
Described antiseptic is sodium benzoate, ethylparaben, methyl parahydroxybenzoate, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, and concentration is respectively 0.1～3%.
Described stabilizing agent is mannitol, sorbitol, lactose, sodium citrate, and concentration is respectively 0.6～6%.
Another order of the present invention is to provide the preparation method of lentinan gel, and its technical scheme is as follows:
A preparation method for lentinan gel, comprises the following steps:
1) thickening agent, wetting agent, antiseptic, stabilizing agent and water are mixed in ratio claimed in claim 1, stir, form water-soluable gel substrate;
2) in step 1) in add lentinan in the gel-type vehicle that forms, the injected volume of lentinan adds according to 0.1 microgram～200 microgram/every gram of gel-type vehicle;
3) under the pressure condition of 0.07～0.15MPa, will add the gel-type vehicle of lentinan under the condition of 115～126 ℃, high temperature sterilize 10～30 minutes, is lentinan gel after being cooled to room temperature.
Lentinan gel provided by the invention has the following advantages:
1, lentinan gel of the present invention is containing hormone, nontoxic to skin, have no stimulation, can be for treatments such as the skin scald of infant, skin eczemas.
2, lentinan gel of the present invention can regulate patient's immunity, promotes skin trauma reparation, and has the effect of bacterial-infection resisting.
3, lentinan gel of the present invention can directly spread upon because scalding etc. on the skin wound causing, easy to use, is convenient to clean.
The specific embodiment
Following examples are used for illustrating the present invention, but are not used for limiting the scope of the invention.
Embodiment 1:
Get 1 gram of Carboxymethyl cellulose sodium, 2 grams of glycerol, 0.1 gram of sodium benzoate, 1 gram, mannitol, add purified water to 100 gram, mix, be stirred into water-soluble base, add the lentinan (purity is greater than 96%) of 500 micrograms, after stirring, at 0.1MPa, under 121 ℃ of conditions, sterilizing is 15 minutes, is cooled to room temperature, is lentinan gel.
Embodiment 2:
Get 2 grams of sodium carboxymethylcellulose pyces, 5 grams of propylene glycol, 1 gram of ethylparaben, 3 grams of sorbitol, add purified water to 100 gram, mix, be stirred into water-soluble base, add the lentinan (purity is greater than 96%) of 300 micrograms, after stirring, at 0.1MPa, under 121 ℃ of conditions, sterilizing is 20 minutes, is cooled to room temperature, is lentinan gel.
Embodiment 3:
5 grams of taking polyethylene glycols, 5 grams of propylene glycol, 3 grams of methyl parahydroxybenzoate, 1 gram of lactose,, add purified water to 100 gram, mix, be stirred into water-soluble base, the lentinan (purity is greater than 96%) that adds 200 micrograms, after stirring, at 0.1MPa, under 121 ℃ of conditions, sterilizing is 15 minutes, be cooled to room temperature, be lentinan gel.
Embodiment 4:
Get 3 grams of chitosans, 3 grams of glycerol, 2 grams of butyl p-hydroxybenzoates, 5 grams of sodium citrates,, add purified water to 100 gram, mix, be stirred into water-soluble base, the lentinan (purity is greater than 96%) that adds 800 micrograms, after stirring, at 0.1MPa, under 121 ℃ of conditions, sterilizing is 15 minutes, be cooled to room temperature, be lentinan gel.
Embodiment 5:
Get 2 grams of Carboxymethyl cellulose sodium, 3 grams of glycerol, 0.1 gram of sodium benzoate, 3 grams, mannitol, add purified water to 100 gram, mix, be stirred into water-soluble base, add the lentinan (purity is greater than 96%) of 1000 micrograms, after stirring, at 0.15MPa, under 126 ℃ of conditions, sterilizing is 10 minutes, is cooled to room temperature, is lentinan gel.
Embodiment 6:
Get 1 gram of sodium carboxymethylcellulose pyce, 1 gram of propylene glycol, 0.2 gram of sodium benzoate, 5 grams, mannitol, add purified water to 100 gram, mix, be stirred into water-soluble base, add the lentinan (purity is greater than 96%) of 1500 micrograms, after stirring, at 0.07MPa, under 115 ℃ of conditions, sterilizing is 30 minutes, is cooled to room temperature, is lentinan gel.
Stability, toxicological experiment that the present invention relates to medicine etc. is as follows:
1, stability experiment: place after 12 months under the condition of 25 ℃ ± 2 ℃ of temperature, relative humidity 60% ± 10%, the indexs such as the active constituent content of preparation, moisture, outward appearance, pH value, uniformity have no significant change, and illustrate that the preparation of invention has good stability.
2, microbial limit experiment: staphylococcus aureus and bacillus pyocyaneus all do not detect, and meet the requirements.
3, skin irritation test: lentinan gel is applied to respectively the normal and tested district of damaged skin of rabbit with every gram containing 0.2 milligram, 0.4 milligram, 0.8 milligram, 1 gram respectively, and area is 50cm
2, result shows, single administration and to inferior administration, skin irritation response strength < 0.5 minute, illustrate lentinan gel single administration and multiple dosing to rabbit the complete and equal nonirritant of damaged skin.
Test method:
Single administration irritant test: get 40 of healthy rabbits, be divided into intact skin group and damaged skin group.5 groups of intact skin components, 4 every group, male and female half and half, i.e. positive drug matched group, three dosed administration groups (low dosage, middle dosage, high dose), substrate matched group etc.In test first 24 hours, by animal vertebra both sides unhairing, self consubstantiality compared, and area is 50cm
2, three dosage groups of intact skin group lentinan gel and substrate matched group by 1 gram/be only applied to left side, right side is coated with normal saline.The skin of sterilizing after the cropping of damaged skin group is also made " # " font cut with sterile surgical cutter, and the skin of take occurs that slight oozing of blood is as degree, and grouping and medication, dosage, with intact skin group, are wrapped up sub-cage rearing with gauze after each test group coating.After 24 hours, with warm water, wash away residual tested material, remove to observe and to record after 1h, 24h after tested material, 48h, 72h and smear position and have or not the situations such as erythema and edema.
Multiple dosing irritant test: get 40 of healthy rabbits, method is the same, every day coating,, Continuous Observation is smeared position and is had or not the situations such as erythema and edema, successive administration carries out histopathologic examination by sacrifice of animal by skin sample in 7 days.
Result of the test and evaluation:
Every treated animal evaluation is evaluated according to " skin irritation intensity " evaluation criterion in < < study of tcm new drug guide (pharmacy, pharmacology, toxicology) > >.The results are shown in Table 1, table 2.As seen from table, single administration and multiple dosing, have no erythema and edema phenomenon, animal general body state is good, without behavior change, mark equal < 0.5 minute of skin irritation response strength, pathological observation no abnormality seen phenomenon, illustrate that lentinan gel single administration and multiple dosing, to rabbit intact skin and the equal nonirritant of damaged skin, prove that preparation medication of the present invention is safer simultaneously.
Table 1 single administration skin irritation appraisal result
Table 2 multiple dosing skin irritation appraisal result
4, sensitivity test: 30 of extracting waste healthy guinea pigs, male and female half and half, are divided into matrix group, positive controls, medicine group at random, 10 every group.Before test, 24h cuts off 20cm in back part of animal left side
2unhairing district, each group gives corresponding tested medicine, dosage be 1.0g/ only; Positive group gives 1%2,4-dinitrochlorobenzene 1.0mL, each repeat administration of 7d and 14d 1 time (administration is 3 times altogether).After last administration, 14d is excitability contact administration, and before administration, each group of 24h cuts off 20cm respectively at right side
2unhairing district, and give corresponding tested medicine, positive group gives 0.1%2,4-dinitrochlorobenzene, warm water washes away medicine, at once observe, with reference to hypersensitive evaluation criterion in < < study of tcm new drug guide (pharmacy, pharmacology, toxicology) > >, evaluate.Result shows, lentinan gel is without anaphylaxis.
In order to show that lentinan gel of the present invention is to the trauma care effect because scalding, burning and cause, the clinical practice situation of this gel is as follows:
Usage and consumption: by after scald or II degree fire victim's skin trauma place wiped clean, by the size of wound area, be evenly applied to site of injury (being less than the thickness of 1mm), suitably wrapping,, every day 1-3 time.
Effect assessment: clinical application effect, by doctor's synthetic determination, divides recovery from illness, effective, effective, invalid four classes.Clinical therapeutic efficacy is in Table 3.
Table 3. clinical treatment observation result
As seen from the above table, lentinan gel is to reaching more than 96% because of the trauma care effective percentage of scalding, burn causes, and clinical effectiveness is better.
Claims (6)
1. a lentinan gel, is characterized in that, this gel is made by following raw material:
Gel-type vehicle (mass percent):
Thickening agent 0.1～10 wetting agent 0.1～20 antiseptic 0.1～3
Stabilizing agent 0.1～10 purified water is 57～99.6
Lentinan raw material (purity is greater than 96%, and weight average molecular weight is 40～800,000): 0.1 microgram～200 microgram/every gram of gel-type vehicle.
2. lentinan gel according to claim 1, is characterized in that: thickening agent is Carboxymethyl cellulose sodium, methylcellulose, Polyethylene Glycol, chitosan, and concentration is respectively 0.6～6%.
3. lentinan gel according to claim 1, is characterized in that: wetting agent is glycerol, propylene glycol, and concentration is respectively 0.1～10%.
4. lentinan gel according to claim 1, is characterized in that: antiseptic is sodium benzoate, ethylparaben, methyl parahydroxybenzoate, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, and concentration is respectively 0.1～3%.
5. lentinan gel according to claim 1, is characterized in that: stabilizing agent is mannitol, sorbitol, lactose, sodium citrate, and concentration is respectively 0.6～6%.
6. a preparation method for lentinan gel claimed in claim 1, comprises the following steps:
1) thickening agent, wetting agent, antiseptic, stabilizing agent and water are mixed in ratio claimed in claim 1, stir, form water-soluable gel substrate;
2) in step 1) in add lentinan in the gel-type vehicle that forms, the injected volume of lentinan adds according to 0.1 microgram～200 microgram/every gram of gel-type vehicle;
3) under the pressure condition of 0.07～0.15MPa, will add the gel-type vehicle of lentinan under the condition of 115～126 ℃, high temperature sterilize 10～30 minutes, is lentinan gel after being cooled to room temperature.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109044964A (en) * | 2018-10-16 | 2018-12-21 | 长江师范学院 | A kind of edible fungi polysaccharide gelling agent and its preparation method and application |
| CN112972693A (en) * | 2021-02-25 | 2021-06-18 | 华中科技大学 | Polysaccharide complex for long-acting inhibition of postoperative recurrence of tumor and preparation and application thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1235827A (en) * | 1998-05-18 | 1999-11-24 | 北京麦迪海药业有限责任公司 | Estradiol benzoate gel agent and its preparing method |
-
2014
- 2014-04-29 CN CN201410176857.9A patent/CN104027298A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1235827A (en) * | 1998-05-18 | 1999-11-24 | 北京麦迪海药业有限责任公司 | Estradiol benzoate gel agent and its preparing method |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109044964A (en) * | 2018-10-16 | 2018-12-21 | 长江师范学院 | A kind of edible fungi polysaccharide gelling agent and its preparation method and application |
| CN112972693A (en) * | 2021-02-25 | 2021-06-18 | 华中科技大学 | Polysaccharide complex for long-acting inhibition of postoperative recurrence of tumor and preparation and application thereof |
| CN112972693B (en) * | 2021-02-25 | 2022-06-14 | 华中科技大学 | Polysaccharide complex for long-acting inhibition of postoperative recurrence of tumor and preparation and application thereof |
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Application publication date: 20140910 |