CN106474313A - A kind of medical radiation-ray preventive emulsifiable paste and preparation method thereof - Google Patents

A kind of medical radiation-ray preventive emulsifiable paste and preparation method thereof Download PDF

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Publication number
CN106474313A
CN106474313A CN201510528819.XA CN201510528819A CN106474313A CN 106474313 A CN106474313 A CN 106474313A CN 201510528819 A CN201510528819 A CN 201510528819A CN 106474313 A CN106474313 A CN 106474313A
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China
Prior art keywords
aloe
skin
powder
emulsifiable paste
decolored
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Pending
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CN201510528819.XA
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Chinese (zh)
Inventor
肖本友
李健和
张献冲
吴静红
刘耀
陈炳艳
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Kang Bao Medical Health Products (hunan) Co Ltd
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Kang Bao Medical Health Products (hunan) Co Ltd
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Priority to CN201510528819.XA priority Critical patent/CN106474313A/en
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Abstract

The present invention relates to a kind of medical radiation-ray preventive emulsifiable paste and preparation method thereof, its effective ingredient is made up of stearic acid, lanoline, PEG400, Aloe extract, Oleum Sesami, triethanolamine, preservative, water.The medical radiation-ray preventive emulsifiable paste of the present invention is mainly used in the protection that various ionizing radiation include the inflammatory injury that β, γ, x-ray ray and radiosiotope irradiate skin, mucosa causes, it is conducive to the skin alleviated and treat acute radiodermatitises and be dried very much, keep the wild skin wet of radiation, isolation environment unfavorable factor is intervened, accelerate skin microcirculation speed, releive skin tight feeling, accelerate healing speed, also tumor patient radiotherapy will not be caused to interfere simultaneously.

Description

A kind of medical radiation-ray preventive emulsifiable paste and preparation method thereof
Technical field
The present invention relates to field of medicine preparations, particularly to a kind of formula of medical radiation-ray preventive emulsifiable paste, it is mainly used for various ionizing radiation The protection of the inflammatory injury causing including β, γ, x-ray ray and radiosiotope irradiation skin, mucosa, it is conducive to alleviating and treats Acute radiodermatitises and the skin being dried very much, keep the wild skin wet of radiation, isolation environment unfavorable factor is intervened, and accelerates skin microcirculation Speed, skin tight feeling of releiving, accelerate healing speed, also tumor patient radiotherapy will not be caused to interfere simultaneously.
Background technology
Radiodermatitis (adiodermatitis) are to irradiate because various ionizing radiation include β, γ, x-ray ray and radiosiotope The inflammatory injury that skin, mucosa cause.With to the understanding of lonizing radiation and the raising of preventive means, people there has been to the Vigilance of such disease Significantly improve, but be applied to the continuous popularization of medical diagnosiss and treatment with lonizing radiation, and the continuous development of atomic energy industry, Ren Qunjie The chance of tactile lonizing radiation is continuously increased, and therefore primary disease has increase trend.
Radiotherapy is the Main Means for the treatment of malignant tumor, and the modal damage of radiotherapy is exactly to lead to radiodermatitis.Ray passes through electricity From producing substantial amounts of free radical in vivo, free radical may result in normal skin mucosa different degrees of damage.Ionization radiation injury epithelium Germinal layer cell and veins beneath the skin, first result in the blood capillary reflex dilatation irradiating tissue, form congested reaction, and macroscopic appearance shows as erythema. Nucleic acid is very sensitive to ionizing radiation, during radiation skin injury, the nucleic acid biosynthesis block of skin, and tissue Nucleic Acid reduces, and is unfavorable for cell Reparation.Being gradually increased with radiological dose, skin injury reaches skin corium, Marjoram Extract, congested cause microcirculation disturbance, vascular endothelial cell Proliferation and swelling, vascular wall thickens, and tube chamber narrows and attenuates, thus vascular occlusion.Cause radiation wild local blood supply insufficiency, so that material nutrition is exchanged and be subject to Arrive impact, the histiocyte irradiating local occurs degeneration necrosis to lead to extensive fibrosiss.According to RTOG acute radiation injury grade scale, will radiate The acute skin injury occurring in therapeutic process is divided into 5 grades:0 grade is that skin is unchanged;1 grade is erythema, and launched field skin is micro- red, prurituss sometimes;2 Level is pigmentation, skin slightly pigmentation, duskiness;3 grades be dry reaction, the obvious pigmentation of skin, nigrescence drying, have skin crackle and Dryness is peeled;4 grades is wet reaction, and severe pigmentation hydroderma, chickenpox, is oozed out, can be had ulceration.
The related research of domestic medical radiation-ray preventive, be primarily directed to according to ray to tissue, the mechanism of cell injury and develop, include freedom Base scavenger superoxide dismutase (SOD), can fast and effectively pass through skin and wound surface, remove a large amount of free radicals that skin surface produces, in advance Pharmaceutical preparation that is anti-and mitigating radiation skin injury, such as patent:ZL 200510116829.9、CN 101069741A、CN 103751770 A; But superoxide dismutase (SOD) makes that pharmaceutical formulation stability is bad, complex technical process, raw material and production cost are higher, need during use A agent and B agent mixing are reused.
The medical radiation-ray preventive emulsifiable paste of the present invention, it is conducive to the skin alleviated and treat acute radiodermatitises and be dried very much, keeps The wild skin wet of radiation, isolation environment unfavorable factor is intervened, and accelerates skin microcirculation speed, skin tight feeling of releiving, accelerates healing speed, Avoid tumor patient radiotherapy being caused interfere simultaneously.
Content of the invention
The technical problem to be solved in the present invention is to provide a kind of medical radiation-ray preventive emulsifiable paste and preparation method thereof, and the present invention can be to various ionizing radiation The inflammatory injury causing including β, γ, x-ray ray and radiosiotope irradiation skin, mucosa plays the role of protection.In order to solve this Technical problem this medical radiation-ray preventive emulsifiable paste adds the effective ingredient such as Aloe extract, Oleum sesami, triethanolamine, lanoline, PEG400.
Aloe extract refers to Aloe as raw material, cleaned, remove the peel, squeeze the juice, decolouring, filtering, concentrating, being dried, sterilizing etc. a kind of or The aloe product that more than two kinds working procedure processing are obtained, its chemical composition include carbohydrate, anthraquinone analog compound, enzyme (polypeptide), aminoacid, Vitamin and steroid and other compounds, have the effects such as promotion wound healing, antiviral, antifungal, also have regulation immunity of organism Power, the effect of radioprotective;In radiodermatitis, the low expression of basic fibroblast growth factor (bFGF) and epidermal growth factor (EGF) It is the one of the main reasons of its indolence.Basic fibroblast growth factor (bFGF) is that a kind of important mitogenesis is former, by other point Secrete or autocrine, endocrine mechanism play many important physiological function.BFGF can directly act on tissue repair cell (such as fibroblast, interior Chrotoplast), shorten cell cycle conversion time, accelerate the propagation of cell, while causing granulation tissue undue growth at wound, inducing cell The synthesis of epimatrix, stimulates the hypertrophy of connective tissue, accelerates epithelial cell to divide a word with a hyphen at the end of a line propagation, ultimately results in wound healing or formation cicatrix.Epidermal growth The factor (EGF) is former for mitosiss stimulation, can accelerate cell division, promotes propagation, can also change the chemotaxiss of cell, increases cell migration. In the radiation damage of skin, the synthetic cell of Endogenous EGF and bFGF is mainly macrophage, fibroblast and vascular endothelial cell etc., and By autocrine and paracrine mode, participate in cellular metabolism and the propagation of damage location, promote wound repair.And radiate and cause these cells in quantity Decline functionally is the main cause that Endogenous EGF and bFGF reduce, and these three cytothesiss and the method for propagation can be promoted all to improve spoke Penetrate the synthesis of Endogenous EGF and bFGF and secretion in damage.Aloe extract can improve macrophage, vascular endothelial cell, fibroblast With quantity and the function of epidermis cell, promote synthesis and the secretion of Endogenous EGF and bFGF, thus postponing the time of radiation injury appearance, mitigation Degree of injury and reduction the rate of injury, can also shorten wound healing time, accelerate healing speed, rapid pain relief.
Oleum sesami is the fatty oil obtaining from the mature seed milling process of flax plant sesame (Sesamum indicum L), containing lignanoids Compound and tocopherols material, wherein Lignanoids compounds include sesamin (Sesamolin) and sesamolin (Sesamolin , also referred to as sesamolin), there is superoxide dismutase (SOD) and remove free radical, antioxidation similar effect in skin.
Lanoline can radiate wild surface and form one layer of natural oils and fatss protecting film, have holding skin wet, adjust skin oil-water balance, reduce Skin water loss acts on.
Medical radiation-ray preventive emulsifiable paste is conducive to the skin alleviated and treat acute radiodermatitises and be dried very much, keeps the wild skin of radiation wet Profit, isolation environment unfavorable factor is intervened, and accelerates skin microcirculation speed, skin tight feeling of releiving, accelerates healing speed, simultaneously also will not be right Tumor patient radiotherapy causes to interfere.
A kind of medical radiation-ray preventive emulsifiable paste and preparation method thereof is it is characterised in that the component of described emulsifiable paste and weight percent content are:
The preferable consumption of heretofore described stearic acid is 3.0~20.0%, and optimum consumption is 6.0~15.0%.
The preferable consumption of heretofore described lanoline is 1.0~8.0%, and optimum consumption is 2.0~5.0%.
Heretofore described Aloe extract refers to Aloe as raw material, cleaned, remove the peel, squeeze the juice, decolouring, filtering, concentrating, being dried, The aloe product that one or two or more kinds working procedure processing such as sterilization is obtained is complete including decolored aloe gel juice, no bleaching Aloe gel juice, decolored aloe Leaf juice, no bleaching aloe juice, decolored aloe gelin proportion rubber powder, no bleaching aloe gel powder, decolored aloe full leaf powder, no bleaching aloe whole-leaf powder, Decolored aloe gel spray drying powder, no bleaching Aloe gel spray drying powder, decolored aloe gel lyophilized powder, the freezing of no bleaching Aloe gel Xeraphium, decolored aloe full leaf spray drying powder, no bleaching aloe full leaf spray drying powder, decolored aloe full leaf lyophilized powder, no bleaching Aloe One or two or more kinds mixture of full leaf lyophilized powder.
The preferable consumption of heretofore described Aloe extract is 0.01~15.0%, and optimum consumption is 0.2~10.0%.
Heretofore described preservative is glucose chlorhexidine, chlorhexidine acetate, benzalkonium chloride, benzethonium chloride, poly (hexamethylene), gathers Dimension ketone iodine, lysozyme, hydrogen peroxide, urea peroxide, benzylalcohol, benzoic acid, potassium sorbate, phenoxyethanol, the one of which such as parabenses or Two kinds of things mixed above.
Heretofore described a kind of medical radiation-ray preventive emulsifiable paste and preparation method thereof it is characterised in that:Comprise the following steps that:
(1) take stearic acid, lanoline, Oleum sesami to be heated to more than 75 DEG C dissolvings, stir evenly, obtain solution A.
(2) taking polyethylene glycol 400, Aloe extract, triethanolamine, preservative, water are heated to more than 75 DEG C dissolvings, stir evenly, obtain solution B.
(3) solution B is added in solution A, 75 DEG C about stirring 20min, cooling, obtains final product.
Specific embodiment
Embodiment one
A kind of medical radiation-ray preventive emulsifiable paste and preparation method thereof is it is characterised in that the constituent content of described emulsifiable paste is:
Processing step:
(1) take stearic acid, lanoline, Oleum sesami to be heated to more than 75 DEG C dissolvings, stir evenly, obtain solution A.
(2) taking polyethylene glycol 400,200:1 decolored aloe gel lyophilized powder, triethanolamine, ethyl hydroxybenzoate, water are heated to 75 DEG C Above dissolving, stirs evenly, obtains solution B.
(3) solution B is added in solution A, 75 DEG C about stirring 20min, cooling, obtains final product.
System stability:System is the emulsifiable paste of single stable, in 37 DEG C ± 2 DEG C of temperature, places 3 under conditions of relative humidity 75% ± 5% Moon test sample items quality index no significant change;In 2500 turns/min, it is centrifuged 20 minutes, no lamination.
Biological assessment:
Cell toxicity test is carried out to embodiment one emulsifiable paste using mtt assay, cytotoxicity grade has been judged with cell relative growth rate (RGR), Its cytotoxicity of result is 1 grade, is qualified.
Embodiment one emulsifiable paste lixiviating solution is injected in the Intradermal of test rabbit, 24h, 48h and 72h after injection, all non-show of rabbit is tested in perusal Speckle, edema and necrosis phenomena, this is to animal body no Intradermal irritant reaction.
With albino guinea-pig as animal subject, (GPMT) is tested using maximal dose, the lixiviating solution of embodiment one emulsifiable paste is injected in Cavia porcelluss Intradermal, After carrying out Intradermal induction, stick in induction period not test (N.T.) position local and excited, observe, in different time, the skin feelings that Cavia porcelluss excite position respectively Condition, excites position and the skin erythema of each observing time and edema reaction to be classified with Magnusson and Kligman grade scale to each. Erythema and edema in result, and sensitization test (STT) is feminine gender, shows embodiment one emulsifiable paste to animal body no sensitivity response.
Using the sodium chloride lixiviating solution of embodiment one emulsifiable paste and vegetable oil lixiviating solution as test group, it is injected in respectively in Mice with matched group, And general state, toxicity performance and the dead animal number of test group and matched group is observed and records in 4h, 24h, 48h, 72h.Result shows, that is, Shi Fanying, 4h, 24h, 48h, 72h observe avirulence symptoms, and body weight does not also decline, and illustrates that embodiment one emulsifiable paste no Acute systemic toxicity is anti- Should.
Embodiment two
A kind of medical radiation-ray preventive emulsifiable paste and preparation method thereof is it is characterised in that the constituent content of described emulsifiable paste is:
Processing step:
(1) take stearic acid, lanoline, Oleum sesami to be heated to more than 75 DEG C dissolvings, stir evenly, obtain solution A.
(2) taking polyethylene glycol 400,200:1 decolored aloe gel lyophilized powder, triethanolamine, methyl hydroxybenzoate, propylparaben, Water is heated to more than 75 DEG C dissolvings, stirs evenly, obtains solution B.
(3) solution B is added in solution A, 75 DEG C about stirring 20min, cooling, obtains final product.
System stability:System is the emulsifiable paste of single stable, in 37 DEG C ± 2 DEG C of temperature, places 3 under conditions of relative humidity 75% ± 5% Moon test sample items quality index no significant change;In 2500 turns/min, it is centrifuged 20 minutes, no lamination.
Biological assessment:
Cell toxicity test is carried out to embodiment two emulsifiable paste using mtt assay, cytotoxicity grade has been judged with cell relative growth rate (RGR), Its cytotoxicity of result is 1 grade, is qualified.
Embodiment two emulsifiable paste lixiviating solution is injected in the Intradermal of test rabbit, 24h, 48h and 72h after injection, all non-show of rabbit is tested in perusal Speckle, edema and necrosis phenomena, this is to animal body no Intradermal irritant reaction.
With albino guinea-pig as animal subject, (GPMT) is tested using maximal dose, the lixiviating solution of embodiment two emulsifiable paste is injected in Cavia porcelluss Intradermal, After carrying out Intradermal induction, stick in induction period not test (N.T.) position local and excited, observe, in different time, the skin feelings that Cavia porcelluss excite position respectively Condition, excites position and the skin erythema of each observing time and edema reaction to be classified with Magnusson and Kligman grade scale to each. Erythema and edema in result, and sensitization test (STT) is feminine gender, shows embodiment two emulsifiable paste to animal body no sensitivity response.
Using the sodium chloride lixiviating solution of embodiment one emulsifiable paste and vegetable oil lixiviating solution as test group, it is injected in respectively in Mice with matched group, And general state, toxicity performance and the dead animal number of test group and matched group is observed and records in 4h, 24h, 48h, 72h.Result shows, that is, Shi Fanying, 4h, 24h, 48h, 72h observe avirulence symptoms, and body weight does not also decline, and illustrates that embodiment two emulsifiable paste no Acute systemic toxicity is anti- Should.
Embodiment three
A kind of medical radiation-ray preventive emulsifiable paste and preparation method thereof is it is characterised in that the constituent content of described emulsifiable paste is:
Processing step:
(1) take stearic acid, lanoline, Oleum sesami to be heated to more than 75 DEG C dissolvings, stir evenly, obtain solution A.
(2) taking polyethylene glycol 400, decolored aloe gel juice, triethanolamine, methyl hydroxybenzoate, propylparaben, water are heated to 75 DEG C Above dissolving, stirs evenly, obtains solution B.
(3) solution B is added in solution A, 75 DEG C about stirring 20min, cooling, obtains final product.
System stability:System is the emulsifiable paste of single stable, in 37 DEG C ± 2 DEG C of temperature, places 3 under conditions of relative humidity 75% ± 5% Moon test sample items quality index no significant change.
Biological assessment:
Cell toxicity test is carried out to embodiment three emulsifiable paste using mtt assay, cytotoxicity grade has been judged with cell relative growth rate (RGR), Its cytotoxicity of result is 1 grade, is qualified.
Embodiment three emulsifiable paste lixiviating solution is injected in the Intradermal of test rabbit, 24h, 48h and 72h after injection, all non-show of rabbit is tested in perusal Speckle, edema and necrosis phenomena, this is to animal body no Intradermal irritant reaction.
With albino guinea-pig as animal subject, (GPMT) is tested using maximal dose, the lixiviating solution of embodiment three emulsifiable paste is injected in Cavia porcelluss Intradermal, After carrying out Intradermal induction, stick in induction period not test (N.T.) position local and excited, observe, in different time, the skin feelings that Cavia porcelluss excite position respectively Condition, excites position and the skin erythema of each observing time and edema reaction to be classified with Magnusson and Kligman grade scale to each. Erythema and edema in result, and sensitization test (STT) is feminine gender, shows embodiment three emulsifiable paste to animal body no sensitivity response.
Using the sodium chloride lixiviating solution of embodiment one emulsifiable paste and vegetable oil lixiviating solution as test group, it is injected in respectively in Mice with matched group, And general state, toxicity performance and the dead animal number of test group and matched group is observed and records in 4h, 24h, 48h, 72h.Result shows, that is, Shi Fanying, 4h, 24h, 48h, 72h observe avirulence symptoms, and body weight does not also decline, and illustrates that embodiment three emulsifiable paste no Acute systemic toxicity is anti- Should.
Although, above, with general explanation and specific embodiment, the present invention is made with detailed explanation, on the basis of the present invention, Can make some modifications or improvements, this will be apparent to those skilled in the art.Therefore, without departing from theon the basis of the spirit of the present invention Modifications or improvements, belong to the scope of protection of present invention.

Claims (4)

1. a kind of medical radiation-ray preventive emulsifiable paste and preparation method thereof is it is characterised in that the component of described emulsifiable paste and weight percent content are:
2. Aloe extract refers to Aloe as raw material according to claim 1, cleaned, remove the peel, squeeze the juice, decolouring, filtering, The aloe product that one or two or more kinds working procedure processing is obtained such as concentrate, be dried, sterilizing, including decolored aloe gel juice, not taking off Color Aloe gel juice, decolored aloe full leaf juice, no bleaching aloe juice, decolored aloe gelin proportion rubber powder, no bleaching aloe gel powder, Decolored aloe full leaf powder, no bleaching aloe whole-leaf powder, decolored aloe gel spray drying powder, no bleaching Aloe gel are spray-dried Powder, decolored aloe gel lyophilized powder, no bleaching Aloe gel lyophilized powder, decolored aloe full leaf spray drying powder, not Decolored aloe full leaf spray drying powder, decolored aloe full leaf lyophilized powder, no bleaching aloe full leaf lyophilized powder one kind or two Plant thing mixed above.
3. preservative is glucose chlorhexidine, chlorhexidine acetate, benzalkonium chloride, benzethonium chloride, poly- six Asias according to claim 1 Methyl guanidinesalt, povidone iodine, lysozyme, hydrogen peroxide, urea peroxide, benzylalcohol, benzoic acid, potassium sorbate, phenoxyethanol, The one of which such as parabenses or two kinds of things mixed above.
4. according to claim 1 a kind of medical radiation-ray preventive emulsifiable paste and preparation method thereof it is characterised in that:Including following technique step Suddenly:
(1) take stearic acid, lanoline, Oleum sesami to be heated to more than 75 DEG C dissolvings, stir evenly, obtain solution A;
(2) taking polyethylene glycol 400, Aloe extract, triethanolamine, preservative, water are heated to more than 75 DEG C dissolvings, stir evenly, Obtain solution B;
(3) solution B is added in solution A, 75 DEG C about stirring 20min, cooling, you can.
CN201510528819.XA 2015-08-26 2015-08-26 A kind of medical radiation-ray preventive emulsifiable paste and preparation method thereof Pending CN106474313A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110197734A (en) * 2019-07-13 2019-09-03 四川大学 The preparation method of X-ray shield material based on natural leather
CN110652581A (en) * 2018-06-28 2020-01-07 陕西佰傲再生医学有限公司 Medical ray protection solution with moisturizing and itching relieving effects and preparation method thereof
CN113081897A (en) * 2021-04-14 2021-07-09 刘继昌 Medical ray skin antibacterial repairing agent

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110652581A (en) * 2018-06-28 2020-01-07 陕西佰傲再生医学有限公司 Medical ray protection solution with moisturizing and itching relieving effects and preparation method thereof
CN110197734A (en) * 2019-07-13 2019-09-03 四川大学 The preparation method of X-ray shield material based on natural leather
CN110197734B (en) * 2019-07-13 2022-11-11 四川大学 Preparation method of X-ray shielding material based on natural leather
CN113081897A (en) * 2021-04-14 2021-07-09 刘继昌 Medical ray skin antibacterial repairing agent

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Application publication date: 20170308