阅读说明：本技术 一种医用退热贴及其制备方法 (Medical cooling patch and preparation method thereof ) 是由 高朝彬 牛伟 于 2019-11-29 设计创作，主要内容包括：本发明涉及医药品加工技术领域,具体涉及一种医用退热贴及其制备方法。所述医用退热贴包括底部无纺布基材,与无纺布基材紧密贴接的软塑料薄膜,和置于软塑料薄膜上的药用凝胶层组成；所述药用凝胶层包括油相和水相,油相包括甘油850～1500份、蓖麻油15～75份、聚丙烯酸钠2～15份、CMC 2～10份、甘羟铝1～12份、EDTA 1～13份、乙二胺四乙酸1～9份、钛白粉1～8份；水相包括纯化水100～1000份、酒石酸15～85份、防腐剂1～15份、柠檬黄/亮蓝溶液3～10份；成品医用退热贴的凝胶层质地分散均匀,与皮肤粘结性好,对皮肤刺激性弱,且带有淡淡的玫瑰花清香,贴在皮肤上后不会闻到刺激性气味；同时,在相对分子质量为8800～10000的聚丙烯酸钠的分散作用下,胶凝层分散均匀,能长时间的持续退热。(The invention relates to the technical field of pharmaceutical processing, in particular to a medical antipyretic patch and a preparation method thereof. The medical cooling patch comprises a bottom non-woven fabric base material, a soft plastic film closely attached to the non-woven fabric base material, and a medicinal gel layer arranged on the soft plastic film; the medicinal gel layer comprises an oil phase and a water phase, wherein the oil phase comprises 850-1500 parts of glycerol, 15-75 parts of castor oil, 2-15 parts of sodium polyacrylate, 2-10 parts of CMC, 1-12 parts of dihydroxyaluminum glycinate, 1-13 parts of EDTA, 1-9 parts of ethylene diamine tetraacetic acid and 1-8 parts of titanium dioxide; the water phase comprises 100-1000 parts of purified water, 15-85 parts of tartaric acid, 1-15 parts of preservative and 3-10 parts of lemon yellow/brilliant blue solution; the gel layer of the finished medical defervescence patch has the advantages of uniform dispersion of texture, good adhesion with skin, weak skin irritation, light rose fragrance and no pungent smell after being pasted on the skin; meanwhile, under the dispersion action of the sodium polyacrylate with the relative molecular mass of 8800-10000, the gel layer is uniformly dispersed, and can be continuously annealed for a long time.)

1. A medical cooling patch is characterized by comprising a bottom non-woven fabric base material, a soft plastic film closely attached to the non-woven fabric base material, and a medicinal gel layer arranged on the soft plastic film;

the medicated gel layer comprises an oil phase and an aqueous phase;

wherein the oil phase comprises the following raw materials in parts by weight:

850-1500 parts of glycerol, 15-75 parts of castor oil, 2-15 parts of sodium polyacrylate, 2-10 parts of CMC, 1-12 parts of dihydroxyaluminum glycinate, 1-13 parts of EDTA, 1-9 parts of ethylene diamine tetraacetic acid and 1-8 parts of titanium dioxide;

the water phase comprises the following raw materials in parts by weight:

100-1000 parts of purified water, 15-85 parts of tartaric acid, 1-15 parts of preservative and 3-10 parts of lemon yellow/brilliant blue solution.

2. The medical antipyretic patch as claimed in claim 1, wherein the oil phase further comprises 3-7 parts of an additive phase, and the additive phase comprises 2-8 parts of gypsum, 1-3 parts of sweet wormwood herb, 1-3 parts of nettle dry powder, 1-5 parts of flue-cured tobacco ash and 1-2 parts of rose essential oil.

3. The medical antipyretic patch as claimed in claim 1, wherein the relative molecular mass of the sodium polyacrylate is 8800-10000.

4. The preparation method of the medical antipyretic patch is characterized by comprising the following steps:

a. preparing a water phase: mixing the required weight part of purified water with the lemon yellow/brilliant blue solution, uniformly mixing, mixing with the required weight part of tartaric acid and the preservative, and uniformly stirring at a stirring speed of 300-400 r/min for 15-30 min to prepare a water phase for later use;

b. preparing an oil phase: respectively grinding the required weight parts of sodium polyacrylate, CMC, dihydroxyaluminum glycinate, EDTA and titanium dioxide through a 325-mesh screen, and uniformly mixing to obtain a solid material for later use;

weighing glycerol in required parts by weight, placing the glycerol in a hopper of an egg beater, adding castor oil in required parts by weight, uniformly mixing, adding the standby solid material and the additive phase in required parts by weight, uniformly stirring, stirring at a medium speed of 200-300 r/min for 5min, stirring at a high speed of 780-860 r/min for 20-30 min, grinding and pulping, and screening with a 200-mesh screen to obtain an oil phase for standby;

c. preparing a medicinal gel: pouring the standby oil phase into a stirrer, sealing the stirrer, continuously stirring for 10-15 min at the stirring speed of 2500-3500 r/min, pumping the standby water phase into a feeding hole, sealing the stirrer, continuously stirring for 15-20 min at the stirring speed of 2500-3500 r/min in vacuum, discharging bubbles, and discharging to obtain medicinal gel;

d. gluing: on a perfect and clean coating machine, a soft plastic film is tightly attached to the upper part of the non-woven fabric substrate and is paved; pouring the medicinal gel into a hopper of a coating machine, starting equipment, uniformly coating the medicinal gel on the soft plastic film, controlling the coating thickness to be uniform and consistent, controlling the gel thickness to be 1-1.5 mm, and cutting into sheets with the weight of 8.5-14.0 g to prepare the primary medical antipyretic patch;

e. standing: taking the primary product for defervescence, sticking the defervescence paste in a multi-layer disc, placing the disc on a multi-layer frame, selecting PE to be sealed, and carrying out static culture for 3-5 days under the conditions that the temperature is 25-28 ℃ and the humidity is 60-65%;

f. selecting and packaging: after the resting is finished, after the hot drawing demolding and curing of the primary medical drawing, scraping edges again, shearing into small pieces with the length of 103-107 mm and the width of 43-47 mm, breaking bubbles, checking whether the mass of the small pieces is within 8.0-12 g again, and if not, treating the small pieces as waste products; if yes, detecting the finished product, obtaining the finished medical defervescence patch after the detection is qualified, putting the finished medical defervescence patch into a stainless steel disc, putting the stainless steel disc into a polyethylene bag, and sealing and storing the stainless steel disc.

5. The preparation method of the medical antipyretic patch as claimed in claim 4, wherein the vacuum stirring pressure is-0.7 to 1.5 MPa.

6. The preparation method of the medical antipyretic patch as claimed in claim 4, wherein the detection method of the finished product is as follows:

the initial adhesive force of the medicinal gel layer of the finished medical defervescence patch is controlled to be not less than that of No. 4 steel ball, the water content is controlled to be not less than 45 percent, and the medicinal gel layer is controlled to be a viscous colloid from blue-green to yellow-green.

Technical Field

The invention relates to the technical field of pharmaceutical processing, in particular to a medical antipyretic patch and a preparation method thereof.

Background

When a "pyrogen" appears in the human body, it often causes fever, which is essentially a resistant manifestation of the body, and the process is a battle against which leukocytes clear pathogenic factors. When the fever is higher than 39 ℃, the patient is asked to be within a safe range in time besides the rest of the patient, so as to avoid the occurrence of collective functional disorder and the aggravation of the disease. Especially for children with poor immunity, physical cooling is adopted instead of forced use of antipyretics for treatment in order to find pathogenic cause, so as to avoid covering the etiology and missing the optimal treatment opportunity.

Common physical cooling methods include an ice application method, an alcohol wiping method, a sticking antipyretic patch and the like, but the ice application method has limited sustainable cooling time, insufficient fitting degree with an affected part and insufficient comfort level, so that the antipyretic patch is difficult to be used for children and infants; although the alcohol wiping method has obvious cooling effect, the alcohol wiping method has strong skin irritation and is easy to damage the health of infants; the antipyretic patch belongs to the most common daily physical cooling method, but the commercially available antipyretic patches have large water content, poor heat dissipation effect and infirm sticking, and in addition, most commercially available antipyretic patches only have the cooling effect and have no treatment effect, and the antipyretic patches have short antipyretic duration and unexpected and obvious effect.

Disclosure of Invention

In order to solve the problems, improve the antipyretic effect of the antipyretic patch and weaken the stimulation effect of the existing antipyretic patch on the body, the invention provides a medical antipyretic patch and a preparation method thereof.

The invention is realized by the following technical scheme:

a medical antipyretic patch comprises a bottom non-woven fabric substrate, a soft plastic film closely attached to the non-woven fabric substrate, and a medicinal gel layer disposed on the soft plastic film;

the pharmaceutical gel comprises an oil phase and a water phase;

wherein the oil phase comprises the following raw materials in parts by weight:

850-1500 parts of glycerol, 15-75 parts of castor oil, 2-15 parts of sodium polyacrylate, 2-10 parts of CMC, 1-12 parts of dihydroxyaluminum glycinate, 1-13 parts of EDTA, 1-9 parts of ethylene diamine tetraacetic acid and 1-8 parts of titanium dioxide;

the water phase comprises the following raw materials in parts by weight:

100-1000 parts of purified water, 15-85 parts of tartaric acid, 1-15 parts of preservative and 3-10 parts of lemon yellow/brilliant blue solution.

Preferably, the oil phase further comprises 3-7 parts of an additive phase, and the additive phase comprises 2-8 parts of gypsum, 1-3 parts of sweet wormwood herb, 1-3 parts of nettle dry powder, 1-5 parts of flue-cured tobacco ash and 1-2 parts of rose essential oil. The rose essential oil in the additive phase can increase the faint scent of the finished antipyretic patch and neutralize the pungent smell in the oil phase; the traditional Chinese medicinal materials of the flue-cured tobacco ash, the sweet wormwood herb, the gypsum and the nettle are mixed and applied, so that the finished medical antipyretic patch has the effects of clearing away heat and toxic materials, clearing away heart-fire and inducing resuscitation.

Preferably, the relative molecular mass of the sodium polyacrylate is 8800-10000, and when the relative molecular mass of the sodium polyacrylate is 8000-10000, the dispersing performance is optimal, the gel layer of the medical antipyretic patch can be uniformly dispersed, the efficient dispersing and slow-release effect on drug effect components is achieved, the continuous antipyretic time of the medical antipyretic patch is prolonged, the drug effect is mild, and the stimulation effect on patients is low.

A preparation method of a medical antipyretic patch comprises the following steps:

a. preparing a water phase: mixing the required weight part of purified water with the lemon yellow/brilliant blue solution, uniformly mixing, mixing with the required weight part of tartaric acid and the preservative, and uniformly stirring at a stirring speed of 300-400 r/min for 15-30 min to prepare a water phase for later use;

b. preparing an oil phase: respectively grinding the required weight parts of sodium polyacrylate, CMC, dihydroxyaluminum glycinate, EDTA and titanium dioxide through a 325-mesh screen, and uniformly mixing to obtain a solid material for later use;

weighing glycerol in required parts by weight, placing the glycerol in a hopper of an egg beater, adding castor oil in required parts by weight, uniformly mixing, adding the standby solid material and the additive phase in required parts by weight, uniformly stirring, stirring at a medium speed of 200-300 r/min for 5min, stirring at a high speed of 780-860 r/min for 20-30 min, grinding and pulping, and screening with a 200-mesh screen to obtain an oil phase for standby;

c. preparing a medicinal gel: pouring the standby oil phase into a stirrer, sealing the stirrer, continuously stirring for 10-15 min at the stirring speed of 2500-3500 r/min, pumping the standby water phase into a feeding hole, sealing the stirrer, continuously stirring for 15-20 min at the stirring speed of 2500-3500 r/min in vacuum, discharging bubbles, and discharging to obtain medicinal gel;

d. gluing: on a perfect and clean coating machine, a soft plastic film is tightly attached to the upper part of the non-woven fabric substrate and is paved; pouring the medicinal gel into a hopper of a coating machine, starting equipment, uniformly coating the medicinal gel on the soft plastic film, controlling the coating thickness to be uniform and consistent, controlling the gel thickness to be 1-1.5 mm, and cutting into sheets with the weight of 8.5-14.0 g to prepare the primary medical antipyretic patch;

e. standing: taking the primary product for defervescence, sticking the defervescence paste in a multi-layer disc, placing the disc on a multi-layer frame, selecting PE to be sealed, and carrying out static culture for 3-5 days under the conditions that the temperature is 25-28 ℃ and the humidity is 60-65%;

f. selecting and packaging: after the resting is finished, after the hot drawing demolding and curing of the primary medical drawing, scraping edges again, shearing into small pieces with the length of 103-107 mm and the width of 43-47 mm, breaking bubbles, checking whether the mass of the small pieces is within 8.0-12 g again, and if not, treating the small pieces as waste products; if yes, detecting the finished product, obtaining the finished medical defervescence patch after the detection is qualified, putting the finished medical defervescence patch into a stainless steel disc, putting the stainless steel disc into a polyethylene bag, and sealing and storing the stainless steel disc.

Preferably, the vacuum stirring pressure is-0.7 to 1.5 MPa.

Preferably, the finished product detection method is as follows:

the initial adhesion of the medicinal gel layer of the finished medical defervescence patch is controlled to be not less than that of the No. 4 steel ball, the moisture content is not less than 45 percent, the medicinal gel layer is controlled to be a viscous colloid from blue-green to yellow-green, the periphery of the finished medical defervescence patch is neat and free of falling, the isolation protective film is well bonded with the gel layer, and the colloid has faint scent.

The invention has the beneficial effects that:

compared with the prior art, the finished medical defervescence patch prepared by the invention has the advantages that the gel layer is uniformly dispersed in texture, has good adhesion with skin, weak skin irritation and light rose fragrance, and does not smell irritation after being pasted on the skin; meanwhile, under the dispersion action of sodium polyacrylate with the relative molecular mass of 8800-10000, a gel layer is uniformly dispersed and can be continuously annealed for a long time;

in addition, the oil phase also comprises an addition phase, and the flue-cured tobacco ash, the sweet wormwood herb, the gypsum and the nettle are mixed and applied, so that the finished medical antipyretic patch has the effects of clearing away heat and toxic materials, clearing away heart-fire, inducing resuscitation and the like.

Detailed Description

The present invention will be described in further detail with reference to specific embodiments, but the technical solutions provided by the present invention include not only the contents shown in the examples.