CN107412286B - Preparation method of external plaster for treating arthralgia - Google Patents
Preparation method of external plaster for treating arthralgia Download PDFInfo
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- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
- A61K31/404—Indoles, e.g. pindolol
- A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
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- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
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- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7076—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising ingredients of undetermined constitution or reaction products thereof, e.g. rosin or other plant resins
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Abstract
The invention belongs to the technical field of plaster preparations, and particularly relates to a preparation method of an external plaster for treating arthralgia. The method comprises the following steps: cutting rubber into strips, rolling into rubber sheets, swelling and emulsifying in gasoline solvent, adding the above materials into the gasoline solvent soaked with rubber sheets, stirring, filtering to obtain rubber slurry, coating on backing to obtain paste, winding, covering, and packaging. The external plaster for treating arthralgia prepared by the method has the following advantages: good anti-inflammatory and analgesic effects; the volatility is low, and the drug effect durability is good; the swelling and emulsifying effect of the rubber is good, the residual quantity of gasoline is low, and the solvent is not easy to leak; the plaster cover liner has good packaging effect and is not easy to be affected with damp; the ingredients are dissolved and dispersed uniformly, and the quality of the plaster is uniform; the plaster has good antibacterial and anti-inflammatory effects and long storage life.
Description
Technical Field
The invention belongs to the technical field of plaster preparations, and particularly relates to a preparation method of an external plaster for treating arthralgia.
Background
The application history of the plaster in China is long, vegetable oil or animal oil is added with medicine and decocted into colloidal substances, the colloidal substances are coated on one surface of cloth, paper or skin and can be pasted on an affected part for a long time, the medicine in the plaster is directly pasted on body surface acupuncture points, the medicine property permeates into subcutaneous tissues from the outside to the inside through the skin and hair, on one hand, the relative advantage of the medicine concentration is generated locally, on the other hand, the medicine can directly reach the focus of viscera loss of regulating menstruation and qi imbalance through the through running of meridians and collaterals, the functional effect of the medicine is exerted, and therefore the maximum whole body pharmacological effect is exerted. The traditional injection and oral therapy damages tissues such as nerves, blood vessels, muscles and the like, so that the patients are not easy to accept, and the methods are easy to lead the medicines to be dispersed all over the whole body through blood circulation, so that the medicines really reaching the local parts of the diseases are few, the dosage is large, but the curative effect is poor. Compared with injection and oral medicines, the plaster avoids the toxic and side effects of oral administration, and meanwhile, the medicine directly acts on the affected part, has high efficacy and obvious effect and is not easy to generate drug resistance.
However, the existing plaster has the following production or use problems: firstly, the effective components of the plaster such as rosin, menthol and the like are easy to volatilize, so that the drug effect is reduced and the drug effect durability is poor; secondly, the adhesive foaming process causes that gasoline, vegetable oil and the like are easy to remain in the plaster, and grease is leaked under the conditions of high temperature or insufficient emulsification and swelling of the matrix; thirdly, the plaster is thin and has poor cohesiveness, and plaster covers such as release paper have poor packaging effect and are easy to be affected with damp; fourthly, the plaster quality is different due to uneven dispersion of all ingredients in the preparation process; and part of raw materials in the plaster, such as rosin and the like, have low solubility in a solvent and are easy to crystallize and separate out to form a plaster block.
Chinese patent CN104367663A, the title of the patent is a plaster for treating cartilage tissue injury and its manufacturing method, application date 2015, 2 months and 25 days, discloses a plaster made of gardenia, menthol, rubber, borneol, zinc oxide, rosin, vaseline, and lanolin, its manufacturing method is crushing rubber, adding gasoline, pulping, soaking, then adding vaseline, lanolin, zinc oxide, rosin, menthol, borneol and fluid extract of gardenia, stirring uniformly to make into paste, then coating paste, cutting into sections, covering with lining, slicing. However, the plaster prepared by the method still has the problems of reduced efficacy, poor efficacy durability, uneven ingredient dispersion and the like caused by volatilization of effective ingredients such as rosin and the like.
Disclosure of Invention
Aiming at the problems of volatilization of active ingredients of the plaster and poor persistence of the drug effect caused by the existing plaster preparation method, the invention aims to provide the preparation method of the external plaster for treating arthralgia, and the external plaster for treating arthralgia prepared by the method has the advantages of low volatility of the active ingredients of rosin, good persistence of the drug effect, uniform distribution of ingredients and uniform plaster quality.
The invention provides the following technical scheme:
a preparation method of an external plaster for treating arthralgia comprises the following steps:
(1) rolling rubber: removing the film from the raw rubber, cutting the raw rubber into rubber strips with the length of 10-18 cm, and putting the rubber strips into a rubber mixing machine for rolling to obtain rubber sheets;
(2) expanding glue: putting the rubber slices into a stirrer, adding a gasoline solvent, stirring at regular time and ultrasonically soaking for later use;
(3) preparing materials: adding a certain amount of camphor, menthol, rosin and ethyl cellulose into ethanol in sequence, stirring and dissolving, then adding a certain amount of zinc oxide to prepare an ethanol mixed solution, adding a certain amount of alpha-cyclodextrin into dimethyl sulfoxide to dissolve, then adding a certain amount of indomethacin and dyclonine hydrochloride, stirring uniformly to obtain a dimethyl sulfoxide mixed solution, adding a certain amount of lanolin into diethyl ether, stirring and dissolving uniformly to obtain a diethyl ether mixed solution;
(4) pulping: mixing the ethanol mixed solution, the dimethyl sulfoxide mixed solution and the ether mixed solution obtained in the step (3), adding the ethanol mixed solution, the dimethyl sulfoxide mixed solution and the ether mixed solution into the gasoline solvent obtained in the step (2), mixing and stirring the mixture uniformly with the swelled rubber sheets, and sieving the mixture to obtain rubber cement;
(5) gluing: feeding the back lining into two rolling cylinders of a glue spreader, adding mucilage into the glue spreader, and coating the mucilage on the back lining to prepare a plaster coating agent;
(6) oil removal: sending the paste coating agent obtained in the step (5) into a cold air environment for oil removal treatment;
(7) reel: heating the reeling machine and controlling the temperature of each oven in the reeling machine, sending the degreased paste coating agent to the reel of the reeling machine, and cutting off the paste coating agent once every 100m long roll;
(8) packaging: feeding the paste coating agent and the release paper of the reel into a needle machine for treatment so as to enable the paste surface coated with the paste coating agent to cover the release paper, and then coating a protective layer on the outer side of the release paper;
(9) packaging: slicing according to the specified size, bagging and packaging to obtain the external plaster for treating arthralgia.
The preparation method of the external plaster for treating arthralgia comprises the following steps: cutting rubber into strips, rolling to form rubber sheets, soaking the rubber sheets in gasoline solvent to swell and emulsify the rubber sheets, adding the raw materials into the gasoline solvent soaked with the rubber sheets, stirring uniformly, filtering to prepare mucilage, coating the mucilage on a back lining to prepare a paste coating agent, and then coiling, covering and packaging. Firstly, the raw materials are respectively prepared into feed liquid in the burdening process, so that the phenomenon that rosin, menthol, lanolin and camphor are dissolved and dispersed unevenly or are not dissolved sufficiently to cause blocky residues because the rosin, the menthol, the lanolin and the camphor are directly added into gasoline for soaking rubber sheets is avoided. The ethyl cellulose added into the prepared ethanol mixed solution can promote the swelling and emulsification of rubber and improve the adhesive property of the plaster at the same time. More importantly, the ethyl cellulose can form a water-insoluble framework in the swollen rubber, and is further strengthened through an oil removal process, so that volatile components such as rosin, menthol, lanolin, camphor and the like are locked, released outwards slowly, and crystallization of the rosin and the like is inhibited. The alpha-cyclodextrin added into the prepared ether mixed solution has a cage-like structure which can envelop indomethacin and dyclonine hydrochloride, delay the release rate and prolong the drug property of the plaster. And the alpha-cyclodextrin has the functions of diminishing inflammation, relieving pain and inhibiting bacterial growth. The mutual action of zinc oxide, ethyl cellulose, rosin, lanolin and the like can achieve the effects of thickening, softening and promoting emulsification, promote the full and uniform mixing of all ingredients and rubber, promote the full swelling of the rubber and avoid the external permeation of gasoline. Therefore, the components in the external plaster for treating arthralgia prepared by the method, in particular menthol, camphor, rosin and the like are fully dissolved and uniformly dispersed, the appearance of lumps, rosin crystals and the like is avoided, the retention effect of ethyl cellulose and alpha-cyclodextrin enables the release rate of volatile components such as rosin and the like and indometacin and the like to be slow, the drug effect volatility is reduced, and the drug effect duration effect is good.
As an improvement of the method, the gasoline solvent used in the step (2) is formed by mixing No. 120 gasoline and ethanol, wherein the volume percentage of the No. 120 gasoline is 80-90%, and the weight ratio of the rubber sheet to the gasoline solvent is 1: 4.2-6.8. The No. 120 gasoline has good rubber swelling effect, and can accelerate the full mixing of the gasoline solvent, the ethanol mixed solution and the ether mixed solution after being mixed with ethanol, and strengthen the uniform mixing of all ingredients and the swollen rubber.
As an improvement of the method of the invention, the stirring process in the step (2) is as follows: stirring for 2 minutes every 3 hours, then continuously soaking for more than 24 hours until the rubber sheet is fully swelled and softened, wherein the stirring speed is 30-40 r/min, the soaking temperature is 10-30 ℃, and ultrasound is performed during stirring, the ultrasound frequency is 50-60 Hz, and the ultrasound frequency is 45-75W. After stirring and full soaking, the rubber sheet is fully swelled and softened, and the swelling speed of the rubber sheet is accelerated by ultrasonic.
As an improvement of the method of the invention, the components in the step (3) are respectively in parts by weight: 2350-2820 parts of indomethacin, 167-200 parts of dyclonine hydrochloride, 8900-10680 parts of camphor, 3900-4680 parts of menthol, 31000-37200 parts of rubber, 34000-40800 parts of zinc oxide, 26000-31200 parts of rosin, 4000-4800 parts of wool fat, 3900-4680 parts of dimethyl sulfoxide, 3500-5000 parts of ethyl cellulose and 800-1200 parts of alpha-cyclodextrin. The zinc oxide acts as a filler and reacts with the rosin to form an octyl salt of rosin acid, which promotes emulsification of the rubber. Lanolin and menthol play a role in softening rubber, and lanolin can cooperate with ethyl cellulose to enhance viscosity. The menthol, the rosin and the camphor have the functions of cooling, relieving itching, reducing swelling, relieving pain, sterilizing and inhibiting bacteria by providing aromatic odor.
As an improvement of the method, the weight ratio of camphor to ethanol in the step (3) is as follows: the camphor is 1: 4-7, and the ratio of lanolin to ethyl ether in parts by weight is as follows: lanolin and diethyl ether are 1: 1.5-2.5, and the dissolving temperature is 10-20 ℃. Fully promotes the full dissolution and uniform dispersion of all ingredients, and improves the uniform mixing of all mixed feed liquid and the swelling rubber.
As an improvement of the method, the temperature of the cold air environment in the step (6) is 3-8 ℃, the air speed is 3-5 m/s, and the standing time is 3-6 hours. After cold air degreasing treatment, solvents such as gasoline, ether and the like in the paste coating agent are fully escaped, further the gasoline and the like are prevented from seeping out of the paste, the improvement of the skeleton strength of ethyl cellulose and alpha-cyclodextrin is promoted, the preservation of effective components in the paste is enhanced, and the medicine property durability of the paste is improved.
As an improvement of the method of the invention, the temperature of each oven in the reeling machine in the step (7) is as follows in sequence: the temperature of the first oven is 60 +/-5 ℃, the temperature of the second oven is 90 +/-5 ℃, and the temperature of the third oven is 70 +/-5 ℃. The program temperature control strengthens the bonding strength between the plaster and the back lining in the plaster coating agent.
As an improvement of the method, the thickness of the protective layer in the step (8) is 2-5 μm, and the protective layer is formed by mixing and spraying the following components in parts by weight: 15-35 parts of carboxylated chitosan, 3-8 parts of guar gum ether, 1-2 parts of ethyl cellulose, 10-15 parts of ethanol and 80-100 parts of water. By applying a protective layer to the surface of the release paper, volatile components are prevented from escaping by evaporation on the one hand, and moisture is prevented on the other hand. The carboxylated chitosan in the protective layer has an antibacterial effect, and acts together with guar gum ether to form a thin film layer under the action of ethyl cellulose, so that the volatilization of components can be effectively prevented, and the effect of prolonging the drug effect is achieved.
The invention has the following beneficial effects:
the external plaster for treating arthralgia prepared by the method has the following advantages: (1) good anti-inflammatory and analgesic effects; (2) the volatility of rosin, menthol and the like in the plaster is low, and the drug effect durability is good; (3) the swelling and emulsifying effect of the rubber is good, the residual quantity of gasoline is low, and the solvent is not easy to leak; (4) the paste has good viscosity; (4) the plaster cover liner has good packaging effect and is not easy to be affected with damp; (5) the ingredients are dissolved and dispersed uniformly, and the quality of the plaster is uniform; (6) rosin and the like can not be crystallized and separated out in the using process, so that the plaster in the plaster is prevented from being coagulated into blocks; (7) the plaster has good antibacterial and anti-inflammatory effects and long storage life.
Detailed Description
The following further describes the embodiments of the present invention.
The starting materials used in the present invention are commercially available or commonly used in the art, unless otherwise specified, and the methods in the following examples are conventional in the art, unless otherwise specified.
Example 1
A preparation method of an external plaster for treating arthralgia comprises the following steps:
(1) rolling rubber: removing a film from raw rubber, cutting the raw rubber into rubber strips with the length of 10cm, putting the rubber strips into a rubber mixing machine, and rolling to obtain rubber sheets, so that grid patterns are formed on two sides of each rubber sheet, and the thickness of each rubber sheet is 3 mm;
(2) expanding glue: putting the rubber sheet into a stirrer, adding a gasoline solvent, stirring at regular time and soaking by ultrasound for later use, wherein the gasoline solvent is prepared by mixing No. 120 gasoline and ethanol, the volume percentage of the No. 120 gasoline is 80%, the weight ratio of the rubber sheet to the gasoline solvent is 1:4.2, and the stirring and soaking process is as follows: stirring for 2 minutes every 3 hours, then continuously soaking for more than 24 hours until the rubber sheet is fully swelled and softened, preferably 25 hours, wherein the stirring speed is 30r/min, the soaking temperature is 10 ℃, and ultrasonic assistance is applied in the stirring process, the ultrasonic frequency is 50Hz, and the ultrasonic frequency is 45W;
(3) preparing materials: adding camphor, menthol, rosin and ethyl cellulose into ethanol in sequence, stirring and dissolving, and then adding zinc oxide to prepare ethanol mixed liquor; dissolving alpha-cyclodextrin in dimethyl sulfoxide, adding indomethacin and dyclonine hydrochloride, and stirring to obtain dimethyl sulfoxide mixed solution; adding ether into lanolin, stirring and dissolving uniformly to obtain ether mixed solution. The weight of each component is as follows: 2820g of indomethacin, 200g of dyclonine hydrochloride, 10680g of camphor, 4680g of menthol, 37200g of rubber, 40800g of zinc oxide, 31200g of rosin, 4800g of lanolin, 4680g of dimethyl sulfoxide, 5000g of ethyl cellulose and 1200g of alpha-cyclodextrin. The weight ratio of camphor to ethanol is as follows: the weight ratio of lanolin to ethyl ether is 1:2.5, and the dissolving temperature is 10 ℃. In addition, before use, the rosin is stir-fried for 25 minutes at the temperature of 160 ℃, then is crushed and filtered for use, and the specification of a filter screen is 120 meshes;
(4) pulping: mixing the ethanol mixed solution, the dimethyl sulfoxide mixed solution and the diethyl ether mixed solution obtained in the step (3), adding the ethanol mixed solution, the dimethyl sulfoxide mixed solution and the diethyl ether mixed solution into the gasoline solvent obtained in the step (2), mixing and stirring the mixture uniformly, and sieving the mixture by a 80# 60# copper sieve to obtain a mucilage;
(5) gluing: feeding the back lining into two rolling cylinders of a glue spreader, adding mucilage into the glue spreader, and coating the mucilage on the back lining to prepare a plaster coating agent;
(6) oil removal: feeding the paste coating agent obtained in the step (5) into a cold air environment for oil removal treatment, wherein the temperature of the cold air environment is 3 ℃, the air speed is 3m/s, and the standing time is 3 hours;
(7) reel: heating the reeling machine and controlling the temperature of each oven in the reeling machine, sending the degreased paste coating agent into the reeling machine reel, cutting off once every 100m long roll, wherein the temperature of each oven in the reeling machine is as follows: the temperature of the first oven is 60 +/-5 ℃, the temperature of the second oven is 90 +/-5 ℃, the temperature of the third oven is 70 +/-5 ℃, and a small sample is cut after the reel starts for 5min to test the paste content;
(8) packaging: feeding the paste coating agent and the release paper on a reel into a needle machine for treatment so as to enable the paste surface of the paste coating agent to cover the release paper, and then coating a protective layer on the outer side of the release paper, wherein the thickness of the protective layer is 2 mu m, and the protective layer is prepared by mixing the following components: 35g of carboxylated chitosan, 8g of guar gum ether, 2g of ethyl cellulose, 15g of ethanol and 100g of water;
(9) packaging: slicing according to the specified size, bagging and packaging to obtain the external plaster for treating arthralgia.
Example 2
A preparation method of an external plaster for treating arthralgia comprises the following steps:
(1) rolling rubber: removing a film from raw rubber, cutting the raw rubber into rubber strips with the length of 15cm, putting the rubber strips into a rubber mixing machine, and rolling to obtain rubber sheets, so that grid patterns are formed on two sides of each rubber sheet, and the thickness of each rubber sheet is 4 mm;
(2) expanding glue: putting the rubber sheet into a stirrer, adding a gasoline solvent, stirring at regular time and soaking by ultrasound for later use, wherein the gasoline solvent is prepared by mixing No. 120 gasoline and ethanol, the volume percentage of the No. 120 gasoline is 85%, the weight ratio of the rubber sheet to the gasoline solvent is 1:5.5, and the stirring and soaking process is as follows: stirring for 2 minutes every 3 hours, then continuously soaking for more than 24 hours until the rubber sheet is fully swelled and softened, preferably 27 hours, wherein the stirring speed is 35r/min, the soaking temperature is 20 ℃, and ultrasonic assistance is applied in the stirring process, the ultrasonic frequency is 55Hz, and the ultrasonic frequency is 60W;
(3) preparing materials: adding camphor, menthol, rosin and ethyl cellulose into ethanol in sequence, stirring and dissolving, and then adding zinc oxide to prepare ethanol mixed liquor; dissolving alpha-cyclodextrin in dimethyl sulfoxide, adding indomethacin and dyclonine hydrochloride, and stirring to obtain dimethyl sulfoxide mixed solution; adding ether into lanolin, stirring and dissolving uniformly to obtain ether mixed solution. Wherein the weight of each component is respectively as follows: 2350g of indomethacin, 167g of dyclonine hydrochloride, 8900g of camphor, 3900g of menthol, 31000g of rubber, 34000g of zinc oxide, 26000g of rosin, 4000g of lanolin, 3900-468 g of dimethyl sulfoxide, 3500g of ethyl cellulose and 800g of alpha-cyclodextrin. The weight ratio of camphor and ethanol is 1:4, the weight ratio of lanolin and diethyl ether is 1:1.5, and the dissolving temperature is 15 ℃. In addition, before use, the rosin is stir-fried for 20 minutes at the temperature of 170 ℃, then is crushed and filtered for use, and the specification of a filter screen is 140 meshes;
(4) pulping: mixing the ethanol mixed solution, the dimethyl sulfoxide mixed solution and the diethyl ether mixed solution obtained in the step (3), adding the ethanol mixed solution, the dimethyl sulfoxide mixed solution and the diethyl ether mixed solution into the gasoline solvent obtained in the step (2), mixing and stirring the mixture uniformly, and sieving the mixture by a 80# 60# copper sieve to obtain a mucilage;
(5) gluing: feeding the back lining into two rolling cylinders of a glue spreader, adding mucilage into the glue spreader, and coating the mucilage on the back lining to prepare a plaster coating agent;
(6) oil removal: feeding the paste coating agent obtained in the step (5) into a cold air environment for oil removal treatment, wherein the temperature of the cold air environment is 6 ℃, the air speed is 4m/s, and the standing time is 4 hours;
(7) reel: heating the reeling machine and controlling the temperature of each oven in the reeling machine, sending the degreased paste coating agent into the reeling machine reel, cutting off once every 100m long roll, wherein the temperature of each oven in the reeling machine is as follows: the temperature of the first oven is 60 +/-5 ℃, the temperature of the second oven is 90 +/-5 ℃, the temperature of the third oven is 70 +/-5 ℃, and a small sample is cut after the reel starts for 5min to test the paste content;
(8) packaging: feeding the paste coating agent and the release paper on a reel into a needle machine for treatment so as to enable the paste surface of the paste coating agent to cover the release paper, and then coating a protective layer on the outer side of the release paper, wherein the thickness of the protective layer is 4 mu m, and the protective layer is prepared by mixing the following components: 25g of carboxylated chitosan, 5.5g of guar gum ether, 1.5g of ethyl cellulose, 12.5g of ethanol and 90g of water;
(9) packaging: slicing according to the specified size, bagging and packaging to obtain the external plaster for treating arthralgia.
Example 3
A preparation method of an external plaster for treating arthralgia comprises the following steps:
(1) rolling rubber: removing a film from raw rubber, cutting the raw rubber into rubber strips with the length of 10cm, putting the rubber strips into a rubber mixing machine, and rolling to obtain rubber sheets, so that grid patterns are formed on two sides of each rubber sheet, and the thickness of each rubber sheet is 5 mm;
(2) expanding glue: putting the rubber sheet into a stirrer, adding a gasoline solvent, stirring at regular time and soaking by ultrasound for later use, wherein the gasoline solvent is formed by mixing No. 120 gasoline and ethanol, the volume percentage of the No. 120 gasoline is 90%, the weight ratio of the rubber sheet to the gasoline solvent is 1:4.2, and the stirring and soaking process is as follows: stirring for 2 minutes every 3 hours, then continuously soaking for more than 24 hours until the rubber sheet is fully swelled and softened, wherein the stirring speed is 40r/min, the soaking temperature is 30 ℃, and ultrasonic assistance is applied in the stirring process, the ultrasonic frequency is 60Hz, and the ultrasonic frequency is 75W;
(3) preparing materials: adding camphor, menthol, rosin and ethyl cellulose into ethanol in sequence, stirring and dissolving, and then adding zinc oxide to prepare ethanol mixed liquor; dissolving alpha-cyclodextrin in dimethyl sulfoxide, adding indomethacin and dyclonine hydrochloride, and stirring to obtain dimethyl sulfoxide mixed solution; adding ether into lanolin, stirring and dissolving uniformly to obtain ether mixed solution. Wherein the weight of each component is respectively as follows: 3085g of indometacin, 183.5g of dyclonine hydrochloride, 9790g of camphor, 4290g of menthol, 34100g of rubber, 37400g of zinc oxide, 28600g of rosin, 4400g of lanolin, 4290g of dimethyl sulfoxide, 4250g of ethyl cellulose and 1000g of alpha-cyclodextrin. The weight ratio of camphor and ethanol is 1:5.5, the weight ratio of lanolin and diethyl ether is 1:2, and the dissolving temperature is 20 ℃. In addition, before use, the rosin is stir-fried for 15 minutes at the temperature of 180 ℃ and then is crushed and filtered for use, and the specification of a filter screen is 160 meshes;
(4) pulping: mixing the ethanol mixed solution, the dimethyl sulfoxide mixed solution and the diethyl ether mixed solution obtained in the step (3), adding the ethanol mixed solution, the dimethyl sulfoxide mixed solution and the diethyl ether mixed solution into the gasoline solvent obtained in the step (2), mixing and stirring the mixture uniformly, and sieving the mixture by a 80# 60# copper sieve to obtain a mucilage;
(5) gluing: feeding the back lining into two rolling cylinders of a glue spreader, adding mucilage into the glue spreader, and coating the mucilage on the back lining to prepare a plaster coating agent;
(6) oil removal: feeding the paste coating agent obtained in the step (5) into a cold air environment for oil removal treatment, wherein the temperature of the cold air environment is 8 ℃, the air speed is 5m/s, and the standing time is 6 hours;
(7) reel: heating the reeling machine and controlling the temperature of each oven in the reeling machine, sending the degreased paste coating agent into the reeling machine reel, cutting off once every 100m long roll, wherein the temperature of each oven in the reeling machine is as follows: the temperature of the first oven is 60 +/-5 ℃, the temperature of the second oven is 90 +/-5 ℃, the temperature of the third oven is 70 +/-5 ℃, and a small sample is cut after the reel starts for 5min to test the paste content;
(8) packaging: feeding the paste coating agent and the release paper on a reel into a needle machine for treatment so as to enable the paste surface of the paste coating agent to cover the release paper, and then coating a protective layer on the outer side of the release paper, wherein the thickness of the protective layer is 5 mu m, and the protective layer is prepared by mixing the following components: 15g of carboxylated chitosan, 3g of guar gum ether, 1g of ethyl cellulose, 10g of ethanol and 80g of water;
(9) packaging: slicing according to the specified size, bagging and packaging to obtain the external plaster for treating arthralgia.
Performance testing
(1) And (3) solvent extravasation: each of 3 patches prepared in examples 1 to 3 was allowed to stand in a sealed environment at 40. + -. 2 ℃ for 2 days, 5 days, and 7 days, and the cap side (release paper side) of the patch was observed to have no dripping and bleeding, and the results are shown in Table 1.
TABLE 1
It can be seen from table 1 that the external penetration of oil drops of the plaster placed at 40 ± 2 ℃ is not obvious, 4 pieces of plaster still have no external penetration of oil drops after 7 days of placement, 2 pieces of plaster can only see slight oil marks, 1 piece of plaster has 1 oil drop external penetration, and 2 pieces of plaster have 2 oil drops external penetration.
(2) Volatilization of drug properties: each of 3 patches prepared in examples 1 to 3 was covered with a liner, placed in a 25. + -. 2 ℃ ventilation chamber with one side of the patch facing upward and left standing for 2 days, 5 days, and 7 days, and the remaining amount of peppermint in the patch was measured at each time period, and the results are shown in Table 2.
TABLE 2
| Examples | 2 days | 5 days | 7 days |
| Example 1 | 98.6±0.3％ | 91.2±0.3％ | 90.5±0.3％ |
| Example 2 | 97.4±0.3％ | 91.3±0.3％ | 90.8±0.3％ |
| Example 3 | 99.2±0.3％ | 93.1±0.3％ | 91.2±0.3％ |
As can be seen from table 2, the volatility of volatile components represented by peppermint in the patch was reduced, the volatilization amount was small, and the volatilization was mainly concentrated in the period from day 2 to day 5, mainly because the concentration of volatile components in the patch was high at the beginning and sufficiently escaped after being left for 2 days under ventilation.
(3) And (3) testing the drug effect: 6 pieces of each of the plasters prepared in examples 1 to 3 were applied to the skin of a rabbit recovered from the depilating treatment, and the skin penetration rate of the plaster was measured at regular intervals, wherein the measurement indexes include the content of the remaining mint and the content of indomethacin in the plaster, and the measurement results are shown in table 3.
TABLE 3
From the table above, the plaster of the invention has a good transdermal rate, the average transdermal rate of indometacin after 48 hours reaches 61.4%, and compared with the residual amount of mint of about 90% after 7 days in table 2, the residual amount of mint of the plaster applied to the skin is obviously reduced, and the escape rate from the plaster is obviously increased, which shows that the plaster prepared by the preparation method of the invention has good biological application effect and obvious effect.
The external plaster for treating arthralgia prepared by the preparation method has good effects of diminishing inflammation and easing pain, and has the advantages of low volatility, good drug effect durability, good swelling and emulsifying effects of rubber, low gasoline residue, difficult solvent exosmosis, good packaging effect of a plaster cover liner, difficult dampness, uniform plaster quality, good antibacterial and anti-inflammatory effects and long storage life.
Claims (4)
1. A preparation method of an external plaster for treating arthralgia comprises the following steps:
(1) rolling rubber: removing the film from the raw rubber, cutting the raw rubber into rubber strips with the length of 10-18 cm, and putting the rubber strips into a rubber mixing machine for rolling to obtain rubber sheets;
(2) expanding glue: putting the rubber slices into a stirrer, adding a gasoline solvent, stirring at regular time and ultrasonically soaking for later use;
(3) preparing materials: adding a certain amount of camphor, menthol, rosin and ethyl cellulose into ethanol in sequence, stirring and dissolving, then adding a certain amount of zinc oxide to prepare an ethanol mixed solution, adding a certain amount of alpha-cyclodextrin into dimethyl sulfoxide to dissolve, then adding a certain amount of indomethacin and dyclonine hydrochloride, stirring uniformly to obtain a dimethyl sulfoxide mixed solution, adding a certain amount of lanolin into diethyl ether, stirring and dissolving uniformly to obtain a diethyl ether mixed solution;
(4) pulping: mixing the ethanol mixed solution, the dimethyl sulfoxide mixed solution and the ether mixed solution obtained in the step (3), adding the ethanol mixed solution, the dimethyl sulfoxide mixed solution and the ether mixed solution into the gasoline solvent obtained in the step (2), mixing and stirring the mixture uniformly with the swelled rubber sheets, and sieving the mixture to obtain rubber cement;
(5) gluing: feeding the back lining into two rolling cylinders of a glue spreader, adding mucilage into the glue spreader, and coating the mucilage on the back lining to prepare a plaster coating agent;
(6) oil removal: sending the paste coating agent obtained in the step (5) into a cold air environment for oil removal treatment;
(7) reel: heating the reeling machine and controlling the temperature of each oven in the reeling machine, sending the degreased paste coating agent to the reel of the reeling machine, and cutting off the paste coating agent once every 100m long roll;
(8) packaging: feeding the paste coating agent and the release paper of the reel into a needle machine for treatment so as to enable the paste surface coated with the paste coating agent to cover the release paper, and then coating a protective layer on the outer side of the release paper;
(9) packaging: slicing according to a specified size, bagging and packaging to obtain an external plaster for treating arthralgia;
the weight parts of the components are respectively as follows: 2350-2820 parts of indomethacin, 167-200 parts of dyclonine hydrochloride, 8900-10680 parts of camphor, 3900-4680 parts of menthol, 31000-37200 parts of rubber, 34000-40800 parts of zinc oxide, 26000-31200 parts of rosin, 4000-4800 parts of wool fat, 3900-4680 parts of dimethyl sulfoxide, 3500-5000 parts of ethyl cellulose and 800-1200 parts of alpha-cyclodextrin;
the stirring process in the step (2) is as follows: stirring for 2 minutes every 3 hours, then continuously soaking for more than 24 hours until the rubber sheet is fully swelled and softened, wherein the stirring speed is 30-40 r/min, the soaking temperature is 10-30 ℃, and the ultrasonic frequency is 50-60 Hz and the ultrasonic power is 45-75W during stirring;
the temperature of the cold air environment in the step (6) is 3-8 ℃, the air speed is 3-5 m/s, and the standing time is 3-6 hours;
the thickness of the protective layer in the step (8) is 2-5 mu m, and the protective layer is formed by mixing and spraying the following components in parts by weight: 15-35 parts of carboxylated chitosan, 3-8 parts of guar gum ether, 1-2 parts of ethyl cellulose, 10-15 parts of ethanol and 80-100 parts of water.
2. The method for preparing an externally-applied plaster for treating arthralgia according to claim 1, wherein the gasoline solvent used in the step (2) is prepared by mixing No. 120 gasoline and ethanol, wherein the volume percentage of the No. 120 gasoline is 80-90%, and the weight ratio of the rubber sheet to the gasoline solvent is 1: 4.2-6.8.
3. The method for preparing an externally-applied plaster for treating arthralgia according to claim 1, wherein the ratio of camphor to ethanol in the step (3) is, by weight: camphor and ethanol =1: 4-7, and the ratio of lanolin to ethyl ether by weight is as follows: lanolin and diethyl ether =1: 1.5-2.5, and the dissolving temperature is 10-20 ℃.
4. The method for preparing an external plaster for treating arthralgia according to claim 1, wherein the temperatures of the respective ovens in the reel machine in the step (7) are, in order: the temperature of the first oven is 60 +/-5 ℃, the temperature of the second oven is 90 +/-5 ℃, and the temperature of the third oven is 70 +/-5 ℃.
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| CN111281860A (en) * | 2019-12-16 | 2020-06-16 | 杭州仁德医药有限公司 | Plaster for treating arthralgia |
| CN111297893B (en) * | 2019-12-18 | 2021-11-12 | 杭州仁德医药有限公司 | Compound indomethacin and dyclonine plaster with waterproof performance and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1144655A (en) * | 1995-05-18 | 1997-03-12 | 湖北药检高等专科学校 | Indomethacin adhesive plaster |
| WO2005000331A2 (en) * | 2003-06-04 | 2005-01-06 | Mucosal Therapeutics, Inc. | Compositions for the treatment and prevention of degenerative joint disorders |
| CN104367663A (en) * | 2014-11-05 | 2015-02-25 | 浙江鼎泰药业有限公司 | Plaster for treating soft tissue injury and production method thereof |
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- 2017-06-26 CN CN201710491868.XA patent/CN107412286B/en active Active
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1144655A (en) * | 1995-05-18 | 1997-03-12 | 湖北药检高等专科学校 | Indomethacin adhesive plaster |
| WO2005000331A2 (en) * | 2003-06-04 | 2005-01-06 | Mucosal Therapeutics, Inc. | Compositions for the treatment and prevention of degenerative joint disorders |
| CN104367663A (en) * | 2014-11-05 | 2015-02-25 | 浙江鼎泰药业有限公司 | Plaster for treating soft tissue injury and production method thereof |
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| Title |
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| 双波长分光光度法测定复方吲哚美辛栓中吲哚美辛的含量;王春艳等;《中国现代应用药学杂志》;20040831;第21卷(第4期);303-304 * |
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