CN115944677A - Notoginseng pain-relieving paste with stable effective components and preparation method thereof - Google Patents
Notoginseng pain-relieving paste with stable effective components and preparation method thereof Download PDFInfo
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Abstract
The invention relates to the technical field of traditional Chinese medicines, in particular to a pseudo-ginseng pain-alleviating paste with stable active ingredients and a preparation method thereof, which comprises a fluid extract prepared from cinnamon, rhubarb, hypericum sampsonii hance, sappan wood, safflower, indian stringbush root, shinyleaf pricklyash root, prepared common monkshood mother root, prepared kusnezoff monkshood root, corydalis tuber, chinese angelica, fourstamen stephania root, himalayan teasel root, erythrina bark, akebia stem, costustoot, ephedra herb, pepper, hot pepper, belvedere fruit and seaweed; 37. grinding Olibanum and Myrrha into powder; mixing Mentholum, camphora, borneolum Syntheticum, and methyl salicylate; the pseudo-ginseng pain-relieving paste is prepared by mixing rubber, rosin, zinc oxide, yellow vaseline, liquid paraffin, lanolin, lithopone, terpene resin, hot melt pressure sensitive adhesive and an antioxidant, mixing, performing low-temperature rubber mixing at 65-85 ℃, and coating baking glue at 75 +/-10 ℃ to obtain the pseudo-ginseng pain-relieving paste.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a pseudo-ginseng pain-alleviating plaster with stable effective components and a preparation method thereof.
Background
The pseudo-ginseng pain-relieving plaster is a unique rubber plaster researched and developed by Hunan Chinese medicinal institute on the basis of a traditional orthopedic external plaster prescription, and has an approved code: the Chinese medicine standard character Z20025171 has the execution standard of WS-10159 (ZD-0159) -2002-2011Z, and mainly comprises 28 medicinal materials and bulk drugs, wherein the medicinal materials comprise pseudo-ginseng, cinnamon, radix aconiti (prepared), radix aconiti agrestis (prepared), ephedra, pepper, sapanwood, safflower, frankincense (prepared), myrrh (prepared), borneol, camphor and the like. The functional indications are as follows: promoting blood circulation, removing blood stasis, dispelling pathogenic wind, removing dampness, warming channels, and dredging collaterals; can be used for treating traumatic injury, rheumatic arthralgia, and pain of shoulder, arm, waist, and leg; the preparation method of the pseudo-ginseng pain-alleviating adhesive comprises a rubber paste solvent method and a hot pressing method, and the pseudo-ginseng pain-alleviating adhesive is obtained through the technical processes of material preparation, rubber mixing and paste preparation.
Chinese patent application publication No.: CN1429571A discloses a TIANQIZHENTONG ointment and its preparation method, which comprises making fluid extract from twenty-one medicinal materials such as cortex Cinnamomi, adding pulverized Notoginseng radix, olibanum, myrrha, camphora, mentholum, borneolum Syntheticum, and methyl salicylate, making into coating with rubber, colophonium, and gasoline as matrix, coating, cutting into segments, and cutting into small pieces; the method adopts a traditional solvent method rubber paste preparation forming process, and a large amount of flammable and explosive diethyl ether is used as a solvent in the production process, so that the method has great potential safety hazard in production and environmental protection problems.
However, the hot-pressing method adopted in China at present generally adopts a rubber paste preparation forming process, because the rubber mixing temperature is high (generally 100-110 ℃), the stability of volatile oil and active ingredients in the paste is difficult to maintain, and the product quality and the curative effect are influenced.
Disclosure of Invention
Therefore, the invention provides the pseudo-ginseng pain-alleviating adhesive plaster with stable active ingredients and the preparation method thereof, which are used for overcoming the problems of safe production and environmental protection of the original solvent method rubber plaster preparation process of the pseudo-ginseng pain-alleviating adhesive plaster in the prior art and simultaneously overcoming the quality problem of poor control on the stability of the active ingredients of the existing hot pressing method rubber plaster preparation process.
In order to achieve the above objects, in one aspect, the present invention provides a method for preparing a pseudo-ginseng pain-alleviating adhesive plaster having stable active ingredients, comprising:
step S1, preparing materials,
weighing medicinal component I including cortex Cinnamomi, radix et rhizoma Rhei, herba Hyperici Sampsonii, lignum sappan, carthami flos, radix Wikstroemae Indicae, radix Zanthoxyli, radix Aconiti Preparata, radix Aconiti Kusnezoffii Preparata, rhizoma corydalis, radix Angelicae sinensis, radix Stephaniae Tetrandrae, radix Dipsaci, cortex Erythrinae, caulis Akebiae, radix aucklandiae, herba Ephedrae, fructus Zanthoxyli, capsici fructus, kochiae fructus and Sargassum, mixing and grinding into coarse powder, soaking 90% ethanol in medicinal component I, percolating with 90% ethanol, collecting percolate, vacuum concentrating under reduced pressure to obtain fluid extract, and cooling;
weighing medicinal component II including Notoginseng radix, olibanum and Myrrha, mixing and grinding into fine powder;
weighing raw material components III including menthol, camphor, borneol and methyl salicylate, and mixing the medicinal material components III;
weighing excipient component IV including rubber, rosin, zinc oxide, yellow vaseline, liquid paraffin, lanoline, lithopone, terpene resin, hot melt pressure sensitive adhesive and antioxidant;
step S2, mixing the rubber,
s21, heating and drying the rubber of the excipient component IV;
step S22, adding the antioxidant, yellow vaseline, lanolin and liquid paraffin of the excipient component IV and stirring;
step S23, adding the rosin and the terpene resin of the excipient component IV and stirring;
s24, cooling to 65-85 ℃, adding lithopone, zinc oxide and hot-melt pressure-sensitive adhesive of the excipient component IV, and stirring;
step S25, adding the fluid extract prepared in the step S1 and stirring;
step S26, adding the fine powder of the pseudo-ginseng, the prepared frankincense and the prepared myrrh which are described in the medicinal component II and stirring;
step S27, adding the mixture of camphor, borneol, menthol and methyl salicylate of the raw material component III, stirring, cooling to room temperature, and filtering to obtain gel;
step S3, preparing the paste,
and (3) after the micelle refined in the step (S2) is detected to be qualified in adhesiveness, selecting a four-side elastic adhesive tape and an anti-sticking film for medicine packaging as cover materials of the plaster respectively, coating by using a coating machine, baking the adhesive at the temperature of 75 +/-10 ℃, rolling the dried ointment, shearing a sample, and slicing and packaging.
Furthermore, the medicinal material component I comprises 90 to 100 parts of cinnamon, 38 to 43 parts of rhubarb, 68 to 75 parts of hypericum sampsonii hance, 55 to 62 parts of sappan wood, 55 to 62 parts of safflower, 47 to 53 parts of Indian stringbush root, 47 to 53 parts of shinyleaf pricklyash root, 70 to 78 parts of prepared common monkshood mother root, 70 to 78 parts of prepared kusnezoff monkshood root, 12 to 20 parts of corydalis tuber, 47 to 53 parts of Chinese angelica, 62 to 70 parts of fourstamen stephania root, 78 to 82 parts of teasel root, 62 to 70 parts of erythrina bark, 47 to 52 parts of akebia stem, 70 to 78 parts of costustoot, 42 to 48 parts of ephedra, 30 to 36 parts of pepper, 80 to 84 parts of hot pepper, 46 to 54 parts of broom cypress fruit and 12 to 20 parts of seaweed by mass;
the mass ratio of the medicinal material component II is 36 to 44 parts of pseudo-ginseng, 36 to 44 parts of prepared frankincense and 36 to 44 parts of prepared myrrh;
the raw material component III comprises 30-36 parts of menthol, 12-20 parts of camphor, 12-20 parts of borneol and 22-28 parts of methyl salicylate by mass ratio.
Furthermore, the excipient component IV comprises 150 to 170 parts of rubber, 6 to 12 parts of rosin, 120 to 140 parts of zinc oxide, 35 to 45 parts of yellow vaseline, 40 to 55 parts of liquid paraffin, 15 to 25 parts of lanolin, 165 to 185 parts of lithopone, 10 to 18 parts of terpene resin, 550 to 650 parts of hot-melt pressure-sensitive adhesive and 2.0 to 3.5 parts of antioxidant by mass ratio.
Preferably, the antioxidant in the excipient component IV is one or two of antioxidant BLE and antioxidant 1010.
Further, the medicinal material component I comprises 100 parts by mass of cinnamon, 41 parts by mass of rhubarb, 74 parts by mass of hypericum sampsonii hance, 58 parts by mass of sappan wood, 58 parts by mass of safflower, 50 parts by mass of Indian stringbush root, 50 parts by mass of shinyleaf pricklyash root, 74 parts by mass of prepared common monkshood mother root, 74 parts by mass of prepared kusnezoff monkshood root, 16 parts by mass of corydalis tuber, 50 parts by mass of Chinese angelica, 66 parts by mass of fourstamen stephania root, 82 parts by mass of himalayan teasel root, 66 parts by mass of erythrina indica lam bark, 50 parts by mass of akebia stem, 74 parts by mass of costustoot, 45 parts by mass of ephedra herb, 33 parts by mass of pepper, 82 parts by mass of hot pepper, 50 parts by mass of broom cypress fruit and 16 parts by mass of seaweed;
the mass ratio of the medicinal material component II is 41 parts of pseudo-ginseng, 41 parts of prepared frankincense and 41 parts of prepared myrrh;
the raw material component III comprises 33 parts of menthol, 16 parts of camphor, 16 parts of borneol and 25 parts of methyl salicylate according to the mass ratio.
The excipient component IV comprises 160 parts of rubber, 8 parts of rosin, 130 parts of zinc oxide, 44.5 parts of yellow vaseline, 48 parts of liquid paraffin, 23 parts of lanolin, 175 parts of lithopone, 15 parts of terpene resin, 604 parts of hot-melt pressure-sensitive adhesive and 3 parts of antioxidant BLE.
Table 1 shows the physical and chemical properties and functions of excipient component IV
Because the pseudo-ginseng pain-alleviating adhesive contains ginsenoside, cinnamaldehyde and other heat-labile and other volatile effective ingredients, plays an important role in the treatment process and is also an important detection index in the quality standard, the ingredients are unstable and part of the ingredients are easy to volatilize in the rubber mixing process at 100-110 ℃ by the conventional hot pressing method, the rubber mixing and baking temperature is controlled to be 65-85 ℃ so as to keep the volatile ingredients in a matrix, but if a formula with excessively high rubber content and excessively low hot-melt pressure-sensitive adhesive content is adopted, the reduction of the rubber mixing and baking temperature causes the basic performance of a rubber mass to be reduced, the excessive rubber causes the rubber mass to be prematurely hardened and agglomerated, other medicinal materials cannot be effectively added and uniformly mixed, the quality of the subsequently prepared ointment in each aspect of coating property, adhesive force, cold and heat resistance, flexibility and the like is reduced, so that the adaptability adjustment of an excipient component IV aiming at the low rubber mixing and baking temperature is needed, the hot-melt adhesive is increased to 550-melt pressure-sensitive adhesive, the rubber quality is stabilized at 150-170 parts, and even if the baking adhesive is prepared at the low temperature, the rubber mixing and baking quality standard can also reach the quality of the high-quality evaluation standard.
Further, in the step S1, the amount of 90% ethanol used for impregnating the medicinal material component I is 2 times of the total mass of the medicinal material component I, the impregnation time is 45-50 hours, the amount of 90% ethanol used for percolating the medicinal material component I is 9 times of the total mass of the medicinal material component I, and the vacuum degree during vacuum pressure reduction is-0.05 MPa.
Further, the relative density of the fluid extract prepared in the step S1 is 1.05-1.20 at 60 ℃.
Preferably, the relative density of the fluid extract prepared in the step S1 is 1.00-1.10 at 60 ℃.
Further, the heating and drying temperature in the step S21 is 50 to 60 ℃, the stirring temperature in the step S22 is 100 to 110 ℃, the stirring time is 1.2 to 1.8 hours, the stirring temperature in the step S23 is 100 to 110 ℃, the stirring time is 0.8 to 1.2 hours, the stirring time in the step S24 is 40min to 1 hour, the stirring time in the step S25 is 25 to 40min, the stirring time in the step S26 is 15 to 20min, and the stirring time in the step S27 is 25 to 40min.
The rubber mixing temperature and the baking temperature are both stabilized at 75 +/-10 ℃, so that most of effective components and volatile oil in the traditional Chinese medicinal materials are favorably kept in a matrix, the contents of main effective components, such as ginsenoside, cinnamaldehyde and the like, are effectively increased, the medicine absorption capacity of a human body in unit time is large, and the treatment effect is improved.
Further, in the baking glue of the step S3, the temperature and the cream content detection are performed once every half hour, the cream content detection is performed again on the dried ointment, and the cream content = (the weight of the ointment plus the weight of the cloth)/100 cm is set 2 The qualified paste content is more than or equal to 1.7g/100cm 2 What is, what isThe running speed of the coater was set to 3.5m/min.
On the other hand, the invention provides a pseudo-ginseng analgesic paste which is prepared by the preparation method and has stable active ingredients.
Compared with the prior art, the invention has the beneficial effects that different materials are stirred at different temperatures in the rubber mixing process, the excipient is mixed at about 105 +/-5 ℃ in the early stage, after basic molding, the rubber mixing temperature is reduced to 65-85 ℃ and the baking temperature is 75 +/-10 ℃ before the extractum and the medicinal material raw materials are added, so that most of volatile oil in the medicinal materials is greatly reduced and the degradation of effective components is greatly reduced, the concentration of the effective components such as ginsenoside Rg1 in a matrix is as high as 1.4g/7 +/-10 cm and is far higher than 0.5g/7 +/-10 cm specified by quality standards, and the treatment effect is improved.
Furthermore, the preparation method greatly increases the amount of the hot-melt pressure-sensitive adhesive by hundreds of grams, reduces the rubber mixing and baking temperature in the process, and keeps the indexes of the paste content, the spreading property, the adhesive force and the like of the prepared pseudo-ginseng pain-relieving paste constant.
Furthermore, animal experiments prove that the pseudo-ginseng pain-alleviating adhesive plaster prepared by the preparation method has no irritation and adverse reaction, and is high in safety and reliability.
Furthermore, the pseudo-ginseng pain-alleviating plaster prepared by the invention has the functions of promoting blood circulation to remove blood stasis, dispelling wind and removing dampness, warming channels and dredging collaterals, and is suitable for traumatic injury, rheumatic arthralgia, shoulder pain, arm pain, waist pain and leg pain.
Furthermore, the preparation method has good safety of the process and simple process flow, and is easy for large-scale industrial popularization.
Furthermore, volatile effective components contained in the pseudo-ginseng analgesic plaster prepared by the preparation method can be stably remained in a matrix, the coating performance of a rubber block obtained by rubber mixing is good, and all quality indexes of the plaster after coating are qualified.
Drawings
FIG. 1 is a process diagram of the preparation method of the pain-alleviating adhesive plaster of panax notoginseng with stable active ingredients according to the embodiment of the present invention;
FIG. 2 is a diagram of the steps of the rubber mixing method in the preparation method of the pseudo-ginseng analgesic cream with stable active ingredients in the embodiment of the invention;
fig. 3 is a process flow chart of the preparation method of the pseudo-ginseng analgesic plaster with stable active ingredients in the embodiment of the invention.
Detailed Description
In order that the objects and advantages of the invention will be more clearly understood, the invention is further described below with reference to examples; it should be understood that the specific embodiments described herein are merely illustrative of the invention and do not delimit the invention.
Preferred embodiments of the present invention are described below with reference to the accompanying drawings. It should be understood by those skilled in the art that these embodiments are only for explaining the technical principle of the present invention, and do not limit the scope of the present invention.
Referring to fig. 1 and 2, fig. 1 is a process diagram of a method for preparing a panax notoginseng analgesic cream with stable active ingredients according to an embodiment of the present invention, and fig. 2 is a process diagram of rubber mixing in the method for preparing the panax notoginseng analgesic cream with stable active ingredients according to an embodiment of the present invention, wherein the method for preparing the panax notoginseng analgesic cream with stable active ingredients according to the present invention comprises:
step S1, preparing materials,
weighing medicinal component I including cortex Cinnamomi, radix et rhizoma Rhei, herba Hyperici Sampsonii, lignum sappan, carthami flos, radix Wikstroemae Indicae, radix Zanthoxyli, radix Aconiti Preparata, radix Aconiti Kusnezoffii Preparata, rhizoma corydalis, radix Angelicae sinensis, radix Stephaniae Tetrandrae, radix Dipsaci, cortex Erythrinae, caulis Akebiae, radix aucklandiae, herba Ephedrae, fructus Zanthoxyli, capsici fructus, kochiae fructus and Sargassum, mixing and grinding into coarse powder, soaking 90% ethanol in medicinal component I, percolating with 90% ethanol, collecting percolate, vacuum concentrating under reduced pressure to obtain fluid extract, and cooling;
weighing medicinal component II including Notoginseng radix, olibanum and Myrrha, mixing and grinding into fine powder;
weighing raw material components III including menthol, camphor, borneol and methyl salicylate, and mixing the medicinal material components III;
weighing excipient component IV including rubber, rosin, zinc oxide, yellow vaseline, liquid paraffin, lanoline, lithopone, terpene resin, hot melt pressure sensitive adhesive and antioxidant;
step S2, mixing the rubber,
s21, heating and drying the rubber of the excipient component IV;
step S22, adding the antioxidant, yellow vaseline, lanolin and liquid paraffin of the excipient component IV and stirring;
step S23, adding the rosin and the terpene resin of the excipient component IV and stirring;
s24, cooling to 65-85 ℃, adding lithopone, zinc oxide and hot-melt pressure-sensitive adhesive of the excipient component IV, and stirring;
step S25, adding the fluid extract prepared in the step S1 and stirring;
step S26, adding the fine powder of the pseudo-ginseng, the prepared frankincense and the prepared myrrh of the medicinal material component II and stirring;
step S27, adding the mixture of camphor, borneol, menthol and methyl salicylate of the raw material component III, stirring, cooling to room temperature, and filtering to obtain gel;
step S3, preparing the paste,
and (3) after the rubber dough refined in the step (S2) is detected to be qualified in adhesiveness, selecting a four-sided elastic adhesive tape and an anti-sticking film for medicine packaging as cover materials of the plaster respectively, coating by using a coating machine, baking the adhesive at the temperature of 75 +/-10 ℃, rolling the dried plaster, shearing a sample, and slicing and packaging.
Example 1
A method for preparing Notoginseng radix analgesic paste with stable effective components comprises:
step S1, preparing materials,
weighing medicinal material components I which comprise 95g of cinnamon, 40g of rhubarb, 70g of hypericum sampsonii hance, 58g of sappan wood, 58g of safflower, 50g of Indian stringbush root, 50g of shinyleaf pricklyash root, 74g of prepared common monkshood mother root, 74g of prepared kusnezoff monkshood root, 16g of corydalis tuber, 50g of Chinese angelica, 68g of fourstamen stephania root, 80g of himalayan teasel root, 66g of erythrina bark, 50g of akebia stem, 74g of costus root, 45g of ephedra, 34g of pepper, 82g of hot pepper, 50g of broom cypress fruit and 16g of seaweed, mixing and grinding the medicinal material components I into coarse powder, mixing and soaking the medicinal materials according to a mass ratio of 2:1, then percolating the medicinal materials by 90% of ethanol which is 9 times of the mass of the medicinal materials, collecting percolate, decompressing and concentrating to obtain a fluid extract with the relative density of 1.05 at 60 ℃, and cooling the fluid extract for later use;
weighing medicinal component II including Notoginseng radix 40g, olibanum 40g and Myrrha 40g, mixing and grinding into fine powder;
weighing raw material components III including 32g of menthol, 16g of camphor, 16g of borneol and 25g of methyl salicylate, and mixing the raw material components III for later use;
weighing excipient component IV comprising 153g of rubber, 6g of rosin, 130g of zinc oxide, 37g of yellow vaseline, 40g of liquid paraffin, 15g of lanolin, 165g of lithopone, 18g of terpene resin, 650g of hot-melt pressure-sensitive adhesive and 3g of antioxidant BLE for later use;
step S2, mixing the rubber,
step S21, heating and drying rubber to 55 ℃, cutting the rubber into blocks, and plasticating the blocks into mesh sheets in a rubber mixing mill;
step S22, adding an antioxidant, yellow vaseline, lanolin and liquid paraffin, and stirring at 105 ℃ for 1.5 hours;
step S23, adding rosin and terpene resin, and stirring at 105 ℃ for 1h;
s24, cooling to 75 ℃, adding lithopone, zinc oxide and hot-melt pressure-sensitive adhesive, and stirring for 50min;
step S25, adding the fluid extract prepared in the step S1 and stirring for 30min;
step S26, adding the fine powder of the pseudo-ginseng, the prepared frankincense and the prepared myrrh, and stirring for 20min;
and S27, adding a mixture of camphor, borneol, menthol and methyl salicylate, stirring for 30min, cooling to room temperature, and filtering to obtain the gel.
Step S3, preparing the paste,
after the refined rubber blocks are detected to be qualified in adhesiveness, selecting a four-side elastic rubber cloth and an anti-sticking film for medicine packaging as plaster cover lining materials, respectively, coating by using a transfer coating machine, setting the running speed of the coating machine to be 3.5m/min, baking the rubber, setting the baking temperature to be 75 ℃, recording the temperature once every half hour and detecting the plaster content once, rolling the dried plaster evenly when rolling the dried plaster, then taking down, and detecting the plaster content of the dried plaster againSetting the paste content = (paste weight + cloth weight)/100 cm 2 The qualified paste content is more than or equal to 1.7g/100cm 2 Shearing the sample, slicing and packaging.
Example 2
The difference from the example 1 is that 158g of rubber, 7g of rosin, 135g of zinc oxide, 35g of yellow vaseline, 40g of liquid paraffin, 15g of lanolin, 170g of lithopone, 17g of terpene resin, 625g of hot melt pressure sensitive adhesive and 3g of antioxidant BLE are taken in the step S1 for later use.
Example 3
The difference from the example 1 is that 168g of rubber, 8g of rosin, 140g of zinc oxide, 40g of yellow vaseline, 45g of liquid paraffin, 20g of lanolin, 175g of lithopone, 11.5g of terpene resin, 600g of hot melt pressure sensitive adhesive and 1010.5 g of antioxidant are taken in the step S1 for later use.
Example 4
The difference from the example 1 is that 170g of rubber, 9g of rosin, 139g of zinc oxide, 45g of yellow vaseline, 50g of liquid paraffin, 25g of lanolin, 180g of lithopone, 17.5g of terpene resin, 550g of hot melt pressure sensitive adhesive and 1010.5 g of antioxidant are taken in the step S1 for later use.
Example 5
The difference from the example 3 is that in the step S1, rubber 163, rosin 8.5g, zinc oxide 135.5g, yellow vaseline 36g, liquid paraffin 50g, lanolin 16g, lithopone 170g, terpene resin 14g, hot melt pressure sensitive adhesive 605.5g and antioxidant BLE3g are taken for standby.
Example 6
The difference from the example 3 is that 168g of rubber, 8g of rosin, 137g of zinc oxide, 39.5g of yellow vaseline, 46g of liquid paraffin, 20g of lanolin, 174g of lithopone, 13g of terpene resin, 590g of hot melt pressure sensitive adhesive and 1010.5 g of antioxidant are taken in the step S1 for standby.
Example 7
The difference from example 6 is that 169g of rubber, 7.5g of rosin, 140g of zinc oxide, 43g of yellow vaseline, 42g of liquid paraffin, 24g of lanolin, 180g of lithopone, 16g of terpene resin, 575g of hot-melt pressure-sensitive adhesive and 1010.5 g of antioxidant are taken in step S1.
Example 8
The difference from the embodiment 6 is that 163g of rubber, 8.5g of rosin, 135.5g of zinc oxide, 36g of yellow vaseline, 50g of liquid paraffin, 16g of lanolin, 170g of lithopone, 12g of terpene resin, 605.5g of hot melt pressure sensitive adhesive and 3g of antioxidant BLE are taken in the step S1 for standby; the rubber mixing temperature in step S2 was 65 ℃.
Example 9
The difference from the embodiment 6 is that 160g of rubber, 8g of rosin, 130g of zinc oxide, 44.5g of yellow vaseline, 48g of liquid paraffin, 23g of lanolin, 175g of lithopone, 15g of terpene resin, 604g of hot-melt pressure-sensitive adhesive and 3g of antioxidant BLE are taken in the step S1 for later use; the rubber mixing temperature in step S2 was 75 ℃.
Example 10
The difference from the embodiment 6 is that 167g of rubber, 7.5g of rosin, 140g of zinc oxide, 43g of yellow vaseline, 42g of liquid paraffin, 24g of lanolin, 180g of lithopone, 14.5g of terpene resin, 575g of hot-melt pressure-sensitive adhesive and 1010.5 g of antioxidant are taken in the step S1 for standby; the rubber mixing temperature in step S2 was 85 ℃.
Comparative example 1
The difference from the embodiment 9 is that the compounding ratio of the excipient component IV in the step S1 is 362.5g rubber, 180g rosin, 200g zinc oxide, 64.5g yellow vaseline, 35g liquid paraffin, 35g lanolin, 287.5g lithopone, 15g terpene resin, 10g hot melt pressure sensitive adhesive and 3g antioxidant BLE; the rubber mixing temperature in the step S2 is 105 ℃; the baking temperature in step S3 is 105 ℃.
Comparative example 2
The difference from the embodiment 9 is that the compounding ratio of the excipient component IV in the step S1 is 362.5g rubber, 180g rosin, 200g zinc oxide, 64.5g yellow vaseline, 35g liquid paraffin, 35g lanolin, 287.5g lithopone, 15g terpene resin, 10g hot melt pressure sensitive adhesive and 3g antioxidant BLE; the rubber mixing temperature in the step S2 is 80 ℃; in the step S3, the baking temperature is 80 ℃.
Evaluation criteria
The comprehensive evaluation indexes of the appearance, the adhesive force, the skin following performance and the like of the plaster are measured by a method carried by Chinese pharmacopoeia and documents, the dosage of a prescription matrix and the rubber mixing temperature are evaluated according to orthogonal experimental design, as shown in table 2, the table 2 is the comprehensive evaluation index,
table 3 shows the comprehensive evaluation record of each example
Recording temperature and detecting paste content every half an hour in the process of baking the adhesive, detecting the paste content of the dried ointment again, and setting the paste content = (weight of the ointment plus weight of cloth)/100 cm 2 The content of ginsenoside is determined by thin-layer scanning method, the details are shown in the Chinese drugstore 2004, vol 18, no. 7 paper, content of ginsenoside Rg1 in Tianqi analgesic plaster by thin-layer scanning method, the obtained results are shown in Table 4, table 4 is the content of effective components of examples 8-10,
an accelerated stability examination experiment was performed on example 9, and data of ginsenoside content in example 9 from the factory and example 9 placed in a high-temperature and high-humidity environment (40 ℃, and relative humidity of more than 75%) are shown in table 5 below, where table 5 shows the content of ginsenoside Rg1 in the ointment of example 9 under different conditions,
as shown in tables 2 to 3, the quality of the obtained glue is better and better from the embodiment 1 to the embodiment 10, the best embodiment is the embodiment 9, and the effect is better as the components of other embodiments are closer to the embodiment 9; as shown in Table 3, while the rubber mixing temperature in the examples 8-10 is compared with the influence of the rubber mixing temperature on the quality of the obtained rubber, the temperature in the example 8 is lower than 65 ℃, the main effective components and volatile oil in the rubber are well preserved and are close to 75 ℃ with moderate temperature in the example 9, but the spreading performance of the rubber is poor; in the embodiment 10, the temperature is higher than 85 ℃, the coating performance of the obtained colloid amount is better, but the stability of the main effective component in the colloid is poor, while in the comparative example 1, the mixing temperature is as high as 105 ℃, the content of the ginsenoside Rg1 which is the main effective component is far inferior to that in the embodiments 8-10, so the optimal mixing temperature is 75 ℃; in the comparative example 2, the rubber content is as high as dozens of times of that of the hot-melt pressure-sensitive adhesive, so that when the temperature is reduced to 80 ℃ in the step S2 of the preparation process, the rubber begins to harden and cannot be continuously and uniformly stirred with the added medicine, coating cannot be carried out, and rubber mixing fails, therefore, in order to reduce the temperature of rubber mixing and rubber baking to reduce the loss of volatile active ingredients, the formula adjustment of an excipient must be correspondingly made, and the prepared ointment can meet the requirements on various properties; as shown in table 5, the content of ginsenoside in example 9 shipped from the beginning and in example 9 placed under high temperature and high heat was not greatly reduced, and was significantly higher than the national standard, indicating that the pseudo-ginseng analgesic plaster of the present invention has stable and high content of active ingredients.
A plurality of experimental rabbits are taken and divided into an experimental group and a control group, the pain relieving plaster of the panax notoginseng is pasted on the left side of the dehaired skin of the experimental group, the hot melt pressure sensitive adhesive of the matrix is pasted on the right side of the dehaired skin of the experimental group, the fixation is carried out for 4 hours, the plaster is removed and the skin is cleaned, the administration is carried out once a day for 7 days continuously, the control group is not treated, the skin administration position of the experimental group is observed, the experimental group and the control group do not have anaphylactic reaction, and the skin is free from erythema, edema, erosion and necrosis, and the skin affinity of the invention is high, and the invention has no side effect.
Referring to fig. 3, which is a process flow diagram of a preparation method of a pseudo-ginseng analgesic cream with stable active ingredients in an embodiment of the present invention, compared with a traditional solvent method pseudo-ginseng analgesic cream preparation method, the present invention improves a gum mass matrix, i.e., an excipient component IV, increases the amount of a hot-melt pressure-sensitive adhesive, reduces the rubber content, and removes dangerous solvents such as ether, and a series of excipients component IV are adjusted under the condition of low-temperature gum mixing and baking, so that the stability of the obtained pseudo-ginseng analgesic cream, such as the content, the spreadability, the adhesion and the like, is maintained, and as the gum mixing and baking temperature is low, the gum mass cooling time is greatly reduced, the preparation efficiency is improved, and the safety of the whole process is also improved.
And (3) detecting the paste content once every half hour in the glue baking process of the step (S3), detecting the paste content of the dried paste again, acquiring a plurality of paste content detection data, and fitting the acquired paste content detection data into a paste content change curve, and adjusting the running speed of the coating machine in real time according to the paste content change curve by a PLC (programmable logic controller) of the coating machine so as to enable the paste content of the paste to be qualified, wherein the PLC comprises a data acquisition module for acquiring the detection data and a control module connected with the data acquisition module and used for adjusting the running speed of the coating machine according to the data acquired by the data acquisition module.
The data acquisition module acquires ith cream content detection data Q in the baking process i I-1 th plaster content detection data Q i-1 The ith detection data Q of the paste content i The paste content Q0 corresponding to the position on the curve of the change of the paste content i The comparison is carried out, and the comparison is carried out,
under the comparison result of the first paste content, the control module judges that the paste content meets the standard;
under the comparison result of the second paste content, the control module calculates Q i And Q0 i To determine the processing mode of the coating machine;
wherein, the difference value of paste content DeltaQ = | Q is set i -Q0 i I, the comparison result of the first paste content satisfies Q i Is equal to Q0 i The comparison result of the second paste content satisfies Q i Is not equal to Q0 i 。
The control module is provided with a paste content difference standard delta Q0, delta Q0 is more than 0.05 and less than 0.1, the control module compares the paste content difference delta Q with the delta Q0 and determines the processing mode of the coating machine according to the comparison result, wherein,
the first processing mode is to adjust the running speed of the coating machine;
the second processing mode is to calculate the ith detection data Q of the paste content i And the data Q of the detection of the cream content of the i-1 th time i-1 The operation speed of the coating machine is finely adjusted according to the slope k;
wherein, slope k = (Q) is set i -Q i-1 ) And 0.5, the first treatment mode satisfies that delta Q is more than or equal to delta Q0, and the second treatment mode satisfies that delta Q is less than delta Q0.
The control module adjusts the running speed of the coating machine under a first processing mode, calculates the difference value sigma of the paste content difference value delta Q and the paste content difference value standard delta Q0, sets sigma = delta Q-delta Q0, is provided with a first preset paste content difference value sigma 1 and a second preset paste content difference value sigma 2,0.01 < sigma 1 < sigma 2 < 0.05, compares the paste content difference value sigma with the sigma 1 and the sigma 2 respectively and determines the adjusting mode of the coating machine according to the comparison result, wherein,
the first adjusting mode is that the operating speed of the coating machine is adjusted to a first operating speed V1 by selecting a first adjusting coefficient alpha 1;
the second adjusting mode is that the second adjusting coefficient alpha 2 is selected to adjust the running speed of the coating machine to a second running speed V2;
the third adjusting mode is that the third adjusting coefficient alpha 3 is selected to adjust the running speed of the coating machine to a third running speed V3;
the first adjusting mode satisfies that sigma is more than or equal to sigma 2, the second adjusting mode satisfies that sigma 1 is more than or equal to sigma and is less than sigma 2, the third adjusting mode satisfies that sigma is less than sigma 1, V0 is the preset operating speed of the coating machine, and alpha 3 is more than 0.01 and is more than alpha 2 and is more than alpha 1 and is less than 0.03;
if Q i ＞Q0 i Then Vn = V0 × (1 + α n), where n =1,2,3;
if Q i ＜Q0 i Then Vn = V0 × (1- α n).
This embodiment provides a preferred embodiment, setting the preset coater operating speed V0=3.5m/min.
Under a second processing mode, the control module calculates the average slope kp of the cream content change curve corresponding to the ith time from the (i-1) th time, and the control module detects the cream content detection data Q of the ith time i And the (i-1) th plaster content detection data Q i-1 Is compared with the average slope kp,
under the first slope comparison result, the control module judges that the operating speed of the coating machine needs to be finely adjusted so as to increase the operating speed;
under the second slope comparison result, the control module judges that the operating speed of the coating machine needs to be finely adjusted so as to reduce the operating speed;
under the third slope comparison result, the control module judges that fine adjustment of the running speed of the coating machine is not needed;
wherein the first slope comparison result satisfies k > kp, the second slope comparison result satisfies k < kp, and the third slope comparison result satisfies k = kp.
The control module calculates the difference value delta k between the slope k and the average slope kp under the first slope comparison result, sets delta k = k-kp, is provided with a first preset slope difference value delta k1 and a second preset slope difference value delta k2, and the delta k1 is less than the delta k2, respectively compares the delta k with the delta k1 and the delta k2 and determines a fine adjustment mode for increasing the running speed of the coating machine according to the comparison result, wherein,
the first operation speed increase fine adjustment mode is that the operation speed of the coating machine is finely adjusted to a first fine increase operation speed Va1 by selecting a first fine adjustment coefficient beta 1, and Va1= V0+ V0 × beta 1 is set;
the second operation speed increase fine adjustment mode is that the second fine adjustment coefficient beta 2 is selected to fine adjust the operation speed of the coating machine to a second fine increase operation speed Va2, and Va2= V0+ V0 × beta 2 is set;
the third operation speed increase fine adjustment mode is that the third fine adjustment coefficient beta 3 is selected to fine adjust the operation speed of the coating machine to a third micro increase operation speed Va3, and Va3= V0+ V0 × beta 3 is set;
the first operation speed increasing and fine-tuning mode meets the condition that delta k is more than or equal to delta k2, the second operation speed increasing and fine-tuning mode meets the condition that delta k is more than or equal to delta k1 and less than delta k2, the third operation speed increasing and fine-tuning mode meets the condition that delta k is more than or equal to delta k1, V0 is a preset coating machine operation speed, beta 3 is more than 0 and less than beta 2 and less than beta 1 and less than 0.01, V0 is a preset operation speed adjustment amount, and V0 is more than 0.1m/min and less than V0 and less than 0.15m/min.
The control module calculates the difference value delta k ' between the slope k and the average slope kp under the second slope comparison result, sets delta k ' = kp-k, compares the delta k ' with delta k1 and delta k2 respectively and determines a fine adjustment mode for reducing the running speed of the coating machine according to the comparison result, wherein,
the first operation speed reduction fine adjustment mode is that the operation speed of the coating machine is finely adjusted to a first reduction operation speed Vb1 by selecting a first fine adjustment coefficient beta 1, and Vb1= V0-V0 multiplied by beta 1 is set;
the second operation speed reduction fine adjustment mode is that the second fine adjustment coefficient beta 2 is selected to fine adjust the operation speed of the coating machine to a second reduction operation speed Vb2, and Vb2= V0-V0 multiplied by beta 2 is set;
the third running speed reduction fine adjustment mode is that the running speed of the coating machine is fine adjusted to a third reduction running speed Vb3 by selecting a third fine adjustment coefficient beta 3, and Vb3= V0-V0 x beta 3 is set;
wherein, the first operation speed reduction fine adjustment mode satisfies that delta k ' is more than or equal to delta k2, the second operation speed reduction fine adjustment mode satisfies that delta k1 is more than or equal to delta k ' is less than delta k2, and the third operation speed reduction fine adjustment mode satisfies that delta k ' is less than delta k1.
The invention ensures that the paste content of the pseudo-ginseng pain-alleviating adhesive plaster is uniform and meets the standard by finely controlling the running speed of the coating machine.
So far, the technical solutions of the present invention have been described in connection with the preferred embodiments shown in the drawings, but it is apparent to those skilled in the art that the scope of the present invention is not limited to these specific embodiments. Equivalent changes or substitutions of related technical features can be made by those skilled in the art without departing from the principle of the invention, and the technical scheme after the changes or substitutions can fall into the protection scope of the invention.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention; various modifications and alterations to this invention will become apparent to those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (10)
1. A preparation method of pseudo-ginseng analgesic paste with stable active ingredients is characterized by comprising the following steps:
step S1, preparing materials,
weighing medicinal component I including cortex Cinnamomi, radix et rhizoma Rhei, herba Hyperici Sampsonii, lignum sappan, carthami flos, radix Wikstroemae, radix Zanthoxyli, radix Aconiti Preparata, radix Aconiti Kusnezoffii Preparata, rhizoma corydalis, radix Angelicae sinensis, radix Stephaniae Tetrandrae, radix Dipsaci, cortex Erythrinae, caulis Akebiae, radix aucklandiae, herba Ephedrae, fructus Zanthoxyli, capsici fructus, kochiae fructus and Sargassum, mixing and grinding into coarse powder, mixing and soaking 90% ethanol with medicinal component I, percolating with 90% ethanol, collecting percolate, vacuum concentrating under reduced pressure to obtain fluid extract, and cooling;
weighing medicinal component II including Notoginseng radix, olibanum and Myrrha, mixing and grinding into fine powder;
weighing raw material components III including menthol, camphor, borneol and methyl salicylate, and mixing the medicinal material components III;
weighing excipient component IV including rubber, rosin, zinc oxide, yellow vaseline, liquid paraffin, lanoline, lithopone, terpene resin, hot melt pressure sensitive adhesive and antioxidant;
step S2, mixing the rubber,
s21, heating and drying the rubber of the excipient component IV;
step S22, adding the antioxidant, yellow vaseline, lanolin and liquid paraffin of the excipient component IV and stirring;
step S23, adding the rosin and the terpene resin of the excipient component IV and stirring;
s24, cooling to 65-85 ℃, adding lithopone, zinc oxide and hot-melt pressure-sensitive adhesive of the excipient component IV, and stirring;
step S25, adding the fluid extract prepared in the step S1 and stirring;
step S26, adding the fine powder of the pseudo-ginseng, the prepared frankincense and the prepared myrrh which are described in the medicinal component II and stirring;
step S27, adding the mixture of camphor, borneol, menthol and methyl salicylate of the raw material component III, stirring, cooling to room temperature, and filtering to obtain gel;
step S3, preparing the paste,
and (3) after the micelle refined in the step (S2) is detected to be qualified in adhesiveness, selecting a four-side elastic adhesive tape and an anti-sticking film for medicine packaging as cover materials of the plaster respectively, coating by using a coating machine, baking the adhesive at the temperature of 75 +/-10 ℃, rolling the dried ointment, shearing a sample, and slicing and packaging.
2. The preparation method of the pseudo-ginseng analgesic paste with stable active ingredients according to claim 1, wherein the mass ratio of the medicinal material component I is 90-100 parts of cinnamon, 38-43 parts of rhubarb, 68-75 parts of hypericum sampsonii hance, 55-62 parts of sappan wood, 55-62 parts of safflower, 47-53 parts of wikstroemia indica, 47-53 parts of zanthoxylum nitidum, 70-78 parts of prepared radix aconiti, 70-78 parts of prepared kusnezoff monkshood root, 12-20 parts of corydalis tuber, 47-53 parts of angelica, 62-70 parts of radix stephaniae tetrandrae, 78-82 parts of teasel root, 62-70 parts of erythrina indica lam bark, 47-52 parts of akebia stem, 70-78 parts of elecampane, 42-48 parts of ephedra herb, 30-36 parts of pepper, 80-84 parts of pepper, 46-54 parts of fructus kochiae and 12-20 parts of seaweed;
the mass ratio of the medicinal material component II is 36 to 44 parts of pseudo-ginseng, 36 to 44 parts of prepared frankincense and 36 to 44 parts of prepared myrrh;
the raw material component III comprises 30-36 parts of menthol, 12-20 parts of camphor, 12-20 parts of borneol and 22-28 parts of methyl salicylate by mass ratio.
3. The method for preparing a pseudo-ginseng analgesic cream with stable active ingredients according to claim 1 or 2, wherein the excipient component IV comprises 150 to 170 parts by mass of rubber, 6 to 12 parts by mass of rosin, 120 to 140 parts by mass of zinc oxide, 35 to 45 parts by mass of yellow vaseline, 40 to 55 parts by mass of liquid paraffin, 15 to 25 parts by mass of lanolin, 165 to 185 parts by mass of lithopone, 10 to 18 parts by mass of terpene resin, 550 to 650 parts by mass of hot melt pressure sensitive adhesive and 2.0 to 3.5 parts by mass of antioxidant.
4. The preparation method of the pseudo-ginseng analgesic paste with stable active ingredients according to claim 2, wherein the medicinal material component I comprises 100 parts by mass of cinnamon, 41 parts by mass of rhubarb, 74 parts by mass of hypericum sampsonii hance, 58 parts by mass of sappan wood, 58 parts by mass of safflower, 50 parts by mass of wikstroemia indica, 50 parts by mass of zanthoxylum nitidum, 74 parts by mass of prepared radix aconiti kusnezoffii, 16 parts by mass of corydalis tuber, 50 parts by mass of angelica sinensis, 66 parts by mass of radix stephaniae tetrandrae, 82 parts by mass of teasel root, 66 parts by mass of erythrina indica lam, 50 parts by mass of akebia stem, 74 parts by mass of elecampane, 45 parts by mass of Chinese ephedra, 33 parts by mass of pepper, 82 parts by mass of capsicum, 50 parts by mass of broom cypress fruit and 16 parts by mass of seaweed;
the mass ratio of the medicinal material component II is 41 parts of pseudo-ginseng, 41 parts of prepared frankincense and 41 parts of prepared myrrh;
the raw material component III comprises 33 parts of menthol, 16 parts of camphor, 16 parts of borneol and 25 parts of methyl salicylate according to the mass ratio.
5. The method for preparing a pseudo-ginseng analgesic cream with stable active ingredients according to claim 3, wherein the excipient component IV comprises 160 parts by mass of rubber, 8 parts by mass of rosin, 130 parts by mass of zinc oxide, 44.5 parts by mass of yellow vaseline, 48 parts by mass of liquid paraffin, 23 parts by mass of lanolin, 175 parts by mass of lithopone, 15 parts by mass of terpene resin, 604 parts by mass of hot-melt pressure-sensitive adhesive and 3 parts by mass of an antioxidant BLE.
6. The method for preparing a pseudo-ginseng analgesic cream with stable active ingredients according to claim 1,2, 4 or 5, wherein the amount of 90% ethanol used for impregnating the medicinal material component I in the step S1 is 2 times of the total mass of the medicinal material component I, the impregnation time is 45 to 50 hours, the amount of 90% ethanol used for percolating the medicinal material component I is 9 times of the total mass of the medicinal material component I, and the vacuum degree during vacuum pressure reduction is-0.05 MPa.
7. The method for preparing a pseudo-ginseng analgesic cream with stable active ingredients according to claim 1,2, 4 or 5, wherein the relative density of the fluid extract prepared in the step S1 is 1.05 to 1.20 at 60 ℃.
8. The method for preparing a pseudo-ginseng analgesic cream having a stable active ingredient according to claim 1,2, 4 or 5, wherein the temperature of the heat drying in step S21 is 50 to 60 ℃, the stirring temperature in step S22 is 100 to 110 ℃, the stirring time is 1.2 to 1.8 hours, the stirring temperature in step S23 is 100 to 110 ℃, the stirring time is 0.8 to 1.2 hours, the stirring time in step S24 is 40min to 1 hour, the stirring time in step S25 is 25 to 40min, the stirring time in step S26 is 15 to 20min, and the stirring time in step S27 is 25 to 40min.
9. The method for preparing pseudo-ginseng analgesic cream with stable active ingredients according to claim 1,2, 4 or 5, wherein the temperature and the cream content detection are performed once every half hour in the baking gel of step S3, the cream content detection is performed again on the dried cream, and the setting is setPaste content = (paste weight + cloth weight)/100 cm 2 The qualified paste content is more than or equal to 1.7g/100cm 2 The coater running speed was set to 3.5m/min.
10. A pseudo-ginseng analgesic plaster prepared by the method for preparing a pseudo-ginseng analgesic plaster stabilized with the active ingredient according to any one of claims 1 to 9.
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