Traditional Chinese medicine composition, infantile antipyretic patch and preparation method of infantile antipyretic patch

Abstract

The invention provides a traditional Chinese medicine composition, an infantile fever cooling patch and a preparation method thereof, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition provided by the invention takes artemisia apiacea and cynanchum atratum as the monarch, notopterygium root as the minister, mint as the guide and artemisia apiacea as the monarch, has the effects of relieving exterior syndrome and clearing heat and is suitable for the constitution of children, the mint and cynanchum atratum are supplemented, notopterygium root has the effects of clearing damp and relieving exterior syndrome, and the traditional Chinese medicine composition is suitable for wind-heat or wind-cold heat transforming syndrome of children exogenous fever, has a good antipyretic effect and is especially suitable for infants. The infantile fever cooling patch is prepared from the traditional Chinese medicine composition, is applied to the umbilical region of an infant for use, has the advantages of definite curative effect, convenience in use, storage and carrying, high patient compliance and adaptability and the like, can avoid crisis caused by invasion of evil heat into pericardium or internal movement of liver wind, and is simple and convenient in method, small in toxic and side effects, reliable in curative effect and free of toxic and side effects. And children patients and parents are easy to accept.

Description

Technical Field

[0001] The present application relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition, a fever-reducing patch for children, and a preparation method thereof. Background Art

[0002] Fever is one of the common clinical symptoms in pediatrics. It is mainly caused by the invasion of pathogens, which adsorb onto the respiratory mucosa and directly damage the local cell tissues of the respiratory tract through replication and reproduction. At the same time, the released toxic substances activate a large number of immune cells, growth factors, and cytokines in the body, causing a series of immune reactions in the body, thus causing fever.

[0003] Infants and young children are a special group. Their central temperature regulation system is not yet fully developed. In addition, their body resistance is poor and they are more likely to be infected, so they often have fever. The pathological causes of fever in infants and young children can be serious or minor. If the fever exceeds 39°C, infants and young children will have convulsions. In severe cases, it can cause sepsis, encephalitis, meningitis, myocarditis, etc. If not treated, it can lead to disability or death.

[0004] When infants and young children have a fever, they should first use physical methods to reduce the temperature. If the body temperature exceeds 38.5℃, drugs are used to reduce the temperature. Antipyretics used by infants and young children need to be used at an interval of more than 4 to 6 hours before they can be used again. Infants and young children often have recurrent fevers, and they will soon have a high fever again after the antipyretics are used to reduce the temperature. At this time, because the interval between antipyretics is not enough and they cannot continue to take antipyretics, many parents can only choose hospitalization and infusion treatment. Therefore, if there is a safe method other than antipyretics to reduce the temperature of infants and young children with high fever, it can reduce the number of infants and young children hospitalized. Summary of the invention

[0005] The purpose of the present application is to provide a Chinese medicine composition, a pediatric antipyretic patch and a preparation method thereof, aiming to solve the problem that existing antipyretic drugs cannot reduce the temperature of infants and young children with recurrent fever.

[0006] To achieve the above objectives, the present application provides a traditional Chinese medicine composition, which comprises, by mass, 1-2 parts of Artemisia annua, 1-2 parts of Psoralea corylifolia, 0.5-1 parts of Mentha arvense, and 1-2 parts of Notopterygium wilfordii.

[0007] Among them, Artemisia annua has the effects of clearing away heat from deficiency, removing bone steaming, relieving summer heat, stopping malaria, and relieving jaundice. In the formula of this Chinese medicine composition, it plays the role of antipyretic analgesic, antibacterial and anti-inflammatory. Artemisia annua mainly contains volatile oil and non-volatile components, among which camphene, isoartemisinin, levorotatory camphor, caryophyllene and pinene account for about 70% of the volatile components. The non-volatile components mainly include epiartemisinin, artemisinin A, artemisinin B, artemisinin C, hydrogenated artemisinin, artemisinic acid, coumarin, flavonoid stigmasterol, β-sitosterol, artemisinin methyl ester and artemisinin etc. Modern pharmacological studies have shown that Artemisia annua decoction, ethyl acetate extract, and n-butanol extract all have obvious antipyretic effects, among which volatile oil, artemisinin and other substances are the main effective ingredients for antipyretic analgesia, antibacterial and anti-inflammatory, and the antipyretic effect may also be the result of the integration of its active ingredient group. The amount of Artemisia annua, for example, can be 1 part, 1.1 parts, 1.2 parts, 1.3 parts, 1.4 parts, 1.5 parts, 1.6 parts, 1.7 parts, 1.8 parts, 1.9 parts, 2 parts, or any value between 1-2 parts.

[0008] The source of the artemisia annua L. in this application is the dried aerial part of Artemisia annua L., a plant of the Asteraceae family, which is obtained by removing impurities, spraying with clean water, slightly moistening, cutting into sections, and drying. The quality requirements comply with the relevant provisions of the Artemisia annua L. on page 198 of the 2015 edition of the Chinese Pharmacopoeia.

[0009] Among them, white mulberry has the effects of clearing heat and cooling blood, promoting diuresis and relieving stranguria, detoxifying and curing sores. In the formula of this Chinese medicine composition, it plays the role of reducing fever and inflammation. It mainly contains C 21 -Steroid saponins, bistorta indica, volatile oils, cardiac glycosides and trace elements, etc. Modern pharmacological research shows that the bistorta water extract is the main effective part for reducing fever and inflammation.

[0010] The source of the white mulberry in this application is the dried root and rhizome of the white mulberry plant Cynanchumatratum Bge. of the Asclepiadaceae family, which is removed from impurities, washed, moistened, cut into sections, and dried. The quality requirements meet the relevant provisions of the white mulberry on page 111 of the 2015 edition of the Chinese Pharmacopoeia. The white mulberry can be, for example, 1 part, 1.1 parts, 1.2 parts, 1.3 parts, 1.4 parts, 1.5 parts, 1.6 parts, 1.7 parts, 1.8 parts, 1.9 parts, 2 parts, or any value between 1-2 parts.

[0011] Among them, peppermint is pungent and cool in nature, and has the effects of dispersing wind-heat, clearing the head, relieving sore throat, clearing rash, and soothing the liver and promoting the flow of qi. In this Chinese medicine composition formula, it plays the role of dispersing wind and relieving the exterior, dispelling wind and relieving itching, and relieving inflammation and pain. Peppermint chemical components mainly contain volatile oils, flavonoids, amino acids, etc. Modern pharmacological research shows that the various components separated from peppermint with dihydroxy-1-2-dihydronaphthalene dicarboxylic acid as the parent nucleus are the main effective ingredients of its anti-inflammatory effect. In vitro tests show that peppermint decoction has a strong antibacterial effect on Staphylococcus epidermidis, Staphylococcus aureus, Proteus, Bacillus bronchisepticus, yellow micrococcus, Pseudomonas aeruginosa, Bacillus cereus, Sarcina lutea, Escherichia coli, Bacillus subtilis, Streptococcus pneumoniae, etc. At the same time, the components such as menthol and menthol contained in peppermint are applied externally through the skin, which may cause changes in the ultrastructure of the skin, thereby showing a significant effect of promoting transdermal absorption.

[0012] The mint of the present application is derived from the dried aerial parts of Menthahaplocalyx Briq., a plant of the Labiatae family, which is removed from old stems and impurities, slightly sprayed with water, slightly moistened, cut into short sections, and promptly dried at low temperature. The quality requirements comply with the relevant provisions of the mint item on page 377 of the first volume of the 2015 edition of the Chinese Pharmacopoeia. For example, the mint can be 0.5 parts, 0.6 parts, 0.7 parts, 0.8 parts, 0.9 parts, 1 part, or any value between 0.5 and 1 part.

[0013] Among them, Notopterygium has the effects of dispelling cold, dispelling wind and dampness, and relieving pain. In the formula of this Chinese medicine composition, it plays the role of dispelling dampness and relieving the symptoms. The chemical components of Notopterygium mainly contain volatile oil, coumarins, flavonoids, organic acids, amino acids, sugars, etc. Modern pharmacological research shows that the volatile oil component is the main effective component of its antibacterial and anti-inflammatory, anti-pathogenic microorganisms, etc., and the water extract is the effective part of its antipyretic and analgesic effects.

[0014] The source of the Notopterygium incisum Ting exH.T.Chang of the Umbelliferae family is the dried rhizome and root, which is removed from impurities, cut into thick slices, and dried. The quality requirements meet the relevant provisions of the Notopterygium incisum Ting exH.T.Chang on page 182 of the first volume of the 2015 edition of the Chinese Pharmacopoeia. For example, the Notopterygium incisum can be 1 part, 1.1 parts, 1.2 parts, 1.3 parts, 1.4 parts, 1.5 parts, 1.6 parts, 1.7 parts, 1.8 parts, 1.9 parts, 2 parts, or any value between 1-2 parts.

[0015] The Chinese medicine composition is formulated with Artemisia annua and Radix Angelicae Dahuricae as the main ingredient, Notopterygium wilfordii as the secondary ingredient, and Mentha asiatica as the envoy. Artemisia annua as the main ingredient can clear away exterior symptoms and heat, which is suitable for children's physique, while Mentha asiatica and Radix Angelicae Dahuricae are pungent and cool to release exterior symptoms, and Notopterygium wilfordii can dispel dampness and clear exterior symptoms, which is suitable for children with exogenous fever or wind-cold fever syndrome, has a good antipyretic effect, can effectively reduce the fever of infants and young children, and Artemisia annua and Radix Angelicae Dahuricae are originally medicines for clearing away deficiency heat, and have mild medicinal properties, which are suitable for children.

[0016] The present application also provides a fever-reducing patch for children, comprising a paste prepared from the above-mentioned traditional Chinese medicine composition.

[0017] The above-mentioned Chinese medicine composition is formulated into a paste coated on a substrate to form a pediatric fever patch, which is applied to the umbilicus of infants and young children when used. The drug applied to the umbilicus is easy to penetrate and absorb from the skin, and the drug molecules can directly diffuse in the blood vessels to enter the systemic circulation, avoiding the first-pass effect of the intestine and liver produced by oral drugs, and improving the bioavailability of the drug. In addition, the mechanical stimulation of the drug applied to the umbilicus on the Shenque acupoint can produce a therapeutic response similar to that of acupoint massage stimulation. Therefore, umbilical therapy integrates the therapeutic effect of meridians and acupoints with the therapeutic effect of drugs, and has both the stimulating effect of drugs on acupoints and the effect of drugs themselves, and the stimulating effect of physical therapy. It has the comprehensive regulatory effect of meridians, acupoints, physical therapy, and drugs, and the various pathways of play can produce mutual compatibility, mutual promotion, mutual stimulation, and superposition effects.

[0018] In some embodiments, the paste further comprises: 0.08-0.16 parts of an adhesive, 0.8-1.6 parts of a filler, 10-20 parts of a moisturizer, 0.14-0.28 parts of a cross-linking agent, 0.042-0.084 parts of a cross-linking agent adjuster, 0.063-0.126 parts of an emulsifier, and 5.1-10.2 parts of water.

[0019] In some embodiments, the binder is selected from carbomer, the filler is selected from partially neutralized sodium polyacrylate, the humectant is selected from glycerol, the cross-linking agent is selected from aluminum glycolate, the cross-linking agent regulator is selected from tartaric acid, and the emulsifier is selected from polysorbate-80.

[0020] The present application also provides a method for preparing the above-mentioned pediatric antipyretic patch, comprising:

[0021] Adding water to part of the glycerol to prepare a glycerol solution, and adding the traditional Chinese medicine composition and the carbomer solution to the glycerol solution and mixing them to obtain a first phase;

[0022] The remaining glycerol, polysorbate-80, partially neutralized sodium polyacrylate, and aluminum glycolate are mixed to obtain a second phase;

[0023] Add tartaric acid to water to dissolve and obtain the third phase;

[0024] Adding the second phase and the third phase into the first phase and stirring evenly to obtain a paste;

[0025] The paste is coated on a substrate, covered with a liner, and air-dried to obtain the fever-reducing patch for children.

[0026] In some embodiments, the Chinese medicine composition is a fine powder, the fine powder can all pass through an 80-mesh sieve, and the weight of the powder that can pass through a 100-mesh sieve is not less than 95% of the weight of the fine powder;

[0027] Optionally, the Chinese medicine composition is obtained by mixing the Artemisia annua, the Psoralea corylifolia, the Mentha arvense and the Notopterygium wilfordii respectively into fine powders;

[0028] Optionally, the mixing time of the Artemisia annua powder, the Pleurotus eryngii powder, the peppermint powder and the Notopterygium wilfordii powder is greater than 10 minutes.

[0029] In some embodiments, the Artemisia annua, the Pleurotus eryngii, the Mentha arvense, and the Notopterygium wilfordii are sterilized using 75% ethanol for 12 h-14 h before being prepared into fine powder.

[0030] In some embodiments, the amount of 75% ethanol used to sterilize the Artemisia annua is 25% of the mass of the Artemisia annua;

[0031] The amount of 75% ethanol used to sterilize the white osmanthus is 20% of the mass of the white osmanthus;

[0032] The amount of 75% ethanol used to sterilize the mint is 26% of the mass of the mint;

[0033] The amount of 75% ethanol used to sterilize the Notopterygium wilfordii is 22% of the mass of the Notopterygium wilfordii.

[0034] In some embodiments, the Artemisia annua, the Pleurotus eryngii, and the Notopterygium wilfordii are sterilized and dried at below 60° C. for at least 4 hours;

[0035] The mint is sterilized and dried at a temperature below 60° C. for at least 3 hours.

[0036] In some embodiments, the preparation method satisfies at least one of the following characteristics:

[0037] A. The mass of the paste on each piece of pediatric antipyretic patch is 19-20g;

[0038] B. The coating thickness of the paste is 2.5±0.1mm;

[0039] C. The drying temperature is 20-25°C, the relative humidity is 50-65%, and the drying time is at least 48 hours;

[0040] D. The mass percentage concentration of the carbomer solution is 4.76%.

[0041] Compared with the prior art, the beneficial effects of this application include:

[0042] The Chinese medicine composition provided in the present application uses Artemisia annua and White mulberry as the main ingredient, Notopterygium wilfordii as the secondary ingredient, and Mentha arvense as the envoy. Artemisia annua as the main ingredient can relieve exterior symptoms and clear away heat, which is suitable for children's physique, and is supplemented by Mentha arvense and White mulberry to relieve exterior symptoms in a pungent and cool way, and Notopterygium wilfordii to dispel dampness and relieve exterior symptoms. It is suitable for children with exogenous fever syndrome caused by wind-heat or wind-cold turning into heat syndrome, has a good antipyretic effect, can effectively reduce the fever of infants and young children, and is especially suitable for infants and young children.

[0043] The pediatric antipyretic patch provided by the present application is prepared from the above-mentioned Chinese medicine composition. The pediatric antipyretic patch is applied to the umbilicus of infants and young children for use. It has a definite therapeutic effect and is convenient to use. It is well received by children and parents. It has the advantages of being easy to use, store and carry, and having high patient compliance and adaptability. The pediatric antipyretic patch can treat exogenous fever in children and prevent crises caused by pathogenic heat invading the pericardium or internal movement of liver wind. The method is simple, the toxic and side effects are small, the efficacy is reliable, and the children and parents are easily accepted. DETAILED DESCRIPTION

[0044] As used herein:

[0045] "Prepared from" is synonymous with "comprising." As used herein, the terms "comprising," "including," "having," "containing," or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a composition, process, method, article, or apparatus that comprises the listed elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such composition, process, method, article, or apparatus.

[0046] The conjunction "consisting of excludes any unspecified element, step, or component. If used in a claim, this phrase renders the claim closed-ended so that it does not include materials other than those described, except for conventional impurities associated therewith. When the phrase "consisting of" appears in a clause of the body of a claim rather than immediately following the subject matter, it limits only the elements described in that clause; other elements are not excluded from the claim as a whole.

[0047] When an amount, concentration, or other value or parameter is expressed as a range, a preferred range, or a range defined by a series of upper preferred values ​​and lower preferred values, this should be understood as specifically disclosing all ranges formed by any pairing of any range upper limit or preferred value with any range lower limit or preferred value, regardless of whether the range is disclosed separately. For example, when a range of "1 to 5" is disclosed, the described range should be interpreted as including ranges "1 to 4", "1 to 3", "1 to 2", "1 to 2 and 4 to 5", "1 to 3 and 5", etc. When a numerical range is described in this article, unless otherwise stated, the range is intended to include its end values ​​and all integers and fractions within the range.

[0048] In these examples, parts and percentages are by mass unless otherwise indicated.

[0049] "Parts by mass" refers to the basic unit of measurement for expressing the mass ratio of multiple components. 1 part can represent any unit mass, such as 1g or 2.689g. If we say that the mass of component A is a parts and the mass of component B is b parts, it means the ratio of the mass of component A to the mass of component B is a:b. Alternatively, it means that the mass of component A is aK and the mass of component B is bK (K is an arbitrary number, indicating a multiple factor). It should not be misunderstood that, unlike the mass parts, the sum of the mass of all components is not limited to 100 parts.

[0050] "And / or" is used to indicate that one or both of the stated situations may occur, for example, A and / or B includes (A and B) and (A or B).

[0051] The embodiments of the present application will be described in detail below in conjunction with specific examples, but it will be appreciated by those skilled in the art that the following examples are only used to illustrate the present application and should not be considered as limiting the scope of the present application. If specific conditions are not specified in the examples, they are carried out according to normal conditions or the conditions recommended by the manufacturer. If the manufacturer is not specified for the reagents or instruments used, they are all conventional products that can be purchased commercially.

[0052] The following examples are described using the mass ratio of 1 part of Artemisia annua, 1 part of Pleurotus eryngii, 0.5 part of Mentha arvense, and 1 part of Notopterygium wilfordii as an example.

[0053] Embodiment 1 Chinese medicine crushing process

[0054] 1.1 Sterilization and drying of medicinal pieces

[0055] It is better to sterilize Chinese medicine during the processing of slices, because bacteria generally only attach to the surface of slices, which can be easily washed off and killed, and the conditions required are relatively mild. If sterilization is performed after the slices have been processed into powder, when the powder already carries a large number of bacteria, it is difficult to achieve sterilization qualification, and a more intense sterilization method is required. Therefore, combined with previous practical experience and current production conditions, the pretreatment sterilization method of Chinese medicine slices in this preparation adopts ethanol sterilization, that is, the surface of the slices is wetted with an appropriate amount of 75% ethanol, and then dried after being sealed at room temperature for 12 hours.

[0056] 1.1.1 75% ethanol dosage

[0057] Weigh 1kg each of Artemisia annua, Rhizoma Cibotii, Mentha chinensis, and Radix Notopterygii, place them in a stainless steel frying pan, use 75% medicinal ethanol as the solvent, stir, and gradually add appropriate amounts of solvents to wet the surface of the pieces, and record the amount of solvent used. The results show that the amount of 75% ethanol used for sterilization of Artemisia annua, Rhizoma Cibotii, Mentha chinensis, and Radix Notopterygii is 0.25, 0.20, 0.26, and 0.22 times of their weight, respectively, which can make the surface of the pieces wet and no residual solvent at the bottom.

[0058] 1.1.2 Selection of temperature during drying

[0059] According to the provisions of the 2015 edition of the Chinese Pharmacopoeia, Artemisia annua, Radix Angelicae Dahuricae, Mentha Root, and Radix Notopterygii, the processing and drying methods of Artemisia annua, Radix Angelicae Dahuricae, and Radix Notopterygii are all "drying", and the processing and drying method of mint slices is "timely low-temperature drying", so the drying method is selected according to production conditions. Since volatile oil is one of the main active ingredients of mint and Radix Notopterygii, and 75% ethanol is used as the solvent, it is appropriate to choose a drying temperature not exceeding 60°C.

[0060] 1.1.3 Selection of drying time

[0061] Take 1kg each of Artemisia annua, Psoralea corylifolia, Mentha arvense and Notopterygium wilfordii slices, place in a stainless steel frying pan, add 0.25, 0.20, 0.26, 0.22 times of their weight of 75% ethanol respectively under stirring to moisten the surface of the slices. Cover the moistened slices and seal them at room temperature for 12 hours, dry below 60℃, and take samples at 2, 3, 4, and 5 hours after drying, measure the moisture content of each sample, and optimize the drying time according to the results. The results are shown in Table 1.

[0062] Table 1 Investigation results of drying time after sterilization of decoction pieces

[0063]

[0064] The results showed that the decoction pieces of Artemisia annua, Pleurotus eryngii and Notopterygium wilfordii could meet the requirements after being sterilized with 75% ethanol and then dried at 60°C for 4 hours, while the decoction pieces of mint could meet the requirements after being sterilized with 75% ethanol and then dried at 60°C for 3 hours.

[0065] 1.1.4 Microbial limit indicators of Artemisia annua, Psoralea corylifolia, Mentha arvense and Notopterygium wilfordii slices before and after sterilization

[0066] Take appropriate amount of each slice before and after sterilization, crush, accurately weigh 10.0g of powder, and test according to the method under the microbial limit test of non-sterile products: microbial count method (General Rule 1105 of Part IV of the 2015 edition of the Chinese Pharmacopoeia), microbial limit test of non-sterile products: control bacteria test method (General Rule 1106) and microbial limit standard of non-sterile drugs (General Rule 1107), and observe the changes in the microbial limit indicators of the slices before and after sterilization. The results are shown in Table 2.

[0067] Table 2 Changes in microbial limits of samples before and after sterilization

[0068]

[0069]

[0070] The results showed that after sterilization with 75% ethanol, the total number of aerobic bacteria, molds and yeasts in the slices decreased significantly compared with before sterilization. Staphylococcus aureus and Pseudomonas aeruginosa were not detected. The number of bacteria brought in by the slices was effectively controlled, which could meet the requirements of microbial control in this product and provide a basis for further preparation.

[0071] 1.1.5 Effects of sterilization and drying on the volatile oil content of decoction pieces

[0072] According to the provisions of each decoction piece in the 2015 edition of the Chinese Pharmacopoeia, combined with the effective components of each decoction piece, the volatile oil in mint and Notopterygium wilfordii is one of the main control index components. The mint and Notopterygium wilfordii decoction pieces before and after sterilization were taken, and the volatile oil determination method (method A) (General Rule 2204 of Part IV of the 2015 edition of the Chinese Pharmacopoeia) was used to determine the changes in the volatile oil content of the decoction pieces before and after sterilization. The results are shown in Table 3.

[0073] Table 3 Changes in volatile oil content of samples before and after sterilization

[0074] Pieces Before sterilization% After sterilization % Retention Rate Mint 0.82 0.70 85.37 Notopterygium wilfordii 1.60 1.42 88.75

[0075] The results showed that after being sterilized and dried in 75% ethanol for 12 hours, the contents of volatile oils in peppermint and Notopterygium wilfordii slices decreased, but the retention rates were all above 85%, indicating that the process was feasible.

[0076] 1.1.6 Summary of sterilization and drying results of medicinal pieces

[0077] Based on the above research results, the sterilization process of Artemisia annua, Psoralea corylifolia, Mentha arvense and Notopterygium wilfordii was determined as follows: take each slice, add 75% ethanol of 20% to 26% of its weight, moisten the surface of the slice, seal and moisten for 12 hours, and dry below 60°C. The total number of bacteria, molds and yeasts in the slices decreased significantly, and Staphylococcus aureus and Pseudomonas aeruginosa were not detected, which effectively controlled the number of bacteria brought into the slices, and the retention rate of the volatile oil content in Mentha arvense and Notopterygium wilfordii slices was above 85%, which can meet the process requirements.

[0078] 1.2 Establishment of crushing process conditions

[0079] Weigh three portions of the above-mentioned Artemisia annua, Psoralea corylifolia, Mentha arvense and Notopterygium wilfordii slices, 300 g each, and grind them into fine powder using a JP-500B high-speed multifunctional grinder. Pass through a No. 5 sieve (80 meshes) and a No. 6 sieve (100 meshes), respectively, collect the fine powder (all the powder can pass through the No. 5 sieve, and the weight of the powder that can pass through the No. 6 sieve is not less than 95% of the weight of the fine powder), weigh it, calculate the fine powder yield, and use the fine powder yield as an indicator to investigate the slice grinding process. The results are shown in Table 4.

[0080] Fine powder yield (%) = (qualified powder weight / feeding amount) × 100%.

[0081] Table 4 Crushing process investigation results

[0082]

[0083] The results show that the fine powder yield of each piece of medicine after crushing is above 92%, which meets the requirements, indicating that the crushing process of the pieces of medicine is feasible. According to Article 32 of the General Rules of the 2015 edition of the Chinese Pharmacopoeia, the sterilization and crushing losses of the pieces of medicine are included in the pre-treatment losses of the medicinal materials.

[0084] Example 2 Preparation process study

[0085] The uniform design method was adopted, and the initial adhesion, lasting adhesion and appearance comprehensive score were used as evaluation indicators to optimize the gel patch molding prescription.

[0086] 2.1 Investigation of the mixing process of fine powder of medicinal pieces

[0087] According to the prescription ratio, 3 portions of fine powders of Artemisia annua were weighed, each portion was 3.5 kg, and placed in a CH10 trough mixer for mixing. The Artemisia annua powder in the prescription was dark green, the mint powder was turquoise, the white mulberry powder was off-white, and the Notopterygium wilfordii powder was brown-black. The color difference of each decoction piece powder was large, so the color uniformity after mixing was used as the evaluation index, and the color was checked at 10, 15, 20, and 25 minutes after mixing. The results are shown in Table 5.

[0088] Table 5 Result table of the mixing process of fine powder of medicinal pieces

[0089]

[0090] From the results, it can be seen that the mixture can be mixed evenly after 15 minutes of mixing, so the mixing time is determined to be 15 minutes.

[0091] 2.2 Selection of excipients

[0092] The gel patch is mainly composed of drugs, adhesives, fillers, moisturizers, cross-linkers, cross-linker adjusters, emulsifiers and water. Carbomer is used as adhesive, partially neutralized sodium polyacrylate as filler, glycerin as moisturizer, aluminum glycolate as cross-linker, tartaric acid as cross-linker adjuster, and polysorbate-80 as emulsifier.

[0093] 2.3 Sample preparation

[0094] During the sample preparation process, the drug and each excipient were added in sequence and mixed according to the process flow of the gel patch and the role of each excipient in the prescription. Since the cross-linking agent affects the viscosity of the adhesive, it is difficult to stir the paste evenly. Therefore, according to the role of excipients such as drug powder, adhesive, filler, cross-linking agent, and the uniform dispersion of the drug and excipients, the drug powder was mixed with an appropriate amount of 50% glycerin and then mixed with the carbomer solution as the first phase; in addition, the cross-linking agent was mixed with the filler, moisturizer, etc. as the second phase, and the cross-linking agent was adjusted to tartaric acid solution as the third phase, so as to be mixed with the above-mentioned ointment.

[0095] The preparation process of the proposed sample is as follows: according to the prescription ratio, weigh 22 portions of fine powder of four medicinal materials such as Artemisia annua, each portion is 35g, according to the arrangement of the experimental design table, take 0.8g of carbomer, add purified water to swell, make it into a uniform transparent solution, the concentration range is 1.22% to 5%, and set aside; weigh 30g of glycerol, add 30g of purified water to make a 50% glycerol solution (according to the preliminary experiment, 60g of 50% glycerol solution should be added to every 35g of fine powder to make a uniform mud Mixture, so as to mix with the rest of the materials), add the above-mentioned medicinal powder, mix well, then add the swollen carbomer solution, stir well, as the first phase; take the remaining glycerin, add polysorbate-80, partially neutralized sodium polyacrylate, aluminum glycolate, mix well, as the second phase; take tartaric acid and purified water, stir to dissolve, as the third phase; add the second phase and the third phase to the first phase respectively, stir well, apply, cover, cut, dry, and obtain the pediatric fever-reducing patch. Determine the initial adhesion and lasting adhesion of the sample, and observe its appearance.

[0096] 2.4 Gel patch quality evaluation indicators and testing methods

[0097] 2.4.1 Initial adhesion

[0098] The slope rolling ball method was used for the measurement. The gel patch was spread flat on a stainless steel plate at an angle of 15 degrees to the horizontal table. A stainless steel ball was rolled over the gel patch placed on the inclined plate. Each sample was measured 5 times. The average value of the largest steel ball that could stick to it was used to evaluate the initial adhesion. The maximum value measured was taken as 100 points, and the rest were compared with it to calculate the score (measured value / maximum value) × 100.

[0099] 2.4.2 Holding force

[0100] Stick the gel patch longitudinally on the middle of the adjacent clean test plate and loading plate, and use a 2000g roller to roll back and forth on the test sample three times. After the gel patch is pasted on the plate, leave it for 20 minutes, fix it vertically on the test frame, hang a 50g brick code along the length of the gel patch, and record the time it takes for it to slip until it falls off. Measure each sample 5 times, and evaluate its adhesion with the average value. The maximum value measured is 100 points, and the others are compared with it to calculate the score by (measured value / maximum value)×100.

[0101] 2.4.3 Comprehensive Appearance Evaluation Scoring Criteria

[0102] Matrix uniformity: The prepared matrix is ​​uniform, fine, and free of granular micelles and spots (8-10 points); the spots are slightly larger but not numerous or more numerous and small in size (5-7 points); the color is uneven, the spots are slightly larger or larger, and the number is large or more numerous (1-4 points).

[0103] Surface gloss: After repeatedly opening the mask, the surface remains smooth and has no pits (10 points); the surface is smooth but has small pits (7-9 points); the surface pits are small but more or slightly larger and more (4-6 points); after opening the mask, part or all of the paste surface cannot return to smoothness (1-3 points).

[0104] Bubble status: The bubbles are small in shape and few in number (8-10 points); the bubbles are small in shape and scattered around (5-7 points); the bubbles are slightly larger in shape and more distributed (3-4 points); the bubbles are larger in shape and more distributed (2 points); the bubbles are large in shape, densely distributed, and large in number (1 point).

[0105] The scores of uniformity, glossiness, number of bubbles, etc. are summed up as the comprehensive appearance score. The maximum value is 100 points, and the rest are compared with it to calculate the score (measured value / maximum value) × 100.

[0106] 2.5 Optimization of formulation ratio

[0107] 2.5.1 Examination factors and levels

[0108] Matrix dosage screening: the finest powder of the fixed slices was 35 g, and the carbomer was 0.4 g. Uniform design experiments were performed on six matrix formulas, including carbomer solution concentration (1.22%-5%), glycerol (37-100 g), tartaric acid (0-0.42 g), polysorbate 80 (0.16-1.00 g), partially neutralized sodium polyacrylate (1.7-8.00 g), and aluminum glycolate (0.54-1.80 g). The best formula was selected, and 22 levels were arranged for each of carbomer concentration, glycerol, tartaric acid, aluminum glycolate, polysorbate-80, and partially neutralized sodium polyacrylate, as shown in Table 6.

[0109] Table 6. Table of factors level for optimal matrix ratio in uniform design

[0110]

[0111] 2.5.2 Uniform design test and results

[0112] According to the proposed factor level plan and the U22 (226) uniform design table, the drug-containing matrix was prepared, coated, cut, and placed in a perforated baking tray. A dehumidifier was turned on in a closed room to control the humidity below 65% and the temperature below 25°C for 48 hours. Then, the test was carried out according to the proposed evaluation indicators and scoring plan. The test results are shown in Table 7.

[0113] Table 7 Uniform design test and results

[0114]

[0115]

[0116] Note: Comprehensive score = (initial adhesion / maximum initial adhesion + lasting adhesion / maximum lasting adhesion + appearance evaluation / maximum appearance evaluation)*100.

[0117] 2.5.3 Data processing

[0118] Taking the comprehensive score as the index and each factor as the variable, the DPS data processing software was used to perform a quadratic polynomial stepwise regression analysis, and the regression equation was obtained: Y = 400.72-13.91X 2 +84.60X 3 +970.17X 5 -0.05X 2 2 -1515.94X 4 *X 4 -755.11X 5 *X 5 +26.040X 1 *X 3 +4.39X 1 *X 4 +2.16X 1 *X 5 +37.69X 2 *X 4 +12.96X 2 *X 5 -440.62X 3 *X 5 +26.08X 3 *X 6 -2382.27X 4 *X 5The equation was tested by F test, and the P values ​​of each coefficient were all less than 0.05, indicating that each coefficient of the equation was significant. The optimal formula calculated according to the equation was carbomer (concentration)-glycerol-tartaric acid-aluminum glycolate-polysorbate 80-partially neutralized sodium polyacrylate (4.76%: 100g: 0.42g: 1.40g: 0.63g: 8.00g). That is, the optimal preparation process is to take 0.8g of carbomer, add purified water to swell into a 4.76% solution, and set aside; take another 30g of glycerol, add purified water to make a 50% glycerol solution, add 35g of the finest medicinal material powder, stir well, and then add the above-mentioned carbomer solution and mix well as the first phase; take another 70g of glycerol, 1.40g of aluminum glycolate, 0.63g of polysorbate, and partially neutralize 8.00g of sodium polyacrylate and mix well as the second phase, take another 0.42g of tartaric acid, add 5ml of purified water to make a tartaric acid solution as the third phase, add the second phase and the third phase to the first phase in turn, stir well, apply, cut, and dry to obtain a pediatric fever relief patch.

[0119] 2.5.4 Verification test

[0120] Three batches of pediatric antipyretic patch samples were prepared according to the preferred preparation process, and their initial adhesion, sustained adhesion and comprehensive appearance scores were measured. Each data is the average of five samples measured, see Table 8.

[0121] Table 8 Verification test results (n=5)

[0122]

[0123]

[0124] The results showed that the pediatric antipyretic patch prepared according to the optimization results of the uniform design test had good ductility, a smooth appearance, good initial adhesion and lasting adhesion, and could meet the adhesion requirements. The comprehensive score was 207.20, indicating that the process was basically stable.

[0125] Example 3 Preferred preparation process conditions

[0126] According to the preferred formulation and preparation method, combined with the preliminary experimental results and existing equipment conditions, the stirring speed is selected to be 250 rpm·min -1 , the mixing process and stirring time of each material were investigated.

[0127] 3.1 Investigation of the first phase material mixing process

[0128] Weigh 35g of the fine powder of the decoction piece according to the prescription ratio, put it in a YN90-120 constant speed mixer, add 30g of glycerol and purified water, and stir at 250rpm·min -1The mixture was stirred for 5 min, 10 min and 15 min respectively, and the appearance of the material was observed. After being stirred evenly, it was regarded as a mixture of drug powder and glycerol. The results are shown in Table 9. 16.8 g of 4.76% carbomer aqueous solution was added to the mixture, and the mixture was stirred at 250 rpm·min. -1 Stir for 5 min, 10 min and 15 min respectively, observe the appearance of the material, and the material after stirring evenly is regarded as the first phase. The results are shown in Table 10.

[0129] Table 9 Mixing results of decoction pieces fine powder, glycerin and water

[0130]

[0131]

[0132] The results showed that the materials could be mixed evenly after stirring for 10 minutes, so the stirring time of the decoction powder and the glycerol aqueous solution was determined to be 10 minutes.

[0133] Table 10 Mixing results of powder glycerol mixture and carbomer aqueous solution

[0134]

[0135] The results showed that the materials could be mixed evenly after stirring for 10 minutes, so the stirring time was determined to be 10 minutes.

[0136] 3.2 Investigation of second phase material mixing

[0137] Take 70g of glycerol, 0.63g of polysorbate 80, 1.4g of aluminum glycolate and 8g of partially neutralized sodium polyacrylate, place them in a YN90-120 constant speed stirrer, add 5 drops of 0.5% lemon yellow aqueous solution as an indicator, and stir at 250rpm min. -1 The mixture was stirred for 5 min, 10 min and 15 min respectively, and the appearance of the material was observed. The material after mixing was regarded as the second phase. The results are shown in Table 11.

[0138] Table 11 Results of the second phase material mixing investigation

[0139]

[0140]

[0141] The results show that after stirring for 10 minutes, the materials can be mixed evenly and stirring for 10 minutes is sufficient.

[0142] 3.3 Preparation of the third phase

[0143] Weigh 0.42 g of tartaric acid, add 5 g of purified water, stir to dissolve, and set aside.

[0144] 3.4 Overall Mixing Process Investigation

[0145] Take the first phase, place it in a YN90-120 constant speed stirrer, add the second phase and the third phase, stir for 5 minutes, 10 minutes and 15 minutes respectively, observe the appearance of the material, and stir until it becomes a uniform viscous paste. The results are shown in Table 12.

[0146] Table 12 Results of the overall mixing process investigation

[0147]

[0148] The results show that after the second and third phases are added to the first phase and stirred for 10 minutes, the materials are mixed evenly, so it is determined that mixing for 10 minutes is sufficient.

[0149] Example 4 Molding Process Study

[0150] 4.1 Coating thickness

[0151] According to the historical dosage of clinical use of the prescription, the daily amount of crude drug is 3.5g, which is approximately equivalent to 19.7g of gel paste according to the process optimization prescription. Since the composition of the preparation is fixed, the paste density is about 0.73g / ml. After calculation, it is coated on a 9cm×12cm non-woven fabric substrate with a thickness of 2.5±0.1mm to meet the dosage requirements.

[0152] 4.2 Drying method

[0153] The appropriate water content in the gel patch has a great influence on its appearance, adhesion, etc. If the water content is too low, the paste will become hard and the adhesion will decrease, affecting the use of the patch; if the water content is too high, the gel patch will easily rot and leak. At the same time, the drying of the gel patch is not only a process of reducing the water content, but also a process of cross-linking the gel colloid. In the study, the appearance and adhesion of the gel patch were used as evaluation indicators to optimize the drying method. The prepared pediatric antipyretic patch was placed at room temperature to dry (20-25°C, relative humidity 50-65%), and dried in an oven at 40°C, 60°C, and 80°C to investigate the effects on the drying time and the properties of the paste. The results are shown in Table 13.

[0154] Table 13 Effects of different drying methods on drying time and performance of pediatric antipyretic plaster

[0155]

[0156] The results showed that when the pediatric fever-reducing patch was air-dried at 20-25°C and relative humidity of 50-65% and dried in an oven at 40°C, 60°C, and 80°C, the drying time was shortened successively with the increase of drying temperature, but the paste began to shrink, the paste became hard, and the viscosity was significantly reduced, which may be caused by the effect of temperature on colloid cross-linking.

[0157] After being left to dry for 48 hours at room temperature with a relative humidity of 50-65%, the paste surface has a uniform and delicate color, no leakage or rotting of the paste, and good viscosity. Considering the needs of energy saving, it is chosen to be left to dry for 48 hours at a temperature of 20-25°C and a relative humidity of 50-65%.

[0158] 4.3 Determination of preparation specifications

[0159] According to the history of clinical use, it is determined that each patch of the preparation contains 3.5g of crude drugs. According to the prescription composition, the theoretical weight of the gel paste made from each 1,000 patches of the preparation is 19.7kg, which is converted to a weight of 19.7g of gel paste applied to each patch. Combined with the gel paste density of about 0.73g / ml, the coating thickness is 2.5±0.1mm on a non-woven fabric with a specification of 9cm×12cm, and each patch contains 3.5g of fine Chinese medicine powder. That is, the finished specification is: each patch (9cm×12cm) is equivalent to 3.5g of decoction pieces.

[0160] Example 5 Pilot Process Study

[0161] Based on the small-scale test in the above experimental example, pilot tests were carried out three times, and the finest powder amount of each batch of pilot pieces was 3.5 kg.

[0162] 5.1 Pilot production site and equipment models and specifications

[0163] Pilot site: Preparation Center of Orthopedic Hospital Affiliated to Guangzhou University of Chinese Medicine (License No.: Yue Zx20150101).

[0164] Food mixer: B80.

[0165] Hydrogel coating machine: Roller type GST-I model.

[0166] Universal crusher: PE-300F.

[0167] Vibrating drug ultrafine pulverizer: LWF-100TB.

[0168] Trough mixer: CH10.

[0169] 5.2 Pilot formulation

[0170] 1kg of Artemisia annua, 1kg of Pleurotus eryngii, 0.5kg of mint, 1kg of Notopterygium wilfordii, 10kg of glycerol, 80g of carbomer, 0.8kg of partially neutralized sodium polyacrylate, 63g of polysorbate 80, 140g of aluminum glycolate, 42g of tartaric acid, and 5.1kg of purified water.

[0171] 5.3 Pilot Detailed Process

[0172] 5.3.1 Pretreatment: Take the pieces of Artemisia annua, Psoralea corylifolia, Mentha arvense and Notopterygium wilfordii, add 75% ethanol (20-30% of the weight of the pieces) to make the surface of the pieces evenly moist, place them in a sealed container for 12 hours, dry them (below 60°C), grind them into fine powder and set aside.

[0173] 5.3.2 Mixing: According to the prescription ratio, take the fine powder of Artemisia annua, Pleurotus eryngii, Mentha arvense and Notopterygium wilfordii slices, mix them in a trough mixer and set aside.

[0174] 5.3.3 Preparation of gel patch:

[0175] Take carbomer, add 1.6kg of purified water, swell to make a uniform transparent solution; take another 3kg of glycerol, add 3kg of purified water and mix well, add the above-mentioned decoction piece powder and mix well; then add the swollen carbomer solution and mix well to form the first phase;

[0176] Take 7 kg of glycerol, add polysorbate 80, partially neutralize sodium polyacrylate, aluminum glycolate, and stir well to prepare the second phase;

[0177] Take tartaric acid, add 500 g of purified water, stir to dissolve, and use as the third phase;

[0178] Add the second phase and the third phase to the first phase, stir well, apply, control the thickness to about 2.5mm, and adjust the amount of ointment in each patch cut according to the specification of 9cm×12cm to 19.7±1g, dry, and you are done.

[0179] 5.3.4 Drying: Place on a drying tray, turn on a dehumidifier in a closed room, control the humidity at 50-65%, and place at 20-25℃ for 48 hours.

[0180] 5.3.5 Quality inspection and packaging: Pack the qualified gel patches into polyester / aluminum / polyethylene composite film bags for pharmaceutical packaging, 2 patches per bag.

[0181] 5.4 Semi-finished product quality control standards and inspection methods

[0182] 5.4.1 Semi-finished products

[0183] Appearance: Tan gel paste; aromatic smell.

[0184] Inspection: The color of the paste is uniform.

[0185] 5.4.2 Finished product

[0186] Appearance: Brown to tan gel patch; evenly coated, uniform surface color, no peeling or loss of adhesion; the backing surface is flat, clean, and has no ointment leakage.

[0187] Ointment content: Check according to the second method of ointment content test method (General Rules 0122 of Part 4 of the 2015 edition of the Chinese Pharmacopoeia), and it should comply with the regulations.

[0188] Excipients: Check according to the excipients test method (General Rules 0122 of Part 4 of the 2015 edition of the Chinese Pharmacopoeia) and it should comply with the regulations.

[0189] 5.5 Pilot test data

[0190] The results are shown in Table 14. It can be seen that after three batches of pilot tests, the process parameters are stable, indicating that the process is basically reasonable and the product quality is stable.

[0191] Table 14 Three batches of pilot results

[0192] batch number 20170701 20170702 20170703 Total feed amount (kg) 3.5 3.5 3.5 Artemisia annua powder mass (kg) 1.0 1.0 1.0 White mulberry powder mass (kg) 1.0 1.0 1.0 Mint powder mass (kg) 0.5 0.5 0.5 Notopterygium wilfordii powder mass (kg) 1.0 1.0 1.0 Carbomer(g) 80 80 80 Partially neutralized sodium polyacrylate (g) 800 800 800 Glycerol (kg) 10 10 10 Polysorbate 80 (g) 63 63 63 Aluminum Glycol Hydroxide(g) 140 140 140 Tartaric acid(g) 42 42 42 Purified water (kg) 5.1 5.1 5.1 Mixture mass (kg) 19.690 19.699 19.705 Theoretical production volume (stickers) 1000 1000 1000 Actual production volume (stickers) 936 952 949 Yield rate (%) 93.60 95.20 94.90

[0193] Example 6 Clinical efficacy observation

[0194] Since 2014, the applicant has conducted clinical efficacy observations on the pediatric antipyretic patch. Inclusion criteria: children aged 6 months and above and under 14 years old. The clinical diagnosis was exogenous fever in children (Western medicine diagnosis: acute upper respiratory tract infection), the syndrome was wind-heat or wind-cold-heat syndrome; the course of fever was within 3 days; blood routine examination indicated viral infection. Exclusion criteria: children had other underlying diseases, and the skin at the application site had acute diseases (such as skin damage, eczema, and impetigo). Based on the principle of voluntary use, the patients were randomly divided into two groups. The treatment group used the pediatric antipyretic patch for external use, and oral antipyretics (ibuprofen dry suspension) were used for body temperature > 38.5℃, and the control group was given physical cooling, and oral antipyretics (ibuprofen dry suspension) were used for body temperature > 38.5℃.

[0195] How to use the pediatric antipyretic patch: The dosage is based on age: 6 months to 1 year old, 1 / 4 patch each time; over 1 year old to 3 years old, 1 / 3 patch each time; over 3 years old to 6 years old, 1 / 2 patch each time; over 6 years old to 14 years old, 1 patch each time. Application site: Umbilical region (Shenque point). Application time: no more than 30 minutes for children under 3 years old, no more than 1 hour for children aged 3-6 years old, and no more than 2 hours for children aged 6-14 years old. ≤3 patches within 24 hours. Give family members a temperature registration form to track and record the fever peak, fever interval, and fever reduction time of the two groups of children.

[0196] Data analysis: There were 80 cases in the treatment group (42 males and 38 females), with an average age of 7.42 years; there were 80 cases in the control group (39 males and 41 females), with an average age of 7.55 years; the baselines (gender, age, and course of disease) of the two groups before treatment were comparable after statistical analysis (P>0.05, see Table 15, Table 16, and Table 17 for details). After treatment, analysis of the two groups showed that the treatment group was superior to the control group in terms of fever course, fever peak, and taking antipyretics. The treatment data of the two groups were statistically processed, and the difference was significant (P<0.05, see Table 18 for details).

[0197] Table 15 Age comparison between the treatment group and the control group

[0198] 6 months to 1 year old 1 to 3 years old 3 to 6 years old 6 to 14 years old Treatment Group 21 26 19 14 Control group 20 27 21 12

[0199] Table 16 Comparison of baseline course of disease before treatment between the treatment group and the control group

[0200]

[0201]

[0202] Table 17 Comparison of gender, age, and baseline course of disease before treatment between the treatment group and the control group

[0203]

[0204] There was no statistical difference in age, fever days and body temperature level between the treatment group and the control group.

[0205] Table 18 Comparison of therapeutic effects between the two groups

[0206] Fever days (days) Number of times antipyretics were taken Thermal peak(℃) Treatment Group 3.48±1.30 2.37±1.41 38.54±1.03 Control group 3.89±1.82 3.67±1.32 39.36±1.05 Statistics 1.960 1.141 1.039 p-value 0.0015 0.2783 0.4319

[0207] By comparison, it can be seen that the pediatric antipyretic patch umbilical application group of the present application can reduce the number of times of taking antipyretic drugs, shorten the fever treatment course and reduce the fever peak.

[0208] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present application, rather than to limit it. Although the present application has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present application.

[0209] In addition, those skilled in the art will appreciate that, although some embodiments herein include certain features included in other embodiments but not other features, the combination of features of different embodiments is meant to be within the scope of the present application and form different embodiments. For example, in the above claims, any one of the claimed embodiments may be used in any combination. The information disclosed in this background technology section is intended only to deepen the understanding of the overall background technology of the present application and should not be regarded as an admission or in any form of implication that the information constitutes prior art known to those skilled in the art.

Claims

1. A Chinese medicine composition, characterized in that: The traditional Chinese medicine composition comprises, by weight: 1-2 parts of Artemisia annua, 1-2 parts of Psoralea corylifolia, 0.5-1 parts of Mentha arvense and 1-2 parts of Notopterygium wilfordii.

2. A fever-reducing patch for children, characterized in that: It comprises a paste prepared from the Chinese medicine composition according to claim 1.

3. The pediatric antipyretic patch according to claim 2, characterized in that: The paste also includes: 0.08-0.16 parts of adhesive, 0.8-1.6 parts of filler, 10-20 parts of moisturizer, 0.14-0.28 parts of cross-linking agent, 0.042-0.084 parts of cross-linking agent adjustment, 0.063-0.126 parts of emulsifier and 5.1-10.2 parts of water.

4. The pediatric fever-reducing patch according to claim 3, characterized in that: The adhesive is selected from carbomer, the filler is selected from partially neutralized sodium polyacrylate, the moisturizer is selected from glycerol, the cross-linking agent is selected from aluminum glycolate, the cross-linking agent regulator is selected from tartaric acid, and the emulsifier is selected from polysorbate-80.

5. A method for preparing the fever-reducing patch for children as claimed in claim 4, characterized in that: include: Adding water to part of the glycerol to prepare a glycerol solution, and adding the traditional Chinese medicine composition and the carbomer solution to the glycerol solution and mixing them to obtain a first phase; The remaining glycerol, polysorbate-80, partially neutralized sodium polyacrylate, and aluminum glycolate are mixed to obtain a second phase; Add tartaric acid to water to dissolve and obtain the third phase; Adding the second phase and the third phase into the first phase and stirring evenly to obtain a paste; The paste is coated on a substrate, covered with a liner, and air-dried to obtain the fever-reducing patch for children.

6. The method for preparing the fever-reducing patch for children according to claim 5, characterized in that: The Chinese medicine composition is a fine powder, the fine powder can all pass through an 80-mesh sieve, and the weight of the powder that can pass through a 100-mesh sieve is not less than 95% of the weight of the fine powder; Optionally, the Chinese medicine composition is obtained by mixing the Artemisia annua, the Psoralea corylifolia, the Mentha arvense and the Notopterygium wilfordii respectively into fine powders; Optionally, the mixing time of the Artemisia annua powder, the Pleurotus eryngii powder, the peppermint powder and the Notopterygium wilfordii powder is greater than 10 minutes.

7. The method for preparing the fever-reducing patch for children according to claim 6, characterized in that: The Artemisia annua, the Psoralea corylifolia, the Mentha arvense and the Notopterygium wilfordii are sterilized using 75% ethanol for 12 h to 14 h before being prepared into fine powder.

8. The method for preparing the fever-reducing patch for children according to claim 7, characterized in that: The amount of 75% ethanol used to sterilize the Artemisia annua is 25% of the mass of the Artemisia annua; The amount of 75% ethanol used to sterilize the white osmanthus is 20% of the mass of the white osmanthus; The amount of 75% ethanol used to sterilize the mint is 26% of the mass of the mint; The amount of 75% ethanol used to sterilize the Notopterygium wilfordii is 22% of the mass of the Notopterygium wilfordii.

9. The method for preparing the fever-reducing patch for children according to claim 8, characterized in that: The Artemisia annua, the Psoralea corylifolia and the Notopterygium wilfordii are sterilized and dried below 60° C. for at least 4 hours; The mint is sterilized and dried at a temperature below 60° C. for at least 3 hours.

10. The method for preparing the fever-reducing patch for children according to any one of claims 5 to 9, characterized in that: Satisfy at least one of the following characteristics: A. The mass of the paste on each piece of pediatric antipyretic patch is 19-20g; B. The coating thickness of the paste is 2.5±0.1mm; C. The drying temperature is 20-25°C, the relative humidity is 50-65%, and the drying time is at least 48 hours; D. The mass percentage concentration of the carbomer solution is 4.76%.

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