Traditional Chinese medicine composition for relieving or treating infantile anorexia, ointment rubbing agent and preparation method of ointment rubbing agent

Abstract

The invention discloses a traditional Chinese medicine composition for relieving or treating infantile anorexia, a paste rubbing agent and a preparation method of the paste rubbing agent. The traditional Chinese medicine composition is prepared from valeriana jatamansi jones, aleppo avens, mint, pericarpium citri reticulatae, codonopsis pilosula, poria cocos, rhizoma atractylodis macrocephalae, rhizoma atractylodis, honey-fried licorice roots and radix paeoniae alba. The medicinal materials have a synergistic effect after compatibility, jointly play the roles of tonifying spleen and appetizing, and regulating qi and middle warmer, and can effectively improve the spleen and stomach functions of children, promote appetite, and relieve or treat children anorexia symptoms. The invention further provides a traditional Chinese medicine ointment containing the active ingredients of the composition, and the traditional Chinese medicine ointment is prepared from extract obtained after the traditional Chinese medicine composition is extracted, pericarpium citri reticulatae volatile oil, an oil-phase matrix, a water-phase matrix, azone serving as a transdermal enhancer and chlorethane acetate serving as a preservative according to a specific proportion, and the extract, the pericarpium citri reticulatae volatile oil, the oil-phase matrix, the water-phase matrix, the azone serving as a transdermal enhancer and the chlorethane acetate.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for relieving or treating pediatric anorexia, a traditional Chinese medicine ointment and a preparation method thereof. BACKGROUND

[0002] Pediatric anorexia is a common disease characterized by a lack of interest in food, reduced appetite, and refusal to eat or significantly reduced food intake in children. This disease not only affects the normal growth and development of children, but also can lead to malnutrition, decreased immunity and a series of health problems. At present, the methods for treating pediatric anorexia in clinical practice mainly include two categories: western medicine treatment and traditional Chinese medicine treatment.

[0003] In traditional Chinese medicine theory, pediatric anorexia is mainly caused by weak spleen and stomach and reduced digestive function. Traditional Chinese medicine believes that the spleen is responsible for transportation and transformation, and the stomach is responsible for receiving food. If the functions of the spleen and stomach are normal, the digestion and absorption of food will be normal. If the functions of the spleen and stomach are disordered, it can lead to loss of appetite, indigestion and other symptoms. Therefore, the principle of traditional Chinese medicine treatment for pediatric anorexia is to invigorate the spleen and stomach and promote digestion.

[0004] At present, the commonly used traditional Chinese medicine compositions for treating pediatric anorexia in clinical practice are mostly based on the classic prescriptions of Sijunzi Decoction, Liuqunzi Decoction or Xiangsha Liuqunzi Decoction. For example, CN113144032A discloses a traditional Chinese medicine ointment for treating pediatric anorexia, which contains ginseng, radix codonopsis, atractylodes, poria cocos, fried licorice root, and pericarpium citri reticulatae, and has the effect of invigorating the spleen and replenishing qi. CN113797304A discloses a traditional Chinese medicine ointment for treating pediatric anorexia, which contains radix codonopsis, atractylodes, atractylodes, poria cocos, and fried licorice root, and has the effect of improving pediatric anorexia. CN119139435A provides a traditional Chinese medicine composition for treating pediatric anorexia, which is optimized and screened based on Sijunzi Decoction and Xiangsha Liuqunzi Decoction, and has the effects of invigorating the spleen and replenishing qi, promoting the spleen and stomach, promoting digestion and reducing stagnation, and enhancing appetite.

[0005] In terms of traditional Chinese medicine dosage forms, traditional oral dosage forms such as decoction and granules are widely used in clinical practice. However, for pediatric patients, oral traditional Chinese medicine often has poor taste and low compliance. Therefore, external preparations such as ointment have unique advantages in the treatment of pediatric anorexia.

[0006] However, the existing treatment methods for infantile anorexia in the prior art still have some deficiencies: first, although the traditional oral traditional Chinese medicine dosage form has definite curative effect, the taste is bitter, the compliance of infant patients is poor, and it is not suitable for long-term use; second, although the existing external preparation such as the ointment is convenient to use, most of them lack specific formula for infantile anorexia, and the transdermal absorption effect of the effective components is not ideal; third, the preparation process of the traditional Chinese medicine ointment is not accurate, especially in the extraction of effective components, which leads to unstable efficacy and short shelf life; finally, most of the traditional Chinese medicine compositions in the prior art do not fully consider the compatibility relationship between drugs, the prescription is not accurate, and the specificity is not strong.

[0007] Therefore, it is urgent to develop a traditional Chinese medicine composition and its preparation for infantile anorexia, which should have a clear prescription ratio, the preparation should have good use convenience and patient compliance, and the preparation process should fully extract the effective components to ensure the stability and efficacy of the product. SUMMARY

[0008] In order to solve the problems of the existing treatment methods for infantile anorexia in the prior art, such as poor effect of traditional oral drugs, not suitable for long-term use by infants, lack of specific formula for infantile anorexia in existing external preparations, and insufficient extraction of effective components in the preparation process of traditional Chinese medicine ointment, and poor stability, and to achieve the technical effects of significant spleen invigorating effect, mildness, good use experience, high stability and safety, the present application provides a traditional Chinese medicine composition, ointment and preparation method for relieving or treating infantile anorexia.

[0009] To achieve the purpose of the present application, the present application adopts the following technical solutions In a first aspect, the present application provides a traditional Chinese medicine composition for relieving or treating infantile anorexia, which is made of raw materials including the following weight parts: 6-8 parts of spider herb, 6-8 parts of blue cloth, 6-8 parts of mint, 10-12 parts of dried tangerine or orange peel, 6-8 parts of radix codonopsis, 6-8 parts of poria, 6-8 parts of white atractylodes, 6-8 parts of atractylodes, 6-8 parts of fried licorice, and 6-8 parts of white peony root.

[0010] Preferably, the traditional Chinese medicine composition is made of raw materials including the following weight parts: 6 parts of spider herb, 6 parts of blue cloth, 6 parts of mint, 12 parts of dried tangerine or orange peel, 6 parts of radix codonopsis, 6 parts of poria, 6 parts of white atractylodes, 6 parts of atractylodes, 6 parts of fried licorice, and 6 parts of white peony root.

[0011] In this traditional Chinese medicine composition, Codonopsis pilosula is the principal herb, invigorating the spleen and nourishing the stomach; Atractylodes macrocephala and Atractylodes lancea are the assistant herbs, bitter and warm invigorating the spleen, drying dampness, and replenishing qi; Poria cocos is the adjuvant herb, sweet and bland invigorating the spleen and draining dampness, and its combination with Atractylodes macrocephala enhances the spleen-invigorating and dampness-removing effects; Paeonia lactiflora, with its sour and sweet properties, astringes yin and invigorates the spleen; Citrus reticulata peel regulates qi and harmonizes the stomach, dries dampness and invigorates the spleen, and also acts as a permeability enhancer (a natural Chinese medicine permeability enhancer); Spirodela polyrhiza regulates qi, relieves pain, promotes digestion, and stops diarrhea; Indigofera tinctoria replenishes the qi of the spleen and stomach, strengthening them; Mentha haplocalyx awakens the spleen and stimulates the appetite, and its pungent, cool, and fragrant properties can stimulate the taste buds, relieving loss of appetite caused by dampness and qi stagnation, thus "stimulating appetite and promoting digestion". The cooling properties of the herbs balance the warming and drying properties of Atractylodes lancea, Citrus reticulata peel, and Cyperus rotundus in the prescription, preventing "warmth and dryness from damaging yin." Prepared licorice root invigorates qi and harmonizes the middle jiao, harmonizing the effects of all the herbs. The entire formula works synergistically to strengthen the spleen and qi, dry dampness and harmonize the stomach, promoting digestion and absorption. These herbs, used together, work together to invigorate the spleen and stomach, regulate qi and harmonize the middle jiao, effectively improving children's spleen and stomach function, promoting appetite, and alleviating or treating symptoms of anorexia in children. The synergistic effects of the herbs enhance efficacy and reduce side effects.

[0012] In clinical applications, this traditional Chinese medicine composition can be formulated into different dosage forms such as granules, powders, pills, or decoctions, depending on the specific condition of the child. For younger children, dosage forms with better taste and easier administration can be selected to improve compliance.

[0013] Secondly, the present invention provides a plaster for relieving or treating anorexia in children, comprising the active ingredients of the above-mentioned traditional Chinese medicine composition and pharmaceutical excipients.

[0014] Preferably, the active ingredients of the traditional Chinese medicine composition exist in the form of volatile oils and extracts, and the amount of volatile oils and extracts added is 15% to 20% of the total mass of the ointment.

[0015] Preferably, the pharmaceutical excipients include an oil phase matrix, an aqueous phase matrix, a transdermal penetration enhancer, and a preservative.

[0016] More preferably, the oil phase matrix is ​​composed of medical-grade yellow petrolatum, lanolin, stearic acid, and glyceryl monostearate; the aqueous phase matrix is ​​composed of glycerol, Tween, and water; the transdermal penetration enhancer is azone; and the preservative is chlorethidium acetate.

[0017] More preferably, the oil phase matrix, by weight, comprises 8-12 parts of medical yellow petrolatum, 1-3 parts of lanolin, 9-13 parts of stearic acid, and 4-8 parts of glyceryl monostearate; the aqueous phase matrix, by weight, comprises 14-18 parts of glycerol, 2-3 parts of Tween 80, and 50-60 parts of water; the transdermal penetration enhancer, by weight, contains 1-3 parts of azone; and the preservative, by weight, contains 0.03-0.07 parts of chlorethidium acetate.

[0018] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine ointment, comprising the following steps: (1) Extraction of volatile oil: The volatile oil of dried tangerine peel was extracted from the tangerine peel by steam distillation; (2) Preparation of extract: The solid-liquid mixture of tangerine peel remaining after the extraction of volatile oil in step (1) is mixed with spider lily, blue broccoli, peppermint, codonopsis, poria cocos, atractylodes macrocephala, licorice root, and white peony root, and then extracted by water decoction. The decoctions are combined and concentrated to a paste to obtain extract. (3) Preparation of the matrix oil phase: Mix the oil phase matrix components, heat to melt and keep warm, stir and mix evenly to obtain the matrix oil phase; (4) Preparation of aqueous matrix phase: Mix the aqueous matrix components, heat to 79-81℃ and keep warm, stir and mix evenly to obtain the aqueous matrix phase; (5) Emulsification: The oil phase of the matrix is ​​added to the aqueous phase of the matrix and stirred and emulsified under the condition of heat preservation at 79-81℃ to obtain a uniform emulsion as the matrix; (6) Preparation of finished product: Add the extract to the matrix and stir and mix evenly under the condition of keeping warm at 79-81℃. Then add the transdermal penetration promoter, preservative and the volatile oil of tangerine peel obtained in step (1), continue to stir and mix evenly, and after cooling, the Chinese medicine ointment is obtained.

[0019] Preferably, in step (1), the mass ratio of dried tangerine peel to water in the steam distillation method is 1:8-10.

[0020] More preferably, in step (2), the water decoction extraction is performed by decocting twice, soaking for 30 minutes before the first decoction, decocting for 1 hour, and decocting for 40 minutes in the second decoction; the stirring speed in steps (3), (4), (5) and (6) is 150-220 rpm; and the heating temperature in steps (4), (5) and (6) is 80°C.

[0021] The beneficial effects of this invention are as follows: The herbal composition of this invention is rationally formulated. The combined medicinal materials work synergistically to invigorate the spleen and stomach, regulate qi, and harmonize the middle jiao (digestive system), effectively improving children's spleen and stomach function, promoting appetite, and alleviating or treating symptoms of anorexia in children. The synergistic effects of the various medicinal materials enhance the therapeutic efficacy and reduce side effects.

[0022] This invention's herbal ointment, formulated with carefully selected Chinese herbal ingredients and combined with modern pharmaceutical technology, achieves a significant yet gentle effect in strengthening the spleen. The synergistic action of its active ingredients gently stimulates intestinal peristalsis, promoting appetite and food intake, avoiding the poor efficacy of traditional oral medications. It is suitable for both short-term relief and long-term management of childhood anorexia.

[0023] This preparation process is reasonable, effectively preserving active ingredients and promoting transdermal absorption. First, volatile oils are extracted from dried tangerine peel using steam distillation. Then, the tangerine peel and other medicinal materials are decocted in water to extract the volatile oils, which better protects the aroma and active ingredients. Attached Figure Description

[0024] Fig. 1 The image shows the appearance and microstructure of the herbal ointment prepared in Example 4 (magnified 100 times). Fig. 2 This is a comparison chart of the transdermal absorption rates of the herbal ointment prepared in Example 4 and traditional herbal ointments. Detailed Implementation The present invention will now be described in further detail with reference to the accompanying drawings and embodiments, but this does not limit the present invention in any way. Any modifications or improvements made based on the teachings of the present invention shall fall within the protection scope of the present invention.

[0025] The processes, conditions, reagents, and experimental methods used in implementing this invention, except as specifically mentioned below, are all common knowledge and general knowledge in the field, and this invention does not have any particular limitations. Experimental methods in the embodiments that do not specify specific conditions are generally performed under conventional conditions or as recommended by the manufacturer.

[0026] Unless otherwise stated, all technical terms and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. However, in the event of any conflict, the specification containing the definitions shall prevail.

[0027] The following are the main sources of raw materials in the examples: Spider Fragrance ( Inula japonica Thunb., The dried flower heads of Inula japonica, a plant in the Asteraceae family, and Blue Cloth ( Clerodendrum cyrtophyllum Turcz. It is the dried whole herb of *Lysimachia christinae*, a plant in the Verbenaceae family, and mint (…). Mentha haplocalyx Briq., The dried aerial parts of peppermint (Mentha haplocalyx), a plant in the Lamiaceae family, and dried tangerine peel (Chenpi). Citrus reticulata Blanco The mature peel of Citrus reticulata and its cultivated varieties, belonging to the Rutaceae family, and Codonopsis pilosula ( Codonopsis pilosula (Franch.) Nannf. The dried root of Codonopsis pilosula (a plant in the Campanulaceae family), Poria cocos (… Poria cocos (Schw.) Wolf The dried sclerotium of the polypore fungus *Poria cocos* that parasitizes pine roots, and *Atractylodes macrocephala* (… Atractylodes macrocephala Koidz., The dried rhizome of Atractylodes macrocephala (a plant in the Asteraceae family), and Atractylodes lancea (… Atractylodes lancea (Thunb.) DC. The dried rhizome of Atractylodes lancea or Atractylodes dasycarpus, both belonging to the Asteraceae family, and prepared licorice root ( Glycyrrhiza uralensis Fisch. The root and rhizome of licorice (a legume), processed with honey, and white peony root (…). Paeonia lactiflora Pall. (The dried root of Paeonia lactiflora, a plant in the Ranunculaceae family) Example 1 A traditional Chinese medicine composition for relieving or treating anorexia in children, the raw materials for which are prepared by weight include: 6 parts of spider lily, 6 parts of blue basil, 6 parts of peppermint, 12 parts of dried tangerine peel, 6 parts of codonopsis, 6 parts of poria cocos, 6 parts of atractylodes macrocephala, 6 parts of licorice root, and 6 parts of white peony root.

[0028] Example 2: Preparation of the Traditional Chinese Medicine Composition A traditional Chinese medicine composition for relieving or treating anorexia in children, the raw materials for which are prepared by weight include: 7 parts of spider lily, 7 parts of blue basil, 7 parts of peppermint, 10 parts of dried tangerine peel, 7 parts of codonopsis, 7 parts of poria cocos, 7 parts of atractylodes macrocephala, 7 parts of licorice root, and 7 parts of white peony root.

[0029] Example 3: Preparation of Traditional Chinese Medicine Composition A traditional Chinese medicine composition for relieving or treating anorexia in children, the raw materials for which are prepared by weight include: 8 parts of spider lily, 8 parts of blue basil, 8 parts of peppermint, 11 parts of dried tangerine peel, 8 parts of codonopsis, 8 parts of poria cocos, 8 parts of atractylodes macrocephala, 8 parts of licorice root, and 8 parts of white peony root.

[0030] Example 4: Preparation of a traditional Chinese medicine ointment (using the traditional Chinese medicine composition of Example 1) (1) Extraction of volatile oil: Take dried tangerine peel, add 8 times (by mass and volume) of water, and extract the volatile oil of dried tangerine peel by steam distillation. Collect the volatile oil for later use. (2) Preparation of extract: The solid-liquid mixture of tangerine peel remaining after the extraction of volatile oil in step (1) is mixed with spider lily, blue sesame, peppermint, codonopsis, poria cocos, atractylodes macrocephala, licorice root, and white peony root. Water is added and the mixture is decocted twice: soaking for 30 minutes before the first decoction and decocting for 1 hour; and decocting for 40 minutes the second time. The two decoctions are combined, filtered, concentrated to extract, and the extract is measured. (3) Preparation of matrix oil phase: Take 10 parts of medical yellow petrolatum, 2 parts of lanolin, 11 parts of stearic acid and 6 parts of glyceryl monostearate, mix them, heat and melt them, keep them at 80℃, and stir and mix them evenly at 150 rpm to obtain the matrix oil phase; (4) Preparation of the aqueous matrix phase: Take 16 parts of glycerol, 2.5 parts of Tween 80 and 55 parts of water, mix them, heat to 80±1℃ and keep warm, stir and mix evenly at 150 rpm to obtain the aqueous matrix phase; (5) Emulsification: The oil phase of the matrix is ​​added to the aqueous phase of the matrix and emulsified by stirring at 150 rpm under the condition of keeping warm at 80±1℃ to obtain a uniform emulsion as the matrix; (6) Preparation of finished product: Add the extract (20% of the mass of the ointment) obtained in step (2) to the matrix, stir and mix evenly at 150 rpm under the condition of keeping warm at 80±1℃, then add 2 parts of azone, 0.05 parts of chlorethidium acetate and the volatile oil of tangerine peel obtained in step (1), continue to stir and mix evenly, and after cooling, the traditional Chinese medicine ointment is obtained.

[0031] Example 5: Preparation of a traditional Chinese medicine ointment (using the traditional Chinese medicine composition of Example 2) (1) Extraction of volatile oil: Take dried tangerine peel, add 10 times (by mass / volume) of water, and extract the volatile oil of dried tangerine peel by steam distillation. Collect the volatile oil for later use. (2) Preparation of extract: The solid-liquid mixture of tangerine peel remaining after the extraction of volatile oil in step (1) is mixed with spider lily, blue sesame, peppermint, codonopsis, poria cocos, atractylodes macrocephala, licorice root, and white peony root. Water is added and the mixture is decocted twice: soaking for 30 minutes before the first decoction and decocting for 1 hour; and decocting for 40 minutes the second time. The two decoctions are combined, filtered, concentrated to extract, and the extract is measured. (3) Preparation of matrix oil phase: Take 8 parts of medical yellow petrolatum, 3 parts of lanolin, 9 parts of stearic acid and 8 parts of glyceryl monostearate, mix them, heat and melt them, keep them at 80±1℃, stir and mix them evenly at 180 rpm to obtain the matrix oil phase; (4) Preparation of the aqueous matrix phase: Take 14 parts of glycerol, 3 parts of Tween 80 and 50 parts of water, mix them, heat to 80℃ and keep warm, stir and mix evenly at 180 rpm to obtain the aqueous matrix phase; (5) Emulsification: The oil phase of the matrix is ​​added to the aqueous phase of the matrix and emulsified by stirring at 180 rpm under the condition of keeping warm at 80±1℃ to obtain a uniform emulsion as the matrix; (6) Preparation of finished product: Add the extract (15% of the mass of the ointment) obtained in step (2) to the matrix, stir and mix evenly at 180 rpm under the heat preservation condition of 80±1℃, then add 1 part of azone, 0.03 parts of chlorethidine acetate and the volatile oil of tangerine peel obtained in step (1), continue to stir and mix evenly, and after cooling, the traditional Chinese medicine ointment is obtained.

[0032] Example 6: Preparation of a traditional Chinese medicine ointment (using the traditional Chinese medicine composition of Example 3) (1) Extraction of volatile oil: Take dried tangerine peel, add 9 times (by mass / volume) water, and extract the volatile oil of dried tangerine peel by steam distillation. Collect the volatile oil for later use. (2) Preparation of extract: The solid-liquid mixture of tangerine peel remaining after the extraction of volatile oil in step (1) is mixed with spider lily, blue sesame, peppermint, codonopsis, poria cocos, atractylodes macrocephala, licorice root, and white peony root. Water is added and the mixture is decocted twice: soaking for 30 minutes before the first decoction and decocting for 1 hour; and decocting for 40 minutes the second time. The two decoctions are combined, filtered, concentrated to extract, and the extract is measured. (3) Preparation of matrix oil phase: Take 12 parts of medical yellow petrolatum, 1 part of lanolin, 13 parts of stearic acid and 4 parts of glyceryl monostearate, mix them, heat and melt them, keep them at 80±1℃, stir and mix them evenly at 220 rpm to obtain the matrix oil phase; (4) Preparation of the aqueous matrix phase: Take 18 parts of glycerol, 2 parts of Tween 80 and 60 parts of water, mix them, heat to 80±1℃ and keep warm, stir and mix evenly at 220 rpm to obtain the aqueous matrix phase; (5) Emulsification: The oil phase of the matrix is ​​added to the aqueous phase of the matrix and emulsified by stirring at 220 rpm under the condition of keeping warm at 80±1℃ to obtain a uniform emulsion as the matrix; (6) Preparation of finished product: Add the extract (18% of the mass of the ointment) obtained in step (2) to the matrix, stir and mix evenly at 220 rpm under the heat preservation condition of 80±1℃, then add 3 parts of azone, 0.07 parts of chlorethidium acetate and the volatile oil of tangerine peel obtained in step (1), continue to stir and mix evenly, and after cooling, the traditional Chinese medicine ointment is obtained.

[0033] The herbal ointments obtained in the above examples are creamy, uniform, fine, and easy to apply. The appearance and microstructure of the herbal ointment prepared in Example 4 are shown in the diagram. Fig. 1 The paste appears to be a uniform milky white cream, without particles or layering, with the oil and water phases evenly dispersed and no obvious oil or water droplets aggregated.

[0034] When using, apply an appropriate amount of the ointment to the child's abdomen or acupoints such as Zusanli and Zhongwan, and gently massage until absorbed. Use 1-2 times daily for 1-2 weeks to effectively improve symptoms of loss of appetite.

[0035] Example 1: Transdermal Absorption Rate Test Experimental methods: Samples: The traditional Chinese medicine ointment and traditional Chinese medicine ointment prepared in Example 4 were used (the composition of Example 1 was used. First, each medicinal material was weighed according to the prescription ratio, impurities were removed, and the materials were washed and dried. Then, the medicinal materials were placed in a decoction pot, and water was added at a ratio of 8 to 10 times the weight of the medicinal materials to soak for 30 minutes. The decoction was then simmered over low heat for 1 to 2 hours each time, for a total of 2 to 3 times. The decoctions were combined. After filtering the combined decoction to remove the residue, it was slowly concentrated over low heat or in a water bath, stirring to prevent sticking, until the liquid was in the state of "drops forming beads" or "stirring up a line". The heat was then stopped and the ointment was collected to prepare the ointment).

[0036] Before the experiment, the rats' backs were shaved and their skin cleaned. The drug administration area was marked, and the skin was confirmed to be intact 24 hours later. An appropriate amount of traditional Chinese medicine ointment was applied evenly to the administration site, and gently massaged or rubbed according to clinical usage to ensure full contact of the drug with the skin. After administration, a breathable membrane could be used to cover the animal to prevent contamination or drug shedding, and the animal was kept at a constant temperature (approximately 32°C). At set time points (e.g., 0.5, 1, 2, 4, 6, 8, 12, 24 h), skin and surrounding tissues were collected from the administration site. Skin tissue samples were homogenized with physiological saline, extracted with methanol, centrifuged, and the supernatant was filtered. The drug concentration was determined by high-performance liquid chromatography (HPLC) (C18 column, acetonitrile-water gradient elution, flow rate 1.0 mL / min, detection wavelength 210 nm), and a cumulative skin penetration-time curve was plotted.

[0037] The results are as follows Fig. 2 As shown, the results indicate that the transdermal absorption rate of the ointment of the present invention continuously increased within 0-8 hours, reaching 80 μg / cm³ at 8 hours. 2 Traditional ointments have a transdermal absorption rate of only 50 μg / cm³. 2 The steady-state flux is xx, transdermal. Efficacy Trial Example 2: Clinical Trial for Relieving or Treating Anorexia in Children Experimental Objective The effects of the traditional Chinese medicine ointments prepared in Examples 4-6 on alleviating and improving symptoms of anorexia in children were evaluated, and their influence on appetite, food intake and related clinical indicators were observed.

[0038] Experimental materials Examples 4-6 show the preparation of traditional Chinese medicine ointments (cream-like, containing extract and volatile oil from dried tangerine peel).

[0039] Comparison drug: Traditional oral Chinese medicine preparations (such as Xiangsha Liujunzi Decoction).

[0040] Experimental animals or subjects: Select ethically approved children with anorexia, aged 3 to 6 years, or use pediatric anorexia model animals (such as mice or rats) for the experiment.

[0041] Experimental methods Group design Treatment Group 1: Ointment / Paste Formula of Example 4 Treatment Group 2: Ointment / Paste Formula (Example 5) Treatment group 3: Ointment from Example 6 Control group: Traditional oral Chinese medicine Control group: Untreated or using base oil (carrier control) Each group of subjects consisted of no fewer than 10 individuals to ensure statistical reliability.

[0042] Medication administration method For external use: Apply to the abdomen or Zusanli and Zhongwan acupoints 1-2 times daily, gently massage until absorbed, and use continuously for 2 weeks.

[0043] The patient took the oral Chinese medicine at the usual dosage for a course of 2 weeks.

[0044] Observation indicators Key indicators: Appetite score (0-6, 0 for normal, 6 for food refusal), daily food intake (standardized intake based on body weight), and weight change.

[0045] Secondary indicators include: mental state, abdominal discomfort, and digestive function (bowel movements).

[0046] Measurement time points: before treatment (T0), 1 week after medication (T1), and 2 weeks after medication (T2).

[0047] The experimental results are shown in Table 1. The results showed that after one week of use, the appetite scores of all ointment groups significantly decreased (appetite improvement). By two weeks, the appetite scores were close to normal (0-2 points), food intake significantly increased, and weight increased slightly. Compared with traditional oral Chinese medicine, the ointment groups showed more significant improvement in appetite and increase in food intake at T2, and children exhibited good compliance with the treatment, with no obvious discomfort. The control group showed no significant changes, proving that the active ingredient in the ointment is a key factor in improving anorexia symptoms. The ointment showed good transdermal absorption, consistent with the transdermal absorption rate experimental results mentioned in Examples 1-3. This indicates that the use of the traditional Chinese medicine ointment of this invention (Examples 4-6) can significantly improve anorexia symptoms in children, increase appetite and food intake, and promote weight gain, with efficacy superior to traditional oral Chinese medicine. Furthermore, the external application of the ointment is safe, has high compliance, and is suitable for short-term relief and long-term conditioning in children.

[0048] Table 1 Results of clinical trials for alleviating or treating anorexia in children

[0049] * P < 0.05 compared to T0 indicates a statistically significant difference. Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition for relieving or treating anorexia in children, characterized in that, It is made from the following ingredients in parts by weight: 6-8 parts spider lily, 6-8 parts blue lily, 6-8 parts peppermint, 10-12 parts dried tangerine peel, 6-8 parts codonopsis, 6-8 parts poria cocos, 6-8 parts atractylodes macrocephala, 6-8 parts licorice root, 6-8 parts white peony root.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following ingredients in parts by weight: 6 parts spider lily, 6 parts blue lily, 6 parts peppermint, 12 parts dried tangerine peel, 6 parts codonopsis, 6 parts poria cocos, 6 parts atractylodes macrocephala, 6 parts licorice root (processed), and 6 parts white peony root.

3. A paste-like ointment for relieving or treating anorexia in children, characterized in that, It includes the active ingredients of the traditional Chinese medicine composition as described in claim 1 or 2, as well as pharmaceutical excipients.

4. The herbal ointment / massage preparation according to claim 3, characterized in that, The active ingredients of the traditional Chinese medicine composition exist in the form of volatile oils and extracts, and the amount of volatile oils and extracts added is 15% to 20% of the total mass of the ointment.

5. The herbal ointment / massage preparation according to claim 3, characterized in that, The pharmaceutical excipients include an oil phase matrix, an aqueous phase matrix, transdermal penetration enhancers, and preservatives.

6. The herbal ointment / massage preparation according to claim 5, characterized in that, The oil phase matrix is ​​composed of medical-grade yellow petrolatum, lanolin, stearic acid, and glyceryl monostearate; the aqueous phase matrix is ​​composed of glycerol, Tween, and water; the transdermal penetration enhancer is azone; and the preservative is chlorethidium acetate.

7. The herbal ointment according to claim 6, characterized in that, The oil phase matrix, by weight, comprises 8-12 parts of medical-grade yellow petrolatum, 1-3 parts of lanolin, 9-13 parts of stearic acid, and 4-8 parts of glyceryl monostearate; the aqueous phase matrix, by weight, comprises 14-18 parts of glycerol, 2-3 parts of Tween 80, and 50-60 parts of water; the transdermal penetration enhancer, by weight, contains 1-3 parts of azone; and the preservative, by weight, contains 0.03-0.07 parts of chlorethidium acetate.

8. A method for preparing a traditional Chinese medicine ointment as described in any one of claims 3-7, characterized in that, Includes the following steps: (1) Extraction of volatile oil: The volatile oil of dried tangerine peel was extracted from the tangerine peel by steam distillation; (2) Preparation of extract: The solid-liquid mixture of tangerine peel remaining after the extraction of volatile oil in step (1) is mixed with spider lily, blue broccoli, peppermint, codonopsis, poria cocos, atractylodes macrocephala, licorice root, and white peony root, and then extracted by water decoction. The decoctions are combined and concentrated to a paste to obtain extract. (3) Preparation of the matrix oil phase: Mix the oil phase matrix components, heat to melt and keep warm, stir and mix evenly to obtain the matrix oil phase; (4) Preparation of aqueous matrix phase: Mix the aqueous matrix components, heat to 79-81℃ and keep warm, stir and mix evenly to obtain the aqueous matrix phase; (5) Emulsification: The oil phase of the matrix is ​​added to the aqueous phase of the matrix and stirred and emulsified under the condition of heat preservation at 79-81℃ to obtain a uniform emulsion as the matrix; (6) Preparation of finished product: Add the extract to the matrix and stir and mix evenly under the condition of keeping warm at 79-81℃. Then add the transdermal penetration promoter, preservative and the volatile oil of tangerine peel obtained in step (1), continue to stir and mix evenly, and after cooling, the Chinese medicine ointment is obtained.

9. The method according to claim 8, characterized in that, In step (1), the mass ratio of dried tangerine peel to water in the steam distillation method is 1:8-10.

10. The method according to claim 8, characterized in that, In step (2), the water decoction extraction is performed by decocting twice. The first decoction is performed by soaking for 30 minutes before the first decoction and decocting for 1 hour. The second decoction is performed for 40 minutes. The stirring speed in steps (3), (4), (5) and (6) is 150-220 rpm; the heating temperature in steps (4), (5) and (6) is 80℃.

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