A traditional Chinese medicine composition for treating infantile colic, a traditional Chinese medicine plaster and a preparation method thereof

Abstract

The application provides a traditional Chinese medicine composition for treating infantile intestinal colic, a traditional Chinese medicine plaster and a preparation method thereof, and relates to the technical field of traditional Chinese medicine. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 1-5 parts of Corydalis, 1-5 parts of clove, 0.5-2.5 parts of cassia, 1-5 parts of safflower, 1-5 parts of amomum, 1-5 parts of amomum, 1-5 parts of atractylodes, and 0.5-2.5 parts of ginger. The medicine is ground, sieved and stored; before plastering, the medicine powder is taken out, mixed with vinegar into a paste and placed on a medical acupoint paste to obtain the traditional Chinese medicine plaster. The traditional Chinese medicine composition is aimed at the traditional Chinese medicine pathogenesis of'spleen cold and qi stagnation', and the traditional Chinese medicine components for warming the spleen and promoting qi are selected, so that infantile intestinal colic can be effectively treated by acupoint plastering, and the application has the characteristics of non-invasiveness, effectiveness, safety and the like.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically a traditional Chinese medicine composition, a traditional Chinese medicine patch, and a method for preparing it for treating infantile colic. Background Technology

[0002] Infantile colic is a common symptom in infants under 5 months of age, with both onset and remission occurring in this group. It is characterized by sudden and persistent crying or irritability at night, and its incidence in children ranges from 5% to 20%. Traditional treatments include dietary adjustments, physical and behavioral modifications, and medication.

[0003] Traditional Chinese medicine has a long history of understanding night crying, with many ancient physicians recognizing that "night crying is caused by cold." In ancient times, night crying in infants was often due to improper care and exposure to cold in the abdomen. In modern times, however, night crying in infants is more often caused by the mother's constitution, prenatal diet, and exposure to air conditioning or cold foods in summer. It is a result of the combined effects of internal and external cold; the stagnation of cold qi leads to pain and night crying. Therefore, based on the TCM pathogenesis of "spleen cold and qi stagnation," using the theory of warming the spleen and promoting qi circulation to intervene in children with colic has a theoretical basis. Summary of the Invention

[0004] In view of this, the purpose of the present invention is to provide a traditional Chinese medicine composition, a traditional Chinese medicine patch, and a method for preparing the same for treating infantile colic. The traditional Chinese medicine composition of the present invention can effectively treat infantile colic when applied to acupoints, and has the characteristics of being non-invasive, effective, and safe.

[0005] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0006] This invention provides a traditional Chinese medicine composition for treating infantile colic, comprising the following raw materials in parts by weight: 1-5 parts of Corydalis rhizome, 1-5 parts of clove, 0.5-2.5 parts of cinnamon, 1-5 parts of costus root, 1-5 parts of amomum villosum, 1-5 parts of cardamom, 1-5 parts of Atractylodes lancea rhizome, and 0.5-2.5 parts of prepared ginger.

[0007] The present invention also provides a traditional Chinese medicine patch for treating infantile colic, the traditional Chinese medicine patch comprising the aforementioned traditional Chinese medicine composition and a medical acupoint patch.

[0008] Preferably, the herbal patch is applied to the Zhongwan and Shenque acupoints.

[0009] The present invention also provides a method for preparing the traditional Chinese medicine patch, comprising the following steps: weighing the traditional Chinese medicine, grinding it, and sieving it to obtain medicinal powder; mixing the medicinal powder with vinegar to form a paste and then applying it to a medical acupoint patch.

[0010] Preferably, the sieving is performed through an 80-100 mesh sieve.

[0011] Preferably, the mass-to-volume ratio of the medicinal powder to vinegar is 1g:0.1-0.5mL.

[0012] Preferably, the thickness of the paste-like consistency applied to the medical acupoint patch is 0.2–0.5 cm.

[0013] Compared with the prior art, the present invention has the following advantages:

[0014] This invention's traditional Chinese medicine composition targets the TCM pathogenesis of "spleen cold and qi stagnation," intervening in infants with colic based on the theory of warming the spleen and promoting qi circulation. In this invention's formula, Corydalis rhizome and clove are the principal herbs, providing warming and pain-relieving effects; Aucklandia lappa and Amomum villosum are the assistant herbs, promoting qi circulation and relieving pain; Amomum cardamomum and Atractylodes lancea are the adjuvant herbs, drying dampness and strengthening the spleen; Cinnamon bark and prepared ginger are the guiding herbs, warming the middle and dispelling cold. This invention's scientifically formulated herbal composition, mixed with vinegar and applied to the Zhongwan and Shenque acupoints, allows the combined effects of the herbs to treat infantile colic. This acupoint application is a "green therapy," with high safety, significant efficacy, and a short treatment course, making it easier for infants and their parents to accept. Attached Figure Description

[0015] Figure 1 The results of the efficacy evaluation of the herbal patch of the present invention;

[0016] Figure 2 The skin manifestations of the herbal patch of the present invention. Detailed Implementation

[0017] This invention provides a traditional Chinese medicine composition for treating infantile colic, preferably comprising the following ingredients in parts by weight: 1-5 parts Corydalis rhizome, 1-5 parts clove, 0.5-2.5 parts cinnamon, 1-5 parts costus root, 1-5 parts amomum villosum, 1-5 parts cardamom, 1-5 parts Atractylodes lancea, and 0.5-2.5 parts prepared ginger; more preferably comprising the following ingredients in parts by weight: 2 parts Corydalis rhizome, 2 parts clove, 1 part cinnamon, 2 parts costus root, 2 parts amomum villosum, 2 parts cardamom, 2 parts Atractylodes lancea, and 1 part prepared ginger.

[0018] The Corydalis Rhizome in this invention is warm in nature and pungent and bitter in taste; it enters the liver and spleen meridians. It has the effects of promoting blood circulation, regulating qi, and relieving pain; it is used for chest and rib pain, abdominal pain, angina pectoris, amenorrhea and dysmenorrhea, postpartum blood stasis, and traumatic swelling and pain.

[0019] Cloves are pungent and warm in nature; they enter the spleen, stomach, lung, and kidney meridians. They have the effects of warming the middle jiao and relieving nausea, tonifying the kidneys and assisting yang. They are used for spleen and stomach deficiency-cold, hiccups and vomiting, poor appetite and diarrhea, cold pain in the heart and abdomen, and kidney deficiency-induced impotence.

[0020] Cinnamon has a pungent and sweet taste and a very hot property. It pertains to the kidney, spleen, heart, and liver meridians. It has the effects of tonifying fire and assisting yang, guiding fire back to its origin, dispelling cold and alleviating pain, and warming and dredging the meridians. It is used for impotence and cold uterus, cold pain in the waist and knees, asthma due to kidney deficiency, floating of deficient yang, dizziness and red eyes, cold pain in the heart and abdomen, deficiency-cold vomiting and diarrhea, cold hernia pain, dysmenorrhea and amenorrhea.

[0021] Costus root is warm in nature, pungent and bitter in taste; it pertains to the spleen, stomach, large intestine, triple energizer, and gallbladder meridians. It has the effects of promoting qi circulation to relieve pain and strengthening the spleen to promote digestion. It is used for chest and hypochondriac pain, abdominal distension and pain, tenesmus after diarrhea and dysentery, indigestion, and loss of appetite.

[0022] Amomum villosum has a pungent taste and a warm property; it pertains to the spleen, stomach, and kidney meridians. It has the effects of promoting digestion by removing dampness, warming the spleen to stop diarrhea, and regulating qi to prevent miscarriage. It is used for obstruction of middle jiao by dampness turbidity, fullness and discomfort in the epigastrium, deficiency-cold of the spleen and stomach, vomiting and diarrhea, morning sickness during pregnancy, and threatened abortion.

[0023] Cardamom has a pungent taste and a warm property; it pertains to the lung, spleen, and stomach meridians. It has the effects of promoting qi circulation by removing dampness, warming the middle jiao to stop vomiting, and promoting appetite. It is used for obstruction of middle jiao by dampness turbidity, loss of appetite, initial stage of damp-warm syndrome, chest distress and lack of appetite, cold-damp vomiting, chest and abdominal distension and pain, and indigestion.

[0024] Atractylodes lancea has a pungent and bitter taste and a warm property. It pertains to the spleen, stomach, and liver meridians. It has the effects of drying dampness to strengthen the spleen, dispelling wind and cold, and improving eyesight. It is used for obstruction of middle jiao by dampness, abdominal distension and fullness, diarrhea, edema, beriberi with flaccidity, rheumatic arthralgia, wind-cold cold, night blindness, and dim and unclear vision.

[0025] Prepared ginger is the processed product of dried ginger, mainly by roasting dried ginger until it bulges, with a brownish surface. It has a pungent taste and a hot property; it pertains to the spleen, stomach, and kidney meridians. It has the effects of warming the meridians to stop bleeding and warming the middle jiao to relieve pain. It is used for bleeding due to yang deficiency, hematemesis, epistaxis, metrorrhagia and metrostaxis, deficiency-cold of the spleen and stomach, abdominal pain and vomiting and diarrhea.

[0026] The present invention also provides a traditional Chinese medicine plaster for treating infantile colic, and the traditional Chinese medicine plaster comprises the above-mentioned traditional Chinese medicine composition and a medical acupoint plaster. In the present invention, the medical acupoint plaster is a blank medical acupoint plaster.

[0027] In the present invention, the traditional Chinese medicine plaster is applied to Zhongwan and Shenque acupoints. The traditional Chinese medicine plaster of the present invention is applied to Zhongwan and Shenque acupoints simultaneously to exert the therapeutic effect.

[0028] The present invention also provides a preparation method of the traditional Chinese medicine plaster, comprising the following steps: weighing the traditional Chinese medicine and then grinding and sieving to obtain medicinal powder; mixing the medicinal powder with vinegar to form a paste and then placing it on the medical acupoint plaster. In the present invention, after mixing the medicinal powder with vinegar to form a paste, it is placed in the center of the medical acupoint plaster and flattened to a thickness of 0.2 - 0.5 cm. The present invention has no special limitation on the grinding method and equipment, and conventional traditional Chinese medicine grinding methods and equipment in the art can be used.

[0029] In the present invention, the sieving is preferably through an 80 - 100 mesh sieve.

[0030] In this invention, the medicinal powder is mixed with vinegar to form a paste. Those skilled in the art can adjust the ratio of the medicinal powder and vinegar according to the mixing conditions. In an optional embodiment, the mass-to-volume ratio of the medicinal powder to vinegar in this invention is 1g:0.1-0.5mL, more preferably 1g:0.2-0.4mL.

[0031] In this invention, the thickness of the paste-like material applied to the medical acupoint patch is preferably 0.2–0.5 cm; more preferably 0.3–0.4 cm.

[0032] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0033] Example 1

[0034] A traditional Chinese medicine composition for treating infantile colic comprises the following ingredients in parts by weight: 2 parts Corydalis rhizome, 2 parts clove, 1 part cinnamon, 2 parts costus root, 2 parts amomum villosum, 2 parts cardamom, 2 parts Atractylodes lancea rhizome, and 1 part prepared ginger.

[0035] Example 2

[0036] A traditional Chinese medicine composition for treating infantile colic comprises the following ingredients in parts by weight: 1 part Corydalis rhizome, 1 part clove, 0.5 part cinnamon, 2 parts costus root, 1 part amomum villosum, 1 part cardamom, 2 parts Atractylodes lancea rhizome, and 0.5 parts prepared ginger.

[0037] Example 3

[0038] A traditional Chinese medicine composition for treating infantile colic comprises the following ingredients in parts by weight: 5 parts Corydalis rhizome, 5 parts clove, 2.5 parts cinnamon, 3 parts costus root, 3 parts amomum villosum, 5 parts cardamom, 5 parts Atractylodes lancea rhizome, and 2.5 parts prepared ginger.

[0039] Example 4

[0040] A traditional Chinese medicine patch for treating infantile colic comprises the following ingredients in parts by weight: 2 parts Corydalis rhizome, 2 parts clove, 1 part cinnamon, 2 parts costus root, 2 parts amomum villosum, 2 parts cardamom, 2 parts Atractylodes lancea rhizome, and 1 part prepared ginger.

[0041] The preparation method of the above-mentioned Chinese herbal plaster is as follows: Grind the medicine into a very fine powder and pass it through an 80-100 mesh sieve to obtain Chinese herbal powder; take the powder and mix it with vinegar at a mass-volume ratio of 1g:0.4mL to form a paste, place it in the center of the medical acupoint patch, and press it flat to a thickness of 0.2-0.5cm.

[0042] Example 5

[0043] A traditional Chinese medicine patch for treating infantile colic comprises the following ingredients in parts by weight: 1 part Corydalis rhizome, 1 part clove, 0.5 part cinnamon, 2 parts costus root, 1 part amomum villosum, 1 part cardamom, 2 parts Atractylodes lancea rhizome, and 0.5 parts prepared ginger.

[0044] The preparation method of the above-mentioned Chinese herbal plaster is as follows: Grind the medicine into a very fine powder and pass it through an 80-100 mesh sieve to obtain Chinese herbal powder; take the powder and mix it with vinegar at a mass-volume ratio of 1g:0.1mL to form a paste, place it in the center of the medical acupoint patch, and press it flat to a thickness of 0.2-0.5cm.

[0045] Example 6

[0046] A traditional Chinese medicine patch for treating infantile colic comprises the following ingredients in parts by weight: 5 parts Corydalis rhizome, 5 parts clove, 2.5 parts cinnamon, 3 parts costus root, 3 parts amomum villosum, 5 parts cardamom, 5 parts Atractylodes lancea rhizome, and 2.5 parts prepared ginger.

[0047] The preparation method of the above-mentioned Chinese herbal plaster is as follows: Grind the medicine into a very fine powder and pass it through an 80-100 mesh sieve to obtain Chinese herbal powder; mix the powder with vinegar at a mass-volume ratio of 1g:0.5mL to form a paste, place it in the center of the medical acupoint patch, and press it flat to a thickness of 0.2-0.5cm.

[0048] Experimental Example 1

[0049] Clinical data

[0050] We collected data from 360 children who met the inclusion criteria for outpatient and inpatient care between July 2021 and June 2023. The study employed a pre- and post-treatment controlled trial protocol, was unblinded, and did not require group assignment.

[0051] Diagnostic criteria

[0052] The Western medicine diagnostic criteria refer to the Rome IV criteria established in 2016, including:

[0053] ① The onset and remission of the disease both occur in infants under 5 months of age. Around 6 weeks of age, infants cry for an average of about 2 hours a day; as they grow to 10-12 weeks of age, the crying time may decrease to about 1 hour a day; and by 3-4 months of age, the symptoms subside.

[0054] ②According to the caregiver, the infant experiences recurrent and persistent crying, restlessness, or irritability, all without any obvious cause. The caregiver is unable to prevent the symptoms from occurring or resolve them independently.

[0055] ③ The infant does not show signs of growth retardation, fever, or illness.

[0056] The diagnostic criteria for night crying in Traditional Chinese Medicine (TCM) are based on the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine: Standards for Diagnosis and Efficacy of Pediatric Diseases and Syndromes in Traditional Chinese Medicine" issued by the State Administration of Traditional Chinese Medicine in 2020.

[0057] ①They cry incessantly at a set time at night (usually around midnight), with varying degrees of intensity, but are quiet during the day.

[0058] ②Most cases do not present with fever, vomiting, diarrhea, canker sores, boils, or external injuries.

[0059] The diagnostic criteria for TCM syndromes are based on the 10th edition of "Traditional Chinese Medicine Pediatrics" (edited by Ma Rong, published by China Traditional Chinese Medicine Press), a national textbook for higher education in the TCM industry.

[0060] ①Main symptoms: Night crying, sometimes crying and sometimes stopping, weak crying, and pale lips when crying.

[0061] ② Accompanying symptoms: Prefers to sleep curled up, prefers to have their abdomen massaged, has a pale complexion, loose stools, and clear urine.

[0062] ③ Tongue and pulse: The tongue is pale, the coating is thin and white, and the finger veins are pale red.

[0063] A diagnosis can be made by observing the main symptoms and any two accompanying symptoms, and by referring to the tongue coating, pulse, and fingerprints.

[0064] Inclusion criteria

[0065] (1) Children aged 0-5 months who meet the diagnostic criteria of traditional Chinese medicine;

[0066] (2) Exclude pathological crying caused by other diseases:

[0067] (3) The TCM diagnosis is spleen cold and qi stagnation syndrome;

[0068] (4) The child has not taken any other medications for treating night crying within the past week:

[0069] (5) Parents sign informed consent and cooperate in completing clinical observation indicators.

[0070] Exclusion criteria

[0071] (1) Those who refuse patch therapy:

[0072] (2) Those with colic caused by other diseases;

[0073] (3) Those who are taking other medications to treat colic;

[0074] (4) Individuals who were allergic to the Chinese medicine ingredients and the application patches in the observation group.

[0075] Exclusion criteria

[0076] (1) Those who did not take the medication as prescribed in the trial protocol after enrollment, which affected the efficacy, or whose efficacy could not be determined;

[0077] (2) Incomplete data affecting the judgment of efficacy.

[0078] Shedding Standard

[0079] (1) Those who cannot adhere to treatment;

[0080] (2) Those who experience severe adverse reactions during clinical observation;

[0081] (3) Patients who develop serious complications or comorbidities during clinical observation;

[0082] (4) Subjects who were unable to complete data collection to evaluate efficacy for various reasons.

[0083] Test methods

[0084] Children who met the inclusion criteria were treated with the traditional Chinese medicine patch described in Example 4.

[0085] The herbal plaster consists of: Corydalis rhizome, clove, cinnamon, costus root, amomum villosum, cardamom, Atractylodes lancea rhizome, and prepared ginger. (The ratio of the herbs is 2:2:1:2:2:2:2:1. All the above herbs are provided by the hospital's pharmacy and have been identified as pure medicinal materials by the pharmacy department.)

[0086] Preparation method: Grind the medicine into a very fine powder, pass it through an 80-100 mesh sieve, and store it in a sterile glass bottle in a sealed container. Before application, take out 3g of the prepared powder, mix it with vinegar to form a paste with a suitable consistency (not too dry or too wet), and mix it fresh each time you use it.

[0087] Acupoints to be selected: Zhongwan (CV12) and Shenque (CV8).

[0088] Application time: Apply once between 7 PM and 11 PM.

[0089] Treatment course: 3 days constitutes 1 course of treatment, and 1 course of treatment is completed.

[0090] For children enrolled in the clinical observation group, their parents were educated about the condition and guided to provide a good home routine and social environment for the children.

[0091] Clinical observation indicators

[0092] Clinical observation is mainly based on the calculation of the scores of the child's main symptoms and TCM syndrome scoring scale before and after treatment, and finally the clinical efficacy improvement is evaluated.

[0093] The main clinical symptoms were scored according to the diagnostic criteria of the Brief Infant Sleep Questionnaire, as shown in Table 1.

[0094] Table 1 Scoring Table for Major Symptoms of Night Crying

[0095]

[0096] Note: Nighttime sleep time is not equal to time spent in bed.

[0097] The TCM syndrome scoring system was developed with reference to the diagnostic criteria for night crying (spleen-cold and qi stagnation syndrome) in the 10th edition of the national higher education textbook for TCM industry, "Traditional Chinese Medicine Pediatrics," as shown in Table 2.

[0098] Table 2 Traditional Chinese Medicine Syndrome Scoring Table

[0099]

[0100]

[0101] Efficacy evaluation criteria

[0102] The clinical efficacy criteria were formulated with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" (edited by Zheng Xiaoyu, China Medical Science and Technology Press, May 2002). The efficacy index (n%) = [(Total score before treatment - Total score after treatment) / Total score before treatment] × 100% (nimodipine method). See Table 3.

[0103] Table 3. Evaluation Criteria for Therapeutic Effect

[0104] therapeutic effect standard Clinically cured Clinical symptoms and signs have disappeared or largely disappeared, and the score has decreased by ≥95%. Effective Clinical symptoms and signs showed significant improvement, with a score reduction of ≥70% in 95% of cases. efficient Clinical symptoms and signs have improved, with 70% of patients showing a reduction in scores of ≥30%. invalid Clinical symptoms and signs show no significant improvement, or even worsen, with a score reduction of <30%.

[0105] Test results

[0106] A survey was conducted via the WeChat public platform "Wenjuanxing" to follow up with parents of infants suffering from colic treated with the herbal patch (Wenpi Xingqi San patch) of this invention. A total of 360 parents participated in the survey, including 188 boys and 172 girls. 197 parents (54.72%) were mixed-fed, 126 (35%) were breastfed, and 37 (10.28%) were formula-fed. The total clinical effective rate after treatment with the Wenpi Xingqi San acupoint patch of this invention was 96.67%, the clinical cure rate was 11.94%, the significant effective rate was 43.33%, the effective rate was 41.39%, and the ineffective rate was 3.33%. The acceptance and satisfaction of the children and parents were high, and no significant adverse reactions were observed. The results are shown in Table 4. Figure 1 , Figure 2 .

[0107] Table 4 Comparison of Clinical Symptoms and Treatment Efficacy

[0108]

[0109]

[0110] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating infantile colic, characterized in that, It is made from the following ingredients in parts by weight: Corydalis rhizome 1-5 parts, cloves 1-5 parts, cinnamon 0.5-2.5 parts, costus root 1-5 parts, amomum villosum 1-5 parts, cardamom 1-5 parts, atractylodes lancea 1-5 parts, and prepared ginger 0.5-2.5 parts.

2. A traditional Chinese medicine patch for treating infantile colic, characterized in that, The herbal patch is made from the herbal composition described in claim 1 and a medical acupoint patch.

3. The traditional Chinese medicine plaster according to claim 2, characterized in that, The herbal plaster is applied to the Zhongwan and Shenque acupoints.

4. The method for preparing the traditional Chinese medicine plaster according to claim 2 or 3, characterized in that, The process includes the following steps: weighing the Chinese herbs, grinding them, and sifting them to obtain medicinal powder; mixing the medicinal powder with vinegar to form a paste, and then applying it to a medical acupoint patch.

5. The preparation method according to claim 4, characterized in that, The sieving process involves passing the material through an 80-100 mesh sieve.

6. The preparation method according to claim 4, characterized in that, The mass-to-volume ratio of the medicinal powder to vinegar is 1g:0.1~0.5mL.

7. The preparation method according to claim 4, characterized in that, After mixing into a paste, the thickness of the paste applied to the medical acupoint patch should be 0.2~0.5cm.

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