CN118105454B

CN118105454B - Pharmaceutical composition for treating infantile vomiting, preparation and application thereof

Info

Publication number: CN118105454B
Application number: CN202410487884.1A
Authority: CN
Inventors: 冯广霞
Original assignee: Hualong Shengai Traditional Chinese Medicine Group Co ltd
Current assignee: Hualong Shengai Traditional Chinese Medicine Group Co ltd
Filing date: 2024-04-23
Publication date: 2024-06-21
Anticipated expiration: 2044-04-23

Abstract

The invention discloses a pharmaceutical composition for treating infantile vomiting, a preparation and application thereof, wherein the pharmaceutical composition comprises the following components in parts by weight: 3-10 parts of dried ginger, 3-9 parts of pinellia tuber, 2-5 parts of coptis chinensis, 3-10 parts of dried orange peel, 6-10 parts of nutgrass galingale rhizome and 5-10 parts of calyx kaki. The pharmaceutical composition can be added with pharmaceutically acceptable auxiliary materials to prepare a preparation. The pharmaceutical composition and the preparation can be used for treating infantile emesis, including acute and chronic gastroenteritis and emesis caused by functional dyspepsia.

Description

Pharmaceutical composition for treating infantile vomiting, preparation and application thereof

Technical Field

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a pharmaceutical composition for treating infantile vomiting, a preparation and application thereof.

Background

1. Common cause of vomiting in children

(1) Acute and chronic gastroenteritis

Gastroenteritis is an inflammation of the digestive tract, which can lead to vomiting, diarrhea or both, sometimes accompanied by fever and abdominal cramps. Most gastroenteritis is caused by the following causes: viruses (most common cause), bacteria, parasites; the more rare causes of gastroenteritis include: chemical toxins, drugs; rarely, gastroenteritis is the result of allergic diseases (eosinophilic gastroenteritis) or food allergies. Viruses are the most common cause of gastroenteritis. Four types of viruses cause most gastroenteritis. Two of the most common are norovirus and rotavirus, most other viral cases being caused by astroviruses or adenoviruses. In kindergarten, school, or other densely populated places, a normal child may be ill by contact with the child or child infected with the relevant virus. Viral gastroenteritis is extremely transmissible and particularly easily transmitted between children. Fecal oral transmission is a common mode of viral gastroenteritis transmission. Viral gastroenteritis can also be transmitted by sneezing and vomiting.

Norovirus affects children typically from 6 months to 18 months. Attacks occur in each season of the year, but 80% occur between 11 months and 4 months of the next year. Most patients become infected after eating contaminated food or water. Because norovirus is very infectious, infection is easily transmitted from person to person. Rotavirus is the most common cause of severe, dehydrated diarrhea in infants and children worldwide. It generally affects infants from 3 to 15 months of age. Rotavirus infectivity is very high. The main infection route is feces taste. Infected infants may transmit infections to adults. In temperate climates, rotavirus infection is most common in winter and less in summer. In tropical climates, they can occur all year round. Astroviruses can infect people of all ages, but usually infect infants and young children. Infection usually occurs in winter, and the route is fecal oral transmission. Enteroadenoviruses primarily infect children under 2 years of age. The disease can occur in each season in one year, and is common in summer. The infection route is fecal oral transmission.

Symptoms of gastroenteritis are usually vomiting, diarrhea, abdominal cramps, fever, inappetence, whatever the cause, the most common symptoms of gastroenteritis are vomiting and diarrhea. Gastroenteritis caused by infection also causes fever. Abdominal pain is also common.

(2) Functional dyspepsia

Functional dyspepsia in children is one or a group of symptoms of children with more than 36 months on the upper abdomen, mainly comprising postprandial fullness, early fullness, pain in the upper abdomen or burning sensation of the upper abdomen, and can also be expressed as anorexia, belch, nausea, vomiting, flatulence in the upper abdomen or acid regurgitation, and a group of common clinical symptoms of organic, systemic or metabolic diseases are eliminated through proper evaluation. The disease can be attributed to the diseases of children's stagnation, children's anorexia, etc. in traditional Chinese medicine. After a large amount of food is taken by children, the children cannot digest the food completely, and symptoms such as nausea and vomiting can be represented.

2. Chinese medicine's knowledge about vomiting

The disease name of vomiting is first found in the book of interior meridian and its cause is also described in detail. For example, the theory of pain in the questions and lifting of the pain in the Su Chan (Su Wen-Mi-Wen-Ji Lun): cold qi is retained in stomach and intestine, and is caused by syncope and adverse rise of qi, so pain and vomiting are also caused. "Su Wen-Zhen Yao Lun" is: all vomiting acids … … are the dominant points of heat and shaoyang, and heat is applied to the stomach, vomiting acids are hunger, and vomiting is the dominant point of dampness, and people feel happy and vomiting is bitter. It is considered that exogenous pathogenic factors such as cold, heat and dampness can cause vomiting.

Antiemetics such as ondansetron, domperidone and the like are commonly used for treating vomiting by Western medicine, and are used for timely supplementing liquid when dehydration occurs and timely controlling infection due to gastroenteritis. Western medicines have side effects on human bodies while exerting efficacy, for example, the safety of anti-emetic medicines for children is not completely verified, and the indications are limited when the western medicines are used. In addition, the compliance of children oral medicines is poor, and the treatment effect is affected. The traditional Chinese medicine has outstanding advantages in the aspect of treatment safety, and the traditional Chinese medicine external treatment method has high matching degree and obvious curative effect in treating the children patients. Therefore, the development of a traditional Chinese medicine for treating the infantile vomiting has very important practical significance in reflecting the unique advantages of traditional Chinese medicine in treating the infantile vomiting.

Disclosure of Invention

Aiming at the defects of the prior art, the invention aims to provide a pharmaceutical composition for treating infantile vomiting, and a preparation and application thereof. The pharmaceutical composition provided by the invention can be used for treating infantile vomiting, and especially has a good treatment effect on vomiting caused by deficiency-cold of spleen and stomach.

The invention aims at realizing the following technical scheme: the pharmaceutical composition for treating the infantile vomiting comprises the following components in parts by weight: 3-10 parts of dried ginger, 3-9 parts of pinellia tuber, 2-5 parts of coptis chinensis, 3-10 parts of dried orange peel, 6-10 parts of nutgrass galingale rhizome and 5-10 parts of calyx kaki.

Preferably, the composition comprises the following components: 3-6 parts of dried ginger, 3-6 parts of pinellia tuber, 2-5 parts of coptis chinensis, 3-6 parts of dried orange peel, 6-9 parts of nutgrass galingale rhizome and 5-6 parts of calyx kaki.

The pharmaceutical composition also comprises 3-6 parts of fructus amomi and 3-10 parts of ginger

The pharmaceutical composition also comprises 2-5 parts of evodia rutaecarpa and 2-5 parts of cinnamon.

The medicine composition also comprises 9-25 parts of codonopsis pilosula and 6-12 parts of bighead atractylodes rhizome.

The preparation of the pharmaceutical composition is prepared by adding pharmaceutically acceptable auxiliary materials into the pharmaceutical composition.

The preparation is powder or paste prepared by a conventional method.

A method of preparing a formulation of a pharmaceutical composition for treating emesis in children comprising the steps of:

(1) Mixing and pulverizing rhizoma Zingiberis, rhizoma Pinelliae, coptidis rhizoma, pericarpium Citri Tangerinae, rhizoma Cyperi, and calyx kaki;

(2) Adding appropriate amount of flour, and mixing with the above powder;

(3) Adding appropriate amount of warm boiled water, and concocting into paste.

The pharmaceutical composition is used for preparing medicines for treating infantile vomiting.

The preparation of the pharmaceutical composition is used for preparing medicines for treating infantile vomiting.

The invention has the beneficial effects that:

the invention takes dried ginger as a monarch drug, and the pungent and hot nature of the dried ginger can warm the middle-jiao and dispel cold. Pinellia tuber, rhizoma Pinelliae, having the actions of lowering adverse flow of qi and relieving vomiting, and coptis chinensis, rhizoma Coptidis, bitter and cold in nature, have the actions of relieving fever and distension in the chest and abdomen and are ministerial drugs. Monarch, minister, assistant and minister drugs, the cold and heat are regulated flatly, and pungent, open and bitter are reduced. In addition, pericarpium Citri Tangerinae and rhizoma Cyperi are added to regulate qi and invigorate spleen, and calyx kaki is used for lowering adverse qi and stopping singultus. The medicines are mutually combined to lead the cold to remove the distension and fullness and eliminate the distension and fullness and the normal ascending and descending, so that the distension and fullness can be removed and the vomiting can be stopped.

The traditional Chinese medicine considers that the etiology of vomiting is multiple, exogenous six-exogenous pathogenic factors, internal injury diet, emotional disorder and insufficient endowment can affect the stomach, and diseased viscera are mainly in the stomach, but have close relations with liver, gall and spleen, and pathogenesis is that the stomach is always qi-descending and the stomach qi is upward reversed. The treatment is based on the principle of harmonizing stomach and descending adverse qi. For those with excessive pathogenic factors, it is advisable to dispel pathogenic factors and regulate the stomach and reduce adverse flow of qi, and it is often used to relieve exterior syndrome, promote digestion, resolve phlegm and resolve depression; for deficiency, it is indicated for the treatment of stomach qi with the actions of strengthening the body resistance, regulating the stomach and lowering the adverse flow of qi, regulating qi movement and lowering qi, usually with the actions of strengthening spleen and stomach, tonifying qi and nourishing yin; the deficiency and excess are treated by examining the principal and secondary aspects of the disease.

Dried ginger: pungent and hot. It enters spleen, stomach, kidney, heart and lung meridians. Warm middle energizer and dispel cold, return yang and activate pulse, warm lung and resolve fluid retention. Can be used for treating cold pain of stomach and abdomen, emesis, diarrhea, cold limbs, and cough and asthma due to cold.

Pinellia ternate: pungent and warm. Enter spleen, stomach and lung meridians. Dry dampness and resolve phlegm, reduce adverse flow of qi and arrest vomiting, relieve distension and fullness and dissipate nodulation. Can be used for treating cough with excessive phlegm, phlegm retention, dizziness, palpitation, dizziness, headache, emesis, regurgitation, chest distress, and globus hystericus; it is indicated for carbuncle and swelling of phlegm.

Coptis root: bitter and cold. It enters heart, spleen, stomach, liver, gall bladder and large intestine meridians. Clear heat and dry dampness, purge fire and detoxify. Can be used for treating damp-heat distention and fullness, emesis, acid regurgitation, dysentery, jaundice, hyperpyrexia, unconsciousness, heart fire excessive, vexation, insomnia, palpitation, blood heat, conjunctival congestion, toothache, diabetes, carbuncle, and furuncle; it is used externally to treat eczema, wet sore and suppurative ear canal. Jiu Huang Lian is good at clearing heat from upper energizer. Can be used for treating conjunctival congestion and aphtha. Rhizoma coptidis can clear stomach, harmonize stomach and arrest vomiting. It is used for treating cold and heat accumulation, damp-heat retention, distention and fullness, and emesis. Yuhuanglian has the functions of soothing liver, regulating stomach and stopping vomiting. Can be used for treating incoordination between liver and stomach, emesis, and acid regurgitation.

Dried orange peel: bitter and pungent, warm. Enter lung and spleen meridians. Regulate qi, invigorate spleen, dry dampness and resolve phlegm. Can be used for treating abdominal distention, anorexia, vomiting and diarrhea, cough with excessive phlegm.

And (3) rhizoma cyperi: pungent, slightly bitter, slightly sweet, and flat. It enters liver, spleen and triple energizer meridians. Liver soothing, qi stagnation relieving, qi regulating, middle energizer regulating, menstruation regulating and pain relieving. Can be used for treating liver depression, qi stagnation, chest and hypochondrium distending pain, hernia pain, breast distending pain, spleen and stomach qi stagnation, epigastric fullness and distention pain, menoxenia, amenorrhea and dysmenorrhea.

Calyx kaki: bitter and astringent, and flat. Enter stomach meridian. Reduce the adverse flow of qi to stop hiccup. Can be used for treating singultus.

Detailed Description

The present invention will be further described with reference to examples, but the present invention is not limited to the examples.

Example 1

A pharmaceutical composition for treating infantile vomiting, comprising the following components: 10g of dried ginger, 9g of pinellia tuber, 2g of coptis root, 6g of dried orange peel, 9g of nutgrass galingale rhizome and 5g of dried persimmon calyx.

Example 2

A pharmaceutical composition for treating infantile vomiting, comprising the following components: 3g of dried ginger, 3g of pinellia tuber, 5g of coptis root, 3g of dried orange peel, 6g of nutgrass galingale rhizome and 6g of dried persimmon calyx.

Example 3

A pharmaceutical composition for treating infantile vomiting, comprising the following components: 6g of dried ginger, 6g of pinellia tuber, 3g of coptis chinensis, 10g of dried orange peel, 10g of nutgrass galingale rhizome and 10g of dried persimmon calyx.

Example 4

A pharmaceutical composition for treating infantile vomiting, comprising the following components: 10g of dried ginger, 6g of pinellia tuber, 3g of coptis chinensis, 10g of dried orange peel, 10g of nutgrass galingale rhizome and 5g of persimmon calyx.

Example 5

A pharmaceutical composition for treating infantile vomiting, comprising the following components: 6g of dried ginger, 9g of pinellia tuber, 2g of coptis root, 6g of dried orange peel, 6g of nutgrass galingale rhizome and 10g of dried persimmon calyx.

Example 6

A pharmaceutical composition for treating infantile emesis is prepared by mixing the pharmaceutical composition of any one of embodiments 1-5, pulverizing, and making into powder or mixing with appropriate amount of flour and the above powder, and adding appropriate amount of warm boiled water to make into paste.

Example 7

A pharmaceutical composition for treating infantile emesis comprises fructus Amomi 3g, rhizoma Zingiberis recens 6g, and the rest of the above materials in example 3.

Example 8

A pharmaceutical composition for treating infantile emesis comprises fructus Amomi 6g, rhizoma Zingiberis recens 3g, and the rest of the above materials in example 2.

Example 9

A pharmaceutical composition for treating infantile emesis comprises fructus Amomi 5g, rhizoma Zingiberis recens 10g, and the rest of the above materials in example 1.

Example 10

A pharmaceutical composition for treating infantile emesis comprises fructus evodiae 2g, cortex Cinnamomi 3g, and the rest is the same as in example 1.

Example 11

A pharmaceutical composition for treating infantile emesis comprises fructus evodiae 5g, cortex Cinnamomi 2g, and the rest is the same as in example 2.

Example 12

A pharmaceutical composition for treating infantile emesis comprises 3g of fructus evodiae and 5g of cortex Cinnamomi, and the rest is the same as in example 3.

Example 13

A pharmaceutical composition for treating infantile emesis comprises radix Codonopsis 9g, atractylodis rhizoma 6g, and the rest of the above materials in example 2.

Example 14

A pharmaceutical composition for treating infantile emesis comprises radix Codonopsis 15g, atractylodis rhizoma 12g, and the rest of the above materials in example 3.

Example 15

A pharmaceutical composition for treating infantile emesis comprises radix Codonopsis 25g, atractylodis rhizoma 9g, and the rest of the above materials in example 1.

Example 16

A formulation of a pharmaceutical composition for treating emesis in children prepared by the steps of:

(1) Weighing Chinese medicinal decoction pieces according to the proportion of the medicinal composition in any one of embodiments 1-5;

(2) Mixing and pulverizing rhizoma Zingiberis, rhizoma Pinelliae, coptidis rhizoma, pericarpium Citri Tangerinae, rhizoma Cyperi, and calyx kaki;

(3) Adding appropriate amount of flour, and mixing with the above powder;

(4) Adding appropriate amount of warm boiled water, and concocting into paste.

Application example-the pharmaceutical composition of the invention is used for treating infantile vomiting.

1. Research method

An infant who accords with the vomiting inclusion standard of deficiency-cold spleen and stomach in the last year is selected, and the medicine composition is used for treatment, so that the clinical curative effect and adverse reaction of the infant are observed.

2. Study object

Infant suffering from vomiting due to deficiency-cold of spleen and stomach

3. Western diagnostic criteria

According to the newly revised roman IV functional emesis diagnostic criteria of 2016, in children/teenagers from 4 to 18 years, all of the following must be met for at least 2 months prior to diagnosis: (1) vomiting occurs on average 1 or more times per week; (2) There is no self-induced vomiting, eating disorders or rumination; (3) With proper evaluation, vomiting symptoms cannot be fully explained by other diseases.

4. Diagnostic criteria for traditional Chinese medicine

The diagnosis standard of the deficiency-cold syndrome of the spleen and stomach of vomiting is formulated by referring to the traditional Chinese medicine diagnosis curative effect standard issued by the national administration of traditional Chinese medicine and the tenth edition of the science of traditional Chinese medicine, as follows:

(1) Main symptoms are as follows: repeated vomiting, long lasting, good and long-lasting vomiting after eating, and most of vomit is clear and thin sputum or undigested matter;

(2) Secondary symptoms: pale complexion, mental fatigue, cold limbs, poor appetite, abdominal pain and loose stool;

(3) Tongue pulse fingerprint: pale tongue with white coating, slow and weak pulse, pale finger print.

If the disease is mainly characterized by 2 or more than 2 symptoms, the vomiting due to deficiency-cold of spleen and stomach can be diagnosed by combining tongue pulse fingerprint.

5. Inclusion criteria

1. Meets the Western diagnosis standard;

2. Meets the diagnostic criteria of traditional Chinese medicine;

3. age 4-14 years, and is not limited for men and women;

4. legal guardians sign informed consent and coordinate with therapists.

6. Exclusion criteria

1. Those who do not meet the diagnostic standards of traditional Chinese and Western medicine;

2. aged under 4 years, or over 14 years;

3. serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system are combined;

4. Mental patients;

5. Allergic to the study drug;

6. The inclusion standard is not met, and the administration is not regulated, so that the treatment effect or the influence of incomplete data and the like on the treatment effect or the safety judgment cannot be judged.

7. Application method

1. Adding and subtracting according to the symptoms of different patients on the basis of basic prescription, and making into ointment, wherein the ointment is applied to Zhongwan acupoint and Shuangmen acupoint for 1 time per day, the application time is 15-20 minutes each time, and 1 treatment course is 5 days;

2. Notice that: when skin allergy appears red itch, the skin is immediately stopped.

8. Overall efficacy criterion

Formulating curative effect evaluation standards by referring to the guidelines (trial) of clinical study of new traditional Chinese medicines:

Therapeutic index n= (pre-treatment integral-post-treatment integral)/pre-treatment integral x 100% (nimodipine method)

Clinical cure: the vomiting is controlled, the whole body condition is good, and the total integral curative effect value N of symptoms is more than or equal to 95 percent;

the effect is shown: the vomit frequency is obviously reduced, other symptoms are obviously improved, and the total integral curative effect value N of the symptoms is more than or equal to 70%;

The method is effective: the times of vomiting are reduced, other symptoms are improved but are not obvious, and the total integral curative effect value of the symptoms is more than or equal to 30% and less than 70%;

Invalidation: symptoms and signs are not improved or even aggravated, and the total integral curative effect value N of the symptoms is less than 30%;

total effective rate = (recovery + onset + efficacy)/total case number x 100%

9. Summary of clinical efficacy

The study observed 60 cases in total. Of these, 26 cases for male patients and 34 cases for female patients; 26 cases of age 4-7 years old, 23 cases of age 7-10 years old, and 11 cases of age 10-14 years old.

The pharmaceutical composition provided by the application is used for treating 60 cases of children suffering from vomiting due to deficiency-cold of spleen and stomach, and has the advantages that a treatment course (5 days) is observed, 12 cases (20%), 30 cases (50%) are cured, 14 cases (percent) are cured, and 4 cases (percent) are not cured. After 1 course of treatment is over, the total effective rate of treatment for 60 patients is 93.3%, and the clinical study observation item see for oneself is a statistical table.

The clinical efficacy statistics table.

Treating a condition	The number of people	Duty ratio of
			Healing	12	20%
Has obvious effect	30	50%
			Effective and effective	14	23.3%
Invalidation of	4	6.7%
			Is always effective	56	93.3%

10. Adverse reactions

Clinical application shows no toxic side effect and adverse reaction.

11. Typical cases

Case 1

The infant Zhang Mou, male, 4 years old for 5 months, the infant is diagnosed by vomiting for 1 day, after examination, the organic lesions and infectious diseases are removed, and the inquiry history shows that the infant is taken after being cooled on the previous day. The symptoms are as follows: the infant has the advantages of cooling before 1 day, and vomit after being eaten into the yoghurt, without spraying, wherein vomit is gastric content, and the vomit is more than 2 times without fever, cough, running nose, abdominal pain and diarrhea. Generally, mental reactions are poor, the stomach is poor, the sleep is poor, the urination is still good, and the stool is not dissolved. Pale tongue with white coating and slow pulse. After the treatment of the medicine composition of the application for 1 course of treatment, the infant can be clinically cured.

Case 2

The children Liu Mou, women, 9 years old, the children repeatedly vomit and diarrhea for 3 days, and the children take the doctor to diagnose the acute gastroenteritis, and the vomit still repeatedly attacks, so the doctor takes the doctor. The symptoms are as follows: the infant has the advantages of vomiting after eating, non-jet shape, clear and thin vomit, less amount, 5 times total, no fever, cough, watery nasal discharge, no abdominal pain and improved diarrhea after treatment. Mental reactions are general, poor appetite, poor sleep, excessive urination and loose stool. A pale tongue and a deep and slow pulse. After the treatment of the medicine composition of the application for 1 course of treatment, the infant can be clinically cured.

Case 3

The infant Zhou Mou, the woman, the age of 12, the infant who has nausea and vomiting for 2 days is treated, the inquiry medical history has a history of unclean diet, and the parents have no obvious improvement after complaints of the parents take the medicine at home. The symptoms are as follows: nausea and vomiting after infant eating, vomit is gastric contents, has a clear and thin texture and a small amount, and is free from fever, abdominal pain and diarrhea for 3 times. The infant is tired and weak, and has poor appetite, and can sleep for a long time. Pale tongue with white coating and slow pulse. After the treatment of the medicine composition of the application for 1 course of treatment, the infant can be clinically cured.

The above cases are only part of the cases observed clinically, and the pharmaceutical composition used is also only part of the pharmaceutical composition, and in actual clinical use, the dosage of the specific drug in the pharmaceutical composition can be arbitrarily selected within the scope of the invention according to different clinical symptoms of patients.

In clinic, prescriptions can be adjusted and modified for different patients:

(1) For severe emesis, fructus Amomi 3-6g and rhizoma Zingiberis recens 3-10g can be added. Fructus Amomi has effects of regulating qi-flowing, warming spleen and eliminating dampness; ginger, rhizoma Zingiberis recens warms the middle energizer to arrest vomiting. The two medicines are added, so that the effects of regulating qi, lowering adverse qi, preventing vomiting and enhancing the effect of preventing vomiting are achieved;

(2) For patients with more than one vomiting, 2-5g of evodia rutaecarpa and 2-5g of cinnamon can be added. Evodia rutaecarpa has the effects of dispelling cold and supporting yang, and lowering adverse qi and preventing vomiting; cinnamon, cortex Cinnamomi nourishes the fire and invigorates the yang, dispels cold, warms and dredges meridians. The two medicines are added to warm and invigorate spleen yang, warm middle energizer and reduce adverse qi and arrest vomiting;

(3) If the stomach is stuffiness and oppression, anorexia and loose stool, 9-25g of radix codonopsis and 6-12g of bighead atractylodes rhizome can be added. Dang Shen and Bai Zhu can strengthen spleen and replenish qi, so they can treat spleen and stomach qi deficiency.

Claims

1. A traditional Chinese medicine composition for external use for treating children's vomiting due to deficiency-cold in spleen and stomach is characterized by comprising the following components in parts by weight: 3-10 parts of dried ginger, 3-9 parts of pinellia tuber, 2-5 parts of coptis chinensis, 3-10 parts of dried orange peel, 6-10 parts of nutgrass galingale rhizome and 5-10 parts of calyx kaki.

2. An external traditional Chinese medicine composition for treating children's vomiting due to deficiency-cold in spleen and stomach is characterized in that 3-6 parts of fructus amomi and 3-10 parts of ginger are added on the basis of the traditional Chinese medicine composition of claim 1.

3. An external traditional Chinese medicine composition for treating children's vomiting due to deficiency-cold in spleen and stomach is characterized in that 2-5 parts of evodia rutaecarpa and 2-5 parts of cinnamon are added on the basis of the traditional Chinese medicine composition of claim 1.

4. An external traditional Chinese medicine composition for treating children's vomiting due to deficiency-cold in spleen and stomach is characterized in that 9-25 parts of radix codonopsitis and 6-12 parts of bighead atractylodes rhizome are added on the basis of the traditional Chinese medicine composition of claim 1.

5. A preparation of a Chinese medicinal composition according to any one of claims 1 to 4, wherein the preparation is prepared by adding pharmaceutically acceptable excipients to the Chinese medicinal composition.

6. The preparation of a Chinese medicinal composition according to claim 5, wherein the preparation is in the form of powder or paste prepared according to a conventional method.

7. Use of a Chinese medicinal composition according to any one of claims 1-4 in the preparation of a topical medicament for the treatment of emesis due to deficiency-cold in the spleen and stomach in children.

8. An application of the preparation of the traditional Chinese medicine composition of claim 5 in preparing external medicines for treating infantile vomiting due to deficiency-cold in spleen and stomach.