CN110812455A

CN110812455A - A liquid oral preparation for treating children anorexia and monophagia, and its preparation method and application

Info

Publication number: CN110812455A
Application number: CN201911058036.4A
Authority: CN
Inventors: 关彦斌
Original assignee: Sunflower Pharmaceutical Group Beijing Pharmaceutical Research Institute Co Ltd
Current assignee: Sunflower Pharmaceutical Group Beijing Pharmaceutical Research Institute Co Ltd
Priority date: 2019-11-01
Filing date: 2019-11-01
Publication date: 2020-02-21

Abstract

The invention relates to a liquid oral preparation for treating children anorexia, monophagia and other diseases, and a preparation method and application thereof. Compared with the prior art, the traditional Chinese medicine composition has the effects of strengthening spleen and stomach, helping digestion and removing food stagnation, and has the functions of regulating the spleen and stomach, improving the immunity of the organism and improving the sub-health state of the organism. Treating infantile anorexia, monophagia, malnutrition, diarrhea due to spleen deficiency, fever, and recurrent infection of respiratory tract and digestive tract.

Description

A liquid oral preparation for treating children anorexia and monophagia, and its preparation method and application

Technical Field

The invention belongs to the technical development field of traditional Chinese medicines for children, and particularly relates to a liquid oral preparation for treating children anorexia, monophagia and other diseases, and a preparation method and application thereof.

Background

Anorexia is a common symptom in children, and is clinically characterized by long-time aversion to eating, reduced food consumption and slow increase of physical quality. The long course of disease may have adverse effects on the growth and development of children and intelligence development.

Acute upper respiratory infection is a common disease in pediatrics, can be caused by various viruses and bacteria, but is more than 90% of viruses, and has common symptoms of high fever, cough, appetite reduction, vomiting, diarrhea, dysphoria and even febrile convulsion. If the disease is not relieved or aggravated after 3-5 days, the infection may attack other parts. Especially, high fever is the main purpose of the parents to see a doctor, often causing the parents to be careless, but improper feeding is very easy to cause a series of feeding complications, and the survival rate of the children with the body quality is reduced.

Astragalus mongholicus and rhizoma picrorhizae residue granules collected and carried by the national drug standard (WS-5745(B-0745) -2014Z) are prepared from 11 medicines of astragalus mongholicus, rhizoma dioscoreae, honey-fried licorice root, poria cocos, dendrobe, fried malt, hawthorn, pawpaw, codonopsis pilosula, dried orange peel and bighead atractylodes rhizome, have the effects of strengthening spleen and stomach, tonifying qi and strengthening exterior to promote digestion, and promoting digestion and removing stagnation, and are used for improving symptoms such as anorexia, monophagia, hyperhidrosis, abnormal stool and susceptibility to cold caused by weakness of spleen and stomach and spleen failure in transportation.

Hippophae rhamnoides (the name of Latin, Hippophae rhamnoides Linn.) is a deciduous shrub of Hippophae of Elaeagnaceae, and contains carotene, alkaloid, fatty acid, vitamin C, etc., wherein the content of vitamin C is the highest, and the vitamin C is the name of vitamin C king. Can effectively regulate gastrointestinal functions; improving immunity, relieving cough and asthma, benefiting lung and eliminating phlegm.

The raspberry is the fruit of raspberry of Rosaceae, also called raspberry, contains abundant vitamin A, vitamin C and many minerals, and has high nutritive value and health care function. The immature Rubi fructus is processed to obtain Chinese medicinal material with effects of nourishing liver and kidney, replenishing essence and blood, consolidating constitution, and warming kidney yang. Modern researches show that because the raspberry contains a large amount of flavonoid substances, the raspberry not only has the effects of resisting bacteria, diminishing inflammation and resisting allergy, but also has the effects of enhancing immunity and resisting aging.

Longan is a food formed by drying longan, also known as fructus alpiniae oxyphyllae and arillus longan. The medicine has mild nature and sweet taste, contains thiamine, riboflavin, nicotinic acid, ascorbic acid and other chemical components, and has the effects of benefiting heart and spleen, tonifying qi and blood, tranquilizing, nourishing blood and preventing miscarriage. Is suitable for insomnia, amnesia, spleen deficiency, diarrhea, lassitude, asthenia, etc.

Taurine (Taurine, Tau), a sulfur-containing amino acid with simple structure in animal body, has the chemical name of 2-aminoethanesulfonic acid, is combined with cholic acid in human and animal bile, has the functions of anti-inflammation, antipyresis, analgesia, sedation, antibiosis, immunity enhancement and the like, and is mainly used for treating diseases such as bronchitis, tonsillitis, cold, fever, infantile spasm and the like clinically.

Disclosure of Invention

The invention relates to a liquid oral preparation for treating children anorexia, monophagia and other diseases, and a preparation method and application thereof, wherein 4 components of sea buckthorn, raspberry, longan and taurine are added in the formula of the liquid oral preparation according to the traditional Chinese medicine syndrome differentiation theory on the basis of astragalus root, dendrobium stem and hawthorn granules recorded in the national medicine standard (WS-5745(B-0745) -2014Z). Based on the original functions, the functions of regulating the spleen and stomach, promoting digestion and removing food stagnation are strengthened. The specific functions are as follows: has effects in regulating spleen and stomach function, enhancing immunity, and improving sub-health state of organism. Treating infantile anorexia, monophagia, malnutrition, diarrhea due to spleen deficiency, fever, and recurrent infection of respiratory tract and digestive tract.

The technical scheme for realizing the invention is as follows:

a liquid oral preparation for treating child anorexia and monophagia, and its preparing process and application are disclosed.

The raw materials comprise astragalus, common yam rhizome, honey-fried licorice root, poria cocos, dendrobium, fried malt, hawthorn, pawpaw, codonopsis pilosula, dried orange peel, bighead atractylodes rhizome, sea buckthorn, raspberry, longan and taurine.

The auxiliary materials comprise a flavoring agent, a preservative and essence.

The solvent comprises deionized water, purified water and distilled water.

The formula and the proportion are as follows:

the invention relates to a liquid oral preparation, which comprises the following components in parts by weight:

1.1, raw materials: 10-50 parts of astragalus membranaceus, 20-100 parts of common yam rhizome, 10-50 parts of honey-fried licorice root, 10-50 parts of poria cocos, 5-50 parts of dendrobium, 5-50 parts of roasted malt, 10-80 parts of hawthorn, 5-50 parts of pawpaw, 5-50 parts of codonopsis pilosula, 10-50 parts of dried orange peel, 5-50 parts of bighead atractylodes rhizome, 10-100 parts of sea buckthorn, 5-30 parts of raspberry, 5-50 parts of longan and 1-10 parts of taurine;

1.2 auxiliary materials: 800 portions of corrective 100, 0.1 to 50 portions of preservative and 0.5 to 5 portions of essence;

1.3 solvent: proper amount.

2. The method can also be as follows:

2.1, raw materials: 30 parts of astragalus membranaceus, 35 parts of common yam rhizome, 20 parts of honey-fried licorice root, 30 parts of poria cocos, 25 parts of dendrobe, 25 parts of fried malt, 32 parts of hawthorn, 25 parts of pawpaw, 28 parts of codonopsis pilosula, 20 parts of dried orange peel, 30 parts of bighead atractylodes rhizome, 35 parts of sea buckthorn, 20 parts of raspberry, 30 parts of longan and 5 parts of taurine;

2.2 auxiliary materials: 700 portions of corrective 200 and preservative, 0.2-40 portions of preservative and 0.5-4 portions of essence;

2.3 solvent: proper amount.

3. The method can also be as follows:

3.1 raw materials: 10-50 parts of astragalus membranaceus, 20-100 parts of common yam rhizome, 10-50 parts of honey-fried licorice root, 10-50 parts of poria cocos, 5-50 parts of dendrobium, 5-50 parts of roasted malt, 10-80 parts of hawthorn, 5-50 parts of pawpaw, 5-50 parts of codonopsis pilosula, 10-50 parts of dried orange peel, 5-50 parts of bighead atractylodes rhizome, 10-100 parts of sea buckthorn, 5-30 parts of raspberry, 5-50 parts of longan and 1-10 parts of taurine;

3.2 auxiliary materials: 1-50 parts of corrigent, 0.1-50 parts of preservative and 0.5-5 parts of essence;

3.3 solvent: proper amount.

4. The method can also be as follows:

4.1 raw materials: 30 parts of astragalus membranaceus, 35 parts of common yam rhizome, 20 parts of honey-fried licorice root, 30 parts of poria cocos, 25 parts of dendrobe, 25 parts of fried malt, 32 parts of hawthorn, 25 parts of pawpaw, 28 parts of codonopsis pilosula, 20 parts of dried orange peel, 30 parts of bighead atractylodes rhizome, 35 parts of sea buckthorn, 20 parts of raspberry, 30 parts of longan and 5 parts of taurine;

4.2 auxiliary materials: 1-50 parts of corrigent, 0.1-50 parts of preservative and 0.5-5 parts of essence;

4.3 solvent: proper amount.

The flavoring agent in the formula and the proportion 1 or 2 is cane sugar.

The flavoring agent in the formula and the proportion 3 or 4 comprises any one or more of steviosin, aspartame, acesulfame potassium, aspartame, glycyrrhizin, neotame and sucralose.

The preservative in the formula and the proportion 1-4 comprises any one or mixture of more of benzoic acid, sorbic acid and salts thereof;

the essence in the formula and the proportion 1-4 comprises any one or more of lemon essence, juicy peach essence, Hami melon essence, grape essence, miscellaneous fruit essence, blueberry essence, banana essence, strawberry essence and orange essence.

The solvent in the formula and the proportion of 1-4 comprises purified water, deionized water and distilled water.

Secondly, the preparation method comprises the following steps:

1. preparation method 1 (sugar-containing oral liquid preparation):

taking the raw materials, the auxiliary materials and the solvent in the formula and the proportion 1 or 2, and preparing the raw materials, the auxiliary materials and the solvent according to the following method;

1.1, taking taurine, adding a small amount of purified water for dissolving to obtain a taurine aqueous solution for later use;

1.2 taking the other 13 medicinal materials such as astragalus and the like, adding water for decoction twice, adding 10-12 times of water for the first time, decocting for 2-3 hours, adding 8-10 times of water for the second time, decocting for 1-2 hours, combining decoction liquids of the two times, filtering, standing the filtrate for 20-40 hours, taking supernate for filtering, concentrating the filtrate under reduced pressure to obtain clear paste with the relative density of 1.2-1.3 at 55-60 ℃, and obtaining the extract of the medicinal materials such as the astragalus and the like for later use;

1.3 extracting the medicinal materials such as the astragalus and the like to obtain clear paste, adding ethanol to ensure that the ethanol content is 60-80%, stirring for 15-30 minutes, standing for 18-24 hours at the temperature of 3-25 ℃, taking supernatant, filtering, recovering ethanol from filtrate until no ethanol smell exists, and concentrating to obtain thick paste with the relative density of 1.25-1.35 at the temperature of 55-60 ℃ to obtain alcohol precipitation thick paste for later use;

1.4 taking the flavoring agent, the preservative and the essence, adding a small amount of purified water for dissolving, and filtering to obtain a dissolving solution of auxiliary materials such as the flavoring agent for standby;

1.5 taking the thick paste, adding taurine aqueous solution, flavoring agent and other auxiliary material dissolved solutions, adding purified water to 70-80% of the preparation amount, stirring for dissolving, standing for 18-24 hours, filtering, adding purified water to the filtrate to the preparation amount, stirring for 15-30 minutes, filling and sterilizing to obtain the finished product.

2. Preparation method 2 (sugar-free liquid oral liquid preparation):

taking the formula and the raw materials, auxiliary materials and solvents in the mixture ratio of 3 or 4, and preparing the mixture according to the following method;

2.1, adding a small amount of purified water into taurine to dissolve the taurine to obtain a taurine aqueous solution for later use;

2.2, taking the rest 13 raw materials such as astragalus and the like, adding water for decocting twice, adding 10-12 times of water for decocting for 2-3 hours for the first time, adding 8-10 times of water for decocting for 1-2 hours for the second time, combining the decoctions for two times, filtering, standing the filtrate for 18-24 hours, taking the supernatant, filtering, and concentrating the filtrate under reduced pressure to obtain clear paste with the relative density of 1.2-1.3 at 55-60 ℃ to obtain the extract of the medicinal materials such as the astragalus and the like for later use;

2.3, extracting the medicinal materials such as the astragalus and the like to obtain clear paste, adding ethanol to ensure that the ethanol content is 60-75 ℃, stirring for 30 minutes, standing for 18-24 hours at the temperature of 5-7 ℃, taking supernatant, filtering, recovering ethanol from filtrate until no ethanol smell exists, and concentrating to obtain thick paste with the relative density of 1.25-1.35 at the temperature of 55-60 ℃ to obtain alcohol precipitation thick paste for later use;

2.4, taking the flavoring agent, the preservative and the essence, adding a small amount of purified water for dissolving, filtering, and obtaining filtrate for later use;

2.5, adding the taurine aqueous solution and the filtrate into the ethanol precipitation thick paste, adding purified water to reach 70-80% of the preparation amount, stirring for 30 minutes, adding purified water to reach the preparation amount, stirring uniformly, filtering, filling, and performing moist heat sterilization at 105 ℃ for 45 minutes to obtain the taurine-containing soft extract.

The filtration in the preparation method 1.2 or 2.2 refers to the filtration by using a 100-sand 250-mesh stainless steel screen.

The filtration in the preparation method 1.3 or 2.3 refers to the filtration by a sand filter stick or a ceramic filter stick or a filter felt with the aperture of 0.8 mu m.

The filtration of the preparation method 1.4, 1.5, 2.4 or 2.5 refers to the filtration by a microporous membrane with the aperture of 0.45-0.68 μm.

The sterilization in the preparation method 1.5 or 2.5 refers to the sterilization by moist heat at 105 ℃ for 45 minutes or the sterilization by moist heat at 121 ℃ for 25 minutes, and the liquid oral preparation also comprises dosage forms such as oral liquid, suspension or syrup and the like.

The invention can also be prepared into solid preparation formulations such as electuary, tablets, capsules and the like.

The application of the invention is as follows: can regulate spleen and stomach function, improve immunity, improve sub-health state of organism, and treat infantile anorexia, monophagia, malnutrition, diarrhea due to spleen deficiency, fever, and recurrent infection of respiratory tract and digestive tract.

Advantageous effects

Detailed Description

The following examples further describe and demonstrate embodiments within the scope of the present invention and are presented for illustrative purposes and are not to be construed as limiting the invention.

The following are various illustrative, non-limiting examples of liquid oral formulations of the present invention.

Example 1 (preparation 1000ml)

Raw materials: 30 parts of astragalus membranaceus, 35 parts of common yam rhizome, 20 parts of honey-fried licorice root, 30 parts of poria cocos, 25 parts of dendrobe, 25 parts of fried malt, 32 parts of hawthorn, 25 parts of pawpaw, 28 parts of codonopsis pilosula, 20 parts of dried orange peel, 30 parts of bighead atractylodes rhizome, 35 parts of sea buckthorn, 20 parts of raspberry, 30 parts of longan and 5 parts of taurine;

auxiliary materials: 400 parts of cane sugar, 10 parts of sodium benzoate and 1 part of grape essence;

solvent: and (5) purifying the water.

The preparation method comprises the following steps:

1. dissolving taurine in a small amount of purified water to obtain a taurine aqueous solution for later use;

2. decocting the rest 13 materials such as radix astragali in water twice, adding 12 times of water for the first time, decocting for 2.5 hr, adding 8 times of water for the second time, decocting for 1 hr, mixing decoctions, filtering with 250 mesh sieve, standing for 24 hr, collecting supernatant, filtering with 250 mesh sieve, concentrating the filtrate under reduced pressure to obtain fluid extract with relative density of 1.2-1.3 at 55-60 deg.C, and collecting fluid extract of radix astragali;

3. extracting the above medicinal materials such as radix astragali, etc. to obtain fluid extract, adding ethanol to make ethanol content at 75 deg.C, stirring for 30 min, standing at 5-7 deg.C for 24 hr, collecting supernatant, filtering with 0.60 μm sand filter stick, recovering ethanol from filtrate until no ethanol smell exists, concentrating to obtain soft extract with relative density of 1.25-1.35 at 55-60 deg.C, and precipitating with ethanol to obtain soft extract;

4. dissolving sucrose, sodium benzoate and grape essence in small amount of purified water, filtering with microporous filter membrane with pore diameter of 0.60 μm, and collecting filtrate;

5. mixing the above soft extract with taurine aqueous solution and filtrate, adding purified water to 70-80% of the preparation amount, stirring for 30 min, adding purified water to 1000ml, stirring, filtering with 0.60 μm microporous membrane, bottling, and sterilizing at 105 deg.C for 45 min.

Example 2 (preparation 1000ml)

auxiliary materials: 3 parts of steviosin, 5 parts of benzoic acid and 1 part of grape essence;

solvent: and (5) purifying the water.

The preparation method comprises the following steps:

dissolving taurine in a small amount of purified water to obtain a taurine aqueous solution for later use;

decocting the rest 13 medicinal materials such as radix astragali in water twice, adding 12 times of water for the first time, decocting for 2 hr, adding 8 times of water for the second time, decocting for 1.5 hr, mixing decoctions, filtering with 250 mesh sieve, standing for 24 hr, collecting supernatant, filtering with 250 mesh sieve, and concentrating the filtrate under reduced pressure to obtain fluid extract with relative density of 1.2-1.3 at 55-60 deg.C, to obtain fluid extract of radix astragali;

extracting the above medicinal materials such as radix astragali, etc. to obtain fluid extract, adding ethanol to make ethanol content at 75 deg.C, stirring for 30 min, standing at 5-7 deg.C for 24 hr, collecting supernatant, filtering with 0.60 μm sand filter stick, recovering ethanol from filtrate until no ethanol smell exists, concentrating to obtain soft extract with relative density of 1.25-1.35 at 55-60 deg.C, and precipitating with ethanol to obtain soft extract;

dissolving steviosin, benzoic acid and grape essence with small amount of purified water, filtering with microporous membrane with pore diameter of 0.60 μm, and collecting filtrate;

mixing the above soft extract with taurine aqueous solution and filtrate, adding purified water to 70-80% of the preparation amount, stirring for 30 min, adding water to 1000ml, stirring, filtering with 0.60 μm microporous membrane, bottling, and sterilizing at 120 deg.C for 25 min.

Example 3

The liquid oral preparation prepared in the embodiment 2 of the invention is used for treating 50 cases of child anorexia.

1. Patient screening:

50 children patients with anorexia and spleen deficiency syndrome differentiation of traditional Chinese medicine are selected and divided into 2 groups according to a random table. The treatment groups comprise 25 cases, 2-3 years old and 5 cases, 3-5 years old and 28 cases, and 17 cases above 5 years old; the statistical calculation shows that 50 cases of the control group, 7 cases of 2-3 years old, 30 cases of 3-5 years old and 13 cases of 6 years old are: the difference is not statistically significant (P > 0.05) and is comparable.

2. Diagnostic criteria:

referring to the diagnosis standard of anorexia of traditional Chinese medicine pediatrics: (1) anorexia and food consumption reduction for a long time without other diseases; (2) the complexion is lusterless, the body is emaciated, but the spirit is still good; (3) there is a history of feeding, such as irregular and quantitative eating, overeating raw or cold food, sweet and thick taste, snacks, or monophagia, etc.; (4) dislike of food intake, poor appetite or occasional polyphagia with abdominal distention, abnormal stool, good spirit, pale red tongue with white greasy or yellowish coating, soft-superficial, slow or smooth and rapid pulse. The spleen-stomach qi deficiency type symptoms are as follows: poor appetite, emaciation, poor appetite, scanty and more stool, lusterless complexion, lassitude, easy sweating, susceptibility to cold, swollen and tender tongue, pale tongue with thin and white coating, and slow and weak pulse.

3. The treatment method comprises the following steps:

treatment groups orally administered the liquid oral formulation obtained in example 2 of the present invention: 1 to 3 years old, 5ml for 1 time and 3 times for 1 day; 1 time after 3-5 years old and 10ml for 1 time, and 3 times after 1 day; 20ml for 1 time and 3 times for 1 day above 6 years old. 1 week is 1 course of treatment, and 2 courses of continuous administration; the control group was administered with the oral liquid of lactobacillin tablet and zinc gluconate for the same treatment period of 1.3.

Statistical treatment: by X²The data are statistically analyzed by the test, and P is less than 0.05, thus having statistical significance.

4. The treatment results are as follows:

the therapeutic effect judgment standard is as follows: according to the standard for diagnosing the common diseases and judging the curative effect, the traditional Chinese medicine has the following effects: the appetite is obviously recovered, the appetite is recovered to 3/4 of the original level, and the original symptoms are basically disappeared; the method has the following advantages: improving appetite, recovering appetite, but not reaching 3/4 of original level, and relieving original symptoms; and (4) invalidation: the appetite and the food intake are not improved, and the results of the clinical curative effects of the two groups are shown in table 1.

Table 1: comparison of clinical effects of two groups

Group of	Number of cases	Show effect	Is effective	Invalidation	Total effective rate (%)
						Treatment group	25	15	9	1	96
Control group	25	8	12	6	80

The curative effect of the two groups of curative effect comparison treatment groups is better than that of the control group, and the difference has statistical significance (P is less than 0.01).

Example 4

The liquid oral preparation prepared in the embodiment 2 of the invention is used for observing the curative effect of treating the children malnutrition.

1. Patient screening:

67 cases of children with malnutrition of 2-7 years old were selected and randomly divided into a treatment group and a control group, and 36 cases of the treatment group and 31 cases of the control group. The treatment groups were 15 men and 21 women; the control group comprises 20 male and 11 female.

2. The treatment method comprises the following steps:

the control group is subjected to general symptomatic treatment, and the liquid oral preparation obtained in the example 2 of the invention is orally taken by the treatment group, 10ml is taken every time after the age of 2-4 years, and 3 times are taken every day; 20ml for 4-7 years old, 3 times per day for 8 weeks. During the test period, the appetite and appetite improvement of the infant patients were recorded every week. Body weight was measured before and 6 months after treatment to understand the change in body weight.

3. The therapeutic effect judgment standard is as follows:

the effect is obvious, and the weight of the treated patient reaches the standard in the observation period; the medicine is effective, the disease incidence frequency is reduced by 50% after treatment, and the weight reaches the standard after treatment; the body weight is not reached after treatment without effect.

The statistical method comprises the following steps:

the measured data are expressed as mean. + -. standard deviation (x. + -.s), and the two-by-two comparison is performed by using t-test.

4. The treatment results are as follows: the clinical effects of the two groups are compared and shown in Table 2.

Table 2: comparison of clinical effects of two groups

Group of	Number of cases	Show effect	Is effective	Invalidation	Total effective rate (%)	p
							Treatment group	36	18	13	5	86.11	＜0.01
Control group	31	1	15	16	51.61	＜0.01

After the treatment, the appetite of the children patients is obviously improved, and the total effective rate is 86.11 percent, so that the appetite of the children patients is recovered to be normal. While the control group of children patients only improve the appetite by 16 percent, and the total effective rate is 51.61 percent.

Example 5

The liquid oral preparation prepared in the embodiment 2 of the invention is used for treating infantile diarrhea caused by spleen deficiency.

1. Diagnostic criteria: refer to the diagnosis standard of 'the complete book of pediatric diagnosis and treatment in modern traditional Chinese medicine'.

2. Patient screening:

according to the above standards, 78 outpatient children with spleen deficiency syndrome were randomly divided into 56 treatment groups and 22 control groups for 1-6 months. The treatment groups were 38 men and 18 women; the control group comprises 14 men and 8 women. The treatment groups had a minimum age of 2 years, a maximum age of 7 years, and an average age of 4.3 years; the control group had a minimum age of 9 months and a maximum age of 8 years, with an average age of 6.2 years. The difference between the two groups of ages is not significant (P > 0.05).

3. Method of treatment

The treatment group takes the oral liquid preparation prepared in the embodiment 2 orally, the age is 2-4 years, 5ml is taken every time, and 3 times are taken every day; 5-7 years old, 10 ml/time, 3 times/day. The contrast group orally takes the lactobacillus tablets for 9 months to 3 years old, 0.5 ml/day and 3 times/day; 10 ml/time for 4-8 years old, 3 times/day. Two groups take 7 days as a treatment course, and 2 treatment courses are continuously observed.

4. Clinical efficacy evaluation criteria

The Chinese medicinal composition is cured according to the 'diagnosis and treatment effect standard of the internal and external gynecologic and pediatric diseases of traditional Chinese medicine' formulated by the State administration of medical science and government (1): the excrement is taken 1 time every day, the formed soft excrement has no mucus, the general symptoms disappear, the appetite is improved, and the excrement is not abnormal in microscopic examination; (2) the effect is shown: the stool frequency is obviously reduced to below 1/3 before treatment, the stool is shaped or soft, and the general symptoms and the stool microscopic examination are obviously improved; (3) the method has the following advantages: the stool frequency is reduced to 1/2 before treatment, and the shape, symptoms and stool microscopic examination are improved; (4) and (4) invalidation: the times and shape of the stool are not improved, and the stool is still abnormal in microscopic examination.

5. The treatment results are as follows: the two groups of therapeutic effects are compared and shown in Table 3.

TABLE 3

Group of	Number of cases	Recovery method	Show effect	Is effective	Invalidation	Total effective rate
							Treatment group	56	18	22	15	1	98.22
Control group	22	1	3	12	6	72.72

Through statistical treatment and analysis, the treatment group is superior to the control group in the aspects of total effective rate, cure rate and significant efficiency, which shows that the liquid oral preparation prepared by the invention has definite curative effect on the infantile spleen deficiency diarrhea.

Description of the drawings: examples 3 to 5 above were assigned to the inner Mongolia hospital for clinical trials.

Claims

1. A liquid oral preparation for treating children anorexia and monophagia, and its preparation method and application are disclosed, wherein the preparation comprises raw materials including radix astragali, rhizoma Dioscoreae, radix Glycyrrhizae Preparata, Poria, herba Dendrobii, fructus Hordei Germinatus preparata, fructus crataegi, fructus Chaenomelis, radix Codonopsis, pericarpium Citri Tangerinae, Atractylodis rhizoma, fructus Hippophae, Rubi fructus, arillus longan, and taurine; the auxiliary materials comprise a flavoring agent, a preservative and essence; the solvent comprises deionized water, purified water and distilled water.

2. The raw materials, the auxiliary materials and a proper amount of solvent according to claim 1, wherein the formula and the mixture ratio are as follows by weight:

2.1, raw materials: 10-50 parts of astragalus membranaceus, 20-100 parts of common yam rhizome, 10-50 parts of honey-fried licorice root, 10-50 parts of poria cocos, 5-50 parts of dendrobium, 5-50 parts of roasted malt, 10-80 parts of hawthorn, 5-50 parts of pawpaw, 5-50 parts of codonopsis pilosula, 10-50 parts of dried orange peel, 5-50 parts of bighead atractylodes rhizome, 10-100 parts of sea buckthorn, 5-30 parts of raspberry, 5-50 parts of longan and 1-10 parts of taurine;

2.2 auxiliary materials: 800 portions of corrective 100, 0.1 to 50 portions of preservative and 0.5 to 5 portions of essence;

2.3 solvent: proper amount.

3. The raw materials, the auxiliary materials and a proper amount of solvent according to claim 2, wherein the formula and the mixture ratio thereof are as follows by weight:

3.1 raw materials: 30 parts of astragalus membranaceus, 35 parts of common yam rhizome, 20 parts of honey-fried licorice root, 30 parts of poria cocos, 25 parts of dendrobe, 25 parts of fried malt, 32 parts of hawthorn, 25 parts of pawpaw, 28 parts of codonopsis pilosula, 20 parts of dried orange peel, 30 parts of bighead atractylodes rhizome, 35 parts of sea buckthorn, 20 parts of raspberry, 30 parts of longan and 5 parts of taurine;

3.2 auxiliary materials: 700 portions of corrective 200 and preservative, 0.2-40 portions of preservative and 0.5-4 portions of essence;

3.3 solvent: proper amount.

4. The raw materials, the auxiliary materials and a proper amount of solvent according to claim 1, wherein the formula and the mixture ratio by weight are as follows:

4.1 raw materials: 10-50 parts of astragalus membranaceus, 20-100 parts of common yam rhizome, 10-50 parts of honey-fried licorice root, 10-50 parts of poria cocos, 5-50 parts of dendrobium, 5-50 parts of roasted malt, 10-80 parts of hawthorn, 5-50 parts of pawpaw, 5-50 parts of codonopsis pilosula, 10-50 parts of dried orange peel, 5-50 parts of bighead atractylodes rhizome, 10-100 parts of sea buckthorn, 5-30 parts of raspberry, 5-50 parts of longan and 1-10 parts of taurine;

4.3 solvent: proper amount.

5. The raw materials, the auxiliary materials and a proper amount of solvent according to claim 4, wherein the formula and the mixture ratio by weight are as follows:

5.1, raw materials: 30 parts of astragalus membranaceus, 35 parts of common yam rhizome, 20 parts of honey-fried licorice root, 30 parts of poria cocos, 25 parts of dendrobe, 25 parts of fried malt, 32 parts of hawthorn, 25 parts of pawpaw, 28 parts of codonopsis pilosula, 20 parts of dried orange peel, 30 parts of bighead atractylodes rhizome, 35 parts of sea buckthorn, 20 parts of raspberry, 30 parts of longan and 5 parts of taurine;

5.2 auxiliary materials: 1-50 parts of corrigent, 0.1-50 parts of preservative and 0.5-5 parts of essence; 3 parts of steviosin, 5 parts of benzoic acid and 1 part of grape essence;

5.3 solvent: proper amount.

6. The raw materials, the auxiliary materials and a proper amount of solvent according to claim 2 or 3, characterized in that the flavoring agent is sucrose.

7. The raw materials, the auxiliary materials and a proper amount of solvent according to claim 4 or 5, characterized in that the flavoring agent comprises any one or more of steviosin, aspartame, acesulfame-K, aspartame, glycyrrhizin, neotame and sucralose.

8. The raw materials, auxiliary materials and appropriate amount of solvent according to claims 1-5, characterized in that the preservative comprises any one or mixture of several of benzoic acid, sorbic acid and salts thereof.

9. The raw materials, the auxiliary materials and the proper amount of solvent according to the claims 1-5, wherein the essence comprises any one or more of but not limited to lemon essence, juicy peach essence, Hami melon essence, grape essence, miscellaneous fruit essence, blueberry essence, banana essence, strawberry essence and orange essence.

10. Raw materials, auxiliary materials and a proper amount of solvent according to claims 1-5, characterized in that the solvent comprises purified water, deionized water, distilled water.

11. The liquid oral preparation for treating children anorexia and monophagia as claimed in claim 1, wherein the preparation method comprises sugar-containing oral liquid preparation and sugar-free oral liquid preparation.

12. The process for preparing a sugar-containing oral liquid preparation according to claim 10, which comprises mixing the above raw materials, adjuvants and solvents of claim 2 or 3 in the following ratio;

12.1, taking taurine, adding a small amount of purified water for dissolving to obtain a taurine aqueous solution for later use;

12.2 taking the other 13 medicinal materials such as astragalus and the like, adding water for decocting twice, adding 10-12 times of water for the first time, decocting for 2-3 hours, adding 8-10 times of water for the second time, decocting for 1-2 hours, combining the decoction liquids of the two times, filtering, standing the filtrate for 20-40 hours, taking the supernatant for filtering, concentrating the filtrate under reduced pressure to obtain clear paste with the relative density of 1.2-1.3 at 55-60 ℃, and obtaining the extract of the medicinal materials such as the astragalus and the like for later use;

12.3 extracting the above radix astragali and other medicinal materials to obtain fluid extract, adding ethanol to make ethanol content 60-80%, stirring for 15-30 min, standing at 3-25 deg.C for 18-24 hr, collecting supernatant, filtering, recovering ethanol from filtrate until no ethanol smell exists, concentrating to obtain soft extract with relative density of 1.25-1.35 at 55-60 deg.C, and precipitating with ethanol to obtain soft extract;

12.4 taking the flavoring agent, the preservative and the essence, adding a small amount of purified water for dissolving, and filtering to obtain a dissolving solution of auxiliary materials such as the flavoring agent for standby;

12.5 taking the thick paste, adding taurine aqueous solution, correctant and other auxiliary material dissolved solutions, adding purified water to 70-80% of the preparation amount, stirring for dissolving, standing for 18-24 hours, filtering, adding purified water to the filtrate to the preparation amount, stirring for 15-30 minutes, filling and sterilizing to obtain the finished product.

13. The method for preparing the sugar-free oral liquid preparation according to claim 10, wherein the preparation method comprises the steps of taking the raw materials, auxiliary materials and solvents in the formula and the mixture ratio of 3 or 4, and preparing the raw materials, the auxiliary materials and the solvents according to the following method;

13.1, taking taurine, adding a small amount of purified water for dissolving to obtain a taurine aqueous solution for later use;

13.2 taking the rest 13 raw materials such as astragalus and the like, adding water for decocting twice, adding 10-12 times of water for the first time, decocting for 2-3 hours, adding 8-10 times of water for the second time, decocting for 1-2 hours, combining the decoctions for two times, filtering, standing the filtrate for 18-24 hours, taking the supernatant, filtering, and concentrating the filtrate under reduced pressure to obtain clear paste with the relative density of 1.2-1.3 at 55-60 ℃ to obtain the extract of the medicinal materials such as the astragalus and the like for later use;

13.3 extracting the above medicinal materials such as radix astragali, etc. to obtain fluid extract, adding ethanol to make ethanol content 60-75 deg.C, stirring for 30 min, standing at 5-7 deg.C for 18-24 hr, collecting supernatant, filtering, recovering ethanol from filtrate until no ethanol smell exists, concentrating to obtain soft extract with relative density of 1.25-1.35 at 55-60 deg.C, and precipitating with ethanol to obtain soft extract;

13.4 taking the flavoring agent, the preservative and the essence, adding a small amount of purified water for dissolving, filtering, and obtaining filtrate for later use;

13.5 taking the thick paste obtained by alcohol precipitation, adding the taurine aqueous solution and the filtrate, adding purified water to 70-80% of the preparation amount, stirring for 30 minutes, adding purified water to the preparation amount, stirring uniformly, filtering, filling, and performing damp-heat sterilization at 105 ℃ for 45 minutes to obtain the finished product.

14. The method according to claim 12 or 13, wherein the filtering in claim 11.2 or 12.2 is performed by using a 100-mesh 250-mesh stainless steel screen.

15. The method according to claim 12 or 13, wherein the filtration according to claim 11.3 or 12.3 is performed by using a sand filter stick or a ceramic filter stick or a filter felt having a pore size of 0.8 μm.

16. The method according to claim 12 or 13, wherein the filtration according to claim 11.4, 11.5, 12.4 or 12.5 is carried out with a microporous membrane having a pore size of 0.45 to 0.68 μm.

17. The method according to claim 12 or 13, wherein the sterilization is performed by moist heat sterilization at 105 ℃ for 45 minutes or moist heat sterilization at 121 ℃ for 25 minutes, according to claim 11.5 or 12.5.

18. The liquid oral preparation for treating children anorexia and monophagia as claimed in claim 1, further comprising oral liquid, suspension or syrup.

19. The liquid oral preparation for treating children anorexia, monophagia and other diseases as claimed in claim 1, wherein the liquid oral preparation can be further prepared into solid preparations such as granules, tablets and capsules.

20. The oral liquid preparation for treating children anorexia, monophagia and other diseases, as well as the preparation method and the application thereof according to claim 1, is characterized in that the application comprises the following components: can regulate spleen and stomach function, improve immunity, improve sub-health state of organism, and treat infantile anorexia, monophagia, malnutrition, diarrhea due to spleen deficiency, fever, and recurrent infection of respiratory tract and digestive tract.