CN114504634A

CN114504634A - Clear liquid for rectal administration of children and preparation method thereof

Info

Publication number: CN114504634A
Application number: CN202111614858.3A
Authority: CN
Inventors: 李兵锁; 李林红; 李杨; 李怡阳; 李浩杰; 孙怡路; 燕天赐; 李泽恩辉; 燕密纳; 李梦茹; 李哲
Original assignee: Xinjiang County Children's Hospital Co ltd
Current assignee: Xinjiang County Children's Hospital Co ltd
Priority date: 2021-12-27
Filing date: 2021-12-27
Publication date: 2022-05-17

Abstract

The invention discloses a clear liquid for rectal administration of children and a preparation method thereof. The clear liquid consists of the following raw materials in parts by mass: 10-15 parts of fructus cannabis, 10-15 parts of Chinese date, 10-15 parts of radix rehmanniae recen, 10-15 parts of pericarpium arecae, 10-15 parts of radix scrophulariae, 10-15 parts of liquorice, 10-15 parts of immature bitter orange, 10-15 parts of fried semen raphani, 10-15 parts of mangnolia officinalis, 5-10 parts of semen trichosanthis, 5-10 parts of rhizoma atractylodis macrocephalae and 5-10 parts of ginger. The invention also provides a using method of the clear liquid, and the clear liquid prepared by the invention has the advantages of high stability, good effect of treating children's food retention and the like.

Description

Clear liquid for rectal administration of children and preparation method thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a clear effusion for rectal administration of children and a preparation method thereof.

Background

The intestinal tract is an immune system of a human body, the activity of the intestinal mucosa determines the health of the intestinal tract, the intestinal mucosa has the functions of absorbing nutrient components and discharging toxin like a plurality of small hands, and as the living standard of people is continuously improved, the dietary structure of children is continuously changed, such as eating high-calorie food, insufficient exercise amount, food stagnation caused by weakness of spleen and stomach and weak transportation and transformation capacity of children, food stagnation is formed, heat is accumulated for a long time, and food stagnation is generated.

The typical manifestations of food retention in children are as follows: in stage one, there is no appetite, halitosis, conjunctival congestion, red lip and red face, respiratory qi heat, feverish palms and soles, insomnia, dysphoria, and teeth grinding; second-order, paroxysmal crying, sticky, vomiting, etc.; three stages: fever, cough, diarrhea, etc. If the food is taken in time at one stage, the disease can be mostly prevented, and if the food is not regulated and protected, the diseases such as fever, cough, diarrhea and the like can be caused.

When children have food accumulation, the nutrition absorption is reduced, the toxin is difficult to discharge, the immunity of the children is low, and the children are easy to get ill, so that the children need to be cleaned of the food accumulation. In paediatrics some children are difficult to take orally, and rectal administration is also a commonly used method.

Rectal administration is a traditional external treatment method in traditional Chinese medicine, and the east Han Zhang Zhongjing initiates anal suppository and enema in Shang Han Lun. The traditional Chinese medicine considers that the lung and the large intestine are exterior and interior and mutually belong to channels and collaterals, the medicine can be absorbed by the rectum and can be upwards transported to the lung, and the lung faces to all channels, and the medicine can reach the disease site through the channels, thereby playing a role in treatment. The results of biopharmaceutical studies and clinical applications in the 40 th 20 th century indicate that drugs can be absorbed rectally to exert systemic effects.

Rectal administration is a method of administering a drug to the rectum through the anus and rapidly entering blood circulation through the intestinal mucosa to allow the drug to exert a therapeutic effect locally or systemically, and is classified into retention enema, rectal instillation, and suppository insertion. The rectal mucosa has an annular special structure, the pH value of rectal liquid is 6.8-7.3, and the environment is mild. Compared with oral administration, rectal administration can avoid the influence of unpleasant odor of the medicine and the stimulation effect on gastric mucosa, reduce the first pass effect of the liver, and improve the bioavailability; rectal administration is safer than injection. After rectal administration, the medicine is absorbed by rectal mucosa and enters systemic circulation, has good safety compared with injection administration, and is widely used for children administration in clinic, namely 'child green therapy'.

Chinese patent CN 108379547A discloses a liquid medicine suitable for rectal administration for children and its preparation method, which comprises radix Codonopsis, Poria, Atractylodis rhizoma, Glycyrrhrizae radix, fructus crataegi preparata, Massa Medicata Fermentata preparata, fructus Hordei Germinatus, radix aucklandiae, fructus Aurantii Immaturus, cortex Magnolia officinalis, pericarpium Arecae, pericarpium Citri Tangerinae, ginger processed pinellia Tuber, herba Agastaches, endothelium corneum Gigeriae Galli preparata, rhizoma Zingiberis recens, Coicis semen, rhizoma Dioscoreae, radix Platycodi, Vinegar rhizoma and rhizoma picrorhizae; the medicine has the effects of tonifying spleen and stomach, promoting digestion and removing food retention, promoting qi circulation and eliminating dampness, and removing intestinal toxins, so as to achieve the effect of treating food retention.

Chinese patent CN 107233546A provides a clear liquid for rectal administration for children and a preparation method thereof, the raw materials comprise patchouli, fried bighead atractylodes rhizome, ginger processed magnolia bark, rhizoma pinellinae praeparata, perilla leaf, angelica dahurica, dried orange peel, poria cocos, platycodon grandiflorum, liquorice, Chinese date, areca peel and ginger, the clear liquid prepared by the method can eliminate excrement or flatulence and mucus after ten minutes, and the effective rate is more than 90%. The invention compares different treatment modes of a plurality of raw materials to obtain clear liquid with different treatment effects, but the inventor does not mention the reason for selecting different treatment modes of the raw materials.

Disclosure of Invention

In view of the above defects of the prior art, the technical problem to be solved by the present invention is that many doctors now adopt a rectal administration method to treat children, but after rectal administration, the drug is not retained and absorbed in the intestinal tract and is directly pulled out, and the drug does not reach the focus and does not achieve the purpose of treatment.

The clear effusion for children administration prepared by the invention has the advantages of high stability, good effect of treating children food retention and the like.

In order to achieve the purpose of the invention, the invention adopts the following technical scheme:

a preparation method of clear liquid for rectal administration of children comprises the following steps:

s1, mixing fructus Cannabis, fructus Jujubae, radix rehmanniae, pericarpium Arecae, radix scrophulariae, radix Glycyrrhizae, fructus Aurantii Immaturus, parched semen Raphani, cortex Magnoliae officinalis, semen Trichosanthis, rhizoma Atractylodis Macrocephalae, and rhizoma Zingiberis recens, grinding into powder, sieving, and mixing to obtain a Chinese medicinal mixture;

s2: mixing and soaking the Chinese medicinal material mixture obtained in the step S1 with water to obtain a mixed solution, adding enzyme, heating for enzymolysis, inactivating the enzyme, and filtering to remove residues to obtain a Chinese medicinal material extracting solution;

s3: and (4) adding normal saline into the traditional Chinese medicine extracting solution obtained in the step S2, fully mixing, adding a cosolvent into the mixed solution, uniformly mixing, and packaging to obtain the clear effusion for rectal administration of children.

Further preferably, the preparation method of the clear liquid for rectal administration for children comprises the following steps:

s1, mixing and grinding 10-15 parts of fructus cannabis, 10-15 parts of Chinese date, 10-15 parts of radix rehmanniae recen, 10-15 parts of pericarpium arecae, 10-15 parts of radix scrophulariae, 10-15 parts of liquorice, 10-15 parts of immature bitter orange, 10-15 parts of fried radish seed, 10-15 parts of mangnolia officinalis, 5-10 parts of semen trichosanthis, 5-10 parts of rhizoma atractylodis macrocephalae and 5-10 parts of ginger into powder, and mixing to obtain a traditional Chinese medicine mixture;

s2: mixing and soaking the traditional Chinese medicine mixture obtained in the step S1 with water of which the mass is 20-30 times that of the mixture to obtain a mixed solution, adding enzyme, heating at 30-50 ℃ for 1-2 hours, then heating to 80-100 ℃ to inactivate the enzyme for 10-15min, and filtering to remove dregs to obtain a traditional Chinese medicine extracting solution, wherein the mass ratio of the traditional Chinese medicine mixture to the enzyme is 100-150: 1;

s3: adding normal saline into the traditional Chinese medicine extracting solution obtained in the step S2, fully mixing, adding a cosolvent into the mixed solution, uniformly mixing, and packaging to obtain the clear effusion for rectal administration of children; the traditional Chinese medicine extract, the cosolvent and the normal saline are as follows by weight percent: 50-75% of a traditional Chinese medicine extracting solution, 2-10% of a cosolvent and 20-45% of normal saline.

Preferably, the enzyme in step S2 is one or a mixture of two or more of cellulase, pectinase, hemicellulase, papain and glucoamylase; preferably, the enzyme in step S2 is cellulase.

Preferably, the cosolvent in step S3 is one or a mixture of sodium carboxymethyl cellulose and gum arabic. More preferably, the cosolvent in step S3 is sodium carboxymethylcellulose and modified gum arabic in a mass ratio (2-5): 1.

Preferably, the modified gum arabic is prepared by the following method: 0.75-1.0g of chitosan is weighed and dissolved in 50-60mL of 0.1-0.2mol/L acetic acid aqueous solution, then 50-60mL of gum arabic aqueous solution with the mass volume concentration of 1.5-2.5% is dripped into the solution, and the reaction is carried out for 30-60min at the temperature of 30-40 ℃, so as to obtain the milky granular modified gum arabic.

Preferably, the normal saline is commercially available 0.85-0.9 wt% normal saline.

The invention also discloses a use method of the clear effusion for rectal administration for children, which comprises the following steps: taking 50-100mL of the clear effusion, ordering the patient to bend the knee at the left side lying position, relieving the urine, raising the hip, filling the liquid medicine at the temperature of about 37-41 ℃ into a plastic hose, filling the liquid medicine into a jar for about 7-10cm, keeping the liquid medicine for 5-10min, and defecating and discharging the medicine when feeling defecation.

The components used in the present invention are illustrated below:

fructus Cannabis is dry mature fruit of Cannabis sativa L. Sweet in nature and mild in nature. It enters spleen, stomach and large intestine meridians. Has effects of loosening bowel to relieve constipation. It can be used for treating constipation due to blood deficiency and fluid deficiency.

Fructus Jujubae is dried mature fruit of Ziziphus jujuba Mill of Rhamnaceae. Sweet in nature and warm in nature. It enters spleen, stomach and heart meridians. Has the effects of invigorating spleen and replenishing qi, nourishing blood and tranquilization, etc. Can be used for treating spleen deficiency, anorexia, asthenia, loose stool, and hysteria of women.

Radix rehmanniae, also known as radix rehmanniae, benzyl, Huaqing rehmanniae, chicken drinking, medulla, etc., is a fresh or dry root tuber of Rehmannia Rehmannia glutinosa libosch. Sweet in nature and cold in nature. It enters heart, liver and kidney meridians. Has the effects of clearing heat, cooling blood, nourishing yin, promoting the production of body fluid and the like. Can be used for treating heat entering nutrient-blood, epidemic febrile disease, macula, hematemesis, epistaxis, yin injury due to fever, crimson tongue, polydipsia, constipation due to body fluid consumption, fever due to yin deficiency, bone steaming, fatigue, internal heat, and diabetes.

Areca peel, which is the dried pericarp of Areca catechu L. Pungent in flavor and slightly warm in nature. It enters spleen, stomach, large intestine and small intestine meridians. Has the effects of promoting the circulation of qi, relieving epigastric distention, promoting diuresis and relieving swelling. Can be used for treating damp obstruction, qi stagnation, abdominal distention, constipation, edema, tinea pedis, edema, and urination difficulty.

Radix scrophulariae is dried root of Scrophulariaceae plant Scrophularia ningpoensis Hemsl. Sweet, bitter, salty and slightly cold. It enters lung, stomach and kidney meridians. Has the effects of clearing heat and cooling blood, nourishing yin and lowering fire, detoxifying and resolving masses and the like. Can be used for treating heat entering nutrient-blood, toxic heat and macula, yin impairment due to fever, crimson tongue with dipsosis, constipation due to body fluid consumption, bone-steaming cough, conjunctival congestion, pharyngalgia, diphtheria, scrofula, carbuncle, and sore.

The Glycyrrhrizae radix is dried root and stem of Glycyrrhiza uralensis Fisch, Glycyrrhiza inflata Bat or Glycyrrhiza glabra L of Leguminosae. Sweet in nature and mild in nature. It enters heart, lung, spleen and stomach meridians. Has the effects of invigorating spleen and replenishing qi, clearing away heat and toxic materials, eliminating phlegm and relieving cough, relieving spasm and pain, and harmonizing the medicines. Can be used for treating weakness of spleen and stomach, asthenia, palpitation, short breath, cough, excessive phlegm, abdominal pain, limb spasm, pain, carbuncle, swelling, sore, and toxic material, and relieving drug toxicity and pungency.

The fructus Aurantii Immaturus is Citrus aurantium L. of Rutaceae and its cultivar or dried young fruit of Citrus sinensis Osbeck. Bitter, pungent, sour and slightly cold in nature. It enters spleen and stomach meridians. Has the effects of breaking qi, removing food retention, eliminating phlegm and relieving distension and fullness. Can be used for treating stagnation, abdominal distention, pain, diarrhea, dysentery, constipation, phlegm stagnation, qi stagnation, thoracic obstruction, and viscera prolapse.

The fried radish seed is a processing method of radish seed, has sweet and pungent taste, mild property, has the effects of promoting digestion and relieving flatulence, and has the effects of lowering qi and reducing phlegm, and is mainly used for treating abdominal fullness, abdominal pain, nausea, acid and rottenness caused by food stagnation.

Magnolia officinalis is dried bark, root bark and branch bark of Magnolia officinalis of Magnoliaceae family, Magnolia officinalis of Magnolia bark of Magnolia officinalis of Magnolia bark of Magnolia officinalis of Magnolia bark of Magnolia officinalis of Magnolia bark of Magnolia bark of Magnolia bark of Magnolia officinalis of Magnolia officinalis of Magnolia of. Bitter and pungent in property and warm in nature. It enters spleen, stomach, lung and large intestine meridians. Has the effects of eliminating dampness and phlegm, descending qi and eliminating fullness, and the like. Can be used for treating damp stagnation, abdominal distention, vomiting, diarrhea, food stagnation, qi stagnation, abdominal distention, constipation, phlegm retention, asthma, and cough.

Semen Trichosanthis is dry seed of Trichosanthes kirilowii Maxim of Trichosanthes of Cucurbitaceae. Also called as semen Trichosanthis. Sweet and cold in nature. It enters lung and large intestine meridians. Has effects of loosening bowel to relieve constipation, relieving chest stuffiness, resolving hard mass, clearing lung-heat, and eliminating phlegm. Can be used for treating phlegm-heat cough, lung carbuncle, empyema, thoracic obstruction, hypochondriac pain, chest stagnation, acute mastitis, intestinal dryness, and constipation.

Atractylodis rhizoma is dried rhizome of Atractylodes macrocephala Koidz of Compositae. Bitter and sweet in property and warm in nature. It enters spleen and stomach meridians. Has the effects of strengthening spleen, tonifying qi, eliminating dampness, inducing diuresis, suppressing sweating, preventing miscarriage and the like. Can be used for treating spleen deficiency, anorexia, abdominal distention, diarrhea, phlegm retention, dizziness, palpitation, edema, spontaneous perspiration, and threatened abortion.

Ginger, fresh rhizome of Zingiber officinale Rosc. Pungent in flavor and slightly warm in nature. It enters lung, spleen and stomach meridians. Has the effects of relieving exterior syndrome, dispelling cold, warming middle-jiao, relieving vomit, eliminating phlegm, relieving cough, and removing fish and crab toxin. Can be used for treating wind-cold type common cold, stomach cold type emesis, cough due to cold phlegm, and fish and crab poisoning.

In the traditional Chinese medicine formula for warming yang and promoting qi circulation used in the research, radix rehmanniae is used for nourishing yin and tonifying kidney, magnolia officinalis is used for moistening phlegm, immature bitter orange is used for breaking qi and removing food retention, the traditional Chinese medicine formula has the effects of exciting gastrointestinal cholinergic M receptors, improving gastrointestinal smooth muscle tension and stimulating intestinal peristalsis, bighead atractylodes rhizome can be used for bidirectionally regulating nervous system and intestinal functions, magnolia officinalis, immature bitter orange, fried radish seed, fructus cannabis and other medicines have the effect of promoting intestinal tract and gastrointestinal peristalsis, and fructus trichosanthis with cough relieving effect is used as an adjuvant to effectively improve gastrointestinal peristalsis of children patients and regulate spleen and stomach transportation and transformation, has the effects of removing food stagnation, relaxing bowels, purging heat and moistening intestines, the retention enema can ensure the effect of traditional Chinese medicine, is not limited by subjective and objective conditions of patients, is simple and easy to implement, can avoid adverse reaction caused by oral administration of the medicine, can not increase gastrointestinal burden, the traditional Chinese medicine is retained to be completely absorbed by the enema, and can directly stimulate intestinal peristalsis, is more beneficial to the recovery of gastrointestinal function. Is remarkable, high in safety and worthy of popularization. At present, the treatment is carried out by the national restriction of injection and infusion, and a plurality of doctors adopt a rectal administration method to treat children, but after rectal administration, the medicine is not retained and absorbed in intestinal tracts and is directly pulled out, and the medicine does not reach the focus and has no treatment effect.

The liquid-clearing medicine prepared by the invention has the functions of activating blood, removing fatigue, promoting qi circulation, removing food retention, tonifying yin and activating yang. The medicine has the advantages of enhancing vital qi of a human body, promoting the improvement of blood flow and metabolism of gastrointestinal mucosa, increasing the secretion of motilin, exciting intestinal smooth muscle, promoting gastrointestinal movement, enhancing the immunity of the human body, enhancing intestinal peristalsis, regulating the sensitivity of large intestine and softening excrement, embodies the concept of treatment and treatment principle differentiation of traditional Chinese medicine, improves the flexibility of medicine application and improves the cure rate of the disease.

The clinical application is as follows:

1) dry stool and difficult discharge; 2) red or deep-red tongue with thin yellow, yellow greasy or yellow thick greasy coating; 3) a deep, forceful or slippery pulse with purple-superficial fingerprint; 4) flushed face, fever, red lips, halitosis; 5) abdominal distension or pain, restlessness at night; 6) loss of appetite, decreased appetite; 7) dark urine 8) for adults and children who are unwilling to take purgatives orally; 9) for adults and children who have no defecation medicine by oral administration; 10) is used for children with spleen and stomach weakness and frequent food retention; 11) used for treating anorexia and poor appetite caused by food retention; 12) used for treating incomplete intestinal obstruction and emesis; 13) used for treating infantile intestinal spasm and crying at midnight; 14) used for infant uneasy sleep and rolling at night; 15) can be used for treating infantile fever due to hand and foot hearts; 16) can be used for adjuvant treatment of common diseases of children.

The invention has the beneficial effects that: 1. the clear liquid is directly absorbed by the large intestine, so that the symptoms of the children can be quickly relieved, dehydration is not easy to cause, the damage of the medicament to the liver and the kidney is avoided, the curative effect is high, and the effect is quick; 2. the medicine is easy to accept by children, does not hurt the spleen and the stomach, has no side effect, no pain, and is safe and reliable; 3. the prepared liquid clearing agent has high stability and good effect of treating food retention; 4. the liquid detergent prepared by the invention has good cleaning performance and can discharge excrement in intestinal tracts in a short time.

Detailed Description

The present invention will be described in further detail with reference to the following specific examples. The procedures, conditions, experimental methods and the like for carrying out the present invention are common knowledge and common general knowledge in the art except for the contents specifically mentioned below, and the present invention is not particularly limited to the contents.

Fructus cannabis, Shanxi province, Shanlo City, Shanzhou province.

Jujube, xingqiang county in the area of origin.

Unprocessed rehmannia root, Wu Zhu city, Wu 38495in Henan province.

Pericarpium Arecae, Dai Li City of Delhong, Yunnan province.

Figwort root, Wufeng county in Yichang city, Hubei province of Productivity.

Gan Cao, Longxi of Deng xi, Su produced in Su province.

Zhi Shi, Yu Jiang City of Hunan province in the production area.

Stir-baked radish seed, Yangyun city, folk music county, Gansu province.

Houpo, Mian Yang city of Sichuan province, North Sichuan county.

Gua Lou ren, the province of Hebei province, Anguo city.

Bai Zhu, produced in Anhui province, Mao Zhou Wei Bao.

Ginger, produced in Luo Ping county, Yunnan province.

The cellulase is purchased from Hippon Biotech limited and has an enzyme activity value of 10 ten thousand IU/g.

Sodium carboxymethylcellulose, purchased from Shandong McRong bioengineering, Inc. at food grade.

Arabic gum, purchased from Nanjing Ximenuo Biotech, Inc., grade food grade.

Chitosan with deacetylation degree not less than 90.0% was purchased from chemical reagents of national drug group, ltd.

Acetic acid, analytically pure, purchased from shin-Etsu development Co., Ltd.

Comparative example 1

A clear liquid for rectal administration of children and a preparation method thereof comprise the following steps:

s1: mixing 12g of fructus cannabis 12g of Chinese date, 12g of radix rehmanniae recen, 12g of areca peel, 12g of radix scrophulariae, 12g of liquorice, 12g of immature bitter orange, 12g of fried semen raphani, 12g of mangnolia officinalis, 7g of semen trichosanthis, 7g of rhizoma atractylodis macrocephalae and 7g of ginger, grinding into powder, sieving with a 10-mesh sieve, and mixing to obtain a traditional Chinese medicine mixture;

s2: mixing and soaking the Chinese medicinal material mixture obtained in the step S1 with 30 times of water by mass to obtain a mixed solution, adding cellulase, heating at 40 ℃ for 2 hours, then heating to 90 ℃ to inactivate enzyme for 10min, and filtering to remove residues to obtain a Chinese medicinal material extracting solution; the mass ratio of the traditional Chinese medicine mixture to the cellulase is 150: 1;

s3: adding normal saline into the traditional Chinese medicine extracting solution obtained in the step S2, fully mixing, and packaging to obtain clear effusion for rectal administration of children; the weight percentages of the traditional Chinese medicine extract and the normal saline are as follows: 60% of Chinese medicinal material extract and 40% of normal saline.

Example 1

s3: adding normal saline into the traditional Chinese medicine extracting solution obtained in the step S2, fully mixing, adding a cosolvent into the mixed solution, uniformly mixing, and packaging to obtain the clear effusion for rectal administration of children; the traditional Chinese medicine extract, the cosolvent and the normal saline are as follows by weight percent: 58% of Chinese medicinal material extract, 2% of cosolvent and 40% of normal saline; the cosolvent is sodium carboxymethyl cellulose.

Example 2

s3: adding normal saline into the traditional Chinese medicine extracting solution obtained in the step S2, fully mixing, adding a cosolvent into the mixed solution, uniformly mixing, and packaging to obtain the clear effusion for rectal administration of children; the traditional Chinese medicine extract, the cosolvent and the normal saline are as follows by weight percent: 58% of Chinese medicinal material extract, 2% of cosolvent and 40% of normal saline; the cosolvent is gum arabic.

Example 3

s2: mixing and soaking the Chinese medicinal material mixture obtained in the step S1 with water 30 times the mass of the Chinese medicinal material mixture to obtain a mixed solution, adding cellulase, heating to 40 ℃ for 2 hours, then heating to 90 ℃ to inactivate enzyme for 10min, and filtering to remove dregs of a decoction to obtain a Chinese medicinal material extracting solution; the mass ratio of the traditional Chinese medicine mixture to the cellulase is 150: 1;

s3: adding normal saline into the traditional Chinese medicine extracting solution obtained in the step S2, fully mixing, adding a cosolvent into the mixed solution, uniformly mixing, and packaging to obtain the clear effusion for rectal administration of children; the traditional Chinese medicine extract, the cosolvent and the normal saline are as follows by weight percent: 58% of Chinese medicinal material extract, 2% of cosolvent and 40% of normal saline; the cosolvent is modified Arabic gum.

The preparation method of the modified Arabic gum comprises the following steps: 0.75g of chitosan is weighed and dissolved in 50mL of 0.1mol/L acetic acid aqueous solution, then 50 mass volume concentration of 1.5% of gum arabic aqueous solution is dripped into the solution, and the reaction is carried out for 30min at 35 ℃ to obtain milk white granular modified gum arabic.

Example 4

s3: adding normal saline into the traditional Chinese medicine extracting solution obtained in the step S2, fully mixing, adding a cosolvent into the mixed solution, uniformly mixing, and packaging to obtain the clear effusion for rectal administration of children; the traditional Chinese medicine extract, the cosolvent and the normal saline are as follows by weight percent: 58% of Chinese medicinal material extract, 2% of cosolvent and 40% of normal saline; the cosolvent is prepared from the following components in a mass ratio of 3: 1 sodium carboxymethylcellulose and gum arabic.

Example 5

s3: adding normal saline into the traditional Chinese medicine extracting solution obtained in the step S2, fully mixing, adding a cosolvent into the mixed solution, uniformly mixing, and packaging to obtain the clear effusion for rectal administration of children; the traditional Chinese medicine extract, the cosolvent and the normal saline are as follows by weight percent: 58% of Chinese medicinal material extract, 2% of cosolvent and 40% of normal saline; the cosolvent is prepared from the following components in a mass ratio of 3: 1 sodium carboxymethylcellulose and modified gum arabic. The modified gum arabic was prepared in the same manner as in example 3.

Test example 1

The clear effusion for rectal administration for children prepared in the comparative example 1 and the examples 1 to 5 is subjected to stability test by adopting an ultraviolet spectrophotometry, and the specific test method is as follows:

measuring the transmittance of the clear liquid for rectal administration of children at 660nm with a 10ml cuvette in a 752 model ultraviolet spectrophotometer₁% of the total weight of the composition. Then 500mL of the clear liquid for rectal administration for children prepared in comparative example 1 and examples 1 to 5 was placed in a brown glass bottle (diameter of the brown glass bottle is 5mm, capacity is 500m), after sealing, the bottle was placed in a constant temperature and humidity test chamber at 40. + -. 2 ℃ and relative humidity of 75. + -. 5% for 6 months, and then measured with a 10mL cuvette in an ultraviolet spectrophotometer model 752 nm at a wavelength of 660nmConstant transmittance of light A₂% of the total weight of the composition. Stability (%) ═ a₂/A₁×100。

The specific test results are shown in table 1.

Table 1: children's rectal administration is with clear hydrops stability test result table

	Stability, is%
		Comparative example 1	50
Example 1	75
		Example 2	78
Example 3	83
		Example 4	88
Example 5	90

The data in table 1 show that the stability of the clear solution prepared by using the single-component cosolvent is obviously lower than that of the clear solution prepared by using the composite cosolvent, and the possible reasons are the synergistic effect of sodium carboxymethyl cellulose and gum arabic, and molecules of gum arabic and sodium carboxymethyl cellulose with negative charges are adsorbed on the surfaces of the effective components of the clear solution, so that the electrostatic repulsion and steric hindrance interaction among the particles of the effective components are improved, the hydrophilic part extends into a large amount of dispersion media to form a thicker hydration film, the steric stabilization effect is enhanced, the precipitation and precipitation of some effective components with poor water solubility are effectively reduced, and the stability of the solution is improved; the modified gum arabic has increased relative molecular mass, and the thicker the adsorption layer formed on the surface of the microparticles, the more steric stabilization is increased, so that the solution stabilizing effect is better than that of unmodified gum arabic.

Test example 2

A clear liquid for rectal administration for children prepared in comparative example 1 and examples 1 to 5 was filled in a plastic hose, and a therapeutic effect test was performed with 50mL of each liquid.

300 children patients aged 8-12 years are selected in hospital outpatient service, and the clinical manifestations are abdominal distension, abdominal pain and diarrhea caused by food retention. The liquid is divided into 6 groups at random, 50 of each group are respectively applied with the clear liquid for rectal administration of children prepared in proportion 1 and examples 1-4, 3 times a day, 1 count each time, rectal administration is carried out, and the improvement of the state of illness of patients is detected after 2 weeks.

Attention points of the infant during medication: 1. free emotion and wind-cold resistance; 2. light and easy to digest, and raw, cold, greasy and spicy foods are forbidden to eat; 3. forced feeding is forbidden, and the infant is favored to eat according to personal preference.

Index of therapeutic efficacy

Observing the defecation character, the defecation interval time, the defecation difficulty or pain condition, the defecation time each time, the abdominal pain and abdominal distension condition, the appetite condition, the halitosis, the nausea and vomiting, the feverish palms and soles, the urine color, the tongue fur pulse condition and the relapse condition of the infant patient, and judging the clinical curative effect according to the quantitative classification standard of the traditional Chinese medicine symptoms and comparing the safety indexes before and after treatment under the normal condition.

Criteria for efficacy assessment

(1) The clinical cure is as follows: the shape, the color, the quality and the taste of the excrement are normal, and no obvious discomfort exists;

(2) the effect is shown: the constipation condition is obviously improved compared with the prior condition, and no obvious discomfort exists;

(3) the method has the following advantages: the constipation condition is improved, and the rest symptoms are improved earlier;

(4) and (4) invalidation: the stool and the accompanying symptoms are not obviously improved compared with the prior art.

The specific data are shown in Table 2.

TABLE 2 patient's condition data sheet

	Recovery method	Show effect	Is effective	Invalidation
					Comparative example 1	10	8	5	27
Example 1	12	10	10	18
					Example 2	14	13	11	12
Example 3	15	13	12	10
					Example 4	18	15	11	4
Example 5	21	16	11	2

Test example 3

Evaluation of cleaning effect: 60 hospital outpatient age 8-12 years of children patients, half of men and women, were randomly divided into 6 groups, and enema tests were performed on rectal sections of patients respectively with the clear effusion prepared in comparative example 1 and examples 1-5, the dosage was 50mL, the enema was injected slowly within 10min, and the cleaning effect was evaluated.

Evaluation criteria: by adopting intestinal microscopic examination, the cleaning effect is divided into 4 grades, good, general, qualified and poor.

1. Opaque mucus does not exist at the fold of the rectum section, and the good cleaning standard is achieved;

2. no impurity residue with the diameter of more than 1mm is left in rectal intestinal endoscopy, and the general cleaning standard is reached;

3. the bowel excrement is discharged within 10min, and the rectum part is unobstructed and has no block with more than 1cm, thus the qualified cleaning standard is reached;

4. defecate did not clear, affecting intestinal patency, and was evaluated as worse.

The evaluation results are shown in Table 3:

TABLE 3 evaluation results of cleaning effect of clear liquid in comparative example 1 and examples 1 to 5

	Evaluation results
		Comparative example 1	Qualified
Example 1	In general
		Example 2	In general
Example 3	In general
		Example 4	Good effect
Example 5	Good effect

Aiming at the limitation of injection and transfusion in China at present, a plurality of doctors treat children by means of enema, but the problem that the medicines are not retained and absorbed in intestinal tracts and are directly pulled out after rectal administration is not solved at present, the medicines do not reach focus and do not have a treatment effect is solved.

The foregoing detailed description of the preferred embodiments of the invention has been presented. It should be understood that numerous modifications and variations could be devised by those skilled in the art in light of the present teachings without departing from the inventive concepts. Therefore, the technical solutions available to those skilled in the art through logic analysis, reasoning and limited experiments based on the prior art should be within the scope of the protection defined by the claims.

Claims

1. A preparation method of clear liquid for rectal administration of children is characterized by comprising the following steps:

s1: mixing fructus Cannabis, fructus Jujubae, radix rehmanniae, pericarpium Arecae, radix scrophulariae, Glycyrrhrizae radix, fructus Aurantii Immaturus, parched Raphani semen, cortex Magnolia officinalis, semen Trichosanthis, Atractylodis rhizoma, and rhizoma Zingiberis recens, grinding into powder, and mixing to obtain Chinese medicinal mixture;

s3: and (4) adding normal saline into the Chinese medicinal material extracting solution obtained in the step S2, fully mixing, adding a cosolvent into the mixed solution, uniformly mixing, and packaging to obtain the clear effusion for rectal administration of children.

2. A method of preparing a clear liquid for rectal administration to a child according to claim 1, comprising the steps of:

s1: mixing and grinding 10-15 parts of fructus cannabis, 10-15 parts of Chinese date, 10-15 parts of radix rehmanniae recen, 10-15 parts of pericarpium arecae, 10-15 parts of radix scrophulariae, 10-15 parts of liquorice, 10-15 parts of immature bitter orange, 10-15 parts of fried semen raphani, 10-15 parts of mangnolia officinalis, 5-10 parts of semen trichosanthis, 5-10 parts of rhizoma atractylodis macrocephalae and 5-10 parts of ginger into powder, and mixing to obtain a traditional Chinese medicine mixture;

s2: mixing and soaking the Chinese medicinal material mixture obtained in the step S1 with water of which the mass is 20-30 times that of the Chinese medicinal material mixture to obtain a mixed solution, adding enzyme, heating at 30-50 ℃ for 1-2 hours, then heating to 80-100 ℃ to inactivate the enzyme for 10-15min, and filtering to remove residues to obtain a Chinese medicinal material extracting solution;

3. The method of claim 1 or 2, wherein the enzyme in step S2 is one or a mixture of two or more of cellulase, pectinase, hemicellulase, papain and glucoamylase.

4. The method for preparing clear liquid for children rectal administration as claimed in claim 1 or 2, wherein the mass ratio of enzyme to Chinese medicinal material mixture in step S2 is 1: 120-150.

5. The method for preparing clear liquid for children' S rectal administration as claimed in claim 1 or 2, wherein the cosolvent in step S3 is one or a mixture of sodium carboxymethylcellulose and gum arabic.

6. A clear liquid for rectal administration to children, which is prepared by the method for preparing a clear liquid for rectal administration to children according to any one of claims 1 to 5.