CN108607057B

CN108607057B - Children's Malong cough and asthma relieving granules and preparation method thereof

Info

Publication number: CN108607057B
Application number: CN201810561075.5A
Authority: CN
Inventors: 刘景萍; 刘全国; 陈克领; 林果
Original assignee: Hainan Huluwa Pharmaceutical Group Co ltd
Current assignee: Hainan Huluwa Pharmaceutical Group Co ltd
Priority date: 2018-06-04
Filing date: 2018-06-04
Publication date: 2021-02-19
Anticipated expiration: 2038-06-04
Also published as: CN108607057A

Abstract

The invention discloses a pediatric 'Malong cough and asthma relieving granule and a preparation method thereof, wherein fried bitter almond, fried peach kernel, purified pinellia tuber, liquorice and gypsum which are used for Malong cough relieving are added with water for extraction, ephedra, earthworm, weeping forsythia capsule, white mulberry root-bark, honey radix stemonae, whiteflower hogfennel root and loquat leaf are added with ethanol for extraction, the obtained extracting solutions are combined, the obtained extracting solutions are subjected to reduced pressure concentration and drying to prepare pediatric Malong cough and asthma relieving extract powder, the obtained extract powder is matched with proper auxiliary materials, the identification items of the whiteflower hogfennel root, loquat leaf and earthworm of the obtained pediatric' Malong cough and asthma relieving granule conform to relevant regulations, the content of active ingredients of the weeping forsythia capsule is high, the mouthfeel is good, and the.

Description

Children's Malong cough and asthma relieving granules and preparation method thereof

Technical Field

The invention relates to the field of medicinal preparations, in particular to granules for relieving cough and asthma of children and a preparation method thereof.

Background

Chronic cough after upper respiratory infection refers to secondary cough after upper respiratory infection, which has persistent symptoms and persistent persistence, and is manifested as paroxysmal cough, especially at night, which is easy to attack after being affected by cold wind and pungent odor, and is difficult to cough with little phlegm.

Cough due to exogenous pathogenic factors refers to the invasion of various pathogenic factors of exogenous pathogenic factors, and also includes intrinsic factors such as insecurity of lung and defense, phlegm turbidity, perennial root, and allergy. Some patients, especially children, often suffer from cough at night, most of which are asthma, but the patients have no asthma symptoms during the day, so the patients are not easy to find out by doctors, and most of the patients have the obvious effect when being treated by asthma.

The cough and asthma relieving granule of the pediatric ephedra, rhizoma gastrodiae and radix clematidis can relieve cough, resolve phlegm, relieve asthma and resist allergy, which is the key point of the diseases, and eight ingredients are cooperated to relieve asthma if the asthma is generated, and to treat cough if the asthma is not generated, so the recipe is obvious. The cough-relieving powder is originally a good prescription for relieving cough, and the former praise has the ideal effects of eliminating phlegm, dredging lung and relieving cough, and has no disadvantage of leaving pathogen of the open-door studios. The medicine has the best effect on exogenous cough, and is most ideal, convenient, effective and cheap. Cough-relieving powder is the basic formula for patients with no trend of cold or heat. The functions are as follows: clear lung heat and resolve phlegm, disperse wind-cold, direct qi downward to relieve cough. The main treatment is as follows: can be used for treating recurrent cough, especially sticky phlegm, difficult expectoration, nasal obstruction and nasal discharge, and allergic cough with symptoms due to phlegm heat, wind cold, heat transformation due to depression, phlegm-heat accumulation, lung disorder, and adverse rising of qi.

The modern pharmacological research result is as follows: the low-concentration ephedrine or pseudoephedrine in the ephedra can cause the bronchiectasis, has more obvious effect on the bronchiectasis in a contraction state, and can relieve the increase of the respiratory resistance of dogs caused by histamine or acetylcholine; ephedrine has central antitussive effect, and can relax bronchial smooth muscle, so it can relieve asthma.

The earthworm 90% alcohol extract has a remarkable effect of relaxing bronchus, hypoxanthine and succinic acid contained in the earthworm can relax bronchus, and resist bronchoconstriction caused by histamine, pilocarpine and pilocarpine, so that the outflow rate of the earthworm is increased by more than 2-3 times; the amino acids extracted from Lumbricus also have effects of relieving asthma and spasm as proved by guinea pig histamine spray test.

The decomposition of bitter apricot seed and peach kernel in vivo produces a trace amount of hydrocyanic acid, which will not cause poisoning and has the function of tranquilizing respiratory center. The peucedanum root can obviously increase the amount of respiratory tract secretion, which indicates that the peucedanum root has the function of eliminating phlegm and has long action time. Fructus forsythiae may have antiallergic effect, and release of allergic medium in lung slice of sensitized guinea pig under antigen stimulation is reduced significantly due to 1 × 10-3g/ml fructus forsythiae ethanol extractive solution.

The decoction of unprocessed rhizoma pinelliae, ginger processed rhizoma pinelliae, ginger soaked rhizoma pinelliae and alum processed rhizoma pinelliae is 0.6-1g/kg for intragastric administration or intravenous injection, has obvious cough relieving effect on cough caused by the injection of cat iodine solution into the thoracic cavity or the electrical stimulation of the superior laryngeal nerve, and can be maintained for more than 5 hours. The mixed solution of alum and water-prepared pinellia has obvious cough relieving effect, and the effect is slightly stronger than that of the raw product and the old prepared product. The crude products of pinellia tuber and rhizoma Pinelliae Cordatae and the alcohol extracts of the new and old processed products are used for gastric lavage of mice, and the new and old processed products of pinellia tuber and rhizoma Pinelliae Cordatae have obvious effect of eliminating phlegm by phenol red process.

The amygdalin contained in the loquat leaves can be gradually decomposed in the digestive tract to generate a trace amount of hydrocyanic acid, but the toxicity of the organism can not be caused, and a certain cough relieving effect is achieved; the decoction and ethyl acetate extract have expectorant and antiasthmatic effects, and the oil and fat also have mild expectorant effect. Cortex Mori has mild antitussive effect. Glycyrrhizic acid at a concentration of 0.46mmol/L can inhibit mast cell degranulation caused by histamine release agent-compound 48/80, thereby preventing release of allergic mediator; the liquorice can also promote the secretion of throat and bronchus, so that sputum is easy to cough out, and the effects of eliminating phlegm and relieving cough are presented.

In 2002, supplement and periodical of 2 nd volume of tropical medicine in China, 84 cases of curative effects of 'Malong Zhike Tang' for treating exogenous cough are reported, namely, the 'Malong Zhike' is a self-prepared prescription, and a basic prescription consisting of 8 medicaments of ephedra, earthworm, liquorice, dried orange peel, radix stemonae, aster, platycodon grandiflorum and cynanchum glaucescens is mainly used for treating various exogenous cough. Through the observation of 84 clinical treatments, 52 cases of obvious effect, 21 cases of effective effect and 11 cases of ineffective effect are achieved, and the total effective rate is 86.9%. Has the characteristics of convenience, low price, effectiveness and suitability for both children and adults.

Exogenous cough is caused by various causes such as exogenous wind pathogen and internal injury. From 10 months to 2000 months in 1999, the cough relieving formula of the pseudoephedrine hydrochloride shows 52 cases of obvious effect, 21 cases of effect and 1 case of no effect and has the total effective rate of 86.90 percent through clinical treatment observation of material cases in outpatient service. The formula has the characteristics of convenience, effectiveness and suitability for both the old and the young, and is suitable for the medical needs of the masses in the social area.

The Chinese patent with the application number of 201410040365.7 discloses a Malong cough-relieving granule and a preparation method thereof, which is prepared from 1 part of Malong cough-relieving and asthma-relieving extract powder, 1 to 100 parts of filler, 0.2 to 15 parts of thickener, 0.3 to 10 parts of adhesive and 0.1 to 8 parts of flavoring agent; the Malong cough and asthma relieving extract powder is prepared by extracting 12 medicinal materials in groups by adding water, and the obtained Malong cough and asthma relieving granules are quickly dissolved in water to form clear and transparent solution with good taste, so that the Malong cough and asthma relieving extract powder is convenient to take and high in bioavailability. The invention extracts all the medicinal materials by water, which can affect the content of effective components of the peucedanum root, the loquat leaf and the earthworm in the product, and causes the lower and unstable content of the effective components of the peucedanum root, the loquat leaf and the earthworm.

Disclosure of Invention

The invention aims to provide a preparation method of cough and asthma relieving granules of polietilenii with controllable quality and high content of effective components, which improves the content and stability of the effective components of the peucedanum root, the loquat leaf and the earthworm in the product, ensures that the identification items of the peucedanum root, the loquat leaf and the earthworm in the product all accord with relevant regulations, and simultaneously improves the content of forsythiaside in the product.

A preparation method of a cough and asthma relieving granule for children comprises the following steps:

(1) adding water into fried bitter apricot kernels, fried peach kernels, purified pinellia tuber, liquorice and gypsum for extracting for 2 times, wherein each time lasts for 1-3 hours, the amount of water for the first time is 5-15 times of the total weight of the five medicinal materials, and the amount of water for the second time is 3-14 times of the total weight of the five medicinal materials, combining extracting solutions obtained in the two times, filtering, concentrating under reduced pressure, cooling, slowly adding ethanol under the stirring condition until the alcohol content of the solution is 65-85%, standing for 24 hours, and filtering and taking supernate to obtain an extracting solution A;

(2) extracting seven ingredients of ephedra, earthworm, forsythia, white mulberry root-bark, honey stemona root, whiteflower hogfennel root and loquat leaf for 2 times by using 55-80% of ethanol, wherein the dosage of the ethanol in two times is 4-14 times of the total weight of the seven ingredients, refluxing for 0.5-3 hours each time, filtering extracting solutions, and combining to obtain an extracting solution B;

(3) mixing the extract A and the extract B, and concentrating under reduced pressure to obtain a concentrated solution; drying the obtained concentrated solution under reduced pressure to obtain extract powder of XIAO ER MA LONG for relieving cough and asthma;

(4) uniformly mixing the pediatric Malong cough and asthma relieving extract paste powder obtained in the step (3) with a filler and a flavoring agent to obtain a mixture, adding a binder to prepare a soft material, granulating the soft material, drying and finishing granules to obtain the pediatric Malong cough and asthma relieving granules;

wherein the weight parts of the medicinal materials are as follows:

1-3 parts of fried bitter almond, 1-3 parts of fried peach kernel, 2-4 parts of purified pinellia tuber, 1-2 parts of liquorice, 4-9 parts of gypsum, 1-2 parts of ephedra, 1-3 parts of earthworm, 1-3 parts of weeping forsythia, 1-3 parts of white mulberry root-bark, 1-3 parts of honey radix stemonae, 1-3 parts of whiteflower hogfennel root and 2-4 parts of loquat leaf;

the weight parts of the raw materials in the step (4) are as follows:

the cough and asthma relieving extract powder comprises, by weight, 1 part of an extract powder of polietilenii, 1-50 parts of a filler, 0.05-5 parts of a flavoring agent and 0.2-5 parts of a binder.

The peucedanum root can obviously increase the amount of respiratory tract secretion, which indicates that the peucedanum root has the function of eliminating phlegm and has long action time. The amygdalin contained in the loquat leaves can be gradually decomposed in the digestive tract to generate a trace amount of hydrocyanic acid, but the toxicity of the organism can not be caused, and a certain cough relieving effect is achieved; the decoction and ethyl acetate extract have expectorant and antiasthmatic effects, and the oil and fat also have mild expectorant effect. The earthworm 90% alcohol extract has a remarkable effect of relaxing bronchus, hypoxanthine and succinic acid contained in the earthworm can relax bronchus, and resist bronchoconstriction caused by histamine, pilocarpine and pilocarpine, so that the outflow rate of the earthworm is increased by more than 2-3 times; the amino acids extracted from Lumbricus also have effects of relieving asthma and spasm as proved by guinea pig histamine spray test.

Based on the advantages of the whiteflower hogfennel root, the loquat leaf and the earthworm, the invention aims at the problem that the content of the whiteflower hogfennel root, the loquat leaf and the earthworm is low and unstable in the product caused by extracting the medicinal materials by water in the prior art, twelve medicinal materials are selected to be extracted by different solvents in groups according to respective characteristics of each medicinal material, wherein, fried bitter apricot seed, fried peach seed, purified pinellia tuber, liquorice and gypsum are extracted by adding water, and seven medicaments of ephedra, earthworm, forsythia, cortex mori radicis, honey radix stemonae, whiteflower hogfennel root and loquat leaf are extracted by adding ethanol.

When the peucedanum root, the loquat leaf and the earthworm are extracted by ethanol, the content of the effective components of the three medicinal materials in the obtained product is high and stable; however, when the product is extracted by water, the content of the active ingredients of the three medicinal materials in the obtained product is low and unstable, so the method improves the content and stability of the active ingredients of the peucedanum root, the loquat leaf and the earthworm in the product, and the identification items of the peucedanum root, the loquat leaf and the earthworm in the product all conform to relevant regulations.

The extraction rate of the ephedra herb is slightly higher than that of the water, so the ephedra herb is extracted by the ethanol, and the ephedra herb, the fried bitter almond and the fried peach kernel are decocted together, which has no influence on the content of the amygdalin, but the total amount of the ephedrine is slightly different.

Fructus forsythiae has anti-inflammatory and antiallergic effects, forsythiaside is the main effective component in folium forsythiae, and the extraction process research of the forsythiaside shows that: the forsythiaside content in the product obtained by water extraction is low and unstable, but when the ethanol dosage is strictly controlled, the forsythiaside content in the product obtained by 2 times of ethanol extraction is obviously improved compared with the prior product, because the ethanol extraction can promote the effective component forsythiaside to be fully dissolved out.

On the contrary, the extraction rate of the effective components of the roasted bitter apricot seeds, the roasted peach seeds, the liquorice and the gypsum is higher when the roasted bitter apricot seeds, the roasted peach seeds, the liquorice and the gypsum are extracted by water than when the effective components are extracted by ethanol, and the toxicity of the rhizoma pinelliae can be reduced only when the rhizoma pinelliae is extracted by water.

Preferably, the temperature of the reduced pressure concentration in the step (1) is 60-85 ℃, the vacuum degree is 0.01-0.08 MPa, and the concentration is carried out to obtain a concentrated solution with the relative density of 1.05-1.35, so as to ensure that the active ingredients in the product are not lost in the concentration process.

Preferably, the temperature of the reduced pressure concentration in the step (3) is 65-85 ℃, the vacuum degree is 0.01-0.08 MPa, and the concentration is carried out to obtain a concentrated solution with the relative density of 1.15-1.35, so as to ensure that the effective components are not lost in the concentration process, shorten the production period and further ensure that the subsequent identification items meet the relevant regulations.

Preferably, the fillers in the step (4) are any two of glucose, sucrose, mannitol, fructose, dextrin and sodium cyclamate, and based on the characteristics of high water content, strong hygroscopicity, easy agglomeration and poor fluidity of the extract powder for relieving cough and asthma of the poliomtelukinum, auxiliary materials are added to improve the physical characteristics of the extract powder, so that the prepared granules have more stable and reliable quality, better granule forming property and better fluidity and dissolubility, are convenient for patients to take, and are suitable for large-scale production.

More preferably, the filler in step (4) is sucrose powder and dextrin, which can further ensure the moldability, flowability and dissolubility of the obtained granules.

Preferably, the flavoring agents in the step (4) are any three of citric acid, sodium cyclamate, aspartame and stevioside, the taste is critical because the product is taken by children, and the optimal taste can be achieved by selecting the three flavoring agents only because the sweetness of the sucrose powder can not cover the bitterness of the traditional Chinese medicine.

Preferably, the binder in step (4) is ethanol with a concentration of 75-90%, so as to ensure that the granulation formability is high and the prepared granules have moderate color and luster and hardness.

Preferably, in the step (4), the drying temperature is 40-70 ℃ and the drying time is 6-10 h, so that the effective components are not damaged, and the final yield of the product, the moisture of the product and the content of fructus forsythiae of the product are ensured.

Preferably, in the step (4), the particle diameters of the extract powder, the filler and the flavoring agent for relieving cough and asthma of the pediatric ephedra herb are not more than 80 meshes, so as to avoid uneven particle color caused by overlarge particle size.

The invention also provides the granules for relieving cough and asthma of children prepared by the method.

The raw medicinal materials adopted by the invention are specifically described as follows:

raw ephedra: pungent, slightly bitter and warm herbs enter lung and bladder meridians, and have the actions of dispelling wind-cold and dispersing lung qi, so they are the essential herb for treating cough and dyspnea due to lung qi obstruction.

Earthworm: salty and cold herbs enter liver, spleen and bladder meridians, and have the actions of clearing heat, dredging collaterals, relieving spasm and relieving asthma. The two medicines are used together to clear heat, ventilate lung, disperse wind-cold, check adverse rise of qi and arrest vomiting.

Bitter apricot seeds: bitter and slightly warm, entering lung and large intestine meridians, directing qi downward to relieve cough and dyspnea.

Stemona root: pungent, bitter and slightly warm, enter lung meridian, moisten lung and descend qi to relieve cough.

Loquat leaf: bitter and slightly cold, entering lung and stomach meridians, clearing lung heat to relieve cough, checking adverse flow of qi to arrest vomiting.

Clearing pinellia tuber: pungent and warm in property, enter spleen, stomach and lung meridians, dry dampness and resolve phlegm, check adverse rise of qi and arrest vomiting. The four medicines are combined, so the effect of the traditional Chinese medicine is on descending qi, eliminating phlegm and relieving cough, and the traditional Chinese medicine has good effect on treating new chronic cough and is a ministerial medicine.

Raw gypsum: sweet, pungent and cold in nature, entering lung and stomach meridians, clearing heat and purging fire;

fructus forsythiae: bitter and slightly cold, entering lung, heart and small intestine channels, clearing away heat and toxic materials, and dispelling wind and heat;

white mulberry root-bark: sweet and cold, entering lung meridian, clearing lung heat, descending qi and relieving asthma;

radix peucedani: pungent, bitter and slightly cold, entering lung meridian, directing qi downward and resolving phlegm, dispersing wind and clearing heat. The four herbs are cold and cool ones, which can help earthworm to clear lung heat, and ephedra to dredge exterior and assist the warm nature of ephedra, and are used as ministerial and adjuvant drugs.

Peach kernel: bitter, sweet and mild, which is responsible for heart, liver and large intestine channels, activates blood and removes stasis, moistens intestines and relieves constipation, relieves cough and asthma, and is beneficial to preventing and treating the symptoms of blood stasis caused by lung qi loss, dispersion and descending and qi activity disorder besides strengthening the cough and asthma relieving effect of the ministerial drug almond;

raw licorice root: sweet and neutral, enter heart, lung, spleen and stomach meridians, and have the effects of clearing away heat and toxic material, expelling phlegm and arresting cough, and harmonizing the drugs. The two herbs are used together as adjuvant drugs.

Compared with the prior art, the invention has the following beneficial effects:

(1) the method divides the twelve medicinal materials into two groups according to the respective characteristics of each medicinal material, extracts the medicinal materials with water and ethanol twice respectively, and strictly controls the dosage of the water and the ethanol at the same time, so that the identification of the peucedanum root, the loquat leaf and the earthworm in the obtained granules for relieving cough and asthma of the children Malong accords with relevant regulations, and simultaneously, the content of the effective components of the forsythia in the product is also improved;

(2) the method of the invention selects three flavoring agents to use together, so that the best taste can be achieved, and the special requirements on the taste when the flavoring agent is taken by children are met;

(3) the method has the advantages of simple operation, no need of any special equipment, low cost and high yield, and is suitable for industrial production.

Detailed Description

Example 1

(1) Adding water into 330g of fried bitter apricot kernels, 360g of fried peach kernels, 380g of rhizoma pinelliae preparata, 210g of liquorice and 1110g of gypsum for extraction for 2 times, each time lasting for 1.5 hours, adding 8 times of water for the first time and 6 times of water for the second time, combining extracting solutions, filtering, concentrating under reduced pressure at the temperature of 60 ℃ and the vacuum degree of 0.08MPa until the relative density is 1.10, cooling, slowly adding ethanol under the stirring condition until the alcohol content of the solution is 75%, standing for 24 hours, and filtering to obtain a supernatant to obtain an extracting solution A;

(2) extracting 220g of ephedra, 260g of earthworm, 330g of forsythia, 340g of cortex mori, 310g of honey radix stemonae, 330g of radix peucedani and 380g of folium eriobotryae with 65% ethanol for 2 times, adding 10 times of ethanol for the first time and 8 times of ethanol for the second time, refluxing for 1 hour each time, filtering the extracting solutions, and combining to obtain an extracting solution B;

(3) mixing the extractive solution A and the extractive solution B, standing, and concentrating under reduced pressure at 65 deg.C and vacuum degree of 0.03MPa to obtain concentrated solution with relative density of 1.15; then the obtained concentrated solution is dried under reduced pressure to prepare 396g of extract powder of the pediatric ephedra stem for relieving cough and asthma;

(4) sieving extract powder and sucrose powder of XIAO ER MA LONG for use with 80 mesh sieve; the cough and asthma relieving extract powder of the pediatric moccasin, 396g, the sucrose powder 345g, the dextrin 241g, the citric acid 20g, the sodium cyclamate 8g and the aspartame 4g are uniformly mixed to obtain a mixture, 62g of 75% ethanol is added to prepare a soft material, the soft material is dried at the temperature of 60 ℃ for 8 hours to obtain granules, and the granules are packaged into 6 g/bag and 167 bags in total.

Example 2

(1) Adding water into 220g of fried bitter almond, 320g of fried peach kernel, 240g of rhizoma pinelliae preparata, 250g of liquorice and 1090g of gypsum for extracting for 2 times, wherein each time is 1.5 hours, 9 times of water is added for the first time, 7 times of water is added for the second time, the extracting solutions are combined, filtered, decompressed and concentrated under the conditions that the temperature is 70 ℃ and the vacuum degree is 0.05MPa until the relative density is 1.10, cooled, slowly added with ethanol under the stirring condition until the alcohol content of the solution is 80 percent, kept stand for 24 hours, and filtered to obtain a supernatant fluid A;

(2) extracting 280g of ephedra, 160g of earthworm, 360g of fructus forsythiae, 200g of cortex mori radicis, 250g of honey radix stemonae, 290g of radix peucedani and 270g of folium eriobotryae with 65% ethanol for 2 times, adding 12 times of ethanol for the first time and 10 times of ethanol for the second time, refluxing for 1 hour each time, filtering the extracting solutions, and combining to obtain an extracting solution B;

(3) mixing the extractive solution A and the extractive solution B, standing, and concentrating under reduced pressure at 80 deg.C and vacuum degree of 0.05MPa to obtain concentrated solution with relative density of 1.35; drying the obtained concentrated solution under reduced pressure to obtain 380g of extract powder of the pediatric ephedra stem for relieving cough and asthma;

(4) sieving extract powder and sucrose powder of XIAO ER MA LONG for use with 80 mesh sieve; 380g of extract powder of the cough and asthma relieving pediatric melastoma herb extract, 405g of sucrose powder, 201g of dextrin, 20g of citric acid, 9g of sodium cyclamate and 9g of aspartame are uniformly mixed to obtain a mixture, 53g of 80% ethanol is added to prepare a soft material, the soft material is dried at 70 ℃ for 6 hours to obtain granules, and the granules are packaged into 6 g/bag and 169 bags in total.

Example 3

(1) Adding water into 280g of fried bitter almond, 380g of fried peach kernel, 310g of rhizoma pinelliae preparata, 180g of liquorice and 1130g of gypsum for extraction for 2 times, adding 9 times of water for the first time, and extracting for 1.5 hours; adding 7 times of water for the second time, extracting for 2 hours, combining the extracting solutions, filtering, concentrating under reduced pressure at 85 ℃ and under the vacuum degree of 0.06MPa until the relative density is 1.20, cooling, slowly adding ethanol under the stirring condition until the alcohol content of the solution is 80%, standing for 24 hours, and filtering to obtain a supernatant to obtain an extracting solution A;

(2) extracting 200g of ephedra, 260g of earthworm, 310g of fructus forsythiae, 380g of cortex mori radicis, 340g of honey radix stemonae, 190g of radix peucedani and 320g of folium eriobotryae with 65% ethanol for 2 times, adding 12 times of ethanol for the first time and 10 times of ethanol for the second time, refluxing for 1 hour each time, filtering the extracting solutions, and combining to obtain an extracting solution B;

(3) mixing the extractive solution A and the extractive solution B, standing, and concentrating under reduced pressure at 70 deg.C and vacuum degree of 0.06MPa to obtain concentrated solution with relative density of 1.31; then, the obtained concentrated solution is dried under reduced pressure to prepare 408g of extract powder of the pediatric ephedra stem for relieving cough and asthma;

(4) sieving extract powder and sucrose powder of XIAO ER MA LONG for use with 80 mesh sieve; 408g of extract powder of the cough and asthma relieving pediatric melastoma herb, 350g of sucrose powder, 180g of dextrin, 40g of citric acid, 20g of sodium cyclamate and 6g of aspartame are uniformly mixed to obtain a mixture, 58g of 80% ethanol is added to prepare a soft material, the soft material is dried at 60 ℃ for 8 hours to obtain granules, and the granules are packaged into 6 g/bag, and 164 bags are used together.

Example 4

(1) Adding water into 350g of fried bitter apricot kernels, 370g of fried peach kernels, 290g of rhizoma pinelliae preparata, 220g of liquorice and 1150g of gypsum for extraction for 2 times, adding 10 times of water for the first time, and extracting for 1.5 hours; adding 8 times of water for the second time, extracting for 2 hours, combining the extracting solutions, filtering, concentrating under reduced pressure at 65 ℃ and under the vacuum degree of 0.04MPa until the relative density is 1.10, cooling, slowly adding ethanol under the stirring condition until the alcohol content of the solution is 85%, standing for 24 hours, and filtering to obtain a supernatant to obtain an extracting solution A;

(2) extracting 240g of ephedra, 280g of earthworm, 270g of fructus forsythiae, 350g of cortex mori radicis, 310g of honey radix stemonae, 210g of radix peucedani and 300g of folium eriobotryae with 75% ethanol for 2 times, adding 14 times of ethanol for the first time and 12 times of ethanol for the second time, refluxing for 1 hour each time, filtering the extracting solutions, and combining to obtain an extracting solution B;

(3) mixing the extractive solution A and the extractive solution B, standing, and concentrating under reduced pressure at 80 deg.C and vacuum degree of 0.05MPa to obtain concentrated solution with relative density of 1.30; drying the obtained concentrated solution under reduced pressure to obtain 412g of extract powder of rhizoma Gastrodiae, radix Aconiti Kusnezoffii, and radix Aconiti Kusnezoffii for relieving cough and asthma;

(4) sieving extract powder and sucrose powder of XIAO ER MA LONG for use with 80 mesh sieve; 412g of extract powder of the pediatric moccasia caspuli for relieving cough and asthma, 360g of sucrose powder, 190g of dextrin, 16g of citric acid, 7g of sodium cyclamate and 7g of aspartame are uniformly mixed to obtain a mixture, 59g of 90% ethanol is added to prepare a soft material, the soft material is dried at 40 ℃ for 10 hours to obtain granules, and the granules are packaged into 6 g/bag, and 163 bags in total.

Comparative example 1

(1) Adding water into 220g of ephedra herb, 330g of fried bitter apricot seed, 360g of fried peach seed, 330g of whiteflower hogfennel root, 310g of honey stemona root and 330g of weeping forsythia fruit for extracting for 2 times, 1.5 hours each time, 8 times of water is added for the first time, 6 times of water is added for the second time, the extracting solutions are combined and filtered, the pressure is reduced and concentrated under the conditions that the temperature is 60 ℃ and the vacuum degree is 0.08MPa until the relative density is 1.10, the cooling and the standing are carried out for 24 hours, and the supernatant is filtered to obtain the extracting solution A;

(2) adding water into 260g of earthworm, 380g of rhizoma pinelliae preparata, 380g of loquat leaf, 340g of white mulberry root-bark, 1110g of gypsum and 210g of liquorice for extracting for 2 times, 1 hour each time, adding 10 times of water for the first time and 8 times of water for the second time, filtering the extracting solution, and combining to obtain an extracting solution B;

(3) mixing the extractive solution A and the extractive solution B, standing, and concentrating under reduced pressure at 65 deg.C and vacuum degree of 0.03MPa to obtain concentrated solution with relative density of 1.15; then, the obtained concentrated solution is dried under reduced pressure to prepare 382g of the Malong cough and asthma relieving extract powder;

(4) sieving extract powder and sucrose powder of XIAO ER MA LONG for use with 80 mesh sieve; mixing 382g of Malong cough and asthma relieving extract powder, 345g of sucrose powder, 241g of dextrin and 4g of aspartame uniformly to obtain a mixture, adding 62g of 75% ethanol to prepare a soft material, drying at 60 ℃ for 8h to obtain granules, and subpackaging into 6 g/bag and 160 bags in total.

Comparative example 2

(1) Adding water of 6 times of the weight of medicinal materials into 300g of ephedra herb, 500g of fried bitter almond, 500g of peach seed, 500g of whiteflower hogfennel root, 500g of honey stemona root and 500g of weeping forsythia, boiling, warm-soaking at 60 ℃ for 3 times for 2 hours each time, combining warm-soaking solutions for later use, and removing medicine residues for later use;

(2) adding water with the weight of 6 times of that of earthworm 400g, pinellia ternate 600g, loquat leaf 600g, mulberry bark 500g, gypsum 1800g and liquorice 300g into the raw materials, boiling, warm-soaking at 50 ℃ for 3 times, 2 hours each time, combining warm-soaking solutions for later use, and discarding medicine residues for later use;

(3) mixing the extractive solutions of (1) and (2), standing, filtering, and concentrating the filtrate under low pressure (vacuum degree of 0.05MPa, temperature of 55 deg.C, relative density of concentrated solution of 1.125);

(4) and (4) spray-drying the concentrated solution obtained in the step (3) (at the air inlet temperature of 120 ℃ and the air outlet temperature of 90 ℃) to obtain 486g of the medicinal powder of the cough relieving extract of the Indian mockstrawberry herb.

Sieving the Malong cough relieving extract powder and hypromellose K4M with 80 mesh sieve respectively, and sieving sucrose with 80 mesh sieve for use.

The method comprises the steps of uniformly mixing 486g of 'Malong' cough-relieving extract powder, 7290g of hydroxypropyl methylcellulose K4M 98g and 50g of stevioside to obtain a mixture, adding cane sugar into the mixture for 2 times, wherein the adding amount of cane sugar is 7290g each time, uniformly mixing after adding cane sugar each time, then adding 243g of 1% polyvinylpyrrolidone and 50% ethanol water solution to prepare a soft material (wherein 1% of the prepared solution is the mass concentration of polyvinylpyrrolidone, and the volume ratio of 50% ethanol water to the solvent is 1: 1), drying at 60-80 ℃ after granulating, drying for 2 hours, granulating, and subpackaging to obtain the 'Malong' cough-relieving granule.

Comparative example 3

(1) Adding water with the weight of 8 times of the medicinal materials into 360g of ephedra herb, 530g of fried bitter apricot seed, 530g of peach seed, 530g of whiteflower hogfennel root, 530g of honey stemona root and 530g of weeping forsythia, boiling, warm-soaking at 65 ℃ for 3 times, 2 hours each time, combining warm-soaking solutions for later use, and removing medicine residues for later use;

(2) adding water with the weight of 8 times of that of earthworm 430g, rhizoma pinelliae preparata 610g, loquat leaf 610g, mulberry bark 530g, gypsum 1820g and liquorice 360g into water, boiling, warm-soaking at 60 ℃ for 3 times, 2 hours each time, combining warm-soaking solutions for later use, and discarding medicine residues for later use;

(3) mixing the extractive solutions of (1) and (2), standing, filtering, and concentrating the filtrate under low pressure (vacuum degree of 0.04MPa, temperature of 55 deg.C, relative density of concentrated solution of 1.15);

(4) and (4) carrying out spray drying on the concentrated solution obtained in the step (3) (at the air inlet temperature of 165 ℃ and the air outlet temperature of 120 ℃) to obtain 492g of the cough-relieving extract powder of the mockstrawberry herb.

492g of ' Julong cough relieving extract powder, 35102 g of hydroxypropyl methylcellulose K4 and 56g of litchi essence are uniformly mixed to obtain a mixture, lactose is added into the mixture for 2 times, the addition amount of lactose is 7740g each time, the lactose is added each time and then uniformly mixed, 252g of 50% ethanol aqueous solution of 2% polyethylene glycol is added to prepare a soft material, the soft material is granulated and dried at 75 ℃ for 3.5 hours, and granules are finished and subpackaged to obtain the ' Julong cough relieving granules '.

The quality of the granules for relieving cough and asthma respectively prepared in examples 1 to 4 and comparative examples 1 to 3 is tested according to the general rules of four preparations and one part of the general rules of Chinese pharmacopoeia 2015, and in the identification experiment of peucedanum root, loquat leaf and earthworm, whether the chromatogram of a test sample shows obvious homochromy spots at the corresponding positions of the chromatogram of a reference medicinal material is observed, when the obvious homochromy spots are shown, the regulations are met, otherwise, the regulations are not met, and the specific test results are shown in the following table:

as can be seen from the table, the identification terms of the peucedanum root, the loquat leaf and the earthworm in the granules for relieving cough and asthma for children obtained in examples 1 to 4 all meet the regulations, which indicates that the content of the effective components of the peucedanum root, the loquat leaf and the earthworm in the obtained product is stable and the extraction rate of the effective components is high; in addition, the product has high content of effective components of fructus forsythiae and good taste. However, the identification items of the peucedanum praeruptorum, the loquat leaves and the earthworms in the granules obtained in the comparative examples 1 to 3 partially do not meet the regulations, which indicates that the contents of the effective components of the peucedanum praeruptorum, the loquat leaves and the earthworms in the obtained product are unstable; in addition, the content of the active ingredients of the forsythia suspense in the product is relatively low.

Claims

1. A preparation method of a cough and asthma relieving granule for children comprises the following steps:

(4) uniformly mixing the pediatric Malong cough and asthma relieving extract paste powder obtained in the step (3) with a filler and a flavoring agent to obtain a mixture, adding a binder to prepare a soft material, granulating the soft material, drying and finishing granules to obtain the pediatric Malong cough and asthma relieving granules; the adhesive in the step (4) is ethanol with the concentration of 75-90%; the drying temperature is 40-70 ℃, and the drying time is 6-10 h;

wherein the weight parts of the medicinal materials are as follows:

the weight parts of the raw materials in the step (4) are as follows:

2. The method for preparing granules for relieving cough and asthma of children according to claim 1, wherein in the step (1), the temperature for decompression and concentration is 60-85 ℃, the vacuum degree is 0.01-0.08 MPa, and the granules are concentrated to a concentrated solution with the relative density of 1.05-1.35.

3. The method for preparing granules for relieving cough and asthma of children according to claim 1, wherein in the step (3), the temperature of reduced pressure concentration is 65-85 ℃, the vacuum degree is 0.01-0.08 MPa, and the concentration is carried out until the relative density is 1.15-1.35.

4. The method for preparing granules for relieving cough and asthma of children according to claim 1, wherein the bulking agent in step (4) is any two of glucose, sucrose powder, mannitol, fructose, dextrin, and sodium cyclamate.

5. The method for preparing granules for relieving cough and asthma of children according to claim 1, wherein the filler in step (4) is sucrose powder and dextrin.

6. The method for preparing granules for relieving cough and asthma of children according to claim 1, wherein the flavoring agent in step (4) is any three of citric acid, sodium cyclamate, aspartame and stevioside.

7. The method for preparing children's Malong cough and asthma relieving granules according to claim 1, wherein in the step (4), the granule particle sizes of the children's Malong cough and asthma relieving extract powder, the filler and the flavoring agent are not more than 80 meshes.

8. An infantile Malong cough and asthma relieving granule, which is prepared by the method of any one of claims 1 to 7.