CN104127761A - Children's soft preparation for strengthening stomach and promoting digestion and preparation method thereof - Google Patents
Children's soft preparation for strengthening stomach and promoting digestion and preparation method thereof Download PDFInfo
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- CN104127761A CN104127761A CN201410355376.4A CN201410355376A CN104127761A CN 104127761 A CN104127761 A CN 104127761A CN 201410355376 A CN201410355376 A CN 201410355376A CN 104127761 A CN104127761 A CN 104127761A
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Abstract
The invention discloses a children's soft preparation for strengthening stomach and promoting digestion and a preparation method thereof. The soft preparation contains a traditional Chinese medicinal composition and other auxiliary materials which are used together to prepare the soft preparation. The traditional Chinese medicinal composition comprises chicken's gizzard membrane, haw, malt or millet sprout and dried orange peel. The soft preparation has efficacy of strengthening stomach and promoting digestion and has a unique taste of common candies.
Description
Technical field
The present invention relates to a kind of soft pharmaceutics, particularly relate to a kind of children's's invigorating the stomach and promoting digestion soft pharmaceutics and preparation method thereof.
Background technology
In real life, the main crowd of food stagnation is child, and poor to the ability to accept of general formulation, drug compliance is poor, and the outward appearance mouthfeel of medicine can directly have influence on application and the curative effect of medicine; In view of the continuous lifting of medical development and preparation technique, urgently develop a kind of pharmaceutical preparation of being accepted by child of being relatively easy to, particularly taking child as the main medicine that uses object, such as the higher quasi drugs that helps digestion of children taking rate.
How the formulation method of pharmaceutics and foods processing technique are carried out to combination, make the soft pharmaceutics that is easy to be accepted by children population, medicine is dispersed in software substrate, and child patient can better, be the problem that the present invention need to solve taking compliance in process.
Summary of the invention
Object of the present invention provides a kind of children's's invigorating the stomach and promoting digestion soft pharmaceutics and preparation method thereof for the problems referred to above exactly.Effect of the existing invigorating the stomach and promoting digestion of soft pharmaceutics of the present invention, has again unique mouthfeel of common confection.
A kind of children's's invigorating the stomach and promoting digestion of one of the present invention soft pharmaceutics and preparation method thereof technical scheme is that this children's's invigorating the stomach and promoting digestion soft pharmaceutics comprises Chinese medicine composition and other adjuvants; The contained Chinese medicine composition of this soft pharmaceutics comprises Endothelium Corneum Gigeriae Galli, Fructus Crataegi, Fructus Hordei Germinatus or Fructus Setariae Germinatus, Pericarpium Citri Reticulatae; Described soft pharmaceutics is soft sweet, soft chewable tablet, QQ sugar, pudding, refreshing tablets or chewing gum.
Described adjuvant, comprises gelatin or epoxy glue, and epoxy glue comprises at least two kinds in carrageenan, gelatin, pectin, agar, Rhizoma amorphophalli powder etc.
Described adjuvant also comprises correctives, and correctives comprises at least one in sweeting agent and aromatic.
Sweeting agent is at least one in sucrose, simple syrup, syrupus aromaticus, stevioside, sorbitol, mannitol, protein sugar, maltose syrup, modified starch, starch syrup; Aromatic is at least one in natural perfume material, essence.
Adjuvant also comprises antiseptic, and antiseptic comprises at least one in potassium sorbate, sorbic acid, benzoic acid, sodium benzoate.
Chinese medicine composition comprises following composition by weight: Endothelium Corneum Gigeriae Galli 2-10 part, Fructus Crataegi 80-150 part, Pericarpium Citri Reticulatae 6-25 part, Fructus Hordei Germinatus or Fructus Setariae Germinatus 60-180 part.Described Fructus Hordei Germinatus or Fructus Setariae Germinatus can be thought parched medicinal material, can be also processed product not.Described Endothelium Corneum Gigeriae Galli is parch.
Chinese medicine composition also comprises at least one in following composition by weight: Rhizoma Dioscoreae 150-200 part, Radix Pseudostellariae 200-250 part, Semen Raphani 20-30 part, Massa Medicata Fermentata 70-130 part, Semen Arecae 20-45 part.
Chinese medicine composition comprises following composition by weight:
Endothelium Corneum Gigeriae Galli 2-10 part, Fructus Crataegi 80-150 part, Pericarpium Citri Reticulatae 6-25 part, Fructus Hordei Germinatus 60-180 part, Rhizoma Dioscoreae 150-200 part;
Or be: Endothelium Corneum Gigeriae Galli 2-10 part, Fructus Crataegi 80-150 part, Pericarpium Citri Reticulatae 6-25 part, Fructus Hordei Germinatus 60-180 part, Radix Pseudostellariae 200-250 part;
Or be: Endothelium Corneum Gigeriae Galli 2-10 part, Fructus Crataegi 80-150 part, Pericarpium Citri Reticulatae 6-25 part, Fructus Hordei Germinatus 60-180 part, Rhizoma Dioscoreae 150-200 part, Radix Pseudostellariae 200-250 part, Semen Raphani 20-30 part;
Or be: Endothelium Corneum Gigeriae Galli 2-10 part, Fructus Crataegi 80-150 part, Pericarpium Citri Reticulatae 6-25 part, Fructus Hordei Germinatus 60-180 part, Massa Medicata Fermentata 70-130 part, Semen Arecae 20-45 part;
Or be: Endothelium Corneum Gigeriae Galli 2-10 part, Fructus Crataegi 80-150 part, Pericarpium Citri Reticulatae 6-25 part, Fructus Setariae Germinatus 60-180 part, Semen Raphani 20-30 part;
Or be: Endothelium Corneum Gigeriae Galli 2-10 part, Fructus Crataegi 80-150 part, Pericarpium Citri Reticulatae 6-25 part, Fructus Setariae Germinatus 60-180 part, Massa Medicata Fermentata 70-130 part, Semen Arecae 20-45, Rhizoma Dioscoreae 150-200 part, Radix Pseudostellariae 200-250 part.
The preparation method of described a kind of children's's invigorating the stomach and promoting digestion soft pharmaceutics, comprises the following steps:
(1) Endothelium Corneum Gigeriae Galli, Fructus Hordei Germinatus warm macerating are extracted to rear filtration, other Chinese medicine compositions decoct with water, decocting liquid is filtered, and merging filtrate, concentrated, make dry cream, pulverize, obtain the powder of pharmaceutically active substance;
(2) gelatin or epoxy glue are mixed with the water of 1-3 times of volume, make gelatin or epoxy glue complete swelling;
(3) gelatin or epoxy glue after swelling step (2) gained are put in water-bath, gelatin or epoxy glue are dissolved completely;
(4) powder that has pharmaceutically active substance step (1) being obtained is mixed homogeneously with sweeting agent, and adds isopyknic pure water;
(5) by step (4) gained mixture heating, sweeting agent is dissolved completely, and boil solids accounting and be not less than 75%, cool;
(6) step (3) gained material is mixed completely with step (5) gained mixture;
(7) step (6) gained mixture is added to residue adjuvant, mix homogeneously;
(8) by step (7) gained mixture note film, cool, the demoulding, oven dry, extension powder, packaging.
The preparation method of described a kind of children's's invigorating the stomach and promoting digestion soft pharmaceutics, specifically comprises the following steps:
(1) Endothelium Corneum Gigeriae Galli, Fructus Hordei Germinatus warm macerating are extracted to secondary, each 2 hours, amount of water was 10 times of amounts of whole medical material weight for the first time, and amount of water is 8 times of amounts of whole medical material weight for the second time, and collecting decoction filters; All the other medical materials decoct with water 2 times, and each 2 hours, amount of water was 10 times of amounts of whole medical material weight for the first time, and amount of water is 8 times of amounts of whole medical material weight for the second time, and collecting decoction filters; Filtrate and decocting liquid merge, concentrated, make dry cream, pulverize, and obtain the powder of pharmaceutically active substance;
(2) gelatin or epoxy glue are mixed with the water of 1-3 times of volume, make gelatin or epoxy glue complete swelling;
(3) gelatin or epoxy glue after swelling step (2) gained are put in 35-65 DEG C of water-bath, gelatin or epoxy glue are dissolved completely;
(4) powder that has pharmaceutically active substance step (1) being obtained is mixed homogeneously with sweeting agent, and adds isopyknic pure water;
(5) by step (4) gained mixture under 90-115 DEG C of condition, sweeting agent is dissolved completely, and boils solids accounting and be not less than 75%, cool, make its temperature between 50-65 DEG C;
(6) step (3) gained mixture is mixed completely with step (5) gained mixture;
(7) step (6) gained mixture is added to residue adjuvant, mix homogeneously;
(8) by step (7) gained mixture note film, cool, the demoulding, oven dry, extension powder, packaging.
Beneficial effect of the present invention is: helping digestion of baby compositions is made up of Fructus Crataegi, Fructus Hordei Germinatus, Massa Medicata Fermentata, Endothelium Corneum Gigeriae Galli, Semen Arecae, Pericarpium Citri Reticulatae, Radix Pseudostellariae, Semen Raphani, Rhizoma Dioscoreae etc.Fructus Crataegi can disappear carnivorous long-pending, promoting digestion and invigorating the stomach; The Fructus Hordei Germinatus wheaten food that can disappear is long-pending, again can invigorating the spleen and regulating the stomach; It is long-pending that Massa Medicata Fermentata can be changed place, and in spleen tune; Endothelium Corneum Gigeriae Galli helps digestion to grind and amasss, kindization combined symptoms; It is stagnant that Semen Arecae declares the sharp vital organs of the human body to stop up, and the capable water of sending down the abnormal ascending QI again can anthelmintic; Pericarpium Citri Reticulatae has activating QI to eliminate phlegm, the effect of stomach function regulating preventing or arresting vomiting; Radix Pseudostellariae has invigorating qi and benefiting blood, promotes the production of body fluid, the effect of tonifying the spleen and stomach; Semen Raphani tells wind-phlegm, and dispersing wind and cold is determined phlegm dyspnea cough, and main therapeutic method to keep the adverse QI flowing downwards eliminate indigestion is stagnant; Rhizoma Dioscoreae contains the material such as amylase, polyphenol oxidase, is conducive to taste digestive and absorptive functions, is the product of the medicine-food two-purpose of flat tonifying the spleen and stomach simply.According to above compatibility, we have relieving dyspepsia, the merit of the relieving distension of regulating the flow of vital energy.
Soft pharmaceutics of the present invention has effect of invigorating the stomach and promoting digestion, can effectively strengthen children's's appetite, has no side effect, and has certain elasticity, has chewiness, fresh and sweet moistening, and meets especially liking of juvenile of consumers in general, is a kind of invigorating the stomach and promoting digestion preparation of uniqueness.
detailed description of the invention:
In order to understand better the present invention, describe technical scheme of the present invention in detail with instantiation below.
embodiment 1
A kind of soft pharmaceutics for children's's invigorating the stomach and promoting digestion, formed by the following weight proportion Chinese medicine composition with promoting digestion and invigorating the stomach function: Endothelium Corneum Gigeriae Galli 10g, Fructus Crataegi 150g, Pericarpium Citri Reticulatae 20g, Fructus Hordei Germinatus 150g, adjuvant adds gelatin 12g, sucrose 25g, maltose syrup 28g, citric acid 1g, potassium sorbate 0.30g, makes soft pharmaceutics.
The preparation flow of the present embodiment is as follows:
The first step, assorts Chinese crude drug by aforementioned Chinese medicinal formulae, according to Chinese Pharmacopoeia medicinal material processing standard by qualified all Chinese medicine processing;
Second step, carries out aseptic process to all Chinese crude drugs;
The 3rd step, extracts secondary by Endothelium Corneum Gigeriae Galli, Fructus Hordei Germinatus warm macerating, and each 2 hours, amount of water was 10 times of amounts of whole medical material weight for the first time, and amount of water is 8 times of amounts of whole medical material weight for the second time, merges immersion, filters; Other Chinese medicines decoct with water 2 times, and each 2 hours, amount of water was 10 times of amounts of whole medical material weight for the first time, and amount of water is 8 times of amounts of whole medical material weight for the second time, and collecting decoction filters; Filtrate merges, concentrated, makes dry cream, pulverizes, and obtains the powder of pharmaceutically active substance;
The 4th step, mixes gelatin with the water of 1-3 times of volume ratio, make gelatin complete swelling;
The 5th step, puts the gelatin after swelling the 4th step gained in 35-65 DEG C of water-bath, and gelatin is dissolved completely;
The 6th step, the powder that has pharmaceutically active substance that the 3rd step is obtained is mixed homogeneously with maltose syrup, sucrose, and adds isopyknic pure water;
The 7th step, under 90-115 DEG C of condition, dissolves sweeting agent in the 6th step gained mixture completely, and boils solids accounting and be not less than 75%, cools, and makes its temperature between 50-65 DEG C;
The 8th step, mixes the 5th step completely with the 7th step gained mixture;
The 9th step, adds potassium sorbate and citric acid, mix homogeneously by the 8th step gained mixture;
The tenth step, by the 9th step gained mixture note film, cool, the demoulding, oven dry, extension powder, packaging, obtain sample A.
Sample A meets the requirement such as loading amount, microorganism under " Chinese Pharmacopoeia " version annex I gel item in 2010 through quality testing.
hesperidin discrimination test:
Get this product 10g, shred, add kieselguhr 4g, grind well, add methanol 20ml, supersound process 30min, filters, and filtrate is concentrated into 2ml, as need testing solution.Separately get Hesperidin reference substance, add methanol and make saturated solution, in contrast product solution.Test according to thin layer chromatography (annex VI B of Chinese Pharmacopoeia version in 2010), draw each 5 l of above-mentioned two kinds of solution, put respectively on the silica gel g thin-layer plate of preparing in same use 1% sodium hydroxide solution, taking ethyl acetate-methanol-water volume ratio (100:17:13) as developing solvent, exhibition is apart from about 4cm, take out, dry, again taking the upper solution of toluene-ethyl acetate-formic acid-water volume ratio (20:10:1:1) as developing solvent, exhibition, apart from about 10cm, is taken out, and dries, spray, with aluminum chloride test solution, is put under ultra-violet lamp (365nm) and is inspected.In test sample chromatograph, with the corresponding position of reference substance chromatograph on, the fluorescence speckle of aobvious same color.
assay test:
Ursolic acid content in sample is measured, and every bag is no less than 0.15mg containing ursolic acid.
Content of hesperidin is measured, and every bag is no less than 0.10mg containing Hesperidin.
moisture:
Loss on drying≤20.0%.
reducing sugar:
Reducing sugar (with glucose meter) >=10.0%
drug efficacy study result
1. helping digestion of baby compositions great ﹑ small dose group and JIANWEI XIAOSHI PIAN, can significantly make dog gastric acidity (free acid and total acid) increase, and the anti-acidity that makes of normal saline matched group reduces.Specifically as shown in table 1:
Table 1
。
With normal saline matched group than the P<0.01 of * *.
2. in the large ﹑ of helping digestion of baby compositions, ﹑ low dose all makes rat gastric juice pepsin unit be significantly higher than matched group, has illustrated and has promoted pepsinia effect, and the low dose of effect of JIANWEI XIAOSHI PIAN effect and children's indigestion tablet quite.As shown in table 2.
Table 2
。
This time research shows that helping digestion of baby compositions has regulate the flow of vital energy effect of relieving distension of helping digestion Zhi ﹑, for its clinical practice provides experimental basis.
toxicological study result
The experiment of helping digestion of baby compositions maximum tolerated dose is with the Cmax (60%) of suspension, maximum volume (0.2ml/10g) is given mouse stomach, every day 3 times, then Continuous Observation 7 days, have no obvious toxic reaction, helping digestion of baby compositions maximum tolerated dose is equivalent to clinical 360 times by kg body weight conversion, has no obvious toxic reaction.
Known according to above test, helping digestion of baby compositions quantity is safer.
embodiment 2
A kind of soft pharmaceutics for children's's invigorating the stomach and promoting digestion, formed by the following weight proportion Chinese medicine composition with promoting digestion and invigorating the stomach function: Endothelium Corneum Gigeriae Galli 6g, Fructus Crataegi 100g, Pericarpium Citri Reticulatae 10g, Fructus Hordei Germinatus 135g, Rhizoma Dioscoreae 170g, adjuvant adds gelatin 10g, sucrose 20g, maltose syrup 30g, citric acid 1g, potassium sorbate 0.30g, makes soft pharmaceutics.
The preparation flow of the present embodiment is as follows:
The first step, assorts Chinese crude drug by aforementioned Chinese medicinal formulae, according to Chinese Pharmacopoeia medicinal material processing standard by qualified all Chinese medicine processing;
Second step, carries out aseptic process to all Chinese crude drugs;
The 3rd step, extracts secondary by Endothelium Corneum Gigeriae Galli, Fructus Hordei Germinatus warm macerating, and each 2 hours, amount of water was 10 times of amounts of whole medical material weight for the first time, and amount of water is 8 times of amounts of whole medical material weight for the second time, merges immersion, filters; Other Chinese medicines decoct with water 2 times, and each 2 hours, amount of water was 10 times of amounts of whole medical material weight for the first time, and amount of water is 8 times of amounts of whole medical material weight for the second time, and collecting decoction filters; Filtrate merges, concentrated, makes dry cream, pulverizes, and obtains the powder of pharmaceutically active substance;
The 4th step, mixes gelatin with the water of 1-3 times of volume ratio, make gelatin complete swelling;
The 5th step, puts the gelatin after swelling the 4th step gained in 35-65 DEG C of water-bath, and gelatin is dissolved completely;
The 6th step, the powder that has pharmaceutically active substance that the 3rd step is obtained is mixed homogeneously with maltose syrup 30g, sucrose 20g, and adds isopyknic pure water;
The 7th step, under 90-115 DEG C of condition, dissolves sweeting agent in the 6th step gained mixture completely, and boils solids accounting and be not less than 75%, cools, and makes its temperature between 50-65 DEG C;
The 8th step, mixes the 5th step completely with the 7th step gained mixture;
The 9th step, adds potassium sorbate 0.30g and citric acid 1g, mix homogeneously by the 8th step gained mixture;
The tenth step, by the 9th step gained mixture note film, cool, the demoulding, oven dry, extension powder, packaging, obtain sample B.
Sample B meets the requirement such as loading amount, microorganism under " Chinese Pharmacopoeia " version annex I gel item in 2010 through quality testing.
hesperidin discrimination test:
Get this product 10g, shred, add kieselguhr 4g, grind well, add methanol 20ml, supersound process 30min, filters, and filtrate is concentrated into 2ml, as need testing solution.Separately get Hesperidin reference substance, add methanol and make saturated solution, in contrast product solution.Test according to thin layer chromatography (annex VI B of Chinese Pharmacopoeia version in 2010), draw each 5 l of above-mentioned two kinds of solution, put respectively on the silica gel g thin-layer plate of preparing in same use 1% sodium hydroxide solution, taking ethyl acetate-methanol-water volume ratio (100:17:13) as developing solvent, exhibition is apart from about 4cm, take out, dry, again taking the upper solution of toluene-ethyl acetate-formic acid-water volume ratio (20:10:1:1) as developing solvent, exhibition, apart from about 10cm, is taken out, and dries, spray, with aluminum chloride test solution, is put under ultra-violet lamp (365nm) and is inspected.In test sample chromatograph, with the corresponding position of reference substance chromatograph on, the fluorescence speckle of aobvious same color.
rhizoma Dioscoreae discrimination test:
Get this product 50g, shred, add kieselguhr 15g, grind well, the 100ml that adds methylene chloride, reflux 2 hours, filter, filtrate evaporate to dryness, residue add methylene chloride 1ml make dissolve, as need testing solution; Separately get Rhizoma Dioscoreae control medicinal material 5g, be made in the same way of control medicinal material solution.
Test according to thin layer chromatography annex VI B, draw above-mentioned two kinds of each 4ul of solution, put respectively on same silica gel g thin-layer plate, taking ethyl acetate-methanol-strong ammonia solution volume ratio as 9:1:0.5 is as developing solvent, launch to take out, airing, spray, with 10% phosphomolybdic acid ethanol solution, is heated to speckle colour developing at 105 DEG C clear.
In test sample chromatograph, be the speckle of aobvious same color on the corresponding position of control medicinal material chromatograph.
assay test:
Ursolic acid content in sample is measured, and every bag is no less than 0.15mg containing ursolic acid.
Content of hesperidin is measured, and every bag is no less than 0.10mg containing Hesperidin.
moisture:
Loss on drying≤20.0%.
reducing sugar:
Reducing sugar (with glucose meter) >=10.0%
embodiment 3
For a soft pharmaceutics for children's's invigorating the stomach and promoting digestion, formed by the Chinese medicine composition of the following weight proportion with promoting digestion and invigorating the stomach function: Endothelium Corneum Gigeriae Galli 6g, Fructus Crataegi 100g, Pericarpium Citri Reticulatae 10g, Fructus Hordei Germinatus 135g, Radix Pseudostellariae 220g.Adjuvant adds gelatin 10g, maltose syrup 30g, and modified starch 5g, mannitol 5g, stevioside 0.5g, benzoic acid 0.3g makes soft pharmaceutics.
Preparation method is with embodiment 1.Wherein Radix Pseudostellariae processing method, with other Chinese medicine ingredients except Endothelium Corneum Gigeriae Galli, Fructus Hordei Germinatus, obtains sample C.
Sample C meets the requirement such as loading amount, microorganism under " Chinese Pharmacopoeia " version annex I gel item in 2010 through quality testing.
hesperidin discrimination test:
Get this product 10g, shred, add kieselguhr 4g, grind well, add methanol 20ml, supersound process 30min, filters, and filtrate is concentrated into 2ml, as need testing solution.Separately get Hesperidin reference substance, add methanol and make saturated solution, in contrast product solution.Test according to thin layer chromatography (annex VI B of Chinese Pharmacopoeia version in 2010), draw each 5 l of above-mentioned two kinds of solution, put respectively on the silica gel g thin-layer plate of preparing in same use 1% sodium hydroxide solution, taking ethyl acetate-methanol-water volume ratio (100:17:13) as developing solvent, exhibition is apart from about 4cm, take out, dry, again taking the upper solution of toluene-ethyl acetate-formic acid-water volume ratio (20:10:1:1) as developing solvent, exhibition, apart from about 10cm, is taken out, and dries, spray, with aluminum chloride test solution, is put under ultra-violet lamp (365nm) and is inspected.In test sample chromatograph, with the corresponding position of reference substance chromatograph on, the fluorescence speckle of aobvious same color.
radix Pseudostellariae discrimination test:
Get this product 50g, shred, add kieselguhr 15g, grind well, reflux 30min, filters, filtrate evaporate to dryness, residue add water 40ml make dissolve, by the large empty adsorption resin column of D101 type, water 200ml eluting, discards water lotion, then uses ethanol 100ml eluting, collect ethanol elution, evaporate to dryness, residue adds methanol 1ml to be made to dissolve, as need testing solution; Separately get Radix Pseudostellariae control medicinal material 5g, decoct with water 2 hours, centrifugal, get supernatant, by the large empty adsorption resin column of D101 type, be made in the same way of control medicinal material solution.
According to thin layer chromatography annex VI B test, draw above-mentioned two kinds of each 20ul of solution, put respectively on same silica gel g thin-layer plate, taking toluene-ethyl acetate volume ratio as 4:1 is as developing solvent, launch to take out airing, spray, with 1% vanillin sulfuric acid solution, is heated to speckle colour developing at 105 DEG C clear.
In test sample chromatograph, be the speckle of aobvious same color on the corresponding position of control medicinal material chromatograph.
assay test:
Ursolic acid content in sample is measured, and every bag is no less than 0.15mg containing ursolic acid.
Content of hesperidin is measured, and every bag is no less than 0.10mg containing Hesperidin.
moisture:
Loss on drying≤20.0%.
reducing sugar:
Reducing sugar (with glucose meter) >=10.0%
embodiment 4
For a soft pharmaceutics for children's's invigorating the stomach and promoting digestion, formed by the Chinese medicine composition of the following weight proportion with promoting digestion and invigorating the stomach function: Endothelium Corneum Gigeriae Galli 6g, Fructus Crataegi 100g, Pericarpium Citri Reticulatae 10g, Fructus Hordei Germinatus 135g, Rhizoma Dioscoreae 170g, Radix Pseudostellariae 220g, Semen Raphani 25g.Adjuvant adds gelatin 10g, starch syrup 30g, and sucrose 10g, protein sugar 10g, sodium benzoate 0.4g makes soft pharmaceutics.
Preparation method is with embodiment 1.Wherein Radix Pseudostellariae, Rhizoma Dioscoreae, Semen Raphani processing method, with other Chinese medicine ingredients except Endothelium Corneum Gigeriae Galli, Fructus Hordei Germinatus, obtain sample D.
Sample D meets the requirement such as loading amount, microorganism under " Chinese Pharmacopoeia " version annex I gel item in 2010 through quality testing.
hesperidin discrimination test:
Get this product 10g, shred, add kieselguhr 4g, grind well, add methanol 20ml, supersound process 30min, filters, and filtrate is concentrated into 2ml, as need testing solution.Separately get Hesperidin reference substance, add methanol and make saturated solution, in contrast product solution.Test according to thin layer chromatography (annex VI B of Chinese Pharmacopoeia version in 2010), draw each 5 l of above-mentioned two kinds of solution, put respectively on the silica gel g thin-layer plate of preparing in same use 1% sodium hydroxide solution, taking ethyl acetate-methanol-water volume ratio (100:17:13) as developing solvent, exhibition is apart from about 4cm, take out, dry, again taking the upper solution of toluene-ethyl acetate-formic acid-water volume ratio (20:10:1:1) as developing solvent, exhibition, apart from about 10cm, is taken out, and dries, spray, with aluminum chloride test solution, is put under ultra-violet lamp (365nm) and is inspected.In test sample chromatograph, with the corresponding position of reference substance chromatograph on, the fluorescence speckle of aobvious same color.
radix Pseudostellariae discrimination test:
Get this product 50g, shred, add kieselguhr 15g, grind well, reflux 30min, filters, filtrate evaporate to dryness, residue add water 40ml make dissolve, by the large empty adsorption resin column of D101 type, water 200ml eluting, discards water lotion, then uses ethanol 100ml eluting, collect ethanol elution, evaporate to dryness, residue adds methanol 1ml to be made to dissolve, as need testing solution; Separately get Radix Pseudostellariae control medicinal material 5g, decoct with water 2 hours, centrifugal, get supernatant, by the large empty adsorption resin column of D101 type, be made in the same way of control medicinal material solution.
According to thin layer chromatography annex VI B test, draw above-mentioned two kinds of each 20ul of solution, put respectively on same silica gel g thin-layer plate, taking toluene-ethyl acetate volume ratio as 4:1 is as developing solvent, launch to take out airing, spray, with 1% vanillin sulfuric acid solution, is heated to speckle colour developing at 105 DEG C clear.
In test sample chromatograph, be the speckle of aobvious same color on the corresponding position of control medicinal material chromatograph.
assay test:
Ursolic acid content in sample is measured, and every bag is no less than 0.15mg containing ursolic acid.
Content of hesperidin is measured, and every bag is no less than 0.10mg containing Hesperidin.
moisture:
Loss on drying≤20.0%.
reducing sugar:
Reducing sugar (with glucose meter) >=10.0%.
embodiment 5
For a soft pharmaceutics for children's's invigorating the stomach and promoting digestion, formed by the Chinese medicine composition of the following weight proportion with promoting digestion and invigorating the stomach function: Endothelium Corneum Gigeriae Galli 6g, Fructus Crataegi 124g, Pericarpium Citri Reticulatae 10g, Fructus Hordei Germinatus 114g, Massa Medicata Fermentata 114g, Semen Arecae 31g.Adjuvant comprises carrageenan 5g, gelatin 5g, and starch syrup 20g, sucrose 10g, sorbic acid 0.4g, simple syrup 15g, makes soft pharmaceutics.
Preparation method is with embodiment 1.Wherein Massa Medicata Fermentata, Semen Arecae processing method, with other Chinese medicine ingredients except Endothelium Corneum Gigeriae Galli, Fructus Hordei Germinatus, obtain sample E.
Sample E meets the requirement such as loading amount, microorganism under " Chinese Pharmacopoeia " version annex I gel item in 2010 through quality testing.
hesperidin discrimination test:
Get this product 10g, shred, add kieselguhr 4g, grind well, add methanol 20ml, supersound process 30min, filters, and filtrate is concentrated into 2ml, as need testing solution.Separately get Hesperidin reference substance, add methanol and make saturated solution, in contrast product solution.Test according to thin layer chromatography (annex VI B of Chinese Pharmacopoeia version in 2010), draw each 5 l of above-mentioned two kinds of solution, put respectively on the silica gel g thin-layer plate of preparing in same use 1% sodium hydroxide solution, taking ethyl acetate-methanol-water volume ratio (100:17:13) as developing solvent, exhibition is apart from about 4cm, take out, dry, again taking the upper solution of toluene-ethyl acetate-formic acid-water volume ratio (20:10:1:1) as developing solvent, exhibition, apart from about 10cm, is taken out, and dries, spray, with aluminum chloride test solution, is put under ultra-violet lamp (365nm) and is inspected.In test sample chromatograph, with the corresponding position of reference substance chromatograph on, the fluorescence speckle of aobvious same color.
semen Arecae discrimination test:
Get this product 25g, shred, add kieselguhr 10g, grind well, add chloroform 100ml and liquor ammoniae fortis 12ml, supersound process 15 minutes, filter, filtrate is placed in separatory funnel, adds 20% hydrochloric acid solution 50ml, jolting, divides and gets sour water layer, adds strong ammonia solution and adjusts pH value approximately 9, extract 2 times with chloroform jolting, each 40ml, merges chloroform liquid, naturally volatilize, residue adds methanol 0.5ml to be made to dissolve, as need testing solution.Separately get Semen Arecae control medicinal material 2g, be made in the same way of control medicinal material solution.Test according to thin layer chromatography (annex VI B of Chinese Pharmacopoeia version in 2010), draw each 10 l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, taking chloroform-methanol-ammonia volume ratio (92:8:1) as developing solvent, launch, take out, dry, spray is with rare bismuth potassium iodide test solution.In test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, aobvious identical Chinese red speckle.
assay test:
Ursolic acid content in sample is measured, and every bag is no less than 0.15mg containing ursolic acid.
Content of hesperidin is measured, and every bag is no less than 0.10mg containing Hesperidin.
moisture:
Loss on drying≤20.0%.
reducing sugar:
Reducing sugar (with glucose meter) >=10.0%.
embodiment 6
For a soft pharmaceutics for children's's invigorating the stomach and promoting digestion, formed by the following weight proportion Chinese medicine composition with promoting digestion and invigorating the stomach function: Endothelium Corneum Gigeriae Galli 8g, Fructus Crataegi 120g, Pericarpium Citri Reticulatae 12g, Fructus Setariae Germinatus 150g, Semen Raphani 25g.Adjuvant comprises gelatin 5g, pectin 5g, and maltose syrup 20g, modified starch 10g, sucrose 20g, sodium benzoate 0.4g, makes soft pharmaceutics.
Preparation method is with embodiment 1.Wherein Semen Raphani processing method, with other Chinese medicine ingredients except Endothelium Corneum Gigeriae Galli, Fructus Setariae Germinatus, obtains sample F.
Sample F meets the requirement such as loading amount, microorganism under " Chinese Pharmacopoeia " version annex I gel item in 2010 through quality testing.
hesperidin discrimination test:
Get this product 10g, shred, add kieselguhr 4g, grind well, add methanol 20ml, supersound process 30min, filters, and filtrate is concentrated into 2ml, as need testing solution.Separately get Hesperidin reference substance, add methanol and make saturated solution, in contrast product solution.Test according to thin layer chromatography (annex VI B of Chinese Pharmacopoeia version in 2010), draw each 5 l of above-mentioned two kinds of solution, put respectively on the silica gel g thin-layer plate of preparing in same use 1% sodium hydroxide solution, taking ethyl acetate-methanol-water volume ratio (100:17:13) as developing solvent, exhibition is apart from about 4cm, take out, dry, again taking the upper solution of toluene-ethyl acetate-formic acid-water volume ratio (20:10:1:1) as developing solvent, exhibition, apart from about 10cm, is taken out, and dries, spray, with aluminum chloride test solution, is put under ultra-violet lamp (365nm) and is inspected.In test sample chromatograph, with the corresponding position of reference substance chromatograph on, the fluorescence speckle of aobvious same color.
assay test:
Ursolic acid content in sample is measured, and every bag is no less than 0.15mg containing ursolic acid.
Content of hesperidin is measured, and every bag is no less than 0.10mg containing Hesperidin.
moisture:
Loss on drying≤20.0%.
reducing sugar:
Reducing sugar (with glucose meter) >=10.0%.
embodiment 7
For a soft pharmaceutics for children's's invigorating the stomach and promoting digestion, formed by the following weight proportion Chinese medicine composition with promoting digestion and invigorating the stomach function: Endothelium Corneum Gigeriae Galli 8g, Fructus Crataegi 120g, Pericarpium Citri Reticulatae 12g, Fructus Setariae Germinatus 150g, Massa Medicata Fermentata 120g, Semen Arecae 30g, Rhizoma Dioscoreae 180g, Radix Pseudostellariae 220g.Adjuvant comprises agar 5g, Rhizoma amorphophalli powder 5g, and gelatin 5g, stevioside 0.5g, syrupus aromaticus 20g, sucrose 30g, sodium benzoate 0.3g, makes soft pharmaceutics.
Preparation method is with embodiment 1.Wherein Radix Pseudostellariae, Rhizoma Dioscoreae processing method, with other Chinese medicine ingredients except Endothelium Corneum Gigeriae Galli, Fructus Setariae Germinatus, obtain sample G.
Sample G meets the requirement such as loading amount, microorganism under " Chinese Pharmacopoeia " version annex I gel item in 2010 through quality testing.
hesperidin discrimination test:
Get this product 10g, shred, add kieselguhr 4g, grind well, add methanol 20ml, supersound process 30min, filters, and filtrate is concentrated into 2ml, as need testing solution.Separately get Hesperidin reference substance, add methanol and make saturated solution, in contrast product solution.Test according to thin layer chromatography (annex VI B of Chinese Pharmacopoeia version in 2010), draw each 5 l of above-mentioned two kinds of solution, put respectively on the silica gel g thin-layer plate of preparing in same use 1% sodium hydroxide solution, taking ethyl acetate-methanol-water volume ratio (100:17:13) as developing solvent, exhibition is apart from about 4cm, take out, dry, again taking the upper solution of toluene-ethyl acetate-formic acid-water volume ratio (20:10:1:1) as developing solvent, exhibition, apart from about 10cm, is taken out, and dries, spray, with aluminum chloride test solution, is put under ultra-violet lamp (365nm) and is inspected.In test sample chromatograph, with the corresponding position of reference substance chromatograph on, the fluorescence speckle of aobvious same color.
radix Pseudostellariae discrimination test:
Get this product 50g and shred, add kieselguhr 15g, grind well, add methanol 100ml, reflux 30min, filters, filtrate evaporate to dryness, residue add water 40ml make dissolve, by the large empty adsorption resin column of D101 type, water 200ml eluting, discards water lotion, then uses ethanol 100ml eluting, collect ethanol elution, evaporate to dryness, residue adds methanol 1ml to be made to dissolve, as need testing solution; Separately get Radix Pseudostellariae control medicinal material 5g, decoct with water 2 hours, centrifugal, get supernatant, by the large empty adsorption resin column of D101 type, be made in the same way of control medicinal material solution.
According to thin layer chromatography annex VI B test, draw above-mentioned two kinds of each 20ul of solution, put respectively on same silica gel g thin-layer plate, taking toluene-ethyl acetate volume ratio as 4:1 is as developing solvent, launch to take out airing, spray, with 1% vanillin sulfuric acid solution, is heated to speckle colour developing at 105 DEG C clear.
In test sample chromatograph, be the speckle of aobvious same color on the corresponding position of control medicinal material chromatograph.
semen Arecae discrimination test:
Get this product 25g, shred, add kieselguhr 10g, grind well, add chloroform 100ml and liquor ammoniae fortis 12ml, supersound process 15 minutes, filter, filtrate is placed in separatory funnel, adds 20% hydrochloric acid solution 50ml, jolting, divides and gets sour water layer, adds strong ammonia solution and adjusts pH value approximately 9, extract 2 times with chloroform jolting, each 40ml, merges chloroform liquid, naturally volatilize, residue adds methanol 0.5ml to be made to dissolve, as need testing solution.Separately get Semen Arecae control medicinal material 2g, be made in the same way of control medicinal material solution.Test according to thin layer chromatography (annex VI B of Chinese Pharmacopoeia version in 2010), draw each 10 l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, taking chloroform-methanol-ammonia volume ratio (92:8:1) as developing solvent, launch, take out, dry, spray is with rare bismuth potassium iodide test solution.In test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, aobvious identical Chinese red speckle.
assay test:
Ursolic acid content in sample is measured, and every bag is no less than 0.15mg containing ursolic acid.
Content of hesperidin is measured, and every bag is no less than 0.10mg containing Hesperidin.
moisture:
Loss on drying≤20.0%.
reducing sugar:
Reducing sugar (with glucose meter) >=10.0%.
embodiment 8
For a soft pharmaceutics for children's's invigorating the stomach and promoting digestion, formed by the Chinese medicine composition of the following weight proportion with promoting digestion and invigorating the stomach function: Endothelium Corneum Gigeriae Galli 2g, Fructus Crataegi 80g, Pericarpium Citri Reticulatae 24g, Fructus Hordei Germinatus 170g, Massa Medicata Fermentata 70g, Semen Arecae 25g.Adjuvant comprises carrageenan 10g, gelatin 8g, and starch syrup 20g, sucrose 20g, sorbic acid 0.4g, simple syrup 15g, makes soft pharmaceutics.
Preparation method is with embodiment 1.Wherein Massa Medicata Fermentata, Semen Arecae processing method, with other Chinese medicine ingredients except Endothelium Corneum Gigeriae Galli, Fructus Hordei Germinatus, obtain sample H.
Sample H meets the requirement such as loading amount, microorganism under " Chinese Pharmacopoeia " version annex H gel item in 2010 through quality testing.
hesperidin discrimination test:
Get this product 10g, shred, add kieselguhr 4g, grind well, add methanol 20ml, supersound process 30min, filters, and filtrate is concentrated into 2ml, as need testing solution.Separately get Hesperidin reference substance, add methanol and make saturated solution, in contrast product solution.Test according to thin layer chromatography (annex VI B of Chinese Pharmacopoeia version in 2010), draw each 5 l of above-mentioned two kinds of solution, put respectively on the silica gel g thin-layer plate of preparing in same use 1% sodium hydroxide solution, taking ethyl acetate-methanol-water volume ratio (100:17:13) as developing solvent, exhibition is apart from about 4cm, take out, dry, again taking the upper solution of toluene-ethyl acetate-formic acid-water volume ratio (20:10:1:1) as developing solvent, exhibition, apart from about 10cm, is taken out, and dries, spray, with aluminum chloride test solution, is put under ultra-violet lamp (365nm) and is inspected.In test sample chromatograph, with the corresponding position of reference substance chromatograph on, the fluorescence speckle of aobvious same color.
semen Arecae discrimination test:
Get this product 25g, shred, add kieselguhr 10g, grind well, add chloroform 100ml and liquor ammoniae fortis 12ml, supersound process 15 minutes, filter, filtrate is placed in separatory funnel, adds 20% hydrochloric acid solution 50ml, jolting, divides and gets sour water layer, adds strong ammonia solution and adjusts pH value approximately 9, extract 2 times with chloroform jolting, each 40ml, merges chloroform liquid, naturally volatilize, residue adds methanol 0.5ml to be made to dissolve, as need testing solution.Separately get Semen Arecae control medicinal material 2g, be made in the same way of control medicinal material solution.Test according to thin layer chromatography (annex VI B of Chinese Pharmacopoeia version in 2010), draw each 10 l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, taking chloroform-methanol-ammonia volume ratio (92:8:1) as developing solvent, launch, take out, dry, spray is with rare bismuth potassium iodide test solution.In test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, aobvious identical Chinese red speckle.
assay test:
Ursolic acid content in sample is measured, and every bag is no less than 0.15mg containing ursolic acid.
Content of hesperidin is measured, and every bag is no less than 0.10mg containing Hesperidin.
moisture:
Loss on drying≤20.0%.
reducing sugar:
Reducing sugar (with glucose meter) >=10.0%.
embodiment 9
For a soft pharmaceutics for children's's invigorating the stomach and promoting digestion, formed by the Chinese medicine composition of the following weight proportion with promoting digestion and invigorating the stomach function: Endothelium Corneum Gigeriae Galli 10g, Fructus Crataegi 140g, Pericarpium Citri Reticulatae 6g, Fructus Hordei Germinatus 170g, Radix Pseudostellariae 250g.Adjuvant adds gelatin 15g, maltose syrup 30g, and modified starch 8g, mannitol 10g, stevioside 0.8g, benzoic acid 0.6g makes soft pharmaceutics.
Preparation method is with embodiment 1.Wherein Radix Pseudostellariae processing method, with other Chinese medicine ingredients except Endothelium Corneum Gigeriae Galli, Fructus Hordei Germinatus, obtains sample I.
Sample I meets the requirement such as loading amount, microorganism under " Chinese Pharmacopoeia " version annex I gel item in 2010 through quality testing.
hesperidin discrimination test:
Get this product 10g, shred, add kieselguhr 4g, grind well, add methanol 20ml, supersound process 30min, filters, and filtrate is concentrated into 2ml, as need testing solution.Separately get Hesperidin reference substance, add methanol and make saturated solution, in contrast product solution.Test according to thin layer chromatography (annex VI B of Chinese Pharmacopoeia version in 2010), draw each 5 l of above-mentioned two kinds of solution, put respectively on the silica gel g thin-layer plate of preparing in same use 1% sodium hydroxide solution, taking ethyl acetate-methanol-water volume ratio (100:17:13) as developing solvent, exhibition is apart from about 4cm, take out, dry, again taking the upper solution of toluene-ethyl acetate-formic acid-water volume ratio (20:10:1:1) as developing solvent, exhibition, apart from about 10cm, is taken out, and dries, spray, with aluminum chloride test solution, is put under ultra-violet lamp (365nm) and is inspected.In test sample chromatograph, with the corresponding position of reference substance chromatograph on, the fluorescence speckle of aobvious same color.
radix Pseudostellariae discrimination test:
Get this product 50g, shred, add kieselguhr 15g, grind well, reflux 30min, filters, filtrate evaporate to dryness, residue add water 40ml make dissolve, by the large empty adsorption resin column of D101 type, water 200ml eluting, discards water lotion, then uses ethanol 100ml eluting, collect ethanol elution, evaporate to dryness, residue adds methanol 1ml to be made to dissolve, as need testing solution; Separately get Radix Pseudostellariae control medicinal material 5g, decoct with water 2 hours, centrifugal, get supernatant, by the large empty adsorption resin column of D101 type, be made in the same way of control medicinal material solution.
According to thin layer chromatography annex VI B test, draw above-mentioned two kinds of each 20ul of solution, put respectively on same silica gel g thin-layer plate, taking toluene-ethyl acetate volume ratio as 4:1 is as developing solvent, launch to take out airing, spray, with 1% vanillin sulfuric acid solution, is heated to speckle colour developing at 105 DEG C clear.
In test sample chromatograph, be the speckle of aobvious same color on the corresponding position of control medicinal material chromatograph.
assay test:
Ursolic acid content in sample is measured, and every bag is no less than 0.15mg containing ursolic acid.
Content of hesperidin is measured, and every bag is no less than 0.10mg containing Hesperidin.
moisture:
Loss on drying≤20.0%.
reducing sugar:
Reducing sugar (with glucose meter) >=10.0%.
Claims (10)
1. children's's invigorating the stomach and promoting digestion soft pharmaceutics, is characterized in that, comprises Chinese medicine composition and other adjuvants; The contained Chinese medicine composition of this soft pharmaceutics comprises Endothelium Corneum Gigeriae Galli, Fructus Crataegi, Fructus Hordei Germinatus or Fructus Setariae Germinatus, Pericarpium Citri Reticulatae.
2. a kind of children's's invigorating the stomach and promoting digestion soft pharmaceutics according to claim 1, is characterized in that, described soft pharmaceutics is soft sweet, soft chewable tablet, QQ sugar, pudding, refreshing tablets or chewing gum.
3. a kind of children's's invigorating the stomach and promoting digestion soft pharmaceutics according to claim 2, is characterized in that, described adjuvant, comprises gelatin or epoxy glue, and epoxy glue comprises at least two kinds in carrageenan, gelatin, pectin, agar, Rhizoma amorphophalli powder etc.
4. a kind of children's's invigorating the stomach and promoting digestion soft pharmaceutics according to claim 3, it is characterized in that, described adjuvant also comprises correctives, correctives comprises at least one in sweeting agent and aromatic, and sweeting agent is at least one in sucrose, simple syrup, syrupus aromaticus, stevioside, sorbitol, mannitol, protein sugar, maltose syrup, modified starch, starch syrup; Aromatic is at least one in natural perfume material, essence.
5. a kind of children's's invigorating the stomach and promoting digestion soft pharmaceutics according to claim 4, is characterized in that, described adjuvant also comprises antiseptic, and antiseptic comprises at least one in potassium sorbate, sorbic acid, benzoic acid, sodium benzoate.
6. a kind of children's's invigorating the stomach and promoting digestion soft pharmaceutics according to claim 5, is characterized in that, Chinese medicine composition comprises following composition by weight: Endothelium Corneum Gigeriae Galli 2-10 part, Fructus Crataegi 80-150 part, Pericarpium Citri Reticulatae 6-25 part, Fructus Hordei Germinatus or Fructus Setariae Germinatus 60-180 part.
7. a kind of children's's invigorating the stomach and promoting digestion soft pharmaceutics according to claim 6, it is characterized in that, Chinese medicine composition also comprises at least one in following composition by weight: Rhizoma Dioscoreae 150-200 part, Radix Pseudostellariae 200-250 part, Semen Raphani 20-30 part, Massa Medicata Fermentata 70-130 part, Semen Arecae 20-45 part.
8. a kind of children's's invigorating the stomach and promoting digestion soft pharmaceutics according to claim 6, is characterized in that, Chinese medicine composition comprises following composition by weight:
Endothelium Corneum Gigeriae Galli 2-10 part, Fructus Crataegi 80-150 part, Pericarpium Citri Reticulatae 6-25 part, Fructus Hordei Germinatus 60-180 part, Rhizoma Dioscoreae 150-200 part;
Or be: Endothelium Corneum Gigeriae Galli 2-10 part, Fructus Crataegi 80-150 part, Pericarpium Citri Reticulatae 6-25 part, Fructus Hordei Germinatus 60-180 part, Radix Pseudostellariae 200-250 part;
Or be: Endothelium Corneum Gigeriae Galli 2-10 part, Fructus Crataegi 80-150 part, Pericarpium Citri Reticulatae 6-25 part, Fructus Hordei Germinatus 60-180 part, Rhizoma Dioscoreae 150-200 part, Radix Pseudostellariae 200-250 part, Semen Raphani 20-30 part;
Or be: Endothelium Corneum Gigeriae Galli 2-10 part, Fructus Crataegi 80-150 part, Pericarpium Citri Reticulatae 6-25 part, Fructus Hordei Germinatus 60-180 part, Massa Medicata Fermentata 70-130 part, Semen Arecae 20-45 part;
Or be: Endothelium Corneum Gigeriae Galli 2-10 part, Fructus Crataegi 80-150 part, Pericarpium Citri Reticulatae 6-25 part, Fructus Setariae Germinatus 60-180 part, Semen Raphani 20-30 part;
Or be: Endothelium Corneum Gigeriae Galli 2-10 part, Fructus Crataegi 80-150 part, Pericarpium Citri Reticulatae 6-25 part, Fructus Setariae Germinatus 60-180 part, Massa Medicata Fermentata 70-130 part, Semen Arecae 20-45, Rhizoma Dioscoreae 150-200 part, Radix Pseudostellariae 200-250 part.
9. the preparation method of a kind of children's's invigorating the stomach and promoting digestion soft pharmaceutics as claimed in claim 6, is characterized in that, comprises the following steps:
(1) Endothelium Corneum Gigeriae Galli, Fructus Hordei Germinatus warm macerating are extracted to rear filtration, other Chinese medicine compositions decoct with water, decocting liquid is filtered, and merging filtrate, concentrated, make dry cream, pulverize, obtain the powder of pharmaceutically active substance;
(2) gelatin or epoxy glue are mixed with the water of 1-3 times of volume, make gelatin or epoxy glue complete swelling;
(3) gelatin or epoxy glue after swelling step (2) gained are put in water-bath, gelatin or epoxy glue are dissolved completely;
(4) powder that has pharmaceutically active substance step (1) being obtained is mixed homogeneously with sweeting agent, and adds isopyknic pure water;
(5) by step (4) gained mixture heating, sweeting agent is dissolved completely, and boil solids accounting and be not less than 75%, cool;
(6) step (3) gained material is mixed completely with step (5) gained mixture;
(7) step (6) gained mixture is added to residue adjuvant, mix homogeneously;
(8) by step (7) gained mixture note film, cool, the demoulding, oven dry, extension powder, packaging.
10. the preparation method of a kind of children's's invigorating the stomach and promoting digestion soft pharmaceutics according to claim 9, is characterized in that, specifically comprises the following steps:
(1) Endothelium Corneum Gigeriae Galli, Fructus Hordei Germinatus warm macerating are extracted to secondary, each 2 hours, amount of water was 10 times of amounts of whole medical material weight for the first time, and amount of water is 8 times of amounts of whole medical material weight for the second time, and collecting decoction filters; All the other medical materials decoct with water 2 times, and each 2 hours, amount of water was 10 times of amounts of whole medical material weight for the first time, and amount of water is 8 times of amounts of whole medical material weight for the second time, and collecting decoction filters; Filtrate and decocting liquid merge, concentrated, make dry cream, pulverize, and obtain the powder of pharmaceutically active substance;
(2) gelatin or epoxy glue are mixed with the water of 1-3 times of volume, make gelatin or epoxy glue complete swelling;
(3) gelatin or epoxy glue after swelling step (2) gained are put in 35-65 DEG C of water-bath, gelatin or epoxy glue are dissolved completely;
(4) powder that has pharmaceutically active substance step (1) being obtained is mixed homogeneously with sweeting agent, and adds isopyknic pure water;
(5) by step (4) gained mixture under 90-115 DEG C of condition, sweeting agent is dissolved completely, and boils solids accounting and be not less than 75%, cool, make its temperature between 50-65 DEG C;
(6) step (3) gained mixture is mixed completely with step (5) gained mixture;
(7) step (6) gained mixture is added to residue adjuvant, mix homogeneously;
(8) by step (7) gained mixture note film, cool, the demoulding, oven dry, extension powder, packaging.
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2014
- 2014-07-24 CN CN201410355376.4A patent/CN104127761A/en active Pending
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Application publication date: 20141105 |