CN1698851A - Stomach nourishing dispersible tablet with aucklandia root and amomum fruit and its preparation method - Google Patents
Stomach nourishing dispersible tablet with aucklandia root and amomum fruit and its preparation method Download PDFInfo
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Abstract
The invention relates to a stomach nourishing dispersible tablet with aucklandia root and amomum fruit and its preparation method which comprises, choosing raw material according to official drug standards, extracting volatile oil and extractive, preparing inclusion compound from the volatile oil by employing beta-cyclodextrin or hydroxypropyl beta-cyclodextrin, concentrating and drying the extractive into dried extract powder, choosing right amount of microcrystalline cellulose, stevioside, mannitol, sodium carboxymethylstarch, miropowdered silica gel, low substituted methylcellulose propylene glycol ether as dispersible tablets excipient, low temperation drying the obtained particles, tabletting to obtain the dispersible tablets.
Description
Technical field
The present invention relates to a kind of stomach nourishing dispersible tablet with aucklandia root and amomum fruit and preparation method thereof.
Background technology
The cyperus-amomum stomach preparation is a warming middle-JIAO for easing the stomach, the medicine that solves stomach discomfort such as patient's anorexia, acid regurgitation, dyspepsia, gastral cavilty distending pain, and Ministry of Health of the People's Republic of China's " drug standard Chinese traditional patent formulation preparation " the 20 (Ministry of Health of the People's Republic of China's committee of pharmacopeia 1998) just puts down in writing cyperus-amomum stomach oral liquid and cyperus-amomum stomach soft capsule.Find out according to lot of documents, the multiple volatile oil that contains in the cyperus-amomum stomach preparation plays crucial pharmacological action in its therapeutical effect, the volatile oil contents deficiency will make drug effect reduce, serial cyperus-amomum stomach preparations such as Chinese medicine compound preparation XIANGSHA YANGWEI WAN and improved on this basis XIANGSHAYANGWEI KELI, cyperus-amomum stomach capsule, cyperus-amomum stomach sheet, cyperus-amomum stomach oral liquid because action of high temperature, can make a large amount of volatile oils and lose in its preparation process; The position of such medicine generation drug effect is the stomach the patient, XIANGSHA YANGWEI WAN, cyperus-amomum stomach capsule, cyperus-amomum stomach sheet by oral enter stomach after, because factors such as its hardness is big, disintegrate is slow relatively, effective ingredient release is slow not only influence the curative effect of medicine, and patient's stomach produced stimulate, its application is restricted.Number of patent application 01100749 is the raw material employing nanotechnology of respectively distinguishing the flavor of to the cyperus-amomum stomach preparation prescription, but the nano-pulverization technical difficulty is big, equipment requirements is high, simultaneously, and in crushing process, because the breaking of cell wall, can cause the volatilization loss of a large amount of volatile oil and cause drug effect to reduce; Number of patent application 03118954 is the cyperus-amomum stomach double phases hard capsule, before the preparation hard capsule, earlier volatile oil to be made soft capsule or soft gelatin capsule, preparation requires high, complex process, and the hard capsule after the molding is in the more difficult disintegrate of gastric, effective ingredient more indissoluble goes out, and to stomach generation stimulation in various degree.
Summary of the invention
At above-mentioned situation, the present invention is under the prerequisite that does not change cyperus-amomum stomach preparation prescription composition, provide a kind of effective ingredient of medicine that makes to satisfy the needs of medical treatment and, reduce novel stomach nourishing dispersible tablet with aucklandia root and amomum fruit to the stimulation of stomach in the rapid disintegrate dispersion of stomach, the timely stripping of effective ingredient.On this basis, the present invention also will provide the method and the application of additives in preparation thereof of a kind of stomach nourishing dispersible tablet with aucklandia root and amomum fruit of preparation.
The present invention realizes by following technical proposal:
Stomach nourishing dispersible tablet with aucklandia root and amomum fruit, prescription raw material and amount ratio comprise any one in following two kinds of statutory standards:
Write out a prescription 1.: 154 parts of the Radix Aucklandiae, 154 parts of Fructus Amomis, 221 parts of the Rhizoma Atractylodis Macrocephalaes, 221 parts of Pericarpium Citri Reticulataes, 221 parts in Poria, 221 parts of Rhizoma Pinelliae (processed), 154 parts of Rhizoma Cyperis (vinegar system), 154 parts of Fructus Aurantii Immaturuss, 154 parts of Fructus Amomi Rotunduss (shelling), 154 parts of Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 154 parts of Herba Pogostemonis, 66 parts in Radix Glycyrrhizae, 66 parts in Rhizoma Zingiberis Recens, 110 parts in Fructus Jujubae;
Write out a prescription 2.: 100 parts of Rhizoma Cyperis (vinegar system), 100 parts of Fructus Amomis, 100 parts of Herba Pogostemonis, 100 parts in Poria, 100 parts of Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 100 parts of Rhizoma Pinelliae (processed), 100 parts of the Rhizoma Atractylodis Macrocephalaes, 100 parts of Fructus Aurantii Immaturuss, 50 parts in Radix Glycyrrhizae, 50 parts of Fructus Amomi Rotunduss (shelling), 50 parts of Pericarpium Citri Reticulataes, 50 parts of the Radix Aucklandiae, 40 parts in Fructus Jujubae, 10 parts in Rhizoma Zingiberis Recens;
Preparation method is:
By prescription 1. or prescription 2. extract volatile oil and extract respectively, 1. the Radix Aucklandiae, Fructus Amomi, Herba Pogostemonis, Fructus Amomi Rotundus, Pericarpium Citri Reticulatae are extracted volatile oil by prescription, the aqueous solution after distillation device is in addition collected; Rhizoma Cyperi, Cortex Magnoliae Officinalis, Fructus Aurantii Immaturus, Poria, the Rhizoma Pinelliae, the Rhizoma Atractylodis Macrocephalae, Fructus Jujubae, Rhizoma Zingiberis Recens, Radix Glycyrrhizae nine flavors extract secondary with 80% alcohol heating reflux, each 1-2h, and filtration, merging filtrate reclaim ethanol; Above-mentioned two aqueous solutions merge, and get the cyperus-amomum stomach extract; 2. with Rhizoma Cyperi, Cortex Magnoliae Officinalis, the Rhizoma Atractylodis Macrocephalae, Fructus Aurantii Immaturus, Pericarpium Citri Reticulatae, use 60% alcohol dipping by prescription, collect percolate, standby; Herba Pogostemonis, Fructus Amomi, the Radix Aucklandiae, Fructus Amomi Rotundus, Rhizoma Zingiberis Recens extract volatile oil; Medicinal residues and Poria, the Rhizoma Pinelliae, Fructus Jujubae, Radix Glycyrrhizae decoct with water secondary behind the extraction volatile oil, each 2h, and filtration, filtrate are cooled off in the above-mentioned liquid of filtering of back adding, leave standstill 20-24h, filter, and recovery ethanol gets the cyperus-amomum stomach extract; Volatile oil adopts beta-schardinger dextrin-or hydroxypropyl to be prepared into clathrate, and extract is condensed into thick paste and is dried to dry extract, selects for use corresponding excipient to be prepared into tablet, wherein:
(1) described volatile oil adopts beta-schardinger dextrin-or hydroxypropyl to be prepared into clathrate, and the ratio of volatile oil and beta-schardinger dextrin-is 1: 6-12 (ml/g), and the ratio of volatile oil and hydroxypropyl is 1: 3-10 (ml/g);
(2) extract is condensed into thick paste, is dried to dry extract below 80 ℃;
(3) select for use the 80-120% microcrystalline Cellulose that is equivalent to volatile oil clathrate compound and dry extract total amount, 0.5-5% stevioside, 30-80% mannitol, 10-50% carboxymethyl starch sodium, 1-5% micropowder silica gel, 5-20% low-substituted hydroxypropyl cellulose as excipient; An amount of 80-95% ethanol is made wetting agent;
(4) granulation back granule, cold drying below 60 ℃.
It is 50% alcoholic solution that described volatile oil is made into volume ratio, join in beta-schardinger dextrin-or the hydroxypropyl saturated solution, enclose 1-2h under 15-25 ℃ of 100-120 rev/min of condition, collect enclose liquid, put refrigerator cold-storage 20-24h, sucking filtration, clathrate washs with low amounts of water, 40 ℃ of vacuum drying 4-6h collect clathrate;
Described extract is condensed into thick paste, is dried to dry extract below 80 ℃, is ground into fine powder;
Described volatile oil clathrate compound and dry extract after crushed mix with the 80-120% microcrystalline Cellulose that is equivalent to volatile oil clathrate compound and extractum total amount, 0.5-5% stevioside, 30-80% mannitol, 10-50% carboxymethyl starch sodium, 1-5% micropowder silica gel, 5-20% low-substituted hydroxypropyl cellulose, make soft material in right amount with 80-95% ethanol, 20 mesh sieves are granulated, low-temperature vacuum drying below 60 ℃, 24 mesh sieve granulate, tabletting, by general tablet packing method packing, promptly get product---stomach nourishing dispersible tablet with aucklandia root and amomum fruit through after the assay was approved.
Technical scheme (1):
Stomach nourishing dispersible tablet with aucklandia root and amomum fruit, prescription raw material and amount ratio are 154 parts of the Radix Aucklandiae, 154 parts of Fructus Amomis, 221 parts of the Rhizoma Atractylodis Macrocephalaes, 221 parts of Pericarpium Citri Reticulataes, 221 parts in Poria, 221 parts of Rhizoma Pinelliae (processed), 154 parts of Rhizoma Cyperis (vinegar system), 154 parts of Fructus Aurantii Immaturuss, 154 parts of Fructus Amomi Rotunduss (shelling), 154 parts of Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 154 parts of Herba Pogostemonis, 66 parts in Radix Glycyrrhizae, 66 parts in Rhizoma Zingiberis Recens, 110 parts in Fructus Jujubae.
I--comprises the Radix Aucklandiae with raw material, Fructus Amomi, Herba Pogostemonis, Fructus Amomi Rotundus, Pericarpium Citri Reticulatae extracts volatile oil, institute's volatile oil of carrying adopts beta-schardinger dextrin-by every milliliter of volatile oil, a kind of clathrate that is prepared in the hydroxypropyl, the ratio of volatile oil and beta-schardinger dextrin-is 1: 6-12 (ml/g), the ratio of volatile oil and hydroxypropyl is 1: 3-10 (ml/g), it is 50% alcoholic solution that the volatile oil of carrying is made into volume ratio, join in beta-schardinger dextrin-or the hydroxypropyl saturated solution, constant speed enclose 1-2h under 15-25 ℃ of 100-120 rev/min of condition, collect enclose liquid, put refrigerator cold-storage 20-24h, sucking filtration, clathrate washs with low amounts of water, 40 ℃ of vacuum drying 4-6h collect clathrate; Aqueous solution after distillation device is in addition collected; Raw material II--Rhizoma Cyperi, Cortex Magnoliae Officinalis, Fructus Aurantii Immaturus, Poria, the Rhizoma Pinelliae, the Rhizoma Atractylodis Macrocephalae, Fructus Jujubae, Rhizoma Zingiberis Recens, Radix Glycyrrhizae nine flavors extract secondary with 80% alcohol heating reflux, each 1-2h, and filtration, merging filtrate reclaim ethanol; Above-mentioned two aqueous solutions merge, and are condensed into thick paste, are dried to dry extract below 80 ℃, pulverize.
The stomach nourishing dispersible tablet with aucklandia root and amomum fruit volatile oil clathrate compound and the dry extract after the pulverizing of method for preparing are mixed with 80-120% microcrystalline Cellulose, 0.5-5% stevioside, 30-80% mannitol, 10-50% carboxymethyl starch sodium, 1-5% micropowder silica gel, the 5-20% low-substituted hydroxypropyl cellulose of suitable volatile oil clathrate compound and dry extract total amount, make soft material in right amount with 80-95% ethanol, 20 mesh sieves are granulated, low-temperature vacuum drying below 60 ℃, 24 mesh sieve granulate, tabletting, by general tablet packing method packing, be product---stomach nourishing dispersible tablet with aucklandia root and amomum fruit through after the assay was approved.
Technical scheme (2):
Stomach nourishing dispersible tablet with aucklandia root and amomum fruit, prescription raw material and amount ratio are 100 parts of Rhizoma Cyperis (vinegar system), 100 parts of Fructus Amomis, 100 parts of Herba Pogostemonis, 100 parts in Poria, 100 parts of Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 100 parts of Rhizoma Pinelliae (processed), 100 parts of the Rhizoma Atractylodis Macrocephalaes, 100 parts of Fructus Aurantii Immaturuss, 50 parts in Radix Glycyrrhizae, 50 parts of Fructus Amomi Rotunduss (shelling), 50 parts of Pericarpium Citri Reticulataes, 50 parts of the Radix Aucklandiae, 40 parts in Fructus Jujubae, 10 parts in Rhizoma Zingiberis Recens.
With raw material I---comprise Rhizoma Cyperi, Cortex Magnoliae Officinalis, the Rhizoma Atractylodis Macrocephalae, Fructus Aurantii Immaturus, Pericarpium Citri Reticulatae, use 60% alcohol dipping, collect percolate, standby; Raw material II--comprise Herba Pogostemonis, Fructus Amomi, the Radix Aucklandiae, Fructus Amomi Rotundus, Rhizoma Zingiberis Recens extracts volatile oil, institute's volatile oil of carrying adopts beta-schardinger dextrin-by every milliliter of volatile oil, a kind of clathrate that is prepared in the hydroxypropyl, the ratio of volatile oil and beta-schardinger dextrin-is 1: 6-12 (ml/g), the ratio of volatile oil and hydroxypropyl is 1: 3-10 (ml/g), it is 50% alcoholic solution that the volatile oil of carrying is made into volume ratio, join in beta-schardinger dextrin-or the hydroxypropyl saturated solution, constant speed enclose 1-2h under 15-25 ℃ of 100-120 rev/min of condition, collect enclose liquid, put refrigerator cold-storage 20-24h, sucking filtration, clathrate washs with low amounts of water, 40 ℃ of vacuum drying 4-6h collect clathrate; Raw material II I--comprise extract volatile oil after medicinal residues decoct with water secondary with Poria, the Rhizoma Pinelliae, Fructus Jujubae, Radix Glycyrrhizae, each 2h filters, in the above-mentioned liquid of filtering of filtrate cooling back adding, leave standstill 20-24h, filter, reclaim ethanol, be condensed into thick paste, be dried to dry extract below 80 ℃, pulverize.
Dry extract after product with method for preparing---stomach nourishing dispersible tablet with aucklandia root and amomum fruit volatile oil clathrate compound and the pulverizing and the 80-120% microcrystalline Cellulose that is equivalent to volatile oil clathrate compound and dry extract total amount, the 0.5-5% stevioside, 30-80% mannitol, the 10-50% carboxymethyl starch sodium, the 1-5% micropowder silica gel, the 5-20% low-substituted hydroxypropyl cellulose mixes, make soft material in right amount with 80-95% ethanol, 20 mesh sieves are granulated, low-temperature vacuum drying below 60 ℃, 24 mesh sieve granulate, tabletting, by general tablet packing method packing, be product---stomach nourishing dispersible tablet with aucklandia root and amomum fruit through after the assay was approved.
The present invention is a clathrate process route of selecting optimization for use, the volatile oil that is extracted is carried out enclose, and adopt different additives such as excipient respectively, the novel cyperus-amomum stomach preparation of making according to traditional pressing tablet forming technique, guaranteed that not only the effective ingredient of medicine satisfies the needs of medical treatment, and can make medicine in the rapid disintegrate dispersion of stomach, the timely stripping of effective ingredient, significantly reduced the stimulation that stomach is produced because medicine is difficult to the disintegrate dispersion for a long time, stomach nourishing dispersible tablet with aucklandia root and amomum fruit just can disintegrate in 3 minutes in the water in the time of 15-25 ℃.Can solve patient's anorexia, acid regurgitation, dyspepsia, gastral cavilty distending pain etc. and cause stomach discomfort.
The present invention is further detailed explanation below in conjunction with the drawings and specific embodiments.
Description of drawings
Fig. 1 is preparation technology's schematic flow sheet of technical scheme of the present invention (1).
Fig. 2 is preparation technology's schematic flow sheet of technical scheme of the present invention (2).
The specific embodiment
Embodiment 1
Form and usage ratio by the 20 the 253rd page (Ministry of Health of the People's Republic of China's committee of pharmacopeia 1998) contained cyperus-amomum stomach soft capsule raw material of Ministry of Health of the People's Republic of China's " drug standard Chinese traditional patent formulation preparation ", get Radix Aucklandiae 154g, Fructus Amomi 154g, Rhizoma Atractylodis Macrocephalae 221g, Pericarpium Citri Reticulatae 221g, Poria 221g, Rhizoma Pinelliae (processed) 221g, Rhizoma Cyperi (vinegar system) 154g, Fructus Aurantii Immaturus 154g, Fructus Amomi Rotundus (shelling) 154g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 154g, Herba Pogostemonis 154g, Radix Glycyrrhizae 66g, Rhizoma Zingiberis Recens 66g, Fructus Jujubae 110g.
Method for making:
(1) preparation of cyperus-amomum stomach volatile oil clathrate compound
The Radix Aucklandiae, Fructus Amomi, Herba Pogostemonis, Fructus Amomi Rotundus, Pericarpium Citri Reticulatae are extracted volatile oil with vapor distillation, obtain volatile oil 18ml, it is 50% alcoholic solution that the volatile oil that extracts is made into volume ratio, join in the saturated solution that contains beta-schardinger dextrin-180 grams, rotating speed is 100 rev/mins of stirring 1.5h down in the time of 25 ℃, puts refrigerator cold-storage 24h.Sucking filtration, clathrate washs with low amounts of water, and 40 ℃ of vacuum drying 6h collect clathrate 50g.Aqueous solution after distillation device is in addition collected, and is standby.
(2) preparation of cyperus-amomum stomach dry extract
Rhizoma Cyperi, Cortex Magnoliae Officinalis, Fructus Aurantii Immaturus, Poria, the Rhizoma Pinelliae, the Rhizoma Atractylodis Macrocephalae, Fructus Jujubae, Rhizoma Zingiberis Recens, Radix Glycyrrhizae nine flavors are extracted secondary with 80% alcohol heating reflux, each 2h, filter, reclaim ethanol, merge with the aqueous solution after the above-mentioned distillation, be condensed into thick paste, 70 ℃ are dried to dry extract, pulverize, obtain dry extract 88g.
(3) preparation of stomach nourishing dispersible tablet with aucklandia root and amomum fruit tablet
Press series preparation prescription preparation dispersible tablet:
Cyperus-amomum stomach volatile oil clathrate compound 50g
Cyperus-amomum stomach dry extract 88g
Microcrystalline Cellulose 160g
Stevioside 1g
Mannitol 120g
Carboxymethyl starch sodium 50g
Micropowder silica gel 5g
Low-substituted hydroxypropyl cellulose 25g
The about 150ml of 85% ethanol
Make 1000
Above-mentioned cyperus-amomum stomach volatile oil clathrate compound, cyperus-amomum stomach dry extract, microcrystalline Cellulose, stevioside, mannitol, carboxymethyl starch sodium, micropowder silica gel, low-substituted hydroxypropyl cellulose are mixed in mixing channel, with 85% ethanol system soft material, granulate with 20 mesh sieves, 60 ℃ of vacuum drying oven cold drying, 24 mesh sieve granulate, tabletting, every sheet heavily is 0.5g.By general tablet packing method packing, be product---stomach nourishing dispersible tablet with aucklandia root and amomum fruit through after the assay was approved.
(4) quality examination
Character: be the dark brown sheet; Molten diffusing back solution is sepia, gas perfume (or spice), sweet in the mouth, little hardship in the water.
Differentiate: 1. get 4 of this product, grind, the 40ml that adds diethyl ether, jolting divides and gets ether solution, filters, and put in two test tubes filtrate branch, and a pipe volatilizes, and residue Dropwise 5 % vanillin sulfuric acid solution number droplet promptly shows red, fades to aubergine; One pipe volatilizes to 2ml, puts on filter paper, dries, and spray on blue background, will occur yellow spotting with the alcoholic solution of 0.05% bromophenol blue.
2. get 4 of this product, grind, the 40ml that adds diethyl ether divides three joltings to extract, and divides and gets ether solution, filters, and volatilizes, and adds ethyl acetate 1ml and makes dissolving, as need testing solution.Other gets magnolol honokiol reference substance, adds ethyl acetate and makes the mixed solution that every 1ml contains 2mg, in contrast product solution.According to thin layer chromatography (appendix VIIA of Chinese Pharmacopoeia version in 2000) test, draw each 4 μ l of above-mentioned two kinds of solution and put in same silica gel G F respectively
254On, be developing solvent with cyclohexane extraction-acetone (10: 3), launch, take out, to dry, spray is with 5% vanillin sulfuric acid solution, and it is clear that hot blast blows to the speckle colour developing.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
Check: dispersed homogeneous degree is got 2 of dispersible tablets, puts jolting in the 100ml water, and disintegrate also can be passed through No. 2 sieves (two appendix IA of Chinese Pharmacopoeia version in 2000) fully in 2 minutes 30 seconds, and is up to specification.Other meets every regulation relevant under the tablet item (two appendix IK of Chinese Pharmacopoeia version in 2000).
Embodiment 2
Press embodiment 1 prescription and method, collect cyperus-amomum stomach volatile oil 16.5ml, join in the saturated solution that contains beta-schardinger dextrin-150 grams and carry out 20 ℃ of enclose 2h, obtain volatile oil clathrate compound 48g behind the enclose, obtain cyperus-amomum stomach dry extract 93g, microcrystalline Cellulose is adjusted into 150g, carboxymethyl starch sodium is adjusted into 55g, it is constant that other preparation prescription is pressed embodiment 1, according to embodiment 1 preparation stomach nourishing dispersible tablet with aucklandia root and amomum fruit, and the every heavy 0.5g of theoretical sheet, carry out quality examination by embodiment 1 detection method for quality, every up to specification, the result who wherein carries out the dispersed homogeneous degree inspection is that disintegrate can be 2 minutes 45 seconds by the time of No. 2 sieves also fully.
Embodiment 3
Press embodiment 1 prescription and method, collect cyperus-amomum stomach volatile oil 16ml, join in the saturated solution that contains hydroxypropyl 100 grams and carry out 20 ℃ of enclose 2h, obtain volatile oil clathrate compound 45g behind the enclose, obtain cyperus-amomum stomach dry extract 95g, microcrystalline Cellulose is adjusted into 150g, carboxymethyl starch sodium is adjusted into 55g, it is constant that other preparation prescription is pressed embodiment 1, according to embodiment 1 preparation stomach nourishing dispersible tablet with aucklandia root and amomum fruit, and the every heavy 0.5g of theoretical sheet, carry out quality examination by embodiment 1 detection method for quality, every up to specification, the result who wherein carries out the dispersed homogeneous degree inspection is that disintegrate can be 2 minutes 20 seconds by the time of No. 2 sieves also fully.
Embodiment 4
Form and usage ratio by the 20 the 252nd page (Ministry of Health of the People's Republic of China's committee of pharmacopeia 1998) contained cyperus-amomum stomach oral liquid raw material of Ministry of Health of the People's Republic of China's " drug standard Chinese traditional patent formulation preparation ", get Rhizoma Cyperi (vinegar system) 150g, Fructus Amomi 150g, Herba Pogostemonis 150g, Poria 150g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 150g, Rhizoma Pinelliae (processed) 150g, Rhizoma Atractylodis Macrocephalae 150g, Fructus Aurantii Immaturus 150g, Radix Glycyrrhizae 75g, Fructus Amomi Rotundus (shelling) 75g, Pericarpium Citri Reticulatae 75g, Radix Aucklandiae 75g, Fructus Jujubae 60g, dirt Rhizoma Zingiberis Recens 15g.
(1) preparation of cyperus-amomum stomach volatile oil clathrate compound
The Radix Aucklandiae, Fructus Amomi, Herba Pogostemonis, Fructus Amomi Rotundus, Rhizoma Zingiberis Recens are extracted volatile oil with vapor distillation, obtain volatile oil 8ml, it is 50% alcoholic solution that the volatile oil that extracts is made into volume ratio, join in the saturated solution that contains beta-schardinger dextrin-80 grams, be 120 rev/mins at 25 ℃ of rotating speeds and stir 1.5h down, put refrigerator cold-storage 24h.Sucking filtration, clathrate washs with low amounts of water, and 40 ℃ of vacuum drying 6h collect clathrate 31g.
(2) preparation of cyperus-amomum stomach dry extract
Get Rhizoma Cyperi, Cortex Magnoliae Officinalis, the Rhizoma Atractylodis Macrocephalae, Fructus Aurantii Immaturus, Pericarpium Citri Reticulatae,, flooded 24 hours as solvent with 60% ethanol, slowly percolation is collected about 10 times of medical material amount percolates, and the liquid of filtering is standby.Medicinal residues and Poria, the Rhizoma Pinelliae, Fructus Jujubae, Radix Glycyrrhizae decoct with water secondary behind the extraction volatile oil, and each 2 hours, filtration, filtrate cooling back added in the above-mentioned liquid of filtering, and leave standstill 24 hours, filter, filtrate recycling ethanol is condensed into thick paste, 65 ℃ are dried to dry extract, pulverize, and obtain dry extract 125g.
(3) preparation of stomach nourishing dispersible tablet with aucklandia root and amomum fruit tablet
Press series preparation prescription preparation dispersible tablet:
Cyperus-amomum stomach volatile oil clathrate compound 31g
Cyperus-amomum stomach dry extract 125g
Microcrystalline Cellulose 140g
Stevioside 1g
Mannitol 120g
Carboxymethyl starch sodium 50g
Micropowder silica gel 5g
Low-substituted hydroxypropyl cellulose 25g
The about 150ml of 85% ethanol
Make 1000
Make the stomach nourishing dispersible tablet with aucklandia root and amomum fruit tablet by embodiment 1 method for preparing tablet thereof, the every heavy 0.5g of sheet.
(4) quality examination
Character: identical with embodiment 1.
Differentiate: identical with embodiment 1.
Check: carry out quality examination by embodiment 1 detection method for quality, every up to specification, wherein disintegrate can be 2 minutes 25 seconds by the time of No. 2 sieves also fully.
Embodiment 5
Press embodiment 4 prescription and methods, collect cyperus-amomum stomach volatile oil 8.5ml, join in the saturated solution that contains beta-schardinger dextrin-70 grams and carry out 20 ℃ of enclose 2h, obtain volatile oil clathrate compound 30g behind the enclose, obtain cyperus-amomum stomach dry extract 118g, microcrystalline Cellulose is adjusted into 145g, carboxymethyl starch sodium is adjusted into 55g, it is constant that other preparation prescription is pressed embodiment 4, according to embodiment 1 preparation stomach nourishing dispersible tablet with aucklandia root and amomum fruit, and the every heavy 0.5g of theoretical sheet, carry out quality examination by embodiment 1 detection method for quality, every up to specification, the result who wherein carries out the dispersed homogeneous degree inspection is that disintegrate can be 2 minutes 10 seconds by the time of No. 2 sieves also fully.
Embodiment 6
Press embodiment 4 prescription and methods, collect cyperus-amomum stomach volatile oil 9ml, join in the saturated solution that contains hydroxypropyl 70 gram 25 ℃ and carry out enclose 1.5h, obtain volatile oil clathrate compound 29g behind the enclose, obtain cyperus-amomum stomach dry extract 119g, microcrystalline Cellulose is adjusted into 145g, carboxymethyl starch sodium is adjusted into 55g, it is constant that other preparation prescription is pressed embodiment 4, according to embodiment 1 preparation stomach nourishing dispersible tablet with aucklandia root and amomum fruit, and the every heavy 0.5g of theoretical sheet, carry out quality examination by embodiment 1 detection method for quality, every up to specification, the result who wherein carries out the dispersed homogeneous degree inspection is that disintegrate can be 2 minutes 18 seconds by the time of No. 2 sieves also fully.
Embodiment 7
Preliminarily stabilised investigation to stomach nourishing dispersible tablet with aucklandia root and amomum fruit product of the present invention
(1) test specimen
According to each 3 batches of the stomach nourishing dispersible tablet with aucklandia root and amomum fruit products of embodiment 1, embodiment 3, embodiment 4, the preparation of embodiment 6 same procedure, totally 12 batches.
(2) experimental condition
Accelerated test (40 ℃ of temperature, the humidity 75%) resting period is 1,2,3,6 month;
Room temperature (25 ℃ of temperature, humidity 40-50%) resting period that keeps sample is 1,2,3,6 month.
(3) investigation project and method
Character: ocular estimate.
Differentiate: identical with embodiment 1 employing method.
Check: dispersed homogeneous degree is got 2 of dispersible tablets, puts jolting in the 100ml water, should complete disintegrate also can sieve (two appendix IA of Chinese Pharmacopoeia version in 2000) by No. 2 in 3 minutes.Relevant every regulation and method are with reference to " the content of two appendix IK of Chinese pharmacopoeia version in 2000 under other tablet item.
Microorganism: measure according to microbial limit test (appendix XIIIC of Chinese Pharmacopoeia version in 2000).
(4) investigate the result
12 batch samples kept sample 6 months through accelerated test 6 months and room temperature respectively, its character and discriminating, dispersed homogeneous degree, microorganism and other tablet require every significant change that all do not take place, meet the quality standard regulation, according to 6 months study on the stability situation of accelerated test, this product effect duration can reach more than 2 years.
Claims (4)
1. stomach nourishing dispersible tablet with aucklandia root and amomum fruit is prepared from by one of following prescription raw material and consumption:
Write out a prescription 1.: 154 parts of the Radix Aucklandiae, 154 parts of Fructus Amomis, 221 parts of the Rhizoma Atractylodis Macrocephalaes, 221 parts of Pericarpium Citri Reticulataes, 221 parts in Poria, 221 parts of Rhizoma Pinelliae (processed), 154 parts of Rhizoma Cyperis (vinegar system), 154 parts of Fructus Aurantii Immaturuss, 154 parts of Fructus Amomi Rotunduss (shelling), 154 parts of Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 154 parts of Herba Pogostemonis, 66 parts in Radix Glycyrrhizae, 66 parts in Rhizoma Zingiberis Recens, 110 parts in Fructus Jujubae;
Write out a prescription 2.: 100 parts of Rhizoma Cyperis (vinegar system), 100 parts of Fructus Amomis, 100 parts of Herba Pogostemonis, 100 parts in Poria, 100 parts of Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), 100 parts of Rhizoma Pinelliae (processed), 100 parts of the Rhizoma Atractylodis Macrocephalaes, 100 parts of Fructus Aurantii Immaturuss, 50 parts in Radix Glycyrrhizae, 50 parts of Fructus Amomi Rotunduss (shelling), 50 parts of Pericarpium Citri Reticulataes, 50 parts of the Radix Aucklandiae, 40 parts in Fructus Jujubae, 10 parts in Rhizoma Zingiberis Recens;
Preparation method is:
By prescription 1. or prescription 2. extract volatile oil and extract respectively, 1. the Radix Aucklandiae, Fructus Amomi, Herba Pogostemonis, Fructus Amomi Rotundus, Pericarpium Citri Reticulatae are extracted volatile oil by prescription, the aqueous solution after distillation device is in addition collected; Rhizoma Cyperi, Cortex Magnoliae Officinalis, Fructus Aurantii Immaturus, Poria, the Rhizoma Pinelliae, the Rhizoma Atractylodis Macrocephalae, Fructus Jujubae, Rhizoma Zingiberis Recens, Radix Glycyrrhizae nine flavors extract secondary with 80% alcohol heating reflux, each 1-2h, and filtration, merging filtrate reclaim ethanol; Above-mentioned two aqueous solutions merge, and get the cyperus-amomum stomach extract; 2. with Rhizoma Cyperi, Cortex Magnoliae Officinalis, the Rhizoma Atractylodis Macrocephalae, Fructus Aurantii Immaturus, Pericarpium Citri Reticulatae, use 60% alcohol dipping by prescription, collect percolate, standby; Herba Pogostemonis, Fructus Amomi, the Radix Aucklandiae, Fructus Amomi Rotundus, Rhizoma Zingiberis Recens extract volatile oil; Medicinal residues and Poria, the Rhizoma Pinelliae, Fructus Jujubae, Radix Glycyrrhizae decoct with water secondary behind the extraction volatile oil, each 2h, and filtration, filtrate are cooled off in the above-mentioned liquid of filtering of back adding, leave standstill 20-24h, filter, and recovery ethanol gets the cyperus-amomum stomach extract; Volatile oil adopts beta-schardinger dextrin-or hydroxypropyl to be prepared into clathrate, and extract is condensed into thick paste and is dried to dry extract, selects corresponding additives for use, adopts wet granulation, is prepared into product, it is characterized in that:
(1) volatile oil adopts beta-schardinger dextrin-or hydroxypropyl to be prepared into clathrate, and the ratio of volatile oil and beta-schardinger dextrin-is 1: 6-12 (ml/g), and the ratio of volatile oil and hydroxypropyl is 1: 3-10 (ml/g);
(2) extract is condensed into thick paste, and is dry below 80 ℃, be ground into dry extract;
(3) select for use the 80-120% microcrystalline Cellulose that is equivalent to volatile oil clathrate compound and dry extract total amount, 0.5-5% stevioside, 30-80% mannitol, 10-50% carboxymethyl starch sodium, 1-5% micropowder silica gel, 5-20% low-substituted hydroxypropyl cellulose as excipient; An amount of 80-95% ethanol is made wetting agent;
(4) granulation back granule, cold drying below 60 ℃.
2. the preparation method of stomach nourishing dispersible tablet with aucklandia root and amomum fruit according to claim 1, it is characterized in that it is 50% alcoholic solution that described volatile oil is made into volume ratio, join in beta-schardinger dextrin-or the hydroxypropyl saturated solution, enclose 1-2h under 15-25 ℃ of 100-120 rev/min of condition collects enclose liquid, puts refrigerator cold-storage 20-24h, sucking filtration, clathrate washs with low amounts of water, and 40 ℃ of vacuum drying 4-6h collect clathrate.
3. the preparation method of stomach nourishing dispersible tablet with aucklandia root and amomum fruit according to claim 1 is characterized in that described extract is condensed into thick paste, is dried to dry extract below 80 ℃, is ground into fine powder.
4. according to claim 2, the preparation method of 3 described stomach nourishing dispersible tablet with aucklandia root and amomum fruit, it is characterized in that described volatile oil clathrate compound and dry extract after crushed and the 80-120% microcrystalline Cellulose that is equivalent to volatile oil clathrate compound and extractum total amount, the 0.5-5% stevioside, 30-80% mannitol, the 10-50% carboxymethyl starch sodium, the 1-5% micropowder silica gel, the 5-20% low-substituted hydroxypropyl cellulose mixes, make soft material in right amount with 80-95% ethanol, 20 mesh sieves are granulated, low-temperature vacuum drying below 60 ℃, 24 mesh sieve granulate, tabletting, by general tablet packing method packing, promptly get product through after the assay was approved.
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| CNB2005100315784A CN100342847C (en) | 2005-05-23 | 2005-05-23 | Stomach nourishing dispersible tablet with aucklandia root and amomum fruit and its preparation method |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102000236A (en) * | 2010-11-23 | 2011-04-06 | 康美药业股份有限公司 | Method for preparing volatile oil inclusion compound and application thereof |
| CN103933491A (en) * | 2013-01-21 | 2014-07-23 | 郭继进 | Medicine for treating functional dyspepsia and preparation method thereof |
| CN107308388A (en) * | 2017-07-03 | 2017-11-03 | 广西大海阳光药业有限公司 | A kind of Chinese medicine preparation of expelling phlegm and arresting coughing and preparation method thereof |
| CN107343652A (en) * | 2017-06-27 | 2017-11-14 | 佛山市南海天美事食品有限公司 | A kind of composition of integration of drinking and medicinal herbs is preparing the application in promoting digestive function food |
| CN111658754A (en) * | 2020-06-18 | 2020-09-15 | 黑龙江久久药业有限责任公司 | Sugar-free stomach-nourishing aucklandia and amomum fruit granules and preparation method thereof |
| CN116159121A (en) * | 2022-12-23 | 2023-05-26 | 贵州威利德制药有限公司 | Preparation method of stomach-nourishing medicine combination with amomum vilosum |
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2005
- 2005-05-23 CN CNB2005100315784A patent/CN100342847C/en not_active Expired - Fee Related
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102000236A (en) * | 2010-11-23 | 2011-04-06 | 康美药业股份有限公司 | Method for preparing volatile oil inclusion compound and application thereof |
| CN102000236B (en) * | 2010-11-23 | 2012-05-23 | 康美药业股份有限公司 | Method for preparing volatile oil inclusion compound and application thereof |
| CN103933491A (en) * | 2013-01-21 | 2014-07-23 | 郭继进 | Medicine for treating functional dyspepsia and preparation method thereof |
| CN107343652A (en) * | 2017-06-27 | 2017-11-14 | 佛山市南海天美事食品有限公司 | A kind of composition of integration of drinking and medicinal herbs is preparing the application in promoting digestive function food |
| CN107308388A (en) * | 2017-07-03 | 2017-11-03 | 广西大海阳光药业有限公司 | A kind of Chinese medicine preparation of expelling phlegm and arresting coughing and preparation method thereof |
| CN111658754A (en) * | 2020-06-18 | 2020-09-15 | 黑龙江久久药业有限责任公司 | Sugar-free stomach-nourishing aucklandia and amomum fruit granules and preparation method thereof |
| CN111658754B (en) * | 2020-06-18 | 2022-02-11 | 黑龙江久久药业有限责任公司 | Sugar-free stomach-nourishing aucklandia and amomum fruit granules and preparation method thereof |
| CN116159121A (en) * | 2022-12-23 | 2023-05-26 | 贵州威利德制药有限公司 | Preparation method of stomach-nourishing medicine combination with amomum vilosum |
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|---|---|
| CN100342847C (en) | 2007-10-17 |
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