CN1775272A - Infant spleen-tonifying preparation and new preparing method - Google Patents

Infant spleen-tonifying preparation and new preparing method Download PDF

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Publication number
CN1775272A
CN1775272A CNA2005101159887A CN200510115988A CN1775272A CN 1775272 A CN1775272 A CN 1775272A CN A2005101159887 A CNA2005101159887 A CN A2005101159887A CN 200510115988 A CN200510115988 A CN 200510115988A CN 1775272 A CN1775272 A CN 1775272A
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preparation
parts
active component
radix
medicine
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刘露
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Beijing Fukangren Bio Pharm Tech Co Ltd
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Beijing Fukangren Bio Pharm Tech Co Ltd
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Priority to CNA2005101159887A priority Critical patent/CN1775272A/en
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Abstract

The present invention relates to a Chinese medicine composition and its preparation process. In particular, it relates to a Chinese medicine prescription for curing the diseases of weakness of the spleen and the stomach, fullness in the stomach duct and abdomen, vomiting and diarrhea, no thought of food and drink, etc, and its preparation process. It can be made into dripping pills and soft capsule preparation.

Description

Infant spleen-tonifying preparation and new preparation method
Technical field:
The present invention relates to a kind of Chinese medicine composition and preparation technology thereof, particularly a kind of weakness of the spleen and stomach that is used for, distension and fullness in the abdomen, vomiting is had loose bowels, the prescription of anorexia and preparation technology thereof.
Background technology:
Weakness of the spleen and stomach, distension and fullness in the abdomen, vomiting is had loose bowels, and anorexia is clinical common sympton, and the traditional Chinese medical science is often taked replenishing QI to invigorate the spleen, and the means in the stomach function regulating fortune are treated it, and evident in efficacy, and Infantile Spleen-Strengthening Pill is that it represents medicine.But in the practice, because this medicine is medical material to be beaten powder be used as medicine in preparation, cause impurity many, shortcoming such as dosage is big has a strong impact on its clinical practice.
The preparation of process extraction process preparation of the present invention is easy to dissolving and absorption than elite and thick putting that ordinary pill more can collect medicine, and curative effect is fast, and administration time is short, and therefore, curative effect is better.
The purpose of this invention is to provide a kind of therapeutic domain wide, easily accept, easily absorb, the preparation technology of efficient, low dosage, the Chinese medicine dripping pills that has no side effect, soft capsule, granule, chewable tablet, pill, its pill that makes can be used for curing mainly weakness of the spleen and stomach, distension and fullness in the abdomen, vomiting is had loose bowels, anorexia.
Summary of the invention:
The present invention relates to a kind of prescription and preparation technology thereof of Chinese medicine preparation, it is characterized in that, the preparation of per 1000 dosage units is prepared from by following proportion raw material:
20~120 parts of 2~12 parts of Radix Aucklandiae of 200~1200 parts of Semen Caesalpiniae Minaciss of Radix Codonopsis
20~120 parts of 30~180 parts of Radixs Astragali of 20~120 parts of Poria of Herba Pogostemonis
20~120 parts of 40~240 parts of Radixs Angelicae Dahuricae of 20~120 parts of Massa Medicata Fermentatas of Semen Lablab Album (stir-fry)
20~120 parts in Radix Glycyrrhizae (processed with honey)
Preferably:
40 parts of 4 parts of Radix Aucklandiae of 400 parts of Semen Caesalpiniae Minaciss of Radix Codonopsis
40 parts of 60 parts of Radixs Astragali of 40 parts of Poria of Herba Pogostemonis
40 parts of 80 parts of Radixs Angelicae Dahuricae of 40 parts of Massa Medicata Fermentatas of Semen Lablab Album (stir-fry)
40 parts in Radix Glycyrrhizae (processed with honey)
In more than forming, the weight of medicine is calculated with crude drug, and per 1 part can be 1 gram, also can be kilogram or ton, if be unit with gram, this prescription composition can be made into 1000 doses of pharmaceutical preparatioies.Described 1000 doses of fingers, the final drug preparation of making, as make 1000 of soft capsule preparations, drop pill 1000 balls, granule 1000g etc., also can make big packing as granule, as 100~500 bags, specifically can be 100 bags, 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as taking dose 1 time.
More than form, can be made into the preparation of 50~1000 taking doses,, make 125 bags, take 1~2 bag at every turn, can take altogether 62.5~125 times as granule.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be unit with the milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The raw material of Chinese medicine of said ratio extracts processing through new technology of the present invention, obtain the active constituents of medicine of preparation of the present invention, add suitable excipient as required and make suitable medicinal any dosage form, said preparation can be drop pill, soft capsule, granule, chewable tablet, pill.
The above new technology of the present invention may further comprise the steps:
Method a:(technology 1.)
(1) gets the Radix Aucklandiae, Herba Pogostemonis, the Radix Angelicae Dahuricae three flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 15MPa, temperature are that 50 ℃, reception tank temperature are 30 ℃ with pressure, extract 0.5.0~4.0h under the condition of flow 20L/h, extract; β-CDBao He, optimised process is: β-CD is 1: 6~10 with the water ratio, and oil is 1: 4~12 with β-CD ratio, and ultrasonic 30~70min gets clathrate;
(2) get the residue medical material, decoct with water 24 times, each 0.5~2.5 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) getting the Radix Aucklandiae, Herba Pogostemonis, the Radix Angelicae Dahuricae three flavor medical materials beats powder and is used as medicine;
(2) the residue medical material is handled the same;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing the various preparations except that drop pill and soft capsule of the present invention.
The active constituents of medicine of the preparation of the present invention that above method obtains can be prepared into preparation of the present invention through further processing.
Preparation of the present invention, different dosage form method difference below is the preparation method of several preferred dosage form.
(1) preparation of drop pill
Drop pill of the present invention, wherein the ratio of active component and adjuvant is 1: 0.5~10, and preferred ratio is 1: 2~4, and most preferred ratio is 1: 3.The above adjuvant be specially molecular weight polyethylene glycol between 400 to 10000 Polyethylene Glycol and their mixture, as PEG400 (PEG400), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture or other suitable other auxiliary elements of making drop pill, as glycerol, gelatin or stearic acid sodium etc.
Following steps are taked in the preparation of drop pill of the present invention:
1. be ready to following raw material: active component, adjuvant and/or other inactive ingredients;
2. with the above-mentioned raw materials mix homogeneously;
3. add the transconversion into heat material, move into the drip irrigation of drop pill machine, medicinal liquid splashes in the liquid sub liquid paraffin by water dropper, removes liquid paraffin, selects ball, promptly.
(2) preparation of soft capsule
Soft capsule preparation of the present invention is that active component and pharmaceutically useful organic solvent and the material of making soft capsule shell are formed.Organic solvent wherein is selected from PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, the material of wherein making soft capsule shell is gelatin or arabic gum, water, plasticizer and antiseptic, the weight ratio of gelatin or arabic gum and plasticizer is 1.0: 0.4~1.0 in the soft capsule shell, and the weight ratio of gelatin and water is 1.0: 0.8~1.2; The content of active component is 50mg~500mg in every soft capsule.
The preparation method of preparation of the present invention, the process following steps:
A. get gelatin, glycerol, pure water adds thermosol, adds an amount of antiseptic, preparation rubber;
B. get active component and be dissolved in organic solvent, add suitable quantity of water, be prepared into soft capsule through encapsulating machine.
(3) preparation process of granule is as follows: with the gained active component, add a certain amount of correctives, filler, lubricant, granulate, promptly get granule.
(4) preparation method of chewable tablet is as follows: with the gained active component, add a certain amount of correctives, filler, lubricant, granulate, and drying, tabletting promptly gets chewable tablet.
Filler described in the preparation of granule, chewable tablet is selected from one or more the mixture in lactose, sucrose, dextrin, starch, microcrystalline Cellulose, mannitol, pregelatinized Starch, sorbitol, the xylitol etc.; Described correctives one of is selected from Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, the stevioside or wherein several mixture; Suitable lubricant comprises wherein one or more such as magnesium stearate, Pulvis Talci, micropowder silica gel.
Following data declaration beneficial effect of the present invention by experiment:
In order to prove the Clinical feasibility that changes after the technology, we have carried out its main pharmacodynamics, toxicologic study to this medicine, observe its therapeutical effect, and the clinical experimental basis that provides is provided.
One, to the influence of mice with spleen deficiency
1, the laboratory observation of mice ordinary circumstance is studied
According to literature method, choose 40 of qualified responsive mices, male and female are regardless of, and are divided into 4 groups at random.Technology is extractum group 0.09g/kg 1., technology is extractum group 0.18g/kg 2., and blank group gives normal saline, and model group gives normal saline, equal gastric infusion, every mouse subcutaneous injection reserpine 0.12mg/kg, every day 1 time, 10d continuously, beginning in the 4th day, each organizes corresponding medicine of mouse stomach or normal saline, every day 1 time, 7d continuously.Observe the behavioral activity of mice, outward appearance fur, diet feces etc.Weighed 1 time in per 4 days.The results are shown in Table 1.
The influence of table 1 pair mice growth (x ± s, n=10)
Group Dosage (g/kg) Body weight
0d 3d 6d 9d
Matched group model group technology is 2. extractum group of extractum group technology 1. - - 0.09 0.18 19.1±1.11 19.3±0.82 19.1±0.31 19.3±1.55 21.2±1.04 * 16.6±2.17 18.3±1.88 18.3±1.94 22.3±1.63 ** 15.8±0.93 19.53±1.35 # 19.20±1.03 # 25.40±2.63 *** 14.02±1.23 20.82±1.0 ##* 21.66±3.42 ##*
Annotate: compare with model group *P<0.05, *P<0.01, * *P<0.001 and blank group be #P<0.05 relatively, ##P<0.01 (down together)
Test as seen, model group mice anorexia, just rare, abdomen, chaeta are not flourish, and bradykinesia, hogback are moving less, body cold etc.And the control animals no abnormality seen.Administration treated animal general signs is near normal, and body weight is compared difference highly significant (P<0.01) with the model group mice.
2, the influence that mouse small intestine is moved
Get 40 of mices, the male and female dual-purpose divides 4 groups at random.Reserpine, NS, technology is extractum group 0.09g/kg 1., and technology is extractum group 0.18g/kg 2., and medication is all the same.Fasting 12h (can't help water) before the experiment is made into the suspension oral gavage that contains 5% charcoal end, 10% arabic gum with NS during experiment.With the cervical vertebra dislocation method mice is put to death behind the 15min, the taking-up intestinal tube of cutting open the belly is measured pylorus to charcoal end Front distance, calculates the ratio (seeing Table 2) of charcoal end displacement and small intestinal (extremely returning cecum from pylorus).The result shows, it is hyperfunction that each dosage group all can suppress the enterokinesia that reserpine causes, and do not have significant difference (P>0.05) between the two.
The table 2 pair influence that the reserpine small intestinal is hyperfunction (x ± s)
Group Number of animals (only) Dosage (g/kg) The charcoal end pushes away rate (%)
Matched group model group technology is 2. extractum group of extractum group technology 1. 10 10 10 10 - - 0.09 0.18 49.1±17.13 * 63.05±12.12 44.12±14.07 # 46.34±12.12 #
3, to the exponential influence of mouse thymus spleen immune organ
Get 40 of mices, the male and female dual-purpose divides 4 groups at random.Reserpine, NS, technology is extractum group 0.09g/kg 1., and technology is extractum group 0.18g/kg 2., and medication is all the same.1h after the last administration takes by weighing each Mus body weight, gets thymus then and spleen is weighed, and calculates thymus, spleen immune organ index (mg/g body weight), the results are shown in Table 3.
The influence of table 3 pair mouse thymus and spleen immune organ (x ± s)
Group Number of animals (only) Dosage (g/kg) Thymus index (mg/g) Index and spleen index (mg/g)
Matched group 10 - 0.2767±0.0676 ** 0.35±0.10
Model group technology is 2. extractum group of extractum group technology 1. 10 10 10 - 0.09 0.18 0.0927±0.0591 0.2300±0.0406 ## 0.21 13±0.0422 ## 0.26±0.06 0.27±0.05 0.31±0.08
The result shows that each extractum group all can improve mouse thymus spleen immune organ index, and there was no significant difference (P>0.05) between the two
Two, toxicological study
Acute toxicity test shows that rat oral gavage extract of the present invention fails to measure LD 50
Long term toxicity test: rat grouping, extract of the present invention is irritated stomach, every day three times, connect and annotate 90d, the result, administration group rat and control rats movable, search for food, drinking-water, body weight and multinomial observation indexs such as substantial viscera pathologic finding and histopathology detect, result of the test is not all found any toxicity; Hemogram and hepatic and renal function index and the equal no significant difference of matched group.
The blood vessel irritation of this medicine, allergy and hemolytic test all are negative.
In sum, preparation of the present invention, dropping pill formulation particularly of the present invention and soft capsule preparation are a kind of good treatment weakness of the spleen and stomach, distension and fullness in the abdomen, vomiting is had loose bowels, the medicine of anorexia, and change preparation technology, can obviously strengthen its replenishing QI to invigorate the spleen, stomach function regulating is transported medium clinical efficacy, its hypotoxicity in addition, prolonged application safety, therefore, be worth clinical application.
The specific embodiment:
Further specify the present invention by the following examples, include but not limited to the following example.
Embodiment 1:
The preparation method of drop pill of the present invention:
Prescription:
Radix Codonopsis 328g Semen Caesalpiniae Minacis 3.3g Radix Aucklandiae 33g
Herba Pogostemonis 33g Poria 49g Radix Astragali 33g
Semen Lablab Album (stir-fry) 33g Massa Medicata Fermentata 65.6g Radix Angelicae Dahuricae 33g
Radix Glycyrrhizae (processed with honey) 33g
PEG4000 100g
Make 1000 balls
Preparation method:
(1) gets the Radix Aucklandiae, Herba Pogostemonis, the Radix Angelicae Dahuricae three flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 15MPa, temperature are that 50 ℃, reception tank temperature are 30 ℃ with pressure, extract 40min under the condition of flow 20L/h, extract; β-CDBao He, optimised process is: β-CD is 1: 10 with the water ratio, and oil is 1: 8 with β-CD ratio, and ultrasonic 40min gets clathrate;
(2) get the residue medical material, decoct with water 3 times, each 1 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(3) with above-mentioned extract obtained, the PEG4000 that adds recipe quantity puts into the vessel in heating dissolving, and jolting makes and dissolves into uniform solution, inserts in the fluid reservoir.Keep 80 ℃ the system of dripping temperature, and a control speed, condensed fluid is a liquid paraffin, drips system promptly.
Embodiment 2:
Preparation of soft capsule method of the present invention:
Prescription:
Radix Codonopsis 756g Semen Caesalpiniae Minacis 7.6g Radix Aucklandiae 75.6g
Herba Pogostemonis 75.6g Poria 113g Radix Astragali 75.6g
Semen Lablab Album (stir-fry) 75.6g Massa Medicata Fermentata 151g Radix Angelicae Dahuricae 75.6g
Radix Glycyrrhizae (processed with honey) 75.6g
PEG400 270g
Make 1000
Preparation method:
(1) gets the Radix Aucklandiae, Herba Pogostemonis, the Radix Angelicae Dahuricae three flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 15MPa, temperature are that 50 ℃, reception tank temperature are 30 ℃ with pressure, extract 40min under the condition of flow 20L/h, extract; β-CDBao He, optimised process is: β-CD is 1: 10 with the water ratio, and oil is 1: 8 with β-CD ratio, and ultrasonic 40min gets clathrate;
(2) get the residue medical material, decoct with water 3 times, each 1 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(3) with above-mentioned extract obtained, add an amount of PEG400 and mix and mixing, add the PEG400 of surplus then, promptly get medicinal liquid.It is standby in addition to join gelatin solution by certain prescription.The condition that control is suitable is regulated content weight, obtains soft capsule in the soft capsule machine.
Embodiment 3:
The preparation method of granule of the present invention:
Prescription:
Radix Codonopsis 1200g Semen Caesalpiniae Minacis 12g Radix Aucklandiae 120g
Herba Pogostemonis 120g Poria 180g Radix Astragali 120g
Semen Lablab Album (stir-fry) 120g Massa Medicata Fermentata 240g Radix Angelicae Dahuricae 120g
Radix Glycyrrhizae (processed with honey) 120g
Make 1000g
Preparation method:
(1) getting the Radix Aucklandiae, Herba Pogostemonis, the Radix Angelicae Dahuricae three flavor medical materials beats powder and is used as medicine;
(2) the residue medical material is handled the same;
(3) above active component is merged, add aspartame 5.0g, dextrin 280.0g, granulate, drying sprays into essence 5.0g, promptly gets granule 1000g.
Embodiment 4:
The preparation method of chewable tablet of the present invention:
Prescription:
Radix Codonopsis 400g Semen Caesalpiniae Minacis 4g Radix Aucklandiae 40g
Herba Pogostemonis 40g Poria 60g Radix Astragali 40g
Semen Lablab Album (stir-fry) 40g Massa Medicata Fermentata 80g Radix Angelicae Dahuricae 40g
Radix Glycyrrhizae (processed with honey) 40g
Make 1000
Preparation method:
(1) getting the Radix Aucklandiae, Herba Pogostemonis, the Radix Angelicae Dahuricae three flavor medical materials beats powder and is used as medicine;
(2) the residue medical material is handled the same;
(3) above active component is merged, add aspartame 3.0g, mannitol 270.0g, granulation, drying adds magnesium stearate 3.0g, mixing, and tabletting promptly gets 1000 of chewable tablet.

Claims (10)

1, a kind of Chinese medicine preparation is characterized in that per 1000 dosage units are made by the following weight proportion raw material:
20~120 parts of 2~12 parts of Radix Aucklandiae of 200~1200 parts of Semen Caesalpiniae Minaciss of Radix Codonopsis
20~120 parts of 30~180 parts of Radixs Astragali of 20~120 parts of Poria of Herba Pogostemonis
20~120 parts of 40~240 parts of Radixs Angelicae Dahuricae of 20~120 parts of Massa Medicata Fermentatas of Semen Lablab Album (stir-fry)
20~120 parts in Radix Glycyrrhizae (processed with honey).
2, the compound preparation of claim 1 is characterized in that, per 1000 dosage units are made by the following weight proportion raw material:
40 parts of 4 parts of Radix Aucklandiae of 400 parts of Semen Caesalpiniae Minaciss of Radix Codonopsis
40 parts of 60 parts of Radixs Astragali of 40 parts of Poria of Herba Pogostemonis
40 parts of 80 parts of Radixs Angelicae Dahuricae of 40 parts of Massa Medicata Fermentatas of Semen Lablab Album (stir-fry)
40 parts in Radix Glycyrrhizae (processed with honey).
3, claim 1 or any one Chinese medicine preparation of 2 are drop pill, soft capsule, granule, chewable tablet, pill.
4, the Chinese medicine preparation of claim 3 through described raw material is extracted processing, obtains active component, adds suitable adjuvant as required and makes.
5, the Chinese medicine preparation of claim 4 is characterized in that, described active component prepares through following steps:
Method a:(technology 1.)
(1) gets the Radix Aucklandiae, Herba Pogostemonis, the Radix Angelicae Dahuricae three flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 15MPa, temperature are that 50 ℃, reception tank temperature are 30 ℃ with pressure, extract 0.5.0~4.0h under the condition of flow 20L/h, extract; β-CDBao He, optimised process is: β-CD is 1: 6~10 with the water ratio, and oil is 1: 4~12 with β-CD ratio, and ultrasonic 30~70min gets clathrate;
(2) get the residue medical material, decoct with water 2~4 times, each 0.5~2.5 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) getting the Radix Aucklandiae, Herba Pogostemonis, the Radix Angelicae Dahuricae three flavor medical materials beats powder and is used as medicine;
(2) the residue medical material is handled the same;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing the various preparations except that drop pill and soft capsule of the present invention.
6, the Chinese medicine preparation of claim 5 is characterized in that:
Described drop pill, wherein the ratio of active component and adjuvant is 1: 0.5~10, described adjuvant be molecular weight between 400 to 10000 Polyethylene Glycol and their mixture, be selected from PEG400 (or 600), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture.
Its preparation method is: active constituents of medicine and proper auxiliary materials behind 60~115 ℃ of mix homogeneously, are regulated the water dropper size with control drop pill weight, are that the coolant system of dripping forms with dimethicone or liquid paraffin, and coolant temperature is-10~5 ℃.
7, the Chinese medicine preparation of claim 5 is characterized in that:
Described soft capsule, its content is made up of active component and suitable substrate, and wherein the content of active component is 50mg~500mg in every soft capsule; Substrate wherein is selected from wherein one or more of PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, animal wet goods.
Its preparation method is: with active constituents of medicine and proper auxiliary materials mix homogeneously, obtain uniform suspension and/or solution, regulate content weight, compacting, dry getting final product.
8, the Chinese medicine preparation of claim 5 is characterized in that:
The preparation process of described granule is as follows: with above-mentioned extract obtained, add a certain amount of filler, correctives, lubricant, granulate, promptly get granule;
The preparation method of chewable tablet is as follows: with above-mentioned extract obtained, adds a certain amount of filler, correctives, lubricant, granulates, and drying, tabletting promptly gets chewable tablet.
9, the Chinese medicine preparation of claim 8 is characterized in that:
Described filler is selected from one or more the mixture in lactose, sucrose, dextrin, starch, microcrystalline Cellulose, mannitol, pregelatinized Starch, sorbitol, the xylitol etc.;
Described correctives one of is selected from Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, the stevioside or wherein several mixture;
Suitable lubricant comprises wherein one or more such as magnesium stearate, Pulvis Talci, micropowder silica gel.
10, the preparation method of any one Chinese medicine preparation of claim 1~9 is characterized in that, the process following steps:
Described raw material of Chinese medicine is extracted processing, obtain active component, add suitable adjuvant and make; Wherein said active component prepares through following steps:
Method a:(technology 1.)
(1) gets the Radix Aucklandiae, Herba Pogostemonis, the Radix Angelicae Dahuricae three flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 15MPa, temperature are that 50 ℃, reception tank temperature are 30 ℃ with pressure, extract 0.5.0~4.0h under the condition of flow 20L/h, extract; β-CDBao He, optimised process is: β-CD is 1: 6~10 with the water ratio, and oil is 1: 4~12 with β-CD ratio, and ultrasonic 30~70min gets clathrate;
(2) get the residue medical material, decoct with water 2~4 times, each 0.5~2.5 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) getting the Radix Aucklandiae, Herba Pogostemonis, the Radix Angelicae Dahuricae three flavor medical materials beats powder and is used as medicine;
(2) the residue medical material is handled the same;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing the various preparations except that drop pill and soft capsule of the present invention;
Described drop pill, wherein the ratio of active component and adjuvant is 1: 0.5~10, described adjuvant be molecular weight between 400 to 10000 Polyethylene Glycol and their mixture, be selected from PEG400 (or 600), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture.
Its preparation method is: active constituents of medicine and proper auxiliary materials behind 60~115 ℃ of mix homogeneously, are regulated the water dropper size with control drop pill weight, are that the coolant system of dripping forms with dimethicone or liquid paraffin, and coolant temperature is-10~5 ℃.
Described soft capsule, its content is made up of active component and suitable substrate, and wherein the content of active component is 50mg~500mg in every soft capsule; Substrate wherein is selected from wherein one or more of PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, animal wet goods.
Its preparation method is: active constituents of medicine is mixed with proper auxiliary materials, obtain uniform suspension and/or solution, regulate content weight, compacting, dry getting final product.
CNA2005101159887A 2005-11-18 2005-11-18 Infant spleen-tonifying preparation and new preparing method Pending CN1775272A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105327218A (en) * 2015-12-11 2016-02-17 赵爱良 Spleen and stomach strengthening pill for children and preparation method thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105327218A (en) * 2015-12-11 2016-02-17 赵爱良 Spleen and stomach strengthening pill for children and preparation method thereof

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