CN1857492A - Qingxie preparation and its preparing process - Google Patents
Qingxie preparation and its preparing process Download PDFInfo
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- CN1857492A CN1857492A CN 200610065254 CN200610065254A CN1857492A CN 1857492 A CN1857492 A CN 1857492A CN 200610065254 CN200610065254 CN 200610065254 CN 200610065254 A CN200610065254 A CN 200610065254A CN 1857492 A CN1857492 A CN 1857492A
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Abstract
The present invention relates to Chinese medicine composition and its preparation process, and especially a kind of Chinese medicine composition for treating intestinal heat, food stagnation and constipation and its preparation process. The Chinese medicine composition is preferably prepared into tablet or capsule.
Description
Technical field:
The present invention relates to a kind of Chinese medicine composition and preparation technology thereof, particularly a kind of prescription and preparation technology thereof who is used for intestinal heat, stagnant, constipation.
Background technology:
Intestinal heat, stagnant, constipation are clinically to see symptom more, and the traditional Chinese medical science is often taked heat clearing away, relieving constipation, and the stagnant means that disappear are treated it, and evident in efficacy.Pellets for curing diarrhea 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 medicinal capsule agent that has no side effect, granule, tablet, its pill that makes can be used for curing mainly intestinal heat, stagnant, constipation.
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:
149～405 parts of 297～805 parts of Fructus Aurantii Immaturuss of 1487～4031 parts of Radix Scutellariaes of Radix Et Rhizoma Rhei
25～68 parts in 31～83 parts of Cinnabaris of Radix Glycyrrhizae.Preferably:
158 parts of 313.5 parts of Fructus Aurantii Immaturuss of 1569 parts of Radix Scutellariaes of Radix Et Rhizoma Rhei
27 parts in 32 parts of Cinnabaris of Radix Glycyrrhizae.
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 capsule preparations, 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 capsule, granule, tablet etc.
The above new technology of the present invention may further comprise the steps:
Method a:(technology 1.)
(1) get Cinnabaris, water flies into impalpable powder, and is standby;
(2) get the Fructus Aurantii Immaturus medical material, soaked 30～90 minutes earlier with 50～95% ethanol, reheat reflux, extract, 2～6 times, each 0.5～3 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) get the residue medical material, decoct with water 2～5 times, each 0.5～3 hour, collecting decoction filtered, and it is standby that filtrate is condensed into thick extractum.
Above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as tablet of the present invention and capsule.
Method b:(technology 2.)
(1) gets that Cinnabaris water flies into impalpable powder, the Fructus Aurantii Immaturus medical material is beaten powder and is used as medicine;
(2) prescription residue medical material is handled the same;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as granule of the present invention and chewable tablet.
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 process of capsule is as follows: with the active component of gained, granulate, drying adds a certain amount of lubricant, and mixing is filled, and promptly gets capsule.
(2) preparation process of tablet is as follows: with the active component of gained, add a certain amount of correctives, filler, lubricant, disintegrating agent, granulate, and drying, tabletting promptly gets sheet.
(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 such as 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.
1, to the influence of excess-heat type constipation model mice defecation
Get 40 of mices, fasting (can't help water) 12h before the experiment, mice is divided into 5 groups at random, wherein make excess-heat type constipation model for 4 groups, 1 group is the blank group, 4 groups of modelings gavage 1% suspension that self feces is made respectively, 0.1g/ only even irritates 2d to mice by every day, matched group is given with the volume normal saline, gavage relative medicine respectively for 3 groups in modeling in morning in the 3rd day, technology 1. the extractum group with 0.20g/kg, technology 2. the extractum group with 0.28g/kg, the Fructus Cannabis Bolus group is with 2.0g/kg administration (institute's vehicle all adds 10% active carbon), matched group is irritated the normal saline that contains 10% active carbon, observes 12h continuously, and every Mus is put 1 little cage, the lower berth absorbent paper of little cage, the incubation period of powdered carbon feces and the total number of particles that 12h includes powdered carbon feces appear containing in record first.The results are shown in Table 1.
Table 1 loosening bowel to relieve constipation concentrated pill is to shadow noon of excess-heat type constipation model mice defecation (x ± s)
| Group | Dosage (g/kg) | Discharge the incubation period (h) that contains powdered carbon feces first | The granule number that contains powdered carbon (individual) of discharging in the 12h |
| Matched group model group Fructus Cannabis Bolus group is 2. extractum group of extractum group 1. | 2 0.20 0.28 | 2.37±0.56 * 3.00±0.70 2.18±0.80 * 2.18±0.77 * 2.09±0.85 * | 6.0±2.7 4.4±3.1 9.4±5.1 * 11.7±3.1 ** 10.6±4.2 ** |
Annotate: compare with model group,
*P＜0.05
The result shows that the extractum group has obvious facilitation to excess-heat constipation model mice intestinal peristalsis.
2, antiinflammatory action
Get 32 of the Wistar rats of 160～190g, male and female half and half are divided into 4 groups at random, 8 every group.2 groups to the extractum group, and 1 group is blank, 1 group of positive contrast.Each is organized rat and all uses pentobarbital sodium 35mg/kg intraperitoneal injection of anesthesia, cuts an osculum that is about 1cm at the both sides of every Mus groin, and it is subcutaneous that every side is put into incision with the aseptic cotton balls (adding 10u/ml ampicillin 0.2ml) of 30mg, skin suture.From performing the operation the same day, the administration group is given different extractum 0.11g/kg respectively, and positive controls is given dexamethasone sodium phosphate injection (DS) 5mg/kg, and the blank group irritates stomach, every day 1 time, continuous 6 days for the equal-volume normal saline.Postoperative the 7th day takes out the cotton balls granulation tissue, weighs behind 60 ℃ of oven dry 12h, deducts dry cotton ball weight and promptly gets granuloma weight.Then according to body weight, calculate the granuloma weight of every 100g body weight again.The result shows that technology 2. extractum group has obvious inhibitory action to subcutaneous rat implantation cotton balls formation granuloma, and technology 1. extractum group then has remarkable inhibitory action (P＜0.01), sees Table 2.
Table 2 pair subcutaneous rat forms granulomatous influence (n=8) after implanting cotton balls
| Group | Dosage (g/kg) | The granuloma weight (mg/100g, x ± s) |
| Normal saline technology is 2. extractum group DS of extractum group technology 1. | - 0.10 0.14 0.005 | 85.8±10.7 48.7±12.6 ** 67.1±10.9 * 39.7±13.4 ** |
Compare with normal saline
*P＜0.01,
*P＜0.05
3, analgesic activity
Get 40 of mices, random packet, 10 every group.Wherein 2 groups is the extractum group, and dosage sees Table 3, and the blank group is given and waited the capacity normal saline, positive controls is irritated stomach, administration volume 0.4ml/10g body weight, 1 day 1 time with aspirin 0.3g/kg, continuous 5 days, the last administration was after 1 hour, the equal lumbar injection 0.5% acetum 0.2ml of each mice.Observe and write down the number of times that writhing response (abdominal part indent, stretch hind leg, buttocks is raised) appears in each mice in 15 minutes.The result shows that the extractum group makes the mouse writhing reaction times obviously reduce (P＜0.05), sees Table 3.
The 0.5% ester acid of table 3 pair ip in mice causes the influence (n=10) of writhing response
| Group | Dosage (g/kg) | The writhing response number of times (x ± s) |
| Normal saline technology is 2. extractum group aspirin of extractum group technology 1. | - 0.20 0.28 0.3 | 34±3 17±5 * 16±8 * 10±5 ** |
Compare with normal saline
*P＜0.05,
*P＜0.01
4, 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 the medicines of a kind of good treatment intestinal heat, stagnant, constipation, and change preparation technology, can obviously strengthen its heat clearing away, relieving constipation, disappearing and stagnate waiting 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 tablet of the present invention:
Prescription:
Radix Et Rhizoma Rhei 1569g Radix Scutellariae 313.5g Fructus Aurantii Immaturus 158g
Radix Glycyrrhizae 32g Cinnabaris 27g
Make 1000 balls
Preparation method:
(1) get Cinnabaris, water flies into impalpable powder, and is standby;
(2) get the Fructus Aurantii Immaturus medical material, soaked 30 minutes earlier with 75% ethanol, reheat reflux, extract, 3 times, each 1 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) get the residue medical material, decoct with water 3 times, each 1 hour, collecting decoction filtered, and it is standby that filtrate is condensed into thick extractum;
(4) above active component is merged, add starch 5.0g, mannitol 100.0g, granulation, drying adds magnesium stearate 3.0g, mixing, and tabletting promptly gets tablet.
Embodiment 2:
The preparation method of capsule of the present invention:
Prescription:
Radix Et Rhizoma Rhei 4031g Radix Scutellariae 805g Fructus Aurantii Immaturus 405g
Radix Glycyrrhizae 83g Cinnabaris 68g
Make 1000
Preparation method:
(1) get Cinnabaris, water flies into impalpable powder, and is standby;
(2) get the Fructus Aurantii Immaturus medical material, soaked 30 minutes earlier with 75% ethanol, reheat reflux, extract, 3 times, each 1 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) get the residue medical material, decoct with water 3 times, each 1 hour, collecting decoction filtered, and it is standby that filtrate is condensed into thick extractum;
(4) with above-mentioned extract obtained, add with above-mentioned medicated powder and granulate, add magnesium stearate 3.0g, fill, promptly get capsule.
Embodiment 3:
The preparation method of granule of the present invention:
Prescription:
Radix Et Rhizoma Rhei 4031g Radix Scutellariae 805g Fructus Aurantii Immaturus 405g
Radix Glycyrrhizae 83g Cinnabaris 68g
Make 1000g
Preparation method:
(1) gets that Cinnabaris water flies into impalpable powder, the Fructus Aurantii Immaturus medical material is beaten powder and is used as medicine;
(2) get the residue medical material, decoct with water 3 times, each 1 hour, collecting decoction filtered, and it is standby that filtrate is condensed into thick extractum;
(3) above active component is merged, add aspartame 5.0g, dextrin 500.0g, 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 Et Rhizoma Rhei 1487g Radix Scutellariae 297g Fructus Aurantii Immaturus 149g
Radix Glycyrrhizae 31g Cinnabaris 25g
Make 1000
Preparation method:
(1) gets that Cinnabaris water flies into impalpable powder, the Fructus Aurantii Immaturus medical material is beaten powder and is used as medicine;
(2) get the residue medical material, decoct with water 3 times, each 1 hour, collecting decoction filtered, and it is standby that filtrate is condensed into thick extractum;
(3) above active component is merged, add aspartame 3.0g, mannitol 200.0g, granulation, drying adds magnesium stearate 3.0g, mixing, and tabletting promptly gets 1000 of chewable tablet.
Claims (8)
1, a kind of Chinese medicine preparation is characterized in that per 1000 dosage units are made by the following weight proportion raw material:
149～405 parts of 297～805 parts of Fructus Aurantii Immaturuss of 1487～4031 parts of Radix Scutellariaes of Radix Et Rhizoma Rhei
25～68 parts in 31～83 parts of Cinnabaris of Radix Glycyrrhizae.
2, the compound preparation of claim 1 is characterized in that, per 1000 dosage units are made by the following weight proportion raw material:
158 parts of 313.5 parts of Fructus Aurantii Immaturuss of 1569 parts of Radix Scutellariaes of Radix Et Rhizoma Rhei
27 parts in 32 parts of Cinnabaris of Radix Glycyrrhizae.
3, claim 1 or any one Chinese medicine preparation of 2 are capsule, granule, tablet etc.
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) get Cinnabaris, water flies into impalpable powder, and is standby;
(2) get the Fructus Aurantii Immaturus medical material, soaked 30～90 minutes earlier with 50～95% ethanol, reheat reflux, extract, 2～6 times, each 0.5～3 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) get the residue medical material, decoct with water 2～5 times, each 0.5～3 hour, collecting decoction filtered, and it is standby that filtrate is condensed into thick extractum.
Above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as tablet of the present invention and capsule.
Method b:(technology 2.)
(1) gets that Cinnabaris water flies into impalpable powder, the Fructus Aurantii Immaturus medical material is beaten powder and is used as medicine;
(2) prescription residue medical material is handled the same;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparation
Various preparations such as granule of the present invention and chewable tablet.
6, the Chinese medicine preparation of claim 5 is characterized in that:
The preparation process of capsule is as follows: with the active component of gained, granulate, drying adds a certain amount of lubricant, and mixing is filled, and promptly gets capsule.
The preparation process of tablet is as follows: with the active component of gained, adds a certain amount of correctives, filler, lubricant, disintegrating agent, granulates, and drying, tabletting promptly gets sheet.
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.
7, the Chinese medicine preparation of claim 6 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.
8, the preparation method of any one Chinese medicine preparation of claim 1～7 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) get Cinnabaris, water flies into impalpable powder, and is standby;
(2) get the Fructus Aurantii Immaturus medical material, soaked 30～90 minutes earlier with 50～95% ethanol, reheat reflux, extract, 2～6 times, each 0.5～3 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) get the residue medical material, decoct with water 2～5 times, each 0.5～3 hour, collecting decoction filtered, and it is standby that filtrate is condensed into thick extractum.
Above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as tablet of the present invention and capsule.
Method b:(technology 2.)
(1) gets that Cinnabaris water flies into impalpable powder, the Fructus Aurantii Immaturus medical material is beaten powder and is used as medicine;
(2) prescription residue medical material is handled the same;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as granule of the present invention and chewable tablet.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610065254 CN1857492A (en) | 2006-03-21 | 2006-03-21 | Qingxie preparation and its preparing process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610065254 CN1857492A (en) | 2006-03-21 | 2006-03-21 | Qingxie preparation and its preparing process |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1857492A true CN1857492A (en) | 2006-11-08 |
Family
ID=37296480
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200610065254 Pending CN1857492A (en) | 2006-03-21 | 2006-03-21 | Qingxie preparation and its preparing process |
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| Country | Link |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104523925A (en) * | 2014-12-05 | 2015-04-22 | 湖南中医药高等专科学校 | Traditional Chinese medicinal composition and its application in defecation promotion |
| CN105106603A (en) * | 2015-09-26 | 2015-12-02 | 俞华 | Constipation treatment traditional Chinese medicine |
| CN111419996A (en) * | 2020-06-04 | 2020-07-17 | 青海省人民医院 | Medicine for treating early severe acute pancreatitis |
-
2006
- 2006-03-21 CN CN 200610065254 patent/CN1857492A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104523925A (en) * | 2014-12-05 | 2015-04-22 | 湖南中医药高等专科学校 | Traditional Chinese medicinal composition and its application in defecation promotion |
| CN104523925B (en) * | 2014-12-05 | 2017-05-24 | 湖南中医药高等专科学校 | Traditional Chinese medicinal composition and its application in defecation promotion |
| CN105106603A (en) * | 2015-09-26 | 2015-12-02 | 俞华 | Constipation treatment traditional Chinese medicine |
| CN111419996A (en) * | 2020-06-04 | 2020-07-17 | 青海省人民医院 | Medicine for treating early severe acute pancreatitis |
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