CN1883637A - Middle jiao-warming pain-relieving preparatrion and novel preparation method - Google Patents
Middle jiao-warming pain-relieving preparatrion and novel preparation method Download PDFInfo
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- CN1883637A CN1883637A CN 200610081542 CN200610081542A CN1883637A CN 1883637 A CN1883637 A CN 1883637A CN 200610081542 CN200610081542 CN 200610081542 CN 200610081542 A CN200610081542 A CN 200610081542A CN 1883637 A CN1883637 A CN 1883637A
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Abstract
The invention relates to a Chinese medicinal composition for the treatment of stomach and chest diseases including abdominal distention, as well as the preparing process, wherein the preferred dosage type for the preparation includes soft capsules or dripping pills.
Description
Technical field:
The present invention relates to a kind of Chinese medicine composition and preparation technology thereof, particularly a kind of stagnation of QI cold syndrome of the stomach that is used for, the twinge of breast stomach, the prescription of abdominal distention pain and preparation technology thereof.
Background technology:
Stagnation of QI cold syndrome of the stomach, the twinge of breast stomach, abdominal distention pain is clinically to see symptom more, and the traditional Chinese medical science is often taked promoting QI circulation for relieving depression, and the means of dispersing cold for relieving pain are treated it, and evident in efficacy.Warming middle-JIAO analgesia ball 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, its pill that makes can be used for curing mainly stagnation of QI cold syndrome of the stomach, the twinge of breast stomach, abdominal distention pain.
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:
48～136 parts of 36～102 parts of Radix Aucklandiae of 36～102 parts of Olibanums of Flos Caryophylli (system)
9.5～27 parts of 36～102 parts of Borneolum Syntheticums of 36～102 parts of Fructus Foeniculi of Myrrha (stir-fry)
48～136 parts in 96～272 portions of Lignum Santali Albis of 48～136 portions of Rhizoma Cyperis of Lignum Aquilariae Resinatum (system)
2.5～7 parts in 48～136 parts of Moschus of 48～136 parts of Herba Pogostemonis of Lignum Dalbergiae Odoriferae.
Preferably:
80 parts of 60 parts of Radix Aucklandiae of 60 parts of Olibanums of Flos Caryophylli (system)
16 parts of 60 parts of Borneolum Syntheticums of 60 parts of Fructus Foeniculi of Myrrha (stir-fry)
80 parts in 160 portions of Lignum Santali Albis of 80 portions of Rhizoma Cyperis of Lignum Aquilariae Resinatum (system)
4 parts in 80 parts of Moschus of 80 parts of Herba Pogostemonis of Lignum Dalbergiae Odoriferae
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, capsule, granule, tablet, mixture, fluid extract and extractum, soft extract, powder.
The above new technology of the present invention may further comprise the steps:
Method a:(technology 1.)
(1) gets eight flavor medical materials such as Flos Caryophylli, the Radix Aucklandiae, Fructus Foeniculi, Lignum Aquilariae Resinatum, Rhizoma Cyperi, Lignum Santali Albi, Lignum Dalbergiae Odoriferae, Herba Pogostemonis, adopt steam distillation (or supercritical extraction): medical material is shredded, extract according to an appendix XD of pharmacopeia in 2005 essential oil extraction method, till no longer increasing to the volatile oil height; The volatile oil β-CDBao He, optimised process is: β-CD is 1: 6～12 with the water ratio, and oil is 1: 4～12 with β-CD ratio, and ultrasonic 30～70min gets clathrate;
(2) get Moschus and add ethanol and carry out reflux, extract, 2～4 times, the alcohol solvent consumption is 4～10 times of medical material amount, and concentration of alcohol is 50～90%, return time 0.5～2.0 hour.The ethanol extract concentrating under reduced pressure gets ethanol extraction;
(3) with the medicinal residues behind medicinal residues behind the above ethanol extraction and the extraction volatile oil, extracting in water 2～4 times, amount of water are 4～10 times, each extraction time is 0.5～3 hour, and merge extractive liquid, filters, filtrate decompression is concentrated into the clear paste of relative density 1.18～1.22 (50 ℃ of surveys), put coldly, add ethanol and make and contain alcohol amount and reach 50～80%, stir evenly, left standstill 8～48 hours, get supernatant and reclaim ethanol to be concentrated into relative density be 1.15～1.30 (50), drying, water extract;
(4) get Olibanum, Myrrha medical material, adopt supercritical extraction: in the supercritical extraction jar of packing into, be that 15～40MPa, temperature are to extract 1.0～4.0h under 35～65 ℃, the condition of flow 15～25kg/h with pressure, extract, standby;
(5) get Borneolum Syntheticum, melt the back and add in the said extracted thing.
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 drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) get Olibanum, Myrrha, Borneolum Syntheticum, Moschus medical material and break into fine powder, standby;
(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 tablet of the present invention and capsule.
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.
1, to the influence of rat Ovum Gallus domesticus album foot swelling
Get 40 of healthy male white rats, be divided into 4 groups at random.Dosage and grouping see Table 1, before the experiment Ovum Gallus domesticus album 0.1ml injected to cause under the right back sufficient plantar aponeurosis of rat scorchingly not to compare to cause the scorching left back sufficient sole of the foot, with the difference of both sufficient sole of the foot girths as the swelling level index.Cause the scorching sufficient sole of the foot and be coated with medicine with prescribed dose.The results are shown in Table 1.As shown in Table 1, each extractum group and Anisodus carniolicoides C.Y.Wu et C.Chen are being coated with back 1 hour, and detumescence degree and matched group are relatively learned by statistics and handled difference not remarkable (P＞0.05).Behind the coating 1.5,2.0,2.5,3.0 hours, each extractum group caused the detumescence gradually of scorching foot, detumescence degree and matched group comparing difference highly significant (P＜0.01).
Table 1 pair Ovum Gallus domesticus album cause rat paw edema influence (x ± s, n=10)
| Group | Dosage (g/ only) | Cause scorching back different time (hour) foot swelling degree (mm) | ||||
| 1.0 | 1.5 | 2.0 | 2.5 | 3.0 | ||
| Matched group Anisodus carniolicoides C.Y.Wu et C.Chen technology is 2. extractum group of extractum group technology 1. | - 0.01 0.03 0.05 | 9.9±1.72 8.8±0.63 8.5±2.12 8.7±1.58 | 11.0±0.67 8.6±0.70 ** 8.8±1.39 ** 8.9±2.12 ** | 10.8±1.32 8.7±0.95 ** 8.2±1.03 ** 8.7±1.90 ** | 9.2±0.92 8.9±1.20 7.7±2.11 8.6±1.57 | 5.8±1.48 4.9±1.10 5.3±1.64 5.6±1.55 |
Compare with the blank group
*P＜0.05,
*P＜0.01 (down together)
2, xylol causes the bullate influence of mouse ear
Get 40 of ICR mices, ♀ ♂ half and half, body weight (20 ± 2) g is divided into 4 groups at random, normal saline group, aspirin group and technology 1., 2. extractum group, each organizes equal ig administration, dosage 0.3mL10g
-1Every day 1 time, successive administration 7d, last 1 administration 30min is applied to mouse right ear with 50 μ L dimethylbenzene, left side ear is coated with normal saline 50 μ L, put to death behind the 15min, along the punching of left and right sides auricle same area, the both sides auricle is weighed respectively with the 6mm card punch, as the swelling degree, the results are shown in Table 2 with two auricle weight differences.
Table 2 xylol cause the bullate influence of mouse ear (x ± s, n=10)
| Group | Dosage (gkg -1) | Two auricle weight differences (mg) |
| Matched group aspirin group technology is 2. extractum group of extractum group technology 1. | - 0.2 0.06 0.10 | 7.28±2.16 2.39±1.01 ** 3.15±1.87 * 4.23±2.07 |
By table 2 as seen, technology 1. extractum group xylol induced mice ear swelling the obvious suppression effect is arranged.
3, anti-acetic acid twisting analgesic experiment
Get body weight and be 60 of the healthy Kunming kind white mice of 18～22g, male and female half and half are divided into 4 groups at random, gastric infusion respectively, and the equal lumbar injection 0.6% acetic acid 0.1ml/10g of animal behind the 1h observes and turns round the body number of times in the 15min, the results are shown in Table 3.
The anti-acetic acid twisting analgesic experiment of table 3 (x ± s)
| Group | Dosage (g/kg) | Number of animals (only) | Turn round body number of times (inferior) |
| Matched group YUANHU ZHITONG PIAN group technology is 2. extractum group of extractum group technology 1. | - 1 0.06 0.10 | 15 15 15 15 | 47.14±15.27 26.15±15.34 ** 16.73±11.21 * 20.35±14.26 * |
Annotate: with the matched group ratio,
*P＜0.05,
*P＜0.01
By table 3 as seen, medicine has anti-preferably acetic acid twisting analgesic activity.
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 a kind of good treatment stagnation of QI cold syndrome of the stomachs, the twinge of breast stomach, the medicine of diseases such as abdominal distention pain, and change preparation technology can obviously strengthen its promoting QI circulation for relieving depression, clinical efficacies such as dispersing cold for relieving pain, its hypotoxicity in addition, therefore prolonged application safety, 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:
Flos Caryophylli 36g Olibanum (system) 36g Radix Aucklandiae 48g
Myrrha (stir-fry) 36g Fructus Foeniculi 36g Borneolum Syntheticum 9.5g
Lignum Aquilariae Resinatum 48g Rhizoma Cyperi (system) 96g Lignum Santali Albi 48g
Lignum Dalbergiae Odoriferae 48g Herba Pogostemonis 48g Moschus 2.5g
PEG4000 100g
Make 1000 balls
Preparation method:
(1) gets eight flavor medical materials such as Flos Caryophylli, the Radix Aucklandiae, Fructus Foeniculi, Lignum Aquilariae Resinatum, Rhizoma Cyperi, Lignum Santali Albi, Lignum Dalbergiae Odoriferae, Herba Pogostemonis, adopt steam distillation (or supercritical extraction): medical material is shredded, extract according to an appendix XD of pharmacopeia in 2005 essential oil extraction method, till no longer increasing to the volatile oil height; The volatile oil β-CDBao He, optimised process is: β-CD is 1: 8 with the water ratio, and oil is 1: 6 with β-CD ratio, and ultrasonic 40min gets clathrate;
(2) get Moschus and add ethanol and carry out reflux, extract, 3 times, the alcohol solvent consumption is 6 times of medical material amount, and concentration of alcohol is 80%, return time 1.0 hours.The ethanol extract concentrating under reduced pressure gets ethanol extraction;
(3) with the medicinal residues behind medicinal residues behind the above ethanol extraction and the extraction volatile oil, extracting in water 2 times, amount of water are 8 times, each extraction time is 1 hour, and merge extractive liquid, filters, filtrate decompression is concentrated into the clear paste of relative density 1.18～1.22 (50 ℃ of surveys), put coldly, add ethanol and make and contain alcohol amount and reach 50～80%, stir evenly, left standstill 8～48 hours, get supernatant and reclaim ethanol to be concentrated into relative density be 1.15～1.30 (50), drying, water extract;
(4) get Olibanum, Myrrha medical material, adopt supercritical extraction: in the supercritical extraction jar of packing into, be that 15～40MPa, temperature are to extract 2.0h under 35～65 ℃, the condition of flow 20kg/h with pressure, extract, standby;
(5) get Borneolum Syntheticum, melt the back and add in the said extracted thing.
(6) 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:
Flos Caryophylli 102g Olibanum (system) 102g Radix Aucklandiae 136g
Myrrha (stir-fry) 102g Fructus Foeniculi 102g Borneolum Syntheticum 27g
Lignum Aquilariae Resinatum 136g Rhizoma Cyperi (system) 272g Lignum Santali Albi 136g
Lignum Dalbergiae Odoriferae 136g Herba Pogostemonis 136g Moschus 7g
PEG400 300g
Make 1000
Preparation method:
(1) gets eight flavor medical materials such as Flos Caryophylli, the Radix Aucklandiae, Fructus Foeniculi, Lignum Aquilariae Resinatum, Rhizoma Cyperi, Lignum Santali Albi, Lignum Dalbergiae Odoriferae, Herba Pogostemonis, adopt steam distillation (or supercritical extraction): medical material is shredded, extract according to an appendix XD of pharmacopeia in 2005 essential oil extraction method, till no longer increasing to the volatile oil height; The volatile oil β-CDBao He, optimised process is: β-CD is 1: 8 with the water ratio, and oil is 1: 6 with β-CD ratio, and ultrasonic 40min gets clathrate;
(2) get Moschus and add ethanol and carry out reflux, extract, 3 times, the alcohol solvent consumption is 6 times of medical material amount, and concentration of alcohol is 80%, return time 1.0 hours.The ethanol extract concentrating under reduced pressure gets ethanol extraction;
(3) with the medicinal residues behind medicinal residues behind the above ethanol extraction and the extraction volatile oil, extracting in water 2 times, amount of water are 8 times, each extraction time is 1 hour, and merge extractive liquid, filters, filtrate decompression is concentrated into the clear paste of relative density 1.18～1.22 (50 ℃ of surveys), put coldly, add ethanol and make and contain alcohol amount and reach 50～80%, stir evenly, left standstill 8～48 hours, get supernatant and reclaim ethanol to be concentrated into relative density be 1.15～1.30 (50), drying, water extract;
(4) get Olibanum, Myrrha medical material, adopt supercritical extraction: in the supercritical extraction jar of packing into, be that 15～40MPa, temperature are to extract 2.0h under 35～65 ℃, the condition of flow 20kg/h with pressure, extract, standby;
(5) get Borneolum Syntheticum, melt the back and add in the said extracted thing.
(6) 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:
Flos Caryophylli 180g Olibanum (system) 180g Radix Aucklandiae 240g
Myrrha (stir-fry) 180g Fructus Foeniculi 180g Borneolum Syntheticum 48g
Lignum Aquilariae Resinatum 240g Rhizoma Cyperi (system) 480g Lignum Santali Albi 240g
Lignum Dalbergiae Odoriferae 240g Herba Pogostemonis 240g Moschus 12g
Make 1000g
Preparation method:
(1) get Olibanum, Myrrha, Borneolum Syntheticum, Moschus medical material and break into fine powder, standby;
(2) get eight flavor medical materials such as Flos Caryophylli, the Radix Aucklandiae, Fructus Foeniculi, Lignum Aquilariae Resinatum, Rhizoma Cyperi, Lignum Santali Albi, Lignum Dalbergiae Odoriferae, Herba Pogostemonis, adopt steam distillation (or supercritical extraction): medical material is shredded, extract according to an appendix XD of pharmacopeia in 2005 essential oil extraction method, till no longer increasing to the volatile oil height; The volatile oil β-CDBao He, optimised process is: β-CD is 1: 8 with the water ratio, and oil is 1: 6 with β-CD ratio, and ultrasonic 40min gets clathrate;
(3) with the medicinal residues behind the above extraction volatile oil, extracting in water 2 times, amount of water are 8 times, each extraction time is 1 hour, and merge extractive liquid, filters, filtrate decompression is concentrated into the clear paste of relative density 1.18～1.22 (50 ℃ of surveys), put coldly, add ethanol and make and contain alcohol amount and reach 50～80%, stir evenly, left standstill 8～48 hours, get supernatant and reclaim ethanol to be concentrated into relative density be 1.15～1.30 (50), drying, water extract:
(4) above active component is merged, add aspartame 5.0g, dextrin 170.0g, granulate, drying sprays into essence 5.0g, promptly gets granule 1000g.
Embodiment 4:
The preparation method of chewable tablet of the present invention:
Prescription:
Flos Caryophylli 108g Olibanum (system) 108g Radix Aucklandiae 144g
Myrrha (stir-fry) 108g Fructus Foeniculi 108g Borneolum Syntheticum 29g
Lignum Aquilariae Resinatum 144g Rhizoma Cyperi (system) 288g Lignum Santali Albi 144g
Lignum Dalbergiae Odoriferae 144g Herba Pogostemonis 144g Moschus 7g
Make 1000
Preparation method:
(1) get Olibanum, Myrrha, Borneolum Syntheticum, Moschus medical material and break into fine powder, standby;
(2) get eight flavor medical materials such as Flos Caryophylli, the Radix Aucklandiae, Fructus Foeniculi, Lignum Aquilariae Resinatum, Rhizoma Cyperi, Lignum Santali Albi, Lignum Dalbergiae Odoriferae, Herba Pogostemonis, adopt steam distillation (or supercritical extraction): medical material is shredded, extract according to an appendix XD of pharmacopeia in 2005 essential oil extraction method, till no longer increasing to the volatile oil height; The volatile oil β-CDBao He, optimised process is: β-CD is 1: 8 with the water ratio, and oil is 1: 6 with β-CD ratio, and ultrasonic 40min gets clathrate;
(3) with the medicinal residues behind the above extraction volatile oil, extracting in water 2 times, amount of water are 8 times, each extraction time is 1 hour, and merge extractive liquid, filters, filtrate decompression is concentrated into the clear paste of relative density 1.18～1.22 (50 ℃ of surveys), put coldly, add ethanol and make and contain alcohol amount and reach 50～80%, stir evenly, left standstill 8～48 hours, get supernatant and reclaim ethanol to be concentrated into relative density be 1.15～1.30 (50), drying, water extract;
(4) 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 (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:
48～136 parts of 36～102 parts of Radix Aucklandiae of 36～102 parts of Olibanums of Flos Caryophylli (system)
9.5～27 parts of 36～102 parts of Borneolum Syntheticums of 36～102 parts of Fructus Foeniculi of Myrrha (stir-fry)
48～136 parts in 96～272 portions of Lignum Santali Albis of 48～136 portions of Rhizoma Cyperis of Lignum Aquilariae Resinatum (system)
2.5～7 parts in 48～136 parts of Moschus of 48～136 parts of Herba Pogostemonis of Lignum Dalbergiae Odoriferae.
2, the compound preparation of claim 1 is characterized in that, per 1000 dosage units are made by the following weight proportion raw material:
80 parts of 60 parts of Radix Aucklandiae of 60 parts of Olibanums of Flos Caryophylli (system)
16 parts of 60 parts of Borneolum Syntheticums of 60 parts of Fructus Foeniculi of Myrrha (stir-fry)
80 parts in 160 portions of Lignum Santali Albis of 80 portions of Rhizoma Cyperis of Lignum Aquilariae Resinatum (system)
4 parts in 80 parts of Moschus of 80 parts of Herba Pogostemonis of Lignum Dalbergiae Odoriferae.
3, claim 1 or any one Chinese medicine preparation of 2 are drop pill, capsule, granule, tablet, mixture, fluid extract and extractum, soft extract, powder.
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 eight flavor medical materials such as Flos Caryophylli, the Radix Aucklandiae, Fructus Foeniculi, Lignum Aquilariae Resinatum, Rhizoma Cyperi, Lignum Santali Albi, Lignum Dalbergiae Odoriferae, Herba Pogostemonis, adopt steam distillation (or supercritical extraction): medical material is shredded, extract according to an appendix XD of pharmacopeia in 2005 essential oil extraction method, till no longer increasing to the volatile oil height; The volatile oil β-CDBao He, optimised process is: β-CD is 1: 6～12 with the water ratio, and oil is 1: 4～12 with β-CD ratio, and ultrasonic 30～70min gets clathrate;
(2) get Moschus and add ethanol and carry out reflux, extract, 2～4 times, the alcohol solvent consumption is 4～10 times of medical material amount, and concentration of alcohol is 50～90%, return time 0.5～2.0 hour.The ethanol extract concentrating under reduced pressure gets ethanol extraction;
(3) with the medicinal residues behind medicinal residues behind the above ethanol extraction and the extraction volatile oil, extracting in water 2～4 times, amount of water are 4～10 times, each extraction time is 0.5～3 hour, and merge extractive liquid, filters, filtrate decompression is concentrated into the clear paste of relative density 1.18～1.22 (50 ℃ of surveys), put coldly, add ethanol and make and contain alcohol amount and reach 50～80%, stir evenly, left standstill 8～48 hours, get supernatant and reclaim ethanol to be concentrated into relative density be 1.15～1.30 (50), drying, water extract;
(4) get Olibanum, Myrrha medical material, adopt supercritical extraction: in the supercritical extraction jar of packing into, be that 15～40MPa, temperature are to extract 1.0～4.0h under 35～65 ℃, the condition of flow 15～25kg/h with pressure, extract, standby;
(5) get Borneolum Syntheticum, melt the back and add in the said extracted thing.
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 drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) get Olibanum, Myrrha, Borneolum Syntheticum, Moschus medical material and break into fine powder, standby;
(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 tablet of the present invention and capsule.
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 eight flavor medical materials such as Flos Caryophylli, the Radix Aucklandiae, Fructus Foeniculi, Lignum Aquilariae Resinatum, Rhizoma Cyperi, Lignum Santali Albi, Lignum Dalbergiae Odoriferae, Herba Pogostemonis, adopt steam distillation (or supercritical extraction): medical material is shredded, extract according to an appendix XD of pharmacopeia in 2005 essential oil extraction method, till no longer increasing to the volatile oil height; The volatile oil β-CDBao He, optimised process is: β-CD is 1: 6～12 with the water ratio, and oil is 1: 4～12 with β-CD ratio, and ultrasonic 30～70min gets clathrate;
(2) get Moschus and add ethanol and carry out reflux, extract, 2～4 times, the alcohol solvent consumption is 4～10 times of medical material amount, and concentration of alcohol is 50～90%, return time 0.5～2.0 hour.The ethanol extract concentrating under reduced pressure gets ethanol extraction;
(3) with the medicinal residues behind medicinal residues behind the above ethanol extraction and the extraction volatile oil, extracting in water 2～4 times, amount of water are 4～10 times, each extraction time is 0.5～3 hour, and merge extractive liquid, filters, filtrate decompression is concentrated into the clear paste of relative density 1.18～1.22 (50 ℃ of surveys), put coldly, add ethanol and make and contain alcohol amount and reach 50～80%, stir evenly, left standstill 8～48 hours, get supernatant and reclaim ethanol to be concentrated into relative density be 1.15～1.30 (50), drying, water extract;
(4) get Olibanum, Myrrha medical material, adopt supercritical extraction: in the supercritical extraction jar of packing into, be that 15～40MPa, temperature are to extract 1.0～4.0h under 35～65 ℃, the condition of flow 15～25kg/h with pressure, extract, standby;
(5) get Borneolum Syntheticum, melt the back and add in the said extracted thing.
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 drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) get Olibanum, Myrrha, Borneolum Syntheticum, Moschus medical material and break into fine powder, standby;
(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 tablet of the present invention and capsule.
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 polyglycols and their mixture, be selected from PEG400 (or 600), polyglycols 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.
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200610081542 CN1883637A (en) | 2006-05-26 | 2006-05-26 | Middle jiao-warming pain-relieving preparatrion and novel preparation method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110755537A (en) * | 2019-11-08 | 2020-02-07 | 李本强 | Formula of moxa magnetic moxibustion |
| CN115779023A (en) * | 2022-11-11 | 2023-03-14 | 哈尔滨维新健康生物科技有限公司 | Traditional Chinese medicine composition for treating stomachache and preparation method and application thereof |
-
2006
- 2006-05-26 CN CN 200610081542 patent/CN1883637A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110755537A (en) * | 2019-11-08 | 2020-02-07 | 李本强 | Formula of moxa magnetic moxibustion |
| CN115779023A (en) * | 2022-11-11 | 2023-03-14 | 哈尔滨维新健康生物科技有限公司 | Traditional Chinese medicine composition for treating stomachache and preparation method and application thereof |
| CN115779023B (en) * | 2022-11-11 | 2023-08-08 | 哈尔滨维新健康生物科技有限公司 | Traditional Chinese medicine composition for treating stomachache and preparation method and application thereof |
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