CN1748767A - Lupus preparation and new preparing method - Google Patents
Lupus preparation and new preparing method Download PDFInfo
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- CN1748767A CN1748767A CNA2005101091865A CN200510109186A CN1748767A CN 1748767 A CN1748767 A CN 1748767A CN A2005101091865 A CNA2005101091865 A CN A2005101091865A CN 200510109186 A CN200510109186 A CN 200510109186A CN 1748767 A CN1748767 A CN 1748767A
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Abstract
The present invention relates to a Chinese medicine composition, and especially a kind of Chinese medicine composition for treating lupus erythematosus, systemic scieroderm, dermatomyositis, panniculitis, behcets disease and connective tissue disease and its preparation process. The Chinese medicine composition is preferably prepared into dripping pill and soft capsule.
Description
Technical field:
The present invention relates to a kind of Chinese medicine composition and preparation technology thereof, particularly a kind of therapy system lupus erythematosus, systemic sclerosis, dermatomyositis, panniculitis, behcets disease, the prescription of connective tissue disease and preparation technology thereof.
Background technology:
Systemic lupus erythematosus (sle) (SLE) is a kind of autoimmune disease, and young women pilosity, M-F are 1: 9, and pathological changes is often involved internal organs except that the skin joint damage, especially with kidney, the heart, hepatic injury for seeing more.The traditional Chinese medical science is often taked heat-clearing and toxic substances removing, removing heat from blood, and blood circulation promoting and blood stasis dispelling increases cellular immune function, improves body resistance against diseases, and means such as reduction circulating immune complex are treated it, and evident in efficacy.Lupus pill is that it represents medicine, but in the practice, because this medicine is directly medical material to be beaten powder to be used as medicine in preparation process, impurity is many, and dosage is big, is again ordinary pill, has a strong impact on giving full play to of its curative effect.
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, capsule, tablet, its pill that makes can be used for curing mainly systemic lupus erythematosus (sle), systemic sclerosis, dermatomyositis, panniculitis, behcets disease, connective tissue disease.
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:
27～286.2 parts of 27～286.2 parts of Herba Taraxacis of 27～286.2 parts of Fructus Forsythiaes of Flos Lonicerae
10～107.3 parts of 27～286.2 parts of Radix Et Rhizoma Rhei of 7～71.6 parts of Radix Rehmanniae of Rhizoma Coptidis (wine stir-fry)
13.4～143.1 parts of 1.21～12.9 parts of Radix Paeoniae Rubra of 7～71.6 parts of Scolopendras of Radix Glycyrrhizae (uropodium of decaptitating)
27～286.2 parts of 7～71.6 portions of Radix Scrophulariaes of 7～71.6 parts of Radix Salviae Miltiorrhizaes of Radix Angelicae Sinensis
27～286.2 parts of 10～107.3 portions of Periostracum Cicadaes of 13.4～143.1 parts of Flos Carthamis of Semen Persicae (parch)
13.4～143.1 parts of Bulbus Fritillariae Thunbergiis
Preferably:
53.6 parts of 53.6 parts of Herba Taraxacis of 53.6 parts of Fructus Forsythiaes of Flos Lonicerae
20.1 parts of 53.6 parts of Radix Et Rhizoma Rhei of 13.4 parts of Radix Rehmanniae of Rhizoma Coptidis (wine stir-fry)
26.8 parts of 2.42 parts of Radix Paeoniae Rubra of 13.4 parts of Scolopendras of Radix Glycyrrhizae (uropodium of decaptitating)
53.6 parts of 13.4 portions of Radix Scrophulariaes of 13.4 parts of Radix Salviae Miltiorrhizaes of Radix Angelicae Sinensis
53.6 parts of 20.1 portions of Periostracum Cicadaes of 26.8 parts of Flos Carthamis of Semen Persicae (parch)
26.8 parts of Bulbus Fritillariae Thunbergiis
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, tablet, capsule.
The above new technology of the present invention may further comprise the steps:
Method a:
(1) gets Fructus Forsythiae, take supercritical extraction (or steam distillation), drop in the extraction kettle, extraction kettle, two extraction-containers and storage are heated respectively or cooled off, and when the extraction kettle temperature reaches 35 ℃, the temperature of extraction-container I is 55 ℃, when the temperature of extraction-container II reaches 40 ℃, open CO
2Gas cylinder, when extraction kettle pressure reaches 25Mpa, the pressure of extraction-container I reaches 6Mpa, when extraction-container II pressure reaches 6Mpa, beginning cycling extraction, CO
2Flow is 20kgh
-1About, from the extraction-container discharge hole for discharge, get the yellow green oily liquids behind the extraction 1.5h, the volatile oil beta-cyclodextrin inclusion compound, standby;
(2) get above Fructus Forsythiae medicinal residues, merge prescription residue medical material, with 50～85% soak with ethanol 20～90 minutes, amount of alcohol was 6～14 times of medical material amount, reflux, extract, 2～4 times, and each 0.5～2.5 hour, merge extractive liquid, filtered, and reclaim under reduced pressure gets alcohol extract;
(3) alcohol extract and volatile oil clathrate compound lump together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing drop pill of the present invention and soft capsule preparation.
Method b:
(1) get Fructus Forsythiae, Flos Carthami, be ground into fine powder, standby;
(2) get and remain medical material in the prescription, soaked 20～90 minutes, decocts 2～4 times with 6～12 times of water gagings, each 1.0～2.0h, collecting decoction, filtration, filtrate is condensed into thick paste, and is standby;
(3) fine powder and water extract lump together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing other dosage forms except that drop pill and soft capsule preparation 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.
1, to mice spleen T, the influence of bone-marrow-derived lymphocyte transformation function
Get 60 of ♀ DBA/2 kind mices during experiment, be divided into 4 groups at random, 15 every group.If technology is extractum group (0.46g/kg) 1., technology is extractum group (0.92g/kg) 2., gastric infusion.Positive controls subcutaneous injection hydrocortisone 0.01g/kg, model control group is oral with capacity water.Administration every day 1 time, 7d continuously.Next day after the drug withdrawal, put to death animal, the reference literature method is surveyed the cpm value with liquid scintillation counter (LKB1209RACKRETA), is % with matched group cpm value, observes the lymphocyte transformation suppression ratio of each experimental group.The result shows: two extractum groups all have tangible immunosuppressive action.
Table 1 couple mice spleen T, and the influence of bone-marrow-derived lymphocyte transformation function (x ± s, n=15)
| Group | Dosage (g/kg) | T lymphocyte (cpm) | T lymphocyte transformation suppression ratio (%) | Bone-marrow-derived lymphocyte (cpm) | Bone-marrow-derived lymphocyte transforms suppression ratio (%) |
| Model contrast hydrocortisone technology is 2. extractum group of extractum group technology 1. | - 0.01 0.46 0.92 | 8079.3±1330.3 166.8±17.5d 3646.2±575.1 d 3902.3±788.8 d | 98.6 54.9 51.7 | 2695.9±401.8 243.4±70.2 d 451.5±317.0 d 459.3±223.4 d | 90.9 83.3 83.0 |
Annotate: compare with matched group
dP＜0.001
2, to 2, the influence of 4-dinitrochlorobenzene (DNCB) induced mice skin delayed hypersensitivity
Get 40 of Kunming mouses, be divided into 4 groups, 10 every group, i.e. 1. extractum group (0.46g/kg) of model control group, positive control prednisone acetate tablets (0.01g/kg) group, technology, technology is extractum group (0.92g/kg) 2..Be applied in mouse part skin sensitization with the 5%DNCB alcoholic solution, and the beginning gastric infusion, every day 1 time, 9d is dissolved in the olive oil with 1%DNCB behind the sensitization 7d, and is applied to auris dextra continuously, put to death mice behind the 24h, the difference heavy with left and right sides ear is the delayed hypersensitivity value.The result shows: 1. 2. extractum group (1.25 ± 0.93) g and positive control prednisolone acetate group (1.09 ± 0.57) g and model control group (3.51 ± 1.01) g comparison of extractum group (1.14 ± 0.62) g, technology of two ear method of double differences value technologies about the delayed hypersensitivity mice all has significant inhibitory effect.
3, to the influence of rat toes swelling
Get 40 of Wistar rats, male and female half and half are divided into 4 groups, 10 every group, it is model control group, positive control aspirin group (0.1g/kg), technology be extractum group (0.23g/kg) 1., and technology is extractum group (0.46g/kg) 2., the reference literature method, double mensurations rat left and right sides toes volume before the administration is got the volume of average before as administration, continuous gastric infusion 3d, 1h after last 1 administration, cause inflammation for the rat left and right sides toes ankle joint subcutaneous injection 0.2% solution 0.1mL of histamine, measure respectively and cause scorching back 1,2,4, the volume of 6h rat left and right sides toes swelling calculates and causes scorching front and back volume, respectively organizes the difference of swelling.The result shows: two extractum groups all have antiinflammatory action.
| Group | Dosage (g/kg) | Cause scorching back different time volume difference (mL) | |||
| 1h | 2h | 4h | 6h | ||
| Model control group aspirin group technology is 2. extractum group of extractum group technology 1. | - 0.1 0.23 0.46 | 0.32±0.21 0.17±0.13 0.22±0.08 0.21±0.09 | 0.45±0.21 0.28±0.09 * 0.25±0.13 * 0.26±0.16 * | 0.36±0.17 0.22±0.09 * 0.23±0.07 * 0.24±0.05 * | 0.28±0.18 0.12±0.11 0.15±0.12 0.16±0.12 |
Annotate: compare with matched group
*P＜0.05
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 therapy system lupus erythematosus, systemic sclerosis, dermatomyositis, panniculitis, behcets disease, the medicine of connective tissue disease, and change preparation technology, can obviously strengthen its heat-clearing and toxic substances removing, removing heat from blood, blood circulation promoting and blood stasis dispelling, increase cellular immune function, improve body resistance against diseases, reduce clinical efficacy such as circulating immune complex, 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:
Flos Lonicerae 71g Fructus Forsythiae 71g Herba Taraxaci 71g
Rhizoma Coptidis 17.8g Radix Rehmanniae 71g Radix Et Rhizoma Rhei (wine stir-fry) 26.7g
Radix Glycyrrhizae 17.8g Scolopendra (uropodium of decaptitating) 3.2g Radix Paeoniae Rubra 35.6g
Radix Angelicae Sinensis 17.8g Radix Salviae Miltiorrhizae 17.8g Radix Scrophulariae 71g
Semen Persicae (parch) 35.6g Flos Carthami 26.7g Periostracum Cicadae 71g
Bulbus Fritillariae Thunbergii 35.6g PEG4000 100g
Make 1000 balls
Preparation method:
(1) gets Fructus Forsythiae, take supercritical extraction (or steam distillation), drop in the extraction kettle, extraction kettle, two extraction-containers and storage are heated respectively or cooled off, and when the extraction kettle temperature reaches 35 ℃, the temperature of extraction-container I is 55 ℃, when the temperature of extraction-container II reaches 40 ℃, open CO
2Gas cylinder, when extraction kettle pressure reaches 25Mpa, the pressure of extraction-container I reaches 6Mpa, when extraction-container II pressure reaches 6Mpa, beginning cycling extraction, CO
2Flow is 20kgh
-1About, from the extraction-container discharge hole for discharge, get the yellow green oily liquids behind the extraction 1.5h, the volatile oil beta-cyclodextrin inclusion compound, standby;
(2) get above Fructus Forsythiae medicinal residues, merge prescription residue medical material, with 85% soak with ethanol 40 minutes, amount of alcohol was 10 times of medical material amount, reflux, extract, 3 times, and each 1.5 hours, merge extractive liquid, filtered, and reclaim under reduced pressure gets alcohol 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:
Flos Lonicerae 286.2g Fructus Forsythiae 286.2g Herba Taraxaci 286.2g
Rhizoma Coptidis 71.6g Radix Rehmanniae 286.2g Radix Et Rhizoma Rhei (wine stir-fry) 107.3g
Radix Glycyrrhizae 71.6g Scolopendra (uropodium of decaptitating) 12.9g Radix Paeoniae Rubra 143.1g
Radix Angelicae Sinensis 71.6g Radix Salviae Miltiorrhizae 71.6g Radix Scrophulariae 286.2g
Semen Persicae (parch) 143.1g Flos Carthami 107.3g Periostracum Cicadae 286.2g
Bulbus Fritillariae Thunbergii 143.1g PEG400 300g
Make 1000
Preparation method:
(1) gets Fructus Forsythiae, take supercritical extraction (or steam distillation), drop in the extraction kettle, extraction kettle, two extraction-containers and storage are heated respectively or cooled off, and when the extraction kettle temperature reaches 35 ℃, the temperature of extraction-container I is 55 ℃, when the temperature of extraction-container II reaches 40 ℃, open CO
2Gas cylinder, when extraction kettle pressure reaches 25Mpa, the pressure of extraction-container I reaches 6Mpa, when extraction-container II pressure reaches 6Mpa, beginning cycling extraction, CO
2Flow is 20kgh
-1About, from the extraction-container discharge hole for discharge, get the yellow green oily liquids behind the extraction 1.5h, the volatile oil beta-cyclodextrin inclusion compound, standby;
(2) get above Fructus Forsythiae medicinal residues, merge prescription residue medical material, with 85% soak with ethanol 40 minutes, amount of alcohol was 10 times of medical material amount, reflux, extract, 3 times, and each 1.5 hours, merge extractive liquid, filtered, and reclaim under reduced pressure gets alcohol 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:
Flos Lonicerae 268g Fructus Forsythiae 268g Herba Taraxaci 268g
Rhizoma Coptidis 67g Radix Rehmanniae 268g Radix Et Rhizoma Rhei (wine stir-fry) 100.5g
Radix Glycyrrhizae 67g Scolopendra (uropodium of decaptitating) 12.1g Radix Paeoniae Rubra 134g
Radix Angelicae Sinensis 67g Radix Salviae Miltiorrhizae 67g Radix Scrophulariae 268g
Semen Persicae (parch) 134g Flos Carthami 100.5g Periostracum Cicadae 268g
Bulbus Fritillariae Thunbergii 134g
Make 1000g
Preparation method:
(1) get Fructus Forsythiae, Flos Carthami, be ground into fine powder, standby;
(2) get and remain medical material in the prescription, soaked 40 minutes, decocts 3 times with 10 times of water gagings, each 1.5h, collecting decoction, filtration, filtrate is condensed into thick paste, and is standby;
(3) fine powder and water extract lump together, and add aspartame 5.0g, dextrin 240.0g, granulate, and drying sprays into essence 5.0g, promptly gets granule 1000g.
Embodiment 4:
The preparation method of chewable tablet of the present invention:
Prescription:
53.6 parts of 53.6 parts of Herba Taraxacis of 53.6 parts of Fructus Forsythiaes of Flos Lonicerae
20.1 parts of 53.6 parts of Radix Et Rhizoma Rhei of 13.4 parts of Radix Rehmanniae of Rhizoma Coptidis (wine stir-fry)
26.8 parts of 2.42 parts of Radix Paeoniae Rubra of 13.4 parts of Scolopendras of Radix Glycyrrhizae (uropodium of decaptitating)
53.6 parts of 13.4 portions of Radix Scrophulariaes of 13.4 parts of Radix Salviae Miltiorrhizaes of Radix Angelicae Sinensis
53.6 parts of 20.1 portions of Periostracum Cicadaes of 26.8 parts of Flos Carthamis of Semen Persicae (parch)
26.8 parts of Bulbus Fritillariae Thunbergiis
Make 1000
Preparation method:
(1) get Fructus Forsythiae, Flos Carthami, be ground into fine powder, standby;
(2) get and remain medical material in the prescription, soaked 40 minutes, decocts 3 times with 10 times of water gagings, each 1.5h, collecting decoction, filtration, filtrate is condensed into thick paste, and is standby;
(3) fine powder and water extract lump together, and add aspartame 3.0g, mannitol 200.0g, granulation, and 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:
27～286.2 parts of 27～286.2 parts of Herba Taraxacis of 27～286.2 parts of Fructus Forsythiaes of Flos Lonicerae
10～107.3 parts of 27～286.2 parts of Radix Et Rhizoma Rhei of 7～71.6 parts of Radix Rehmanniae of Rhizoma Coptidis (wine stir-fry)
13.4～143.1 parts of 1.21～12.9 parts of Radix Paeoniae Rubra of 7～71.6 parts of Scolopendras of Radix Glycyrrhizae (uropodium of decaptitating)
27～286.2 parts of 7～71.6 portions of Radix Scrophulariaes of 7～71.6 parts of Radix Salviae Miltiorrhizaes of Radix Angelicae Sinensis
27～286.2 parts of 10～107.3 portions of Periostracum Cicadaes of 13.4～143.1 parts of Flos Carthamis of Semen Persicae (parch)
13.4～143.1 parts of Bulbus Fritillariae Thunbergiis
2, the compound preparation of claim 1 is characterized in that, per 1000 dosage units are made by the following weight proportion raw material:
53.6 parts of 53.6 parts of Herba Taraxacis of 53.6 parts of Fructus Forsythiaes of Flos Lonicerae
20.1 parts of 53.6 parts of Radix Et Rhizoma Rhei of 13.4 parts of Radix Rehmanniae of Rhizoma Coptidis (wine stir-fry)
26.8 parts of 2.42 parts of Radix Paeoniae Rubra of 13.4 parts of Scolopendras of Radix Glycyrrhizae (uropodium of decaptitating)
53.6 parts of 13.4 portions of Radix Scrophulariaes of 13.4 parts of Radix Salviae Miltiorrhizaes of Radix Angelicae Sinensis
53.6 parts of 20.1 portions of Periostracum Cicadaes of 26.8 parts of Flos Carthamis of Semen Persicae (parch)
26.8 parts of Bulbus Fritillariae Thunbergiis
3, claim 1 or any one Chinese medicine preparation of 2 are drop pill, soft capsule, granule, chewable tablet, tablet, capsule.
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 Fructus Forsythiae, take supercritical extraction (or steam distillation), drop in the extraction kettle, extraction kettle, two extraction-containers and storage are heated respectively or cooled off, and when the extraction kettle temperature reaches 35 ℃, the temperature of extraction-container I is 55 ℃, when the temperature of extraction-container II reaches 40 ℃, open CO
2Gas cylinder, when extraction kettle pressure reaches 25Mpa, the pressure of extraction-container I reaches 6Mpa, when extraction-container II pressure reaches 6Mpa, beginning cycling extraction, CO
2Flow is 20kgh
-1About, from the extraction-container discharge hole for discharge, get the yellow green oily liquids behind the extraction 1.5h, the volatile oil beta-cyclodextrin inclusion compound, standby;
(2) get above Fructus Forsythiae medicinal residues, merge prescription residue medical material, with 50～85% soak with ethanol 20～90 minutes, amount of alcohol was 6～14 times of medical material amount, reflux, extract, 2～4 times, and each 0.5～2.5 hour, merge extractive liquid, filtered, and reclaim under reduced pressure gets alcohol extract;
(3) alcohol extract and volatile oil clathrate compound lump together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing drop pill of the present invention and soft capsule preparation.
Method b:(technology 2.)
(1) get Fructus Forsythiae, Flos Carthami, be ground into fine powder, standby;
(2) get and remain medical material in the prescription, soaked 20～90 minutes, decocts 2～4 times with 6～12 times of water gagings, each 1.0～2.0h, collecting decoction, filtration, filtrate is condensed into thick paste, and is standby;
(3) fine powder and water extract lump together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing other dosage forms except that drop pill and soft capsule preparation of the present invention.
6, the Chinese medicine preparation of claim 5, it 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, and 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 process of capsule is as follows: with above-mentioned extract obtained, granulate with medicated powder, add lubricant and fill, promptly get capsule;
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:
(1) gets Fructus Forsythiae, take supercritical extraction (or steam distillation), drop in the extraction kettle, extraction kettle, two extraction-containers and storage are heated respectively or cooled off, and when the extraction kettle temperature reaches 35 ℃, the temperature of extraction-container I is 55 ℃, when the temperature of extraction-container II reaches 40 ℃, open CO
2Gas cylinder, when extraction kettle pressure reaches 25Mpa, the pressure of extraction-container I reaches 6Mpa, when extraction-container II pressure reaches 6Mpa, beginning cycling extraction, CO
2Flow is 20kgh
-1About, from the extraction-container discharge hole for discharge, get the yellow green oily liquids behind the extraction 1.5h, the volatile oil beta-cyclodextrin inclusion compound, standby;
(2) get above Fructus Forsythiae medicinal residues, merge prescription residue medical material, with 50～85% soak with ethanol 20～90 minutes, amount of alcohol was 6～14 times of medical material amount, reflux, extract, 2～4 times, and each 0.5～2.5 hour, merge extractive liquid, filtered, and reclaim under reduced pressure gets alcohol extract;
(3) alcohol extract and volatile oil clathrate compound lump together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing drop pill of the present invention and soft capsule preparation.
Method b:
(1) get Fructus Forsythiae, Flos Carthami, be ground into fine powder, standby;
(2) get and remain medical material in the prescription, soaked 20～90 minutes, decocts 2～4 times with 6～12 times of water gagings, each 1.0～2.0h, collecting decoction, filtration, filtrate is condensed into thick paste, and is standby;
(3) fine powder and water extract lump together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing other dosage forms except that drop pill and soft capsule preparation 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: 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.
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| CNA2005101091865A CN1748767A (en) | 2005-10-20 | 2005-10-20 | Lupus preparation and new preparing method |
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| CNA2005101091865A CN1748767A (en) | 2005-10-20 | 2005-10-20 | Lupus preparation and new preparing method |
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| CN102441032A (en) * | 2011-11-30 | 2012-05-09 | 宋爱民 | Traditional Chinese medicinal preparation for treating skin numbness |
| CN102670746A (en) * | 2012-05-14 | 2012-09-19 | 四川省中医药科学院 | Anti-platelet activation traditional Chinese medicine composition for treating lupus erythematosus |
| CN103599261A (en) * | 2013-11-28 | 2014-02-26 | 谢宗祥 | Traditional Chinese medicine for treating lupus erythematosus |
| CN103735747A (en) * | 2014-01-03 | 2014-04-23 | 铜陵桂生生态养殖有限公司 | Composition for treating toxic heat flaming-type systemic scleroderma |
| CN103751348A (en) * | 2014-01-03 | 2014-04-30 | 铜陵桂生生态养殖有限公司 | Composition for treating meridian-collateral blockage type lupus erythematosus |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102441032A (en) * | 2011-11-30 | 2012-05-09 | 宋爱民 | Traditional Chinese medicinal preparation for treating skin numbness |
| CN102441032B (en) * | 2011-11-30 | 2014-04-02 | 宋爱民 | Traditional Chinese medicinal preparation for treating skin numbness |
| CN102670746A (en) * | 2012-05-14 | 2012-09-19 | 四川省中医药科学院 | Anti-platelet activation traditional Chinese medicine composition for treating lupus erythematosus |
| CN102670746B (en) * | 2012-05-14 | 2013-08-28 | 四川省中医药科学院 | Anti-platelet activation traditional Chinese medicine composition for treating lupus erythematosus |
| CN103599261A (en) * | 2013-11-28 | 2014-02-26 | 谢宗祥 | Traditional Chinese medicine for treating lupus erythematosus |
| CN103751348A (en) * | 2014-01-03 | 2014-04-30 | 铜陵桂生生态养殖有限公司 | Composition for treating meridian-collateral blockage type lupus erythematosus |
| CN103735747A (en) * | 2014-01-03 | 2014-04-23 | 铜陵桂生生态养殖有限公司 | Composition for treating toxic heat flaming-type systemic scleroderma |
| CN103933383A (en) * | 2014-03-20 | 2014-07-23 | 毛杰 | Traditional Chinese medicine for treating systemic lupus erythermatosus |
| CN104958730A (en) * | 2015-07-21 | 2015-10-07 | 焦安贵 | Traditional Chinese medicine preparation for treating nodular panniculitis and preparation method thereof |
| CN105169131A (en) * | 2015-09-15 | 2015-12-23 | 徐辉 | Medicine for treating lupus erythematosus and preparation method of medicine |
| CN105194473A (en) * | 2015-09-15 | 2015-12-30 | 徐辉 | Medicine for treating lupus erythematosus and preparation method thereof |
| US20180303859A1 (en) * | 2015-09-30 | 2018-10-25 | The University Of Tokyo | Agent For Preventing And/Or Treating Scleroderma |
| CN105920236A (en) * | 2016-06-29 | 2016-09-07 | 李肖 | Compound preparation for treating systemic lupus erythematosus and preparation method |
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