CN1257737C - Traditional Chinese medicine composition for treating migraine and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating migraine and preparation method thereof Download PDFInfo
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Abstract
A traditional Chinese medicine composition for treating migraine and a preparation method thereof, the components comprise: 2 to 20 g of ligusticum wallichii, 3 to 25 g of angelica, 2 to 20 g of fructus viticis, 0.3 to 10 g of scorpion, 0.01 to 1 g of artificial musk and 0.05 to 1 g of borneol. The preparation method comprises the following steps: crushing and soaking rhizoma Ligustici Chuanxiong, radix Angelicae sinensis and fructus Vitics Simplicifoliae, extracting and collecting volatile oil; concentrating the water decoction, precipitating with ethanol, standing, collecting supernatant, concentrating under reduced pressure to obtain fluid extract, and drying; pulverizing Moschus and Borneolum Syntheticum; the scorpion can be combined with the components in the step 1 for treatment; or pulverizing the raw materials together with the step 2, or decocting in water, performing enzymolysis, concentrating to obtain fluid extract, drying, and pulverizing; mixing the above fine powders, and adding volatile oil. Can be made into oral preparations such as soft capsule, hard capsule, granule, tablet, and oral liquid. The invention is a pure natural medicine, has the efficacies of promoting blood circulation, removing obstruction in channels, dispelling wind and relieving pain, is mainly used for treating migraine, and can achieve the purpose of treating both principal and secondary aspects of diseases through pharmacological verification.
Description
Technical field
The present invention relates to migrainous Chinese medicine composition of a kind of treatment and preparation method thereof.
Background technology
The western medical treatment migraine often adopts analgesic and NSAID (non-steroidal anti-inflammatory drug), as aspirin, and ibuprofen etc.; Bendectin such as metoclopramide, Ergotamine and dihydroergotamine, sumatriptan, Butuo coffee alkane etc.; The catabasis prophylactic treatment is used β-adrenergic receptor blocker, α always
2Receptor stimulating agent or the like; Though these medicines all have certain curative effect, the diversified side effect that causes often makes patient's " headache ".Adopt the treatment by Chinese herbs migraine that long-range history is arranged, for example the hot soup of the rhizome of chuanxiong of Lee Dong Yuan adopts medicines such as Rhizoma Chuanxiong, Herba Asari, Fructus Viticis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae, Radix Glycyrrhizae, and headache and migraine are had certain curative effect, but reach the treatment standard of modern medicine, also require further study, develop.
Summary of the invention
Chinese medicine composition of the present invention, use for reference some medication experiences of hot soup (Rhizoma Chuanxiong, Herba Asari, Fructus Viticis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae, Radix Glycyrrhizae) of Lee east wall rhizome of chuanxiong and Wang Qingren blood activating decoction, at wind syndrome of head blood stasis folder wind card, select Rhizoma Chuanxiong, Radix Angelicae Sinensis, Fructus Viticis, Scorpio, artificial Moschus and Borneolum Syntheticum Six-element Chinese prescription for use, and according to the migraine characteristics of incidence, be made into preparations such as soft capsule, cause good fortune in the mankind.This medicine reasonable recipe, compatibility is simplified, and determined curative effect reaches treating both the principal and secondary aspects of a disease.
Technical scheme of the present invention is as follows:
The migrainous Chinese medicine composition of a kind of treatment includes the medical material of following component:
Rhizoma Chuanxiong 36～40%, Radix Angelicae Sinensis 36～40%, Fructus Viticis 17～21%, Scorpio 3.0～3.5%, the artificial Moschus 1.2～1.6%, Borneolum Syntheticum 0.1～0.5%.The recommendation ratio is:
Rhizoma Chuanxiong 38%, Radix Angelicae Sinensis 38%, Fructus Viticis 19%, Scorpio 3.3%, the artificial Moschus 1.4%, Borneolum Syntheticum 0.3%.
That is to say that according to this ratio, treatment prescription can be:
Rhizoma Chuanxiong 2～20 grams, Radix Angelicae Sinensis 3～25 grams, Fructus Viticis 2～20 grams, Scorpio 0.3～10 gram, artificial Moschus's 0.01～1 gram, Borneolum Syntheticum 0.05～1 gram.
The prioritization scheme of above-mentioned Chinese medicine composition is that the share of each component is as follows:
Rhizoma Chuanxiong 5～15 grams, Radix Angelicae Sinensis 9～16 grams, Fructus Viticis 6～12 grams, Scorpio 1～7 gram, artificial Moschus's 0.01～1 gram, Borneolum Syntheticum 0.05～1 gram.
Further optimize, optimum formula is: Rhizoma Chuanxiong 4.8 grams, Radix Angelicae Sinensis 4.8 grams, Fructus Viticis 2.4 grams, Scorpio 0.42 gram, artificial Moschus's 0.048 gram, Borneolum Syntheticum 0.18 gram.
The method for preparing above-mentioned Chinese medicine composition:
Step 1, by the prescription quality component (or enlarging quantity in proportion) get Rhizoma Chuanxiong, Radix Angelicae Sinensis, Fructus Viticis, Scorpio, artificial Moschus and Borneolum Syntheticum, standby;
Step 2, get Rhizoma Chuanxiong, Radix Angelicae Sinensis, Fructus Viticis and smash immersion, extract and also collect volatile oil, standby;
Step 3, above decocting liquid concentrate, and precipitate with ethanol leaves standstill, and gets the supernatant concentrating under reduced pressure and gets clear paste, drying;
Step 4, get artificial Moschus, Borneolum Syntheticum and pulverize;
Step 5, Scorpio can:
(1). the medicinal residues that extract behind volatile oil, the decocting with step 1 component merge, decocting once more,
Decocting liquid concentrates, and precipitate with ethanol leaves standstill, and gets the supernatant concentrating under reduced pressure and gets clear paste, drying; Perhaps,
(2). together pulverize with step 2 medical material, perhaps,
(3). separately decocting, with behind the protease hydrolyzed, concentrating under reduced pressure is a clear paste, drying under reduced pressure,
Pulverize;
Step 6, get above each fine powder that makes, mix homogeneously adds volatile oil, promptly.
The Chinese medicine composition of above-mentioned preparation method gained mixes with acceptable carrier on the pharmaceutics, can prepare oral formulations.The oral formulations of making comprises soft capsule, hard capsule, granule, tablet or oral liquid etc.
The further optimization of above-mentioned Chinese medicine composition preparation method, can more specifically select to adopt following three kinds of different schemes:
One of scheme specifically may further comprise the steps:
Step 1, by the prescription the quality component get Rhizoma Chuanxiong, Radix Angelicae Sinensis, Fructus Viticis, Scorpio, artificial Moschus and Borneolum Syntheticum, standby;
Step 2, get Rhizoma Chuanxiong, angelica sinensis is broken into coarse granule, Fructus Viticis is smashed, and adds the water of 5～10 times of amounts, soaks 1～2 hour, extracts 2～5 hours volatile oil, collection volatile oil is standby;
Step 3, above decocting liquid filter, and be after being evaporated to relative density and being the medicinal liquid of 1.10～1.50 (50 ℃), standby; Medicinal residues add 6～9 times in water and decoct twice, and each 1～2 hour, collecting decoction filtered, and are after being evaporated to relative density and being the medicinal liquid of 1.10～1.50 (50 ℃), standby; More than two concentrated solutions merge, put cold, add the ethanol precipitate with ethanol, concentration of alcohol is 50～90%, leaves standstill 30～40 hours, gets supernatant, reclaiming ethanol, to be evaporated to relative density be 1.00～1.50 clear paste, drying is pulverized, and sieves, and is standby;
Step 4, Scorpio add 5～10 times of water gagings, decoct 0.5～1.5 hour, treat that temperature is reduced to 25～50 ℃ after, add 0.2%～0.4% neutral protease (10～110,000 units/g) at twice, constantly stir, each enzymolysis 1～4 hour is warming up to 80～95 ℃ again, filter, be evaporated to relative density and be about 1.10～1.50 clear paste, drying under reduced pressure is pulverized, sieve, standby;
Step 5, artificial Moschus, Borneolum Syntheticum are pulverized, and sieve, and be standby;
Step 6, get above each fine powder that makes, mix homogeneously adds volatile oil, promptly.
Two of the preparation method scheme of above-mentioned Chinese medicine composition, specifically to comprise step down:
Step 1, by the prescription the quality component get Rhizoma Chuanxiong, Radix Angelicae Sinensis, Fructus Viticis, Scorpio, artificial Moschus and Borneolum Syntheticum, standby;
Step 2, get Rhizoma Chuanxiong, angelica sinensis is broken into coarse granule, Fructus Viticis is smashed, and adds the water of 5～10 times of amounts, soaks 1～2 hour, extracts 2～5 hours volatile oil, collection volatile oil is standby;
Step 3, above decocting liquid filter, and be after being evaporated to relative density and being the medicinal liquid of 1.10～1.50 (50 ℃), standby; Medicinal residues and Scorpio add 6～9 times in water and decoct twice, and each 1～2 hour, collecting decoction filtered, and be after being evaporated to relative density and being the medicinal liquid of 1.10～1.50 (50 ℃), standby; More than two concentrated solutions merge, put cold, add the ethanol precipitate with ethanol, concentration of alcohol is 50～90%, leaves standstill 30～40 hours, gets supernatant, reclaiming ethanol, to be evaporated to relative density be 1.00～1.50 clear paste, drying is pulverized, and sieves, and is standby;
Step 4, artificial Moschus, Borneolum Syntheticum are pulverized, and be standby;
Step 5, get above each fine powder that makes, mix homogeneously adds volatile oil, promptly.
Three of the preparation method of above-mentioned Chinese medicine composition specifically may further comprise the steps:
Step 1, by the prescription the quality component get Rhizoma Chuanxiong, Radix Angelicae Sinensis, Fructus Viticis, Scorpio, artificial Moschus and Borneolum Syntheticum, standby;
Step 2, get Rhizoma Chuanxiong, angelica sinensis is broken into coarse granule, Fructus Viticis is smashed, and adds the water of 5～10 times of amounts, soaks 1～2 hour, extracts 2～5 hours volatile oil, collection volatile oil is standby;
Step 3, above decocting liquid filter, and be after being evaporated to relative density and being the medicinal liquid of 1.10～1.50 (50 ℃), standby; Medicinal residues add 6～9 times in water and decoct twice, and each 1～2 hour, collecting decoction filtered, and are after being evaporated to relative density and being the medicinal liquid of 1.10～1.50 (50 ℃), standby; More than two concentrated solutions merge, put cold, add the ethanol precipitate with ethanol, concentration of alcohol is 75～90%, leaves standstill 30～40 hours, gets supernatant, reclaiming ethanol, to be evaporated to relative density be 1.00～1.50 clear paste, drying is pulverized, and sieves, and is standby;
Step 4, artificial Moschus, Borneolum Syntheticum are pulverized and Scorpio is pulverized, and be standby;
Step 5, get above each fine powder that makes, mix homogeneously adds volatile oil, promptly.
More than pulverize in three kinds of preparation methoies, can routine be ground into 80～160 purpose fine powders of looking over so as to check, also can adopt super fine to be ground into 200～300 purpose fine powders.
More than the extraction of Rhizoma Chuanxiong, angelica sinensis and the contained volatile oil of Fructus Viticis in three kinds of preparation methoies, can steam distillation, also can supercritical extraction etc. extraction.
More than in three kinds of preparation methoies the drying of concentrated solution can adopt methods such as drying under reduced pressure, spray drying or vacuum drying.
The preparation of soft capsule method of wherein treating migrainous Chinese medicine composition is, the Chinese medicine composition of gained adds 3%～6% glycerol, Polyethylene Glycol or vegetable oil or Cera Flava mix homogeneously in above-mentioned three kinds of preparation methoies, through soft capsule moulding process, the soft capsule finished product of making.
Described soft capsule moulding process may further comprise the steps:
The preparation of step 1. soft capsule rubber: get glycerol, water adds food coloring, grinds 10 minutes with colloid mill, make mix homogeneously, in the inputization glue jar, be heated to 45 ℃, add gelatin, stir, be heated to 80 ℃, be incubated 40 minutes, be evacuated to-0.06Mpa, stir about 1 hour, extremely till jar interior no bubble, cross 60 order filter clothes, put in the insulation jar, insulation about 60 ℃ promptly gets and the food coloring color rubber solution that is complementary, and is standby;
Step 2. compression moulding: start encapsulating machine, after preparing qualified rubber, carry out ball readjustment examination with liquid paraffin earlier, after treating that loading amount difference is qualified, the suspension of medicine and adjuvant is put into the liquid reservoir at machine top, elder generation's closing liquid paraffin inlet valve, open the medicine inlet valve again, the soft capsule that contains medicine is promptly suppressed and is finished, the first soft capsule that extrudes, by " under an appendix IL of Chinese pharmacopoeia version in 2000 item regulation of soft capsule content uniformity to soft capsule content carry out content uniformity claim fixed, qualified back start continuous production, the soft capsule that suppresses falls into the drum-type drying machine of making net bottom with thin copper wire, and molding in 10～12 hours does not stop to roll;
Step 3. drying: the soft capsule of forming is loaded onto drying cart place in the hothouse that dehydrating unit is housed, regulate temperature, humidity, allow the interior moisture content of rubber slowly evaporate, and gently stir soft capsule every now and then, to prevent the adhesion of soft capsule pill, dry a period of time;
Step 4. is deoiled, granulate, finished product: the soft capsule that drying is good is put into coating pan with the gauze of cleaning and is rolled, the gauze that rolls can absorb and clean the Polyethylene Glycol and the liquid paraffin on soft capsule surface, qualified soft capsule cleans once with ethanol, to clean Polyethylene Glycol and the liquid paraffin of soft capsule appearance remnants, qualified soft capsule, dry in dry sieve, check, packing promptly get the soft capsule finished product.
The treatment migraine soft capsule preparation that the present invention makes, it is rapid to have a disintegrate, special effect, the bioavailability height, good stability, good looking appearance, easy to carry, advantages such as taking convenience.Oral formulations such as the hard capsule that medicine of the present invention is made, granule, tablet, oral liquid also have special effect, and good stability carries advantages such as taking convenience.Oral formulations of the present invention is a natural medicine, has the effect of promoting blood circulation to remove obstruction in the collateral, dispelling wind and relieving pain, is mainly used in the treatment migraine, by the pharmacology checking, can reach the purpose for the treatment of both the principal and secondary aspects of a disease.
In the quality standard, respectively Rhizoma Chuanxiong, Radix Angelicae Sinensis, Borneolum Syntheticum have been carried out the qualitative investigation of TLC,, selected different developing solvents for use, all obtained satisfied result according to different materials, and with this discriminating project as this product.Muscone has been carried out the qualitative investigation of gas phase, and the result is satisfied, also as the discriminating project of this product.Select for use ferulic acid in Rhizoma Chuanxiong, the Radix Angelicae Sinensis as quantitative target, adopt the HPLC method, carried out precision test, repeatability test, solvent stability test and application of sample recovery test respectively, method of proof is feasible, can be used as the quantitative approach of preparation.By the soft capsule that above preparation technology, moulding process and quality standard are produced, the product that becomes high in technological content, steady quality and be easy to control.
The migrainous Chinese medicine composition of treatment of the present invention, checking proves through the preclinical pharmacology toxicity:
1. maximum tolerated dose is 15g/kg, is equivalent to 346 times of the clinical consumption per day of 60kg people.
2. rat continuous irrigation stomach gives drug extract of the present invention three months, observe rat body weight, behavioral activity, finish hematological indices, the blood parameters that rat is measured in the back in administration, the rat main organs coefficient of comparative control group and administration group and carry out histopathologic slide's check.The phase of administration does not as a result see that rat behavior activity, the mental status are unusual to some extent; The pathological examination result does not show internal organs generation pathological change yet.Do not observe rat yet and repeat to give the toxic reaction behind the medicine of the present invention and the target organ of toxicity continuously, therefore think that this supply test product (medicine of the present invention) long-term prescription is safe.
3. medicine of the present invention does not have tangible influence to the content of mediator in the brain of normal mouse.5-HT mediator content descends in the blood stasis model rat brain, and the medicine of the present invention of high dose group can make the mediator 5-HT in the blood stasis model rat brain that tangible rising effect is arranged, and the results are shown in Table 1.
Table 1, Chinese medicine composition of the present invention are to the influence of mediator 5-HT and 5-HIAA in the blood stasis model rat brain (M ± SD)
| Group | Dosage (g/kg) | N | 5-HT(ng/mg) | 5-HIAA(ng/mg) |
| Normal group | - | 10 | 1.14±0.17 | 2.63±0.68 |
| Model group TONGTIAN KOUFUYE group medicine group of the present invention medicine group of the present invention medicine group of the present invention | 10ml/kg 2.07 0.69 0.23 | 10 10 10 10 10 | 0.95±0.15 * 0.96±0.18 1.17±0.24 △ 1.08±0.15 0.90±0.20 | 2.82±0.53 2.22±0.67 △ 2.09±0.82 △ 2.04±0.50 △△ 1.62±0.33 △△ |
Compare with normal group
*P＜0.05,
*Compare with model group P＜0.01
△P＜0.05,
△ △P＜0.01
4. medicine of the present invention has some improvement to the incomplete cerebral ischemia pia mater encephali of low pressure and low reperfusion microcirculation.The microcirculatory blood flow rate of meninges is increased, but to the influence of meningovascular caliber than flunarizine a little less than.When dosage increases, microcirculatory caliber there is certain influence, can makes Marjoram Extract.Increase the supply of brain blood flow.Improve the caused headache of cerebral ischemia, the results are shown in Table 2-table 4.
Table 2, Chinese medicine composition of the present invention are to the incomplete cerebral ischemia pia mater encephali microcirculation of low pressure filling property
The influence of blood flow rate rate of change (%, X ± SD)
| Group | Dosage (g/kg) | After the administration (branch) | |||
| 30 | 60 | 90 | 120 | ||
| Contrast flunarizine group medicine group of the present invention medicine group of the present invention medicine group of the present invention | 0.9mg/kg 2.30 0.77 0.26 | -0.6±17.9 34.7±31.5 * 16.5±12.7 14.8±12.3 8.8±28.8 | -1.6±26.1 88.1±35.5 **60.2±17.3 **45.2±17.8 **38.4±40.4 * | -5.4±27.9 108.5±44.2 **48.8±29.4 **44.8±42.7 *55.9±40.3 ** | -16.9±21.5 63.2±49.0 **32.4±22.6 **17.5±44.0 24.3±22.9 ** |
Annotate: compare with the normal saline matched group,
*P＜0.05,
*P＜0.01.Normal saline matched group, flunarizine group, medicine small dose group n=7 of the present invention, the heavy dose of group of medicine of the present invention n=8.
Table 3, Chinese medicine composition of the present invention are to the incomplete cerebral ischemia pia mater encephali microcirculation of low pressure filling property
The influence of blood vessels caliber (μ m, X ± SD)
| Group | Dosage (g/kg) | Normally | Before the administration | After the administration (branch) | |||
| 30 | 60 | 90 | 120 | ||||
| Contrast flunarizine group medicine group of the present invention medicine group of the present invention medicine group of the present invention | 0.9mg/kg 2.30 0.77 0.26 | 37.0±14.1 36.8±11.5 29.7±7.5 275±5.1 27.4±3.1 | 26.1±14.7 17.5±5.5 18.2±8.3 15.2±2.5 19.6±6.0 | 29.2±29.8 23.8±8.3 20.8±7.2 16.4±1.4 18.9±6.2 | 28.9±20.9 28.9±10.2 24.1±8.3 17.3±2.3 19.6±5.4 | 29.1±22.9 28.7±7.5 24.7±10.0 19.0±4.4 20.3±5.8 | 25.6±20.3 25.3±7.0 22.1±8.1 19.1±4.5 19.3±4.3 |
Table 4, Chinese medicine composition of the present invention are to the incomplete cerebral ischemia pia mater encephali microcirculation of low pressure filling property
The influence of blood vessels caliber rate of change (%, X ± SD)
| Group | Dosage (g/kg) | After the administration (branch) | |||
| 30 | 60 | 90 | 120 | ||
| Contrast flunarizine group medicine group of the present invention medicine group of the present invention medicine group of the present invention | - 0.9mg/kg 2.30 0.77 0.26 | 9.9±24.8 37.7±46.6 25.5±32.8 10.9±17.2 -2.2±22.7 | 7.3±22.9 71.7±74.4 * 41.7±29.9 * 18.5±27.3 3.8±21.5 | 5.9±26.4 72.1±44.6 ** 45.5±40.9 * 29.1±47.3 * 8.5±24.5 | -6.0±27.2 46.7±20.2 ** 32.3±35.9 * 31.0±48.4 5.8±24.9 |
Annotate: compare with the normal saline matched group,
*P＜0.05,
*P＜0.01.Normal saline matched group, flunarizine group, medicine small dose group n=7 of the present invention, the heavy dose of group of medicine of the present invention n=8.
5. medicine of the present invention can reduce whole blood viscosity, plasma viscosity and the erythrocyte aggregation index of " syndrome of blood stasis " rat, and can suppress the formation of hematoblastic gathering and thrombosis, therefore think that this medical instrument has the hemorheological property of improvement, anticoagulant and suppress thrombotic effect the results are shown in Table 5-table 7.
Table 5, Chinese medicine composition of the present invention are to the influence of " syndrome of blood stasis " rat whole blood and plasma viscosity (X ± SD)
| Group | Dosage (g/kg) | Number of animals | Whole blood viscosity | Plasma viscosity | |||
| (200.0s -1) | (60.0s -1) | (5.0s -1) | (1.0s -1) | (100.0s -1) | |||
| Normal control | Isometric(al) | 11 | 3.88±0.47 ** | 4.77±0.42 ** | 10.00±0.99 ** | 23.43±3.59 ** | 1.39±0.17 ** |
| Model group | Isometric(al) | 12 | 5.00±0.68 | 6.41±1.02 | 13.63±2.16 | 35.61±5.68 | 1.83±0.20 |
| The Radix Salviae Miltiorrhizae group | 1.0 | 11 | 4.36±0.48 * | 5.18±0.64 ** | 10.34±1.71 ** | 24.61±5.51 ** | 1.52±0.20 ** |
| TONGTIAN KOUFUYE group medicine group of the present invention medicine group of the present invention medicine group of the present invention | 10ml/kg 2.08 0.69 0.23 | 11 11 11 12 | 4.36±0.57 * 4.49±0.49 * 4.63±0.41 4.42±0.39U | 5.26±0.76 **5.42±0.53 **5.46±0.53 *5.44±0.60 ** | 10.72±1.59 **11.27±1.19 **10.94±1.66 **11.42±1.92 * | 25.74±6.08 **26.38±3.32 **25.51±4.48 **27.11±4.41 ** | 1.47±0.2 **1.58±0.14 **1.64±0.16 *1.59±0.16 ** |
Annotate: compare with model:
*P＜0.05
*P＜0.01
Table 6, Chinese medicine composition of the present invention are to the influence of " syndrome of blood stasis " rat platelet aggregation rate (X ± SD)
| Group | Dosage (g/kg) | Number of animals | 1min aggregation rate rate (%) | Maximum agglutination rate (%) | 5min assembles (%) |
| Blank | Isometric(al) | 11 | 19.22±8.99 ** | 28.42±11.14 * | 20.51±12.58 |
| Model group | Isometric(al) | 11 | 41.59±20.86 | 50.25±25.32 | 36.09±31.40 |
| The Radix Salviae Miltiorrhizae group | 1.0 | 11 | 17.70±5.23 ** | 22.99±11.82 ** | 14.65±12.59 * |
| TONGTIAN KOUFUYE group medicine group of the present invention medicine group of the present invention medicine group of the present invention | 10ml/kg 2.08 0.69 0.23 | 11 11 11 11 | 29.07±16.88 21.17±8.58 ** 20.48±5.24 ** 23.69±14.87 * | 34.51±17.13 24.57±9.35 **24.73±5.53 **27.29±14.65 * | 19.89±11.44 9.32±9.02 * 10.85±7.02 * 14.84±10.04 * |
Annotate: compare with model:
*P＜0.05
*P＜0.01
Table 7, Chinese medicine composition of the present invention are to the thrombotic influence of " syndrome of blood stasis " rats in vitro (X ± SD)
| Group | Dosage (g/kg) | Number of animals | Thrombosis length (cm) | Weight in wet base (mg) | Dry weight (mg) |
| Blank | Isometric(al) | 10 | 2.02±0.62 ** | 43.90±9.63 ** | 12.00±3.98 ** |
| Model group | Isometric(al) | 10 | 3.65±1.20 | 108.70±.14.66 | 29.60±6.34 |
| The Radix Salviae Miltiorrhizae group | 1.0 | 10 | 3.90±0.58 | 77.52±11.24 ** | 21.14±3.04 ** |
| TONGTIAN KOUFUYE group medicine group of the present invention medicine group of the present invention medicine group of the present invention | 10ml/kg 2.08 0.69 0.23 | 10 11 10 10 | 3.39±0.97 3.53±0.71 4.34±0.83 3.63±0.86 | 78.13±16.63 ** 80.71±10.57 **③ 85.09±8.03 ** 93.81±7.89 * | 20.44±3.55 * 21.38±2.22 *④ 25.94±6.30 26.94±2.70 |
Annotate: compare with model group
*P＜0.05
*P＜0.01; With more 3. 4. P＜0.01, P＜0.05 of low dose group
6. medicine height of the present invention, middle dosage have the caliber that increases diameter of normal mouse auricula arteriole, venule, high, in, low dose can accelerate the effect of microcirculatory blood flow rate.
7. medicine of the present invention also has good analgesic activity, the results are shown in Table 8.
Table 8, Chinese medicine composition of the present invention to the influence of mice pain threshold (hot plate method, M ± SD, n=10)
| Group | Dosage (g/kg) | Before the medicine | Pain threshold (S) | |||
| 0.5h | 1h | 1.5h | 2h | |||
| Normal group medicine group of the present invention medicine group of the present invention medicine group of the present invention morphine hydrochloride | 0.38 1.15 3.46 2.58 mg/kg | 19.5±5.5 25.9±8.1 22.7±8.7 19.7±7.1 16.4±7.2 | 32.1±20.3 34.2±16.5 36.6±17.4 32.2±18.4 36.6±21.6 | 22.8±14.1 30.8±17.3 40.9±18.1 △ 41.6±21.0 △ 40.7±18.2 △ | 25.7±13.9 29.4±16.2 43.6±16.7 △ 43.6±17.5 △ 41.2±15.5 △ | 28.9±22.1 37.8±18.4 43.1±17.2 36.6±17.0 45.7±18.1 |
Annotate: compare with normal group,
△P＜0.05
Compare with similar drug, of high quality and at a reasonable price being easy to get of medicine raw material of the present invention, preclinical pharmacology studies have shown that determined curative effect, reaches the effect of " effecting a permanent cure " that the traditional Chinese medical science is referred to as.The pharmaceutical preparation of the present invention of above preparation technology, moulding process and quality standard production has efficiently, the good product of safe without toxic side effect.
The specific embodiment
The preparation of embodiment migrainous Chinese medicine composition of 1. treatments of the present invention and preparation thereof
Enlarging dose by following prescription equal proportion gets it filled standby: Rhizoma Chuanxiong 4.8 grams, Radix Angelicae Sinensis 4.8 grams, Fructus Viticis 2.4 grams, Scorpio 0.42 gram, artificial Moschus's 0.048 gram, Borneolum Syntheticum 0.18 gram; Rhizoma Chuanxiong, angelica sinensis are broken into coarse granule, and Fructus Viticis is smashed, and add 9 times of water gagings, soak 1 hour, extract 3 hours volatile oil, collect volatile oil, and be standby; Above decocting liquid filters, and is after being evaporated to relative density and being the medicinal liquid of 1.20 (50 ℃), standby; Medicinal residues respectively 9 times, 6 times water gagings decoct twice, and each 1 hour, collecting decoction filtered, and are after being evaporated to relative density and being the medicinal liquid of 1.20 (50 ℃), standby; More than two concentrated solutions merge, put cold, add the ethanol precipitate with ethanol, concentration of alcohol is 80%, leaves standstill 36 hours, gets supernatant, reclaims ethanol and is evaporated to the clear paste that relative density is 1.18 (50 ℃), drying is pulverized, and sieves, and is standby; Scorpio adds 8 times of water gagings, decocts 0.5 hour, treat that temperature is reduced to 40 ℃ after, add 0.4% neutral protease (10～110,000 units/g) at twice, constantly stir, each enzymolysis 3 hours is warming up to 90 ℃ again, filter, be evaporated to relative density and be about the clear paste of 1.30 (50 ℃), drying under reduced pressure is pulverized, sieve, standby; Artificial Moschus, Borneolum Syntheticum are pulverized, and sieve, and be standby; Get above each fine powder that makes, mix homogeneously adds volatile oil and contains the PEG400 of 5% glycerol an amount of (be equivalent to fine powder weight two times) mix homogeneously, is the migrainous Chinese medicine composition of treatment of the present invention.
Aforementioned pharmaceutical compositions is added in the soft capsule skin repressed one-tenth soft capsule finished product:
Step 1: get glycerol, water adds food coloring, grinds, and mixes, and is heated to 45 ℃, add gelatin, stir, be heated to 80 ℃, be incubated 40 minutes, be evacuated to-0.06Mpa, stir about 1 hour is crossed 60 order filter clothes, and insulation about 60 ℃ promptly gets and the food coloring color rubber solution that is complementary, and is standby;
Step 2: start encapsulating machine, after preparing qualified rubber, carry out ball readjustment examination, after treating that loading amount difference is qualified, Chinese medicine composition is put into liquid reservoir, by " regulation of soft capsule content uniformity under an appendix IL of Chinese pharmacopoeia version in 2000 item, compacting soft capsule, the molding in 10～12 hours of rolling;
Step 3: with dry a period of time of the soft capsule of forming;
Step 4: the soft capsule that drying is good rolls with gauze, absorbs and clean the Polyethylene Glycol and the liquid paraffin on surface, cleans with ethanol, cleans remaining Polyethylene Glycol and liquid paraffin, dries in dry sieve, and check, packing promptly get the soft capsule finished product.
Embodiment 2.
Enlarging dose by following prescription equal proportion gets it filled standby: Rhizoma Chuanxiong 9.6 grams, and Radix Angelicae Sinensis 9.6 grams, Fructus Viticis 4.8 grams, Scorpio 0.84 gram, artificial Moschus's 0.096 gram, Borneolum Syntheticum 0.36 gram, standby; Get Rhizoma Chuanxiong, angelica sinensis is broken into coarse granule, wild pepper smash, add 9 times of water gagings and soaked 1 hour, extracts 3 hours volatile oil, collection volatile oil, standby; Above decocting liquid filters, and is after being evaporated to relative density and being the medicinal liquid of 1.20 (50 ℃), standby; Add 9 times, 6 times water gagings before and after medicinal residues and the Scorpio, decoct twice, each 1 hour, collecting decoction filtered, and is after being evaporated to relative density and being the medicinal liquid of 1.20 (50 ℃), standby; More than two concentrated solutions merge, put cold, add the ethanol precipitate with ethanol, concentration of alcohol is 80%, leaves standstill 35 hours, gets supernatant, reclaims ethanol and is evaporated to the clear paste that relative density is 1.18 (50 ℃), drying is pulverized, and sieves, and is standby; Artificial Moschus, Borneolum Syntheticum are pulverized, and be standby; Get above each fine powder that makes, mix homogeneously, the clathrate of adding volatile oil or volatile oil is the migrainous Chinese medicine composition of treatment of the present invention.
With said medicine with mix with acceptable carrier on the pharmaceutics, prepare corresponding oral formulations.
The preparation of embodiment migrainous Chinese medicine composition of 3. treatments of the present invention and preparation thereof
Enlarging dose by following prescription equal proportion gets it filled standby: Rhizoma Chuanxiong 19.2 grams, and Radix Angelicae Sinensis 19.2 grams, Fructus Viticis 9.6 grams, Scorpio 1.68 grams, artificial Moschus's 0.192 gram, Borneolum Syntheticum 0.72 gram, standby; Get Rhizoma Chuanxiong, angelica sinensis is broken into coarse granule, wild pepper smash, add 9 times of water gagings and soaked 2 hours, extracts 5 hours volatile oil, collection volatile oil, standby; Above decocting liquid filters, and is after being evaporated to relative density and being the medicinal liquid of 1.50 (50 ℃), standby; Add 9 times, 6 times water gagings before and after medicinal residues add and decoct twice, each 2 hours, collecting decoction filtered, and is after being evaporated to relative density and being the medicinal liquid of 1.50 (50 ℃), standby; More than two concentrated solutions merge, put cold, add the ethanol precipitate with ethanol, concentration of alcohol is 90%, leaves standstill 40 hours, gets supernatant, reclaiming ethanol, to be evaporated to relative density be 1.50 clear paste, drying is pulverized, and sieves, and is standby; Artificial Moschus, Borneolum Syntheticum and Scorpio are pulverized, and be standby; Get above each fine powder that makes, mix homogeneously adds volatile oil or volatile oil clathrate compound, is the migrainous Chinese medicine composition of treatment of the present invention.
With said medicine with mix with acceptable carrier on the pharmaceutics, prepare corresponding oral formulations.
Embodiment 4. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 2 grams, Radix Angelicae Sinensis 3 grams, Fructus Viticis 2 grams, Scorpio 0.3 gram, artificial Moschus's 0.01 gram, Borneolum Syntheticum 0.05 gram, all the other are with embodiment 1.
Embodiment 5. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 5 grams, Radix Angelicae Sinensis 9 grams, Fructus Viticis 6 grams, Scorpio 1 gram, artificial Moschus's 0.01 gram, Borneolum Syntheticum 0.05 gram, all the other are with embodiment 1.
Embodiment 6. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 15 grams, Radix Angelicae Sinensis 16 grams, Fructus Viticis 12 grams, Scorpio 7 grams, artificial Moschus's 1 gram, Borneolum Syntheticum 1 gram, all the other are with embodiment 1.
Embodiment 7. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 20 grams, Radix Angelicae Sinensis 25 grams, Fructus Viticis 20 grams, Scorpio 10 grams, artificial Moschus's 1 gram, Borneolum Syntheticum 1 gram, all the other are with embodiment 1.
Embodiment 8. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 2 grams, Radix Angelicae Sinensis 3 grams, Fructus Viticis 2 grams, Scorpio 0.3 gram, artificial Moschus's 0.1 gram, Borneolum Syntheticum 0.5 gram, all the other are with embodiment 1.
Embodiment 9. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 2 grams, Radix Angelicae Sinensis 3 grams, Fructus Viticis 2 grams, Scorpio 0.3 gram, artificial Moschus's 1 gram, Borneolum Syntheticum 1 gram, all the other are with embodiment 1.
Embodiment 10. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 2 grams, Radix Angelicae Sinensis 3 grams, Fructus Viticis 10 grams, Scorpio 3 grams, artificial Moschus's 0.01 gram, Borneolum Syntheticum 0.05 gram, all the other are with embodiment 1.
Embodiment 11. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 2 grams, Radix Angelicae Sinensis 3 grams, Fructus Viticis 10 grams, Scorpio 3 grams, artificial Moschus's 0.1 gram, Borneolum Syntheticum 0.5 gram, all the other are with embodiment 1.
Embodiment 12. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 2 grams, Radix Angelicae Sinensis 3 grams, Fructus Viticis 10 grams, Scorpio 3 grams, artificial Moschus's 1 gram, Borneolum Syntheticum 1 gram, all the other are with embodiment 1.
Embodiment 13. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 2 grams, Radix Angelicae Sinensis 3 grams, Fructus Viticis 20 grams, Scorpio 10 grams, artificial Moschus's 0.01 gram, Borneolum Syntheticum 0.05 gram, all the other are with embodiment 1.
Embodiment 14. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 2 grams, Radix Angelicae Sinensis 3 grams, Fructus Viticis 20 grams, Scorpio 10 grams, artificial Moschus's 0.1 gram, Borneolum Syntheticum 0.5 gram; 315 milliliters in water, all the other are with embodiment 1.
Embodiment 15. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 2 grams, Radix Angelicae Sinensis 3 grams, Fructus Viticis 20 grams, Scorpio 10 grams, artificial Moschus's 1 gram, Borneolum Syntheticum 1 gram, all the other are with embodiment 1.
Embodiment 16. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 10 grams, Radix Angelicae Sinensis 13 grams, Fructus Viticis 2 grams, Scorpio 0.3 gram, artificial Moschus's 0.01 gram, Borneolum Syntheticum 0.05 gram, all the other are with embodiment 1.
Embodiment 17. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 10 grams, Radix Angelicae Sinensis 13 grams, Fructus Viticis 2 grams, Scorpio 0.3 gram, artificial Moschus's 0.1 gram, Borneolum Syntheticum 0.5 gram, all the other are with embodiment 1.
Embodiment 18. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 10 grams, Radix Angelicae Sinensis 13 grams, Fructus Viticis 2 grams, Scorpio 0.3 gram, artificial Moschus's 1 gram, Borneolum Syntheticum 1 gram, all the other are with embodiment 1.
Embodiment 19. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 10 grams, Radix Angelicae Sinensis 13 grams, Fructus Viticis 10 grams, Scorpio 3 grams, artificial Moschus's 0.01 gram, Borneolum Syntheticum 0.05 gram, all the other are with embodiment 1.
Embodiment 20. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 10 grams, Radix Angelicae Sinensis 13 grams, Fructus Viticis 10 grams, Scorpio 3 grams, artificial Moschus's 1 gram, Borneolum Syntheticum 1 gram, all the other are with embodiment 1.
Embodiment 21. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 10 grams, Radix Angelicae Sinensis 13 grams, Fructus Viticis 20 grams, Scorpio 10 grams, artificial Moschus's 0.01 gram, Borneolum Syntheticum 0.05 gram, all the other are with embodiment 1.
Embodiment 22. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 10 grams, Radix Angelicae Sinensis 13 grams, Fructus Viticis 20 grams, Scorpio 10 grams, artificial Moschus's 0.1 gram, Borneolum Syntheticum 0.5 gram, all the other are with embodiment 1.
Embodiment 23. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 10 grams, Radix Angelicae Sinensis 13 grams, Fructus Viticis 20 grams, Scorpio 10 grams, artificial Moschus's 1 gram, Borneolum Syntheticum 1 gram, all the other are with embodiment 1.
Embodiment 24. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 20 grams, Radix Angelicae Sinensis 25 grams, Fructus Viticis 2 grams, Scorpio 0.3 gram, artificial Moschus's 0.01 gram, Borneolum Syntheticum 0.05 gram, all the other are with embodiment 1.
Embodiment 25. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 20 grams, Radix Angelicae Sinensis 25 grams, Fructus Viticis 2 grams, Scorpio 0.3 gram, artificial Moschus's 0.1 gram, Borneolum Syntheticum 0.5 gram, all the other are with embodiment 1.
Embodiment 26. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 20 grams, Radix Angelicae Sinensis 25 grams, Fructus Viticis 2 grams, Scorpio 0.3 gram, artificial Moschus's 1 gram, Borneolum Syntheticum 1 gram, all the other are with embodiment 1.
Embodiment 27. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 20 grams, Radix Angelicae Sinensis 25 grams, Fructus Viticis 10 grams, Scorpio 3 grams, artificial Moschus's 0.01 gram, Borneolum Syntheticum 0.05 gram, all the other are with embodiment 1.
Embodiment 28. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 20 grams, Radix Angelicae Sinensis 25 grams, Fructus Viticis 10 grams, Scorpio 3 grams, artificial Moschus's 0.1 gram, Borneolum Syntheticum 0.5 gram, all the other are with embodiment 1.
Embodiment 29. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 20 grams, Radix Angelicae Sinensis 25 grams, Fructus Viticis 10 grams, Scorpio 3 grams, artificial Moschus's 1 gram, Borneolum Syntheticum 1 gram, all the other are with embodiment 1.
Embodiment 30. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 20 grams, Radix Angelicae Sinensis 25 grams, Fructus Viticis 20 grams, Scorpio 10 grams, artificial Moschus's 0.01 gram, Borneolum Syntheticum 0.05 gram, all the other are with embodiment 1.
Embodiment 31. is substantially the same manner as Example 1, but the prescription ratio is:
Rhizoma Chuanxiong 20 grams, Radix Angelicae Sinensis 25 grams, Fructus Viticis 20 grams, Scorpio 10 grams, artificial Moschus's 0.1 gram, Borneolum Syntheticum 0.5 gram, all the other are with embodiment 1.
Claims (10)
1, the migrainous Chinese medicine composition of a kind of treatment is characterized in that its composition is:
Rhizoma Chuanxiong 2～20 grams, Radix Angelicae Sinensis 3～25 grams, Fructus Viticis 2～20 grams, Scorpio 0.3～10 gram, artificial Moschus's 0.01～1 gram, Borneolum Syntheticum 0.05～1 gram.
2, the migrainous Chinese medicine composition of treatment according to claim 1 is characterized in that, is made by the following raw materials according medical material:
Rhizoma Chuanxiong 5～15 grams, Radix Angelicae Sinensis 9～16 grams, Fructus Viticis 6～12 grams, Scorpio 1～7 gram, artificial Moschus's 0.01～1 gram, Borneolum Syntheticum 0.05～1 gram.
3, the migrainous Chinese medicine composition of treatment according to claim 2 is characterized in that, described raw medicinal material is: Rhizoma Chuanxiong 4.8 grams, Radix Angelicae Sinensis 4.8 grams, Fructus Viticis 2.4 grams, Scorpio 0.42 gram, artificial Moschus's 0.048 gram, Borneolum Syntheticum 0.18 gram.
4, according to claim 1 or the migrainous Chinese medicine composition of 2 or 3 described treatments, it is characterized in that: described Chinese medicine composition also includes acceptable carrier and adjuvant on the pharmaceutics, dosage form is an oral formulations, comprises soft capsule, hard capsule, granule, tablet or oral liquid.
5, the preparation method of the migrainous Chinese medicine composition of the described treatment of a kind of claim 1 may further comprise the steps:
Step 1, by the prescription the quality component get Rhizoma Chuanxiong, Radix Angelicae Sinensis, Fructus Viticis, Scorpio, artificial Moschus and Borneolum Syntheticum, standby;
Step 2, get Rhizoma Chuanxiong, Radix Angelicae Sinensis, Fructus Viticis and smash immersion, extract and also collect volatile oil, standby;
Step 3, above decocting liquid concentrate, and precipitate with ethanol leaves standstill, and gets the supernatant concentrating under reduced pressure and gets clear paste, drying;
Step 4, get artificial Moschus, Borneolum Syntheticum and pulverize;
The treatment step of step 5, Scorpio is:
(1) medicinal residues that extract behind volatile oil, the decocting with step 2 component merge, and enter the step together
Rapid 3, decocting once more, decocting liquid concentrates, and precipitate with ethanol leaves standstill, and gets the supernatant concentrating under reduced pressure and gets clear paste, drying; Perhaps,
(2). pulverize the same with step 4 medical material, perhaps,
(3). separately decocting, with behind the protease hydrolyzed, concentrating under reduced pressure is a clear paste, drying under reduced pressure is pulverized;
Step 6, get above each fine powder that makes, mix homogeneously adds volatile oil, promptly.
6, the preparation method of the migrainous Chinese medicine composition of treatment according to claim 5 is characterized in that it specifically is made up of following steps:
Step 1, get Rhizoma Chuanxiong, Radix Angelicae Sinensis, Fructus Viticis, Scorpio, artificial Moschus and Borneolum Syntheticum by the described quality component of claim 1, standby;
Step 2, get Rhizoma Chuanxiong, angelica sinensis is broken into coarse granule, Fructus Viticis is smashed, and adds the water of 5～10 times of amounts, soaks 1～2 hour, extracts 2～5 hours volatile oil, collection volatile oil is standby;
Step 3, above decocting liquid filter, and relative density is behind 1.10～1.50 the medicinal liquid when being evaporated to 50 ℃, and is standby; Medicinal residues add 6～9 times in water and decoct twice, and each 1～2 hour, collecting decoction filtered, and relative density is behind 1.10～1.50 the medicinal liquid when being evaporated to 50 ℃, and is standby; More than two concentrated solutions merge, put cold, add the ethanol precipitate with ethanol, concentration of alcohol is 50～90%, leaves standstill 30～40 hours, gets supernatant, reclaiming ethanol, to be evaporated to relative density be 1.00～1.50 clear paste, drying is pulverized, and sieves, and is standby;
Step 4, Scorpio add 5～10 times of water gagings, decoct 0.5～1.5 hour, treat that temperature is reduced to 25～50 ℃ after, add 0.2%～0.4% neutral protease at twice, constantly stir, each enzymolysis 1～4 hour is warming up to 80～95 ℃ again, filter, be evaporated to relative density and be about 1.10～1.50 clear paste, drying under reduced pressure is pulverized, sieve, standby;
Step 5, artificial Moschus, Borneolum Syntheticum are pulverized, and sieve, and be standby;
Step 6, get above each fine powder that makes, mix homogeneously adds volatile oil, promptly.
7, the preparation method of Chinese medicine composition according to claim 5 is characterized in that, it specifically is made up of following steps:
Step 1, get Rhizoma Chuanxiong, Radix Angelicae Sinensis, Fructus Viticis, Scorpio, artificial Moschus and Borneolum Syntheticum by the described quality component of claim 1, standby;
Step 2, get Rhizoma Chuanxiong, angelica sinensis is broken into coarse granule, Fructus Viticis is smashed, and adds the water of 5～10 times of amounts, soaks 1～2 hour, extracts 2～5 hours volatile oil, collection volatile oil is standby;
Step 3, above decocting liquid filter, and relative density is behind 1.10～1.50 the medicinal liquid when being evaporated to 50 ℃, and is standby; Medicinal residues and Scorpio add 6～9 times in water and decoct twice, and each 1～2 hour, collecting decoction filtered, and relative density is behind 1.10～1.50 the medicinal liquid when being evaporated to 50 ℃, and is standby; More than two concentrated solutions merge, put cold, add the ethanol precipitate with ethanol, concentration of alcohol is 50～90%, leaves standstill 30～40 hours, gets supernatant, reclaiming ethanol, to be evaporated to relative density be 1.00～1.50 clear paste, drying is pulverized, and sieves, and is standby;
Step 4, artificial Moschus, Borneolum Syntheticum are pulverized, and be standby;
Step 5, get above each fine powder that makes, mix homogeneously adds volatile oil, promptly.
8, the preparation method of Chinese medicine composition according to claim 5 is characterized in that, it specifically is made up of following steps:
Step 1, get Rhizoma Chuanxiong, Radix Angelicae Sinensis, Fructus Viticis, Scorpio, artificial Moschus and Borneolum Syntheticum by the described quality component of claim 1, standby;
Step 2, get Rhizoma Chuanxiong, angelica sinensis is broken into coarse granule, Fructus Viticis is smashed, and adds the water of 5～10 times of amounts, soaks 1～2 hour, extracts 2～5 hours volatile oil, collection volatile oil is standby;
Step 3, above decocting liquid filter, and the relative density that is evaporated to 50 ℃ is behind 1.10～1.50 the medicinal liquid, and is standby; Medicinal residues add 6～9 times in water and decoct twice, and each 1～2 hour, collecting decoction filtered, and the relative density that is evaporated to 50 ℃ is behind 1.10～1.50 the medicinal liquid, and is standby; More than two concentrated solutions merge, put cold, add the ethanol precipitate with ethanol, concentration of alcohol is 75～90%, leaves standstill 30～40 hours, gets supernatant, reclaiming ethanol, to be evaporated to relative density be 1.00～1.50 clear paste, drying is pulverized, and sieves, and is standby;
Step 4, artificial Moschus, Borneolum Syntheticum are pulverized and Scorpio is pulverized, and be standby;
Step 5, get above each fine powder that makes, mix homogeneously adds volatile oil, promptly.
9, according to the preparation method of claim 6 or 7 or 8 described Chinese medicine compositions, it is characterized in that: described pulverizing is to be ground into 80～160 purpose fine powders of looking over so as to check, and perhaps adopts super fine to be ground into 200～300 purpose fine powders; Steam distillation is adopted in the extraction of described Rhizoma Chuanxiong, angelica sinensis and the contained volatile oil of Fructus Viticis, perhaps adopts supercritical fluid extraction; The drying of described concentrated solution adopts drying under reduced pressure, spray drying or vacuum drying.
10, the preparation method of Chinese medicine composition according to claim 9 is characterized in that: described soft capsule moulding process may further comprise the steps:
The clear paste powder of described Chinese medicine composition adds glycerol, Polyethylene Glycol or vegetable oil or the Cera Flava mix homogeneously of 3%-6%, and the soft capsule moulding process is:
Get glycerol, water adds food coloring, grinds 10 minutes with colloid mill, make mix homogeneously, in the inputization glue jar, be heated to 45 ℃, add gelatin, stir, be heated to 80 ℃, be incubated 40 minutes, be evacuated to-0.06Mpa, stir about 1 hour, extremely till jar interior no bubble, cross 60 order filter clothes, put in the insulation jar, insulation about 60 ℃ promptly gets and the food coloring color rubber solution that is complementary, and is standby;
Compression moulding: start encapsulating machine, after preparing qualified rubber, carry out ball readjustment examination with liquid paraffin earlier, after treating that loading amount difference is qualified, the suspension of medicine and adjuvant is put into the liquid reservoir at machine top, elder generation's closing liquid paraffin inlet valve, open the medicine inlet valve again, the soft capsule that contains medicine is promptly suppressed and is finished, to the soft capsule that extrudes earlier, by " under an appendix IL of Chinese pharmacopoeia version in 2000 item regulation of soft capsule content uniformity to the content of soft capsule carry out content uniformity claim fixed, qualified back start continuous production, the soft capsule that suppresses falls into the drum-type drying machine of making net bottom with thin copper wire, and molding in 10-12 hour does not stop to roll;
Dry: as the soft capsule of forming to be loaded onto drying cart place in the hothouse that dehydrating unit is housed, regulate temperature, humidity, allow the interior moisture content of rubber slowly evaporate, and gently stir soft capsule every now and then, to prevent the adhesion of soft capsule pill, dry a period of time;
Deoil, granulate, finished product: the soft capsule that drying is good is put into coating pan with the gauze of cleaning and is rolled, the gauze that rolls can absorb and clean the Polyethylene Glycol and the liquid paraffin on soft capsule surface, qualified soft capsule cleans once with ethanol, to clean Polyethylene Glycol and the liquid paraffin of soft capsule appearance remnants, qualified soft capsule, dry in dry sieve, check, packing promptly get the soft capsule finished product.
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| CNB2003101126511A CN1257737C (en) | 2003-12-16 | 2003-12-16 | Traditional Chinese medicine composition for treating migraine and preparation method thereof |
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| CN101219164B (en) * | 2007-09-29 | 2010-09-08 | 中国药材集团公司 | Traditional Chinese medicine preparation for treating sick headache |
| CN101167817B (en) * | 2007-10-20 | 2011-12-07 | 刘衍 | Traditional Chinese medicine for treating migraine |
| CN104997944A (en) * | 2014-04-16 | 2015-10-28 | 天津药物研究院 | Headache treating pharmaceutical composition, preparation method and uses thereof |
| CN105362410B (en) * | 2015-03-04 | 2020-02-28 | 山东省药学科学院 | Traditional Chinese medicine preparation for treating burns and scalds and preparation method |
| CN107174531A (en) * | 2017-04-28 | 2017-09-19 | 成都永康制药有限公司 | A kind of low temperature drying method of small golden pellets preparation |
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