CN102631467B - Honglong antalgic medicinal composition, and preparation method and application thereof - Google Patents
Honglong antalgic medicinal composition, and preparation method and application thereof Download PDFInfo
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Abstract
The invention relates to a Honglong antalgic medicinal composition, and a preparation method and application thereof. The composition is prepared from the following crude medicaments in parts by weight: 40 to 55 parts of ethanol extract, 25 to 45 parts of aqueous extract and 12 to 28 parts of fine medicinal material powder. According to the novel extraction preparation method, the medicinal materials in the formula are separately extracted by different solvents, and mineral medicaments and toxic medicinal materials in the formula are decocted for a long time, so that effective components can be fully extracted from the mineral medicaments, and the toxicity of the toxic medicinal materials is lowered. On the premise of reserving the curative effects of the conventional preparation, a medicinal preparation prepared by the method can be fast absorbed, and is fast in effect and high in bioavailability, and active ingredients can reach a focus part in a centralized way. In addition, compared with the conventional Honglong antalgic tablet preparation, the preparation prepared from the composition has better curative effects.
Description
Technical field
The present invention relates to a kind of Pharmaceutical composition and its production and application, particularly a kind of red imperial analgesic composition and its production and application.
Background technology
Migraine is also referred to as angioneurotic headache, is a kind of clinical common chronic neural blood vessel illness, its sickness rate height, and the year prevalence of various countries' report, the women is 3.3%～32.6%, the male is 0.7%～16.1%.Migraine can betide any age, falls ill more than adolescence first.Migraine has a strong impact on patient's quality of life, and calendar year 2001, World Health Organization (WHO) was decided to be the chronic disease that disables most with serious migraine, was analogous to dementia, quadriplegia and cacopathia.Migraine pathogeny complexity is not clear and definite as yet so far; Treatment can be divided into acute stages treated and prophylactic treatment based on medicine.The acute stages treated common drug has NSAID (non-steroidal anti-inflammatory drug), barbiturates tranquilizer, opium kind analgesics and tramadol; The prophylactic treatment medicine has: the medicine of beta-blocker, calcium ion channel blocker, Anti-epileptics, antidepressant, NSAID (non-steroidal anti-inflammatory drug) and other kinds.Though the said medicine curative effect certainly, is prone to untoward reaction such as toxic and side effects, addiction, patient's compliance is relatively poor.And traditional Tibetan medicine and pharmacology treatment migraine has unique advantage.The red dragon analgesia of classical Tibetan medicine tablet recipe derives from good " the clinical reading notes of Tibetan medicine " of arranging of sea urchin roe paste; Consciousness-restoring and orifice-opening, removing obstruction in the collateral to relieve pain is used for the treatment of the caused migraine of blood stagnant in cerebral venation syndrome, angioneurotic headache, and clinical practice confirms evident in efficacy, and does not see obvious adverse reaction.
Red dragon analgesia sheet standard numbering: WS-10659(ZD-0659)-2002-2011Z.Red dragon analgesia sheet is made up of Os Draconis 112.0g, Indian Herba Swertiae bimaculatae 67.0g, Flos Carthami 67.0g, Chrysosplenium nudicaule Bunge 14.0g, west szechwan pyrethrum 67.0g, Radix aconiti szechenyiani 14.0g, Tangut aconite 67.0g, Fel Ursi powder 6.6g, sinter 13.5g, Herpetospermum caudigerum Wall. 13.5g, Tangut Przewalskia 13.5g, Parmelia saxatilis Ach. 13.5g, Lagotis brachystachya Maxim. 67.0g, Benzoinum 13.0g, Concha Margaritifera 35.0g.Effect with consciousness-restoring and orifice-opening, removing obstruction in the collateral to relieve pain.Be used for the caused migraine of blood stagnant in cerebral venation syndrome, angioneurotic headache.Be the ancient proved recipe of Tibetan medicine, record that the clinical practice in more than 100 year proves in good " the clinical reading notes of Tibetan medicine " of arranging of sea urchin roe paste, respond well to migraine, vascular headache, enjoy the patient to favor.Red dragon analgesia sheet traditional preparation process method is: Flos Carthami, west szechwan pyrethrum, Radix aconiti szechenyiani, Tangut aconite, Herpetospermum caudigerum Wall., Chrysosplenium nudicaule Bunge decoct with water three times, 2h for the first time, each 1h of second and third time, collecting decoction, filter, being concentrated into relative density is 1.38～1.38(20 ℃) thick paste; All the other Os Draconis etc. nine flavor is ground into fine powder, and is dry, pulverize, sieve with the thick paste mixing, makes granule with Diluted Alcohol, and drying adds starch, and magnesium stearate is an amount of, is pressed into 1000, promptly.
Prior art adopts the fraction medical material to extract about the preparation method of red imperial analgesic, most of medical material is directly pulverized and is used as medicine, directly pulverizing the medical material effective ingredient that is used as medicine discharges slowly, badly influence absorbing of effective ingredient, simultaneously because the crude drug fine powder is used as medicine, also have influence on the underproof problem of hygiology, simultaneously because most of medical material without extraction, also has influence on the development of its preparation.
Summary of the invention
The objective of the invention is to disclose a kind of red imperial analgesic composition made from ad hoc approach, another object of the present invention also is the preparation method and the application of open said composition.
Technical scheme of the present invention is as follows:
A kind of red imperial analgesic composition, make by the raw material of following weight portion:
Ethanol extraction 40-55 weight portion, water extract 40-55 weight portion, medical material fine powder 12-28 weight portion;
Described ethanol extraction makes as follows: get Indian Herba Swertiae bimaculatae 50-80 weight portion, Flos Carthami 50-80 weight portion, Chrysosplenium nudicaule Bunge 10-18 weight portion, west szechwan pyrethrum 50-80 weight portion, Tangut Przewalskia 9-18 weight portion, Herpetospermum caudigerum Wall. 9-18 weight portion totally 6 flavor medical materials mixes, the alcoholic solution reflux, extract, of adding volumetric concentration 50-90% 2-4 time, the alcoholic acid amount that at every turn adds volumetric concentration 50-90% is 6-14 a times of 6 flavor medical material gross weights, extract 1-5h, filter, merge medicinal liquid and get ethanol extraction liquid, the thick paste that to be evaporated to 50 ℃ of relative densities be 1.28-1.35, dry, pulverize, get ethanol extraction;
Described water extract makes as follows: get Radix aconiti szechenyiani 10-18 weight portion, Tangut aconite 50-80 weight portion, Concha Margaritifera 28-42 weight portion, Os Draconis 90-135 weight portion, sinter 9-18 weight portion mixes, doubly measure to decoct with water by the 6-14 of 5 flavor medical material gross weights and extract 1-3h, add Parmelia saxatilis Ach. 9-18 weight portion again, Lagotis brachystachya Maxim. 50-80 weight portion, and adding Parmelia saxatilis Ach., 6-14 times of water gaging of Lagotis brachystachya Maxim. 2 flavor medical material gross weights, decoct again and extract 2-4 time, decoct 2-4h, filter, merging filtrate, the thick paste that to be evaporated to 50 ℃ of relative densities be 1.28-1.35, drying is pulverized, and gets water extract;
Described medical material fine powder makes as follows: get Benzoinum 9-18 weight portion, Fel Ursi powder 3-10 weight portion 2 flavor medical materials, the 80-200 mesh sieve is crossed in 10 ℃ of-30 ℃ of pulverizing, gets the medical material fine powder.
Preferred according to the present invention, a kind of red imperial analgesic composition, make by the raw material of following weight portion:
Ethanol extraction 48.5g, water extract 47.3g, medical material fine powder 19.6g;
Described ethanol extraction makes as follows: get Indian Herba Swertiae bimaculatae 67.0g, Flos Carthami 67.0g, Chrysosplenium nudicaule Bunge 14.0g, west szechwan pyrethrum 67.0g, Tangut Przewalskia 13.5g, Herpetospermum caudigerum Wall. 13.5g totally 6 flavor medical materials mixing, the alcoholic solution reflux, extract, of adding volumetric concentration 75% 2 times, the alcoholic acid amount that at every turn adds volumetric concentration 75% is 8 times of 6 flavor medical material gross weights, extract 3h, filter, merge medicinal liquid and get ethanol extraction liquid, be evaporated to 50 ℃ of relative densities and be 1.33 thick paste, dry, pulverize, get ethanol extraction;
Described water extract makes as follows: get Radix aconiti szechenyiani 14.0g, Tangut aconite 67.0g, Concha Margaritifera 35.0g, Os Draconis 112.0g, sinter 13.5g mixes, 10 times of amounts by 5 flavor medical material gross weights decoct with water extraction 2h, add Parmelia saxatilis Ach. 13.5g again, Lagotis brachystachya Maxim. 67.0g, and adding Parmelia saxatilis Ach., 10 times of water gagings of Lagotis brachystachya Maxim. 2 flavor medical material gross weights, decoct again and extract 2 times, decoct for the first time 3h, 8 times of water gagings by 7 flavor medical material gross weights add for the second time, decoct 2h, filter merging filtrate, be evaporated to 50 ℃ of relative densities and be 1.33 thick paste, drying is pulverized, and gets water extract;
Described medical material fine powder makes as follows: get Benzoinum 13.0g, Fel Ursi powder 6.6g, 120 mesh sieves are crossed in 10 ℃ of-30 ℃ of pulverizing, get the medical material fine powder.
Can add conventional adjuvant in the raw material of a kind of red imperial analgesic composition of the present invention, be prepared into pharmaceutically acceptable any dosage form, comprise tablet, capsule, concentrated pill, drop pill, granule, gel etc. according to common process.Described adjuvant comprises solvent, disintegrating agent, correctives, antiseptic, coloring agent, binding agent, lubricant, substrate etc.
A kind of preparation method of red imperial analgesic composition, step is as follows:
(1) gets the totally 6 flavor medical materials mixing of Indian Herba Swertiae bimaculatae 50-80 weight portion, Flos Carthami 50-80 weight portion, Chrysosplenium nudicaule Bunge 10-18 weight portion, west szechwan pyrethrum 50-80 weight portion, Tangut Przewalskia 9-18 weight portion, Herpetospermum caudigerum Wall. 9-18 weight portion, the alcoholic solution reflux, extract, of adding volumetric concentration 50-90% 2-4 time, the alcoholic acid amount that at every turn adds volumetric concentration 50-90% is 6-14 a times of 6 flavor medical material gross weights, extract 1-5h, filter, merge medicinal liquid and get ethanol extraction liquid, the thick paste that to be evaporated to 50 ℃ of relative densities be 1.28-1.35, dry, pulverize, get ethanol extraction;
(2) get Radix aconiti szechenyiani 10-18 weight portion, Tangut aconite 50-80 weight portion, Concha Margaritifera 28-42 weight portion, Os Draconis 90-135 weight portion, the mixing of sinter 9-18 weight portion, doubly measure to decoct with water by the 6-14 of 5 flavor medical material gross weights and extract 1-3h, add Parmelia saxatilis Ach. 9-18 weight portion, Lagotis brachystachya Maxim. 50-80 weight portion again, and add 6-14 times of water gaging of Parmelia saxatilis Ach., Lagotis brachystachya Maxim. 2 flavor medical material gross weights, decoct again and extract 2-4 time, decoct 2-4h, filter, merging filtrate, the thick paste that to be evaporated to 50 ℃ of relative densities be 1.28-1.35, drying is pulverized, and gets water extract;
(3) get Benzoinum 9-18 weight portion, Fel Ursi powder 3-10 weight portion 2 flavor medical materials, the 80-200 mesh sieve is crossed in 10 ℃ of-30 ℃ of pulverizing, gets the medical material fine powder;
(4) the medical material fine powder that makes of the water extract that makes of the ethanol extraction that step (1) is made, step (2) and step (3) mixes, and promptly gets red imperial analgesic composition.
Preferred according to the present invention, a kind of preparation method of red imperial analgesic composition, step is as follows:
(1) gets Indian Herba Swertiae bimaculatae 67.0g, Flos Carthami 67.0g, Chrysosplenium nudicaule Bunge 14.0g, west szechwan pyrethrum 67.0g, Tangut Przewalskia 13.5g, Herpetospermum caudigerum Wall. 13.5g totally 6 flavor medical materials mixing, the alcoholic solution reflux, extract, of adding volumetric concentration 75% 2 times, the alcoholic acid amount that at every turn adds volumetric concentration 75% is 8 times of 6 flavor medical material gross weights, extract 2h, filter, merge medicinal liquid and get ethanol extraction liquid, be evaporated to 50 ℃ of relative densities and be 1.33 thick paste, drying is pulverized, and gets ethanol extraction;
(2) get Radix aconiti szechenyiani 14.0g, Tangut aconite 67.0g, Concha Margaritifera 35.0g, Os Draconis 112.0g, sinter 13.5g mixing, 10 times of amounts by 5 flavor medical material gross weights decoct with water extraction 2h, add Parmelia saxatilis Ach. 13.5g, Lagotis brachystachya Maxim. 67.0g again, and add 10 times of water gagings of Parmelia saxatilis Ach., Lagotis brachystachya Maxim. 2 flavor medical material gross weights, decoct again and extract 2 times, decoct for the first time 3h, 8 times of water gagings by 7 flavor medical material gross weights add for the second time, decoct 2h, filter merging filtrate, be evaporated to 50 ℃ of relative densities and be 1.33 thick paste, drying is pulverized, and gets water extract;
(3) get Benzoinum 13.0g, Fel Ursi powder 6.6g, 120 mesh sieves are crossed in 10 ℃ of-30 ℃ of pulverizing, get the medical material fine powder;
(4) the medical material fine powder that makes of the water extract that makes of the ethanol extraction that step (1) is made, step (2) and step (3) mixes, and promptly gets red imperial analgesic composition.
The application of a kind of red imperial analgesic composition of the present invention in the medicine of preparation treatment migraine, angioneurotic headache.
The pass of weight portion of the present invention and parts by volume is g/ml or kg/L.
The present invention compared with prior art, beneficial effect is as follows:
1, characteristics of the present invention are to be guidance with the drug activity, take into full account the character of ingredient, different clinical disease needs, and the compliance of medication object and physiological conditions etc., adopt new extraction preparation method, simultaneously, the present invention is according to the physicochemical property of the contained chemical constituent of medical material in the prescription, select for use different solvents to separate extraction, some mineral medicinal materials in the prescription have been carried out long decoction, guaranteed that the active ingredient in the mineral medicinal material can be extracted fully, improved the curative effect of medicine.
2, virose medical material Radix aconiti szechenyiani extracts through long-time, and the hydrolysis of toxic component diester-type alkaloids generates monoester type and lard type alkaloid, plays the effect of attenuation, thereby has reduced the toxicity of medicine, has increased the safety of medicine.
3, compare with conventional formulation, the pharmaceutical preparation of method preparation of the present invention can realize absorbing soon under the prerequisite that keeps former preparation drug effect, and effective ingredient is concentrated and arrived lesions position, and is rapid-action, the bioavailability height.The preparation of the preparation of compositions by preparation of the present invention is compared with former red dragon analgesia tablet preparation simultaneously, has improved curative effect.
The specific embodiment
Following experimental example and embodiment are used to further specify but are not limited to the present invention.Employed red imperial pentazocine preparation is to make with the red imperial analgesic composition of the embodiment of the invention 1 method preparation in the experimental example.
Embodiment 1, the capsular preparation of red imperial analgesic composition
Ethanol extraction 48.5g, water extract 47.3g, medical material fine powder 19.6g;
Be prepared as follows and form:
(1) gets Indian Herba Swertiae bimaculatae 67.0g, Flos Carthami 67.0g, Chrysosplenium nudicaule Bunge 14.0g, west szechwan pyrethrum 67.0g, Tangut Przewalskia 13.5g, Herpetospermum caudigerum Wall. 13.5g totally 6 flavor medical materials mixing, the alcoholic solution reflux, extract, of adding volumetric concentration 75% 2 times, the alcoholic acid amount that at every turn adds volumetric concentration 75% is 8 times of 6 flavor medical material gross weights, extract 3h, filter, merge medicinal liquid and get ethanol extraction liquid, be evaporated to 50 ℃ of relative densities and be 1.33 thick paste, drying is pulverized, and gets ethanol extraction;
(2) get Radix aconiti szechenyiani 14.0g, Tangut aconite 67.0g, Concha Margaritifera 35.0g, Os Draconis 112.0g, sinter 13.5g mixing, 10 times of amounts by 5 flavor medical material gross weights decoct with water extraction 2h, add Parmelia saxatilis Ach. 13.5g, Lagotis brachystachya Maxim. 67.0g again, and add 10 times of water gagings of Parmelia saxatilis Ach., Lagotis brachystachya Maxim. 2 flavor medical material gross weights, decoct again and extract 2 times, decoct for the first time 3h, 8 times of water gagings by 7 flavor medical material gross weights add for the second time, decoct 2h, filter merging filtrate, be evaporated to 50 ℃ of relative densities and be 1.33 thick paste, drying is pulverized, and gets water extract;
(3) get Benzoinum 13.0g, Fel Ursi powder 6.6g, 120 mesh sieves are crossed in 10 ℃ of-30 ℃ of pulverizing, get the medical material fine powder;
(4) the medical material fine powder that makes of the water extract that makes of the ethanol extraction that step (1) is made, step (2) and step (3) mixes, and promptly gets red imperial analgesic composition; According to common process, add conventional adjuvant, make capsule, promptly.
Embodiment 2, the particulate preparation of red imperial analgesic composition
Ethanol extraction 45.6g, water extract 46.2g, medical material fine powder 18.8g;
Be prepared as follows and form:
(1) gets Indian Herba Swertiae bimaculatae 60.0g, Flos Carthami 60.0g, Chrysosplenium nudicaule Bunge 17.0g, west szechwan pyrethrum 60.0g, Tangut Przewalskia 13.5g, Herpetospermum caudigerum Wall. 11.5g totally 6 flavor medical materials mixing, the alcoholic solution reflux, extract, of adding volumetric concentration 60% 2 times, the amount that add the first time is 10 times of 6 flavor medical material gross weights, extract 3h, the amount that add the second time is 8 times of 6 flavor medical material gross weights, extract 2h, filter, merge medicinal liquid and get ethanol extraction liquid, be evaporated to 50 ℃ of relative densities and be 1.34 thick paste, drying is pulverized, and gets ethanol extraction;
(2) get Radix aconiti szechenyiani 17.0g, Tangut aconite 70.0g, Concha Margaritifera 30.0g, Os Draconis 100.0g, sinter 17g mixes, 10 times of amounts by 5 flavor medical material gross weights decoct with water extraction 3h, add Parmelia saxatilis Ach. 15.5g again, Lagotis brachystachya Maxim. 63.0g, and adding Parmelia saxatilis Ach., 10 times of water gagings of Lagotis brachystachya Maxim. 2 flavor medical material gross weights, decoct again and extract 3 times, decoct for the first time 3h, 6 times of water gagings by 7 flavor medical material gross weights add for the second time, decoct 2h, 8 times of water gagings by 7 flavor medical material gross weights add for the third time, decoct 1h, filter merging filtrate, be evaporated to 50 ℃ of relative densities and be 1.32 thick paste, drying is pulverized, and gets water extract;
(3) form proportioning by crude drug and get Benzoinum 12.0g, Fel Ursi powder 6.6g, 120 mesh sieves are crossed in 10 ℃ of-30 ℃ of pulverizing, get the medical material fine powder;
(4) the medical material fine powder that makes of the water extract that makes of the ethanol extraction that step (1) is made, step (2) and step (3) mixes, and promptly gets red imperial analgesic composition; According to common process, add conventional adjuvant, make granule, promptly.
The preparation of embodiment 3, red imperial analgesic composition drop pill
Ethanol extraction 48.5g, water extract 47.3g, medical material fine powder 19.6g;
Be prepared as follows and form:
Step (1)-(3) are with embodiment 1;
(4) the medical material fine powder that makes of the water extract that makes of the ethanol extraction that step (1) is made, step (2) and step (3) mixes, and promptly gets red imperial analgesic composition; According to common process, add conventional adjuvant, make drop pill, promptly.
The preparation of embodiment 4, red imperial analgesic composition concentrated pill
Ethanol extraction 45.6g, water extract 46.2g, medical material fine powder 18.8g;
Be prepared as follows and form:
Step (1)-(3) are with embodiment 2;
(4) the medical material fine powder that makes of the water extract that makes of the ethanol extraction that step (1) is made, step (2) and step (3) mixes, and promptly gets red imperial analgesic composition; According to common process, add conventional adjuvant, make concentrated pill, promptly.
The preparation of embodiment 5, red imperial analgesic composition tablet
Ethanol extraction 48.7g, water extract 45.8g, medical material fine powder 19.6g;
Be prepared as follows and form:
(1) gets Indian Herba Swertiae bimaculatae 67.0g, Flos Carthami 67.0g, Chrysosplenium nudicaule Bunge 14.0g, west szechwan pyrethrum 67.0g, Tangut Przewalskia 13.5g, Herpetospermum caudigerum Wall. 13.5g totally 6 flavor medical materials mixing, the alcoholic solution reflux, extract, of adding volumetric concentration 80% 2 times, the amount that add the first time is 10 times of 6 flavor medical material gross weights, extract 3h, the amount that add the second time is 8 times of 6 flavor medical material gross weights, extract 2h, filter, merge medicinal liquid and get ethanol extraction liquid, be evaporated to 50 ℃ of relative densities and be 1.31 thick paste, drying is pulverized, and gets ethanol extraction;
(2) get Radix aconiti szechenyiani 14.0g, Tangut aconite 67.0g, Concha Margaritifera 35.0g, Os Draconis 112.0g, sinter 13.5g mixing, 10 times of amounts by 5 flavor medical material gross weights decoct with water extraction 3h, add Parmelia saxatilis Ach. 13.5g, Lagotis brachystachya Maxim. 67.0g again, and add 8 times of water gagings of Parmelia saxatilis Ach., Lagotis brachystachya Maxim. 2 flavor medical material gross weights, decoct again and extract 2 times, decoct for the first time 3h, 8 times of water gagings by 7 flavor medical material gross weights add for the second time, decoct 2h, filter merging filtrate, be evaporated to 50 ℃ of relative densities and be 1.32 thick paste, drying is pulverized, and gets water extract;
(3) form proportioning by crude drug and get Benzoinum 13.0g, Fel Ursi powder 5.6g, 120 mesh sieves are crossed in 10 ℃ of-30 ℃ of pulverizing, get the medical material fine powder;
(4) the medical material fine powder that makes of the water extract that makes of the ethanol extraction that step (1) is made, step (2) and step (3) mixes, and promptly gets red imperial analgesic composition; According to common process, add conventional adjuvant, make tablet, promptly.
The preparation of embodiment 6, a kind of red imperial analgesic composition gel
Ethanol extraction 46.7g, water extract 45.8g, medical material fine powder 18.6g;
Be prepared as follows and form:
Step (1)-(3) are with embodiment 5;
(4) the medical material fine powder that makes of the water extract that makes of the ethanol extraction that step (1) is made, step (2) and step (3) mixes, and promptly gets red imperial analgesic composition; According to common process, add conventional adjuvant, make gel, promptly.
Following experimental example is used to further specify but is not limited to the present invention.Employed red imperial analgesic composition is the red imperial analgesic composition with the inventive method embodiment 1 preparation in the experimental example.
Experimental example 1, the experiment of ethanol extraction technical study
One, different screenings of extracting solvent
Take by weighing Indian Herba Swertiae bimaculatae 20.1g, Flos Carthami 20.1g, Chrysosplenium nudicaule Bunge 4.2g, west szechwan pyrethrum 20.1g, Tangut Przewalskia 4.05g, Herpetospermum caudigerum Wall. 4.05g totally 6 flavor medical materials amount to 72.6g, mix and to put in the 1000mL round-bottomed flask, get 4 parts altogether and do following technology:
Technology one (water): add 8 times of water gaging reflux, extract, 2 times, each 2h filters, and filtrate is concentrated into about 100g, claims to decide weight, takes by weighing the concentrated solution that is equivalent to the 5g medical material approximately, measures dried cream, and the remaining liq drying is measured swertiamarin content, calculates total extracted amount.
Technology two (volumetric concentration 40% ethanol): add 8 times of amount 40% alcohol reflux 2 times, each 2h filters, and filtrate is concentrated into about 100g, claim to decide weight, take by weighing the concentrated solution that is equivalent to the 5g medical material approximately, measure dried cream, the remaining liq drying is measured swertiamarin content, calculates total extracted amount.
Technology three (volumetric concentration 75% ethanol): add 8 times of amount 75% alcohol reflux 2 times, each 2h filters, and filtrate is concentrated into about 100g, claim to decide weight, take by weighing the concentrated solution that is equivalent to the 5g medical material approximately, measure dried cream, the remaining liq drying is measured swertiamarin content, calculates total extracted amount.
Technology four (volumetric concentration 90% ethanol): add 8 times of amount 90% reflux, extract, 2 times, each 2h filters, and filtrate is concentrated into about 100g, claim to decide weight, take by weighing the concentrated solution that is equivalent to the 5g medical material approximately, measure dried cream, the remaining liq drying is measured swertiamarin content, calculates total extracted amount.The results are shown in Table 1.
Table 1 is different to extract solvent swertiamarin extracted amount relatively
Annotate: swertiamarin content in the Indian Herba Swertiae bimaculatae medical material: 0.70%.
Conclusion: above-mentioned experimental result shows, use water extraction, swertiamarin content is lower, select 40% ethanol extraction for use, swertiamarin content is high slightly, and 75% ethanol and 90% ethanol swertiamarin content are higher, difference is less, for guaranteeing that effective ingredient can extract to greatest extent in the medicine, also can save production cost simultaneously, preferably adopt volumetric concentration 75% ethanol to extract.
Two, the preferred alcohol adding amount of orthogonal test, extraction time and extraction time
Adopt orthogonal experiment, selected alcohol adding amount, extraction time and extraction time are respectively got three levels as three factors investigating, and design sees the following form 2:
Table 2 factor level table
* annotate: the extraction time in the laboratory is to determine that by extraction time extraction time carries out from front to back successively.
Take by weighing Indian Herba Swertiae bimaculatae 20.1g, Flos Carthami 20.1g, Chrysosplenium nudicaule Bunge 4.2g, west szechwan pyrethrum 20.1g, Tangut Przewalskia 4.05g, Herpetospermum caudigerum Wall. 4.05g totally 6 the flavor medical materials amount to 72.6g, mix and put in the 1000mL round-bottomed flask, get 9 parts altogether, advance process test research, result such as following table 3 by the orthogonal table order:
Table 3 L9(3
4) Orthogonal Experiment and Design table and result
As can be seen from the above table, each factor effect primary and secondary is A〉C 〉 B, optimal processing parameter are A
2B
2C
2Take to measure volumetric concentration 75% alcohol reflux 2 times, extract 2h at every turn with 8 times.
Demonstration test
Adopt the technology that preferably obtains (to add 8 times of amounts of water, extract 2 times, each 2h), take by weighing medical material Indian Herba Swertiae bimaculatae 100.5g, Flos Carthami 100.5g, Chrysosplenium nudicaule Bunge 21g, west szechwan pyrethrum 100.5g, Tangut Przewalskia 20.25g, Herpetospermum caudigerum Wall. 20.25g by formulation ratio, amounting to 363g puts in the flask, repeat said extracted technology, the results are shown in following table 4.
Table 4 quadrature demonstration test result
Conclusion: checking result and orthogonal test basically identical, the extraction process conditional stability is described, feasible.
Experimental example 2, water extraction process research experiment
Adopt orthogonal test to extraction time, amount of water and extraction temperature three factors as investigation, respectively get three levels, design sees the following form 5:
Table 5 decocting boils the orthogonal test table design
* annotate: amount of water in the laboratory and extraction time all are to determine that by extraction time amount of water and extraction time carry out from front to back successively.
Test method
Take by weighing Radix aconiti szechenyiani 2.8g, Tangut aconite 13.4g, Concha Margaritifera 13.4g, Os Draconis 22.4g, sinter 2.7g, Parmelia saxatilis Ach. 2.7g, Lagotis brachystachya Maxim. 13.4g 7 flavor medical materials, every part amounts to 64.4g, takes by weighing 9 parts altogether, decocts with water by the orthogonal table order, extracting solution filters, concentrating under reduced pressure also is settled in the 100ml measuring bottle, and precision is measured 25ml liquid, with water saturated n-butanol extraction 2 times, each 25ml, merge n-butyl alcohol liquid, be dried to constant weight, calculate the n-butanol extraction amount.Result such as following table 6:
Table 6 Orthogonal Experiment and Design table and result
Interpretation of result
Analyzed as can be known by orthogonal experiments extreme difference R: each factor effect primary and secondary is A〉C 〉 B, under the condition of setting, extraction time has the greatest impact to extraction, and extraction time is a principal element, should select optimal level C2, extraction time C2, C3 difference is less, considers to select C from energy savings
2Extraction time, the influence factor was less, so select B
2In sum.The optimum extraction process of determining adds 10 times of water gagings for the first time for decocting with water 2 times, decocts 3h, for the second time, adds 8 times of water gagings, decocts 2h.
Demonstration test
Adopt the technology that preferably obtains (to add 10 times of water gagings for the first time, decoct 3h, add for the second time 8 times of water gagings, decoct 2h), take by weighing by formulation ratio and to get Radix aconiti szechenyiani 14.0g, Tangut aconite 67.0g, Concha Margaritifera 35.0g, Os Draconis 112.0g, sinter 13.5g, Parmelia saxatilis Ach. 13.5g, Lagotis brachystachya Maxim. 67.0g, amount to 322g and put in the flask, repeat said extracted technology, the results are shown in following table 7.
Table 7 quadrature demonstration test result
Conclusion: checking result and orthogonal test basically identical illustrate that the extraction process condition is basicly stable.
Experimental example 3, different decocting time are to the influence of toxic component
The Radix aconiti szechenyiani medical material contains the aconitine toxic component, aconitine can be destroyed through long decoction, the influence of different decocting times to aconitine content investigated in this test, get Radix aconiti szechenyiani 50g, put in the 1000ml round-bottomed flask, add the 500ml decocting and boil, decoct 6h continuously, begin the 25ml that takes a sample from 2h, adding 25ml water then, later every 1h sampling once.Measure aconitine content, met and see Table 8.
The different decocting times of table 8 are to the influence of aconitine content
Conclusion: above data show, the content of aconitine are along with the increase of decocting time, and its content reduces gradually, illustrate that the destructiveness of the long more aconitine of decocting time is big more, and its toxicity is also more little.In view of the foregoing, when decocting, the Radix aconiti szechenyiani medical material is decocted with water 2 ~ 3h earlier, merge the back with all the other medical materials again and continue to decoct.
Experimental example 4, hot-plate analgesic test
1, trial drug and material
SPF level Kunming mouse, female, body weight 18-22g, Shandong University's Experimental Animal Center provides, the quality certification number: scxk (Shandong) 20090001.Thermostat water bath, stainless steel cask, stopwatch.Positive drug: ZHENGTIAN WAN, China Resources Sanjiu Medical ﹠ Pharmaceutical Co., Ltd., lot number: 1109007H.Be subjected to reagent: red dragon analgesia sheet group, (the Qinghai gold is scolded Tibetan medicine Pharmaceutical limited company, lot number: 20110521), test group gives embodiment 1 gained red imperial analgesic composition to give red dragon analgesia sheet.
2, test method
Get body weight 20 ± 2g female mice, licking foot with mice is threshold of pain index, adopts 55 ± 0.5 ℃ of hot plates that the mice pain threshold is screened, and pain threshold is given it up less than 5s or greater than 30s person.Pain threshold mice in 5-30s is divided into 4 groups at random, 10 every group, totally 40, is respectively blank group, positive drug group (ZHENGTIAN WAN group), red dragon analgesia sheet group, test group.Gastric infusion 0.3g crude drug/kg body weight is equivalent to 10 times of clinical people's consumptions, successive administration 5 days, the pain threshold of mensuration mice behind each administration 30min.
Data result with
Expression adopts SPSS17.0 software that data are carried out one factor analysis of variance and LSD organizes comparative analysis in twos more.
3, result of the test see Table 9, table 10.
Table 9 be subjected to the reagent product to the mice hot plate cause the pain influence (
N=10)
Table 10 be subjected to the reagent product to the mice hot plate cause the pain influence (
N=10)
Annotate: * compares with the blank group, P＜0.05; # compares with the positive drug group, P＜0.05
Table 9, table 10 result show: compare red dragon analgesia sheet group, test group mice hot plate response latency significant prolongation with the blank group.Compare administration the 1st day, test group mice hot plate response latency significant prolongation (P＜0.05) with the positive drug group.
Conclusion: reaction has the obvious suppression effect to the mice thermostimulation pain sensation to point out red dragon analgesia sheet, the red imperial analgesic composition of embodiment 1 gained, and the red imperial analgesic composition of embodiment 1 gained is effective to the redder dragon analgesia of maincenter analgesic activity sheet.
Experimental example 5, acetic acid twisting method analgesic test
1, trial drug and material
SPF level Kunming mouse, the male and female dual-purpose, body weight 18-22g, Shandong University's Experimental Animal Center provides, the quality certification number: scxk (Shandong) 20090001.20110715), syringe, stopwatch 0.6% acetic acid (Tianjin Kermel Chemical Reagent Co., Ltd., product batch number:.Positive drug: ZHENGTIAN WAN, China Resources Sanjiu Medical ﹠ Pharmaceutical Co., Ltd., lot number: 1109007H.Be subjected to reagent: red dragon analgesia sheet group, (the Qinghai gold is scolded Tibetan medicine Pharmaceutical limited company, lot number: 20110521), test group gives embodiment 1 gained red imperial analgesic composition to give red dragon analgesia sheet.
2, test method
Get body weight 20 ± 2g mice, be divided into 4 groups at random, 10 every group, be respectively blank group, positive drug group (ZHENGTIAN WAN group), red dragon analgesia sheet group, test group.Gastric infusion 0.3g crude drug/kg body weight is equivalent to 10 times of clinical people's consumptions, and continuously gastric infusion is 5 days, and last gastric infusion 30min pneumoretroperitoneum is injected 0.6% acetum, and every 0.2ml can measure in incubation period of mouse writhing reaction and the 15min and turn round the body number of times.
Data result with
Expression adopts SPSS17.0 software that data are carried out one factor analysis of variance and LSD organizes comparative analysis in twos more.
3, result of the test sees Table 11.
Table 11 Dichlorodiphenyl Acetate cause mouse writhing reaction influence (
N=10)
Annotate: * compares with the blank group, P＜0.05; * compares with the blank group, P＜0.01
Turn round body analgesia rate=(the blank group is on average turned round body number of times-administration group and on average turned round the body number of times)/blank group and on average turn round body number of times * 100%
Table 11 result shows: compare with the blank group, positive drug and red dragon analgesia sheet group, test group acetic acid cause mice and turn round the body number of times in 15 minutes and significantly reduce, and significant difference (p＜0.01) is all arranged; And compare with the blank group, each organizes the mouse writhing response latency prolongation trend, but no difference of science of statistics (P〉0.05).
Conclusion: red dragon analgesia sheet, the red imperial analgesic composition Dichlorodiphenyl Acetate of embodiment 1 gained cause the mouse writhing reaction and have the obvious suppression effect, and the redder dragon analgesia of the periphery analgesic activity of embodiment 1 novel formulation sheet is good.
Experimental example 6, antiinflammatory test
1, trial drug and material
SPF level Male Kunming strain mice, body weight 18-22g, Shandong University's Experimental Animal Center provides, the quality certification number: scxk (Shandong) 20090001.Dimethylbenzene (Tianjin extensively becomes chemical reagent company limited lot number: 20110502), the 0.25mL syringe, and diameter 9 ㎜ card punch.Positive drug: ZHENGTIAN WAN, China Resources Sanjiu Medical ﹠ Pharmaceutical Co., Ltd., lot number: 1109007H.Be subjected to reagent: red dragon analgesia sheet group, (the Qinghai gold is scolded Tibetan medicine Pharmaceutical limited company, lot number: 20110521), test group gives embodiment 1 gained red imperial analgesic composition to give red dragon analgesia sheet.
2, test method
Get 48 of male mices, body weight 20 ± 2g is divided into 4 groups at random, 12 every group, is respectively blank group, positive drug group (ZHENGTIAN WAN group), red dragon analgesia sheet group, test group.Gastric infusion 0.3g crude drug/kg body weight is equivalent to 10 times of clinical people's consumptions, successive administration 5 days, and after the last administration 30 minutes, pure dimethylbenzene was smeared on the two sides before and after the mouse right ear, and 0.02ml/ is only.Behind the 4h mice is taken off cervical vertebra and put to death, cut ears and lay round auricle at same position respectively, weigh with 9mm diameter card punch.Calculate the swelling rate.Swelling rate=(auris dextra sheet weight-left auricle weight)/auris dextra weight.Inhibitory rate of intumesce=(the average swelling rate of the blank group-average swelling rate of administration the group)/average swelling rate of blank group * 100%
Data result with
Expression adopts SPSS17.0 software that data are carried out one factor analysis of variance and LSD organizes comparative analysis in twos more.
3, result of the test sees Table 12.
Table 12 xylol causes the influence of mice auricle swelling
Annotate: * compares with the blank group, P＜0.05; * compares with the blank group, P＜0.01.
Table 12 result shows: compare with the blank group, red dragon analgesia sheet group, embodiment 1 novel formulation group mice ear rate significantly reduce (P＜0.05, P＜0.01); The mice ear rate also reduces.
Conclusion: the red dragon analgesia of result of the test prompting sheet, the red imperial analgesic composition of embodiment 1 gained have certain antiinflammatory action, and the redder dragon analgesia of the antiinflammatory action of the red imperial analgesic composition of embodiment 1 gained sheet is effective.
Claims (6)
1. a red imperial analgesic composition is characterized in that, is made by the raw material of following weight portion:
Ethanol extraction 40-55 weight portion, water extract 40-55 weight portion, medical material fine powder 12-28 weight portion;
Described ethanol extraction makes as follows: get Indian Herba Swertiae bimaculatae 50-80 weight portion, Flos Carthami 50-80 weight portion, Chrysosplenium nudicaule Bunge 10-18 weight portion, west szechwan pyrethrum 50-80 weight portion, Tangut Przewalskia 9-18 weight portion, Herpetospermum caudigerum Wall. 9-18 weight portion totally 6 flavor medical materials mixes, the alcoholic solution reflux, extract, of adding volumetric concentration 50-90% 2-4 time, the alcoholic acid amount that at every turn adds volumetric concentration 50-90% is 6-14 a times of 6 flavor medical material gross weights, extract 1-5h, filter, merge medicinal liquid and get ethanol extraction liquid, the thick paste that to be evaporated to 50 ℃ of relative densities be 1.28-1.35, dry, pulverize, get ethanol extraction;
Described water extract makes as follows: get Radix aconiti szechenyiani 10-18 weight portion, Tangut aconite 50-80 weight portion, Concha Margaritifera 28-42 weight portion, Os Draconis 90-135 weight portion, sinter 9-18 weight portion mixes, doubly measure to decoct with water by the 6-14 of 5 flavor medical material gross weights and extract 1-3h, add Parmelia saxatilis Ach. 9-18 weight portion again, Lagotis brachystachya Maxim. 50-80 weight portion, and adding Parmelia saxatilis Ach., 6-14 times of water gaging of Lagotis brachystachya Maxim. 2 flavor medical material gross weights, decoct again and extract 2-4 time, decoct 2-4h, filter, merging filtrate, the thick paste that to be evaporated to 50 ℃ of relative densities be 1.28-1.35, drying is pulverized, and gets water extract;
Described medical material fine powder makes as follows: get Benzoinum 9-18 weight portion, Fel Ursi powder 3-10 weight portion 2 flavor medical materials, the 80-200 mesh sieve is crossed in 10 ℃ of-30 ℃ of pulverizing, gets the medical material fine powder.
2. a kind of red imperial analgesic composition as claimed in claim 1 is characterized in that, is made by following raw material:
Ethanol extraction 48.5g, water extract 47.3g, medical material fine powder 19.6g;
Described ethanol extraction makes as follows: get Indian Herba Swertiae bimaculatae 67.0g, Flos Carthami 67.0g, Chrysosplenium nudicaule Bunge 14.0g, west szechwan pyrethrum 67.0g, Tangut Przewalskia 13.5g, Herpetospermum caudigerum Wall. 13.5g totally 6 flavor medical materials mixing, the alcoholic solution reflux, extract, of adding volumetric concentration 75% 2 times, the alcoholic acid amount that at every turn adds volumetric concentration 75% is 8 times of 6 flavor medical material gross weights, extract 3h, filter, merge medicinal liquid and get ethanol extraction liquid, be evaporated to 50 ℃ of relative densities and be 1.33 thick paste, dry, pulverize, get ethanol extraction;
Described water extract makes as follows: get Radix aconiti szechenyiani 14.0g, Tangut aconite 67.0g, Concha Margaritifera 35.0g, Os Draconis 112.0g, sinter 13.5g mixes, 10 times of amounts by 5 flavor medical material gross weights decoct with water extraction 2h, add Parmelia saxatilis Ach. 13.5g again, Lagotis brachystachya Maxim. 67.0g, and adding Parmelia saxatilis Ach., 10 times of water gagings of Lagotis brachystachya Maxim. 2 flavor medical material gross weights, decoct again and extract 2 times, decoct for the first time 3h, 8 times of water gagings by 7 flavor medical material gross weights add for the second time, decoct 2h, filter merging filtrate, be evaporated to 50 ℃ of relative densities and be 1.33 thick paste, drying is pulverized, and gets water extract;
Described medical material fine powder makes as follows: get Benzoinum 13.0g, Fel Ursi powder 6.6g, 120 mesh sieves are crossed in 10 ℃ of-30 ℃ of pulverizing, get the medical material fine powder.
3. claim 1 or 2 described a kind of red imperial analgesic compositions is characterized in that, add conventional adjuvant, are prepared into pharmaceutically acceptable any dosage form according to common process.
4. the preparation method of a kind of red imperial analgesic composition as claimed in claim 1 is characterized in that, step is as follows:
(1) gets the totally 6 flavor medical materials mixing of Indian Herba Swertiae bimaculatae 50-80 weight portion, Flos Carthami 50-80 weight portion, Chrysosplenium nudicaule Bunge 10-18 weight portion, west szechwan pyrethrum 50-80 weight portion, Tangut Przewalskia 9-18 weight portion, Herpetospermum caudigerum Wall. 9-18 weight portion, the alcoholic solution reflux, extract, of adding volumetric concentration 50-90% 2-4 time, the alcoholic acid amount that at every turn adds volumetric concentration 50-90% is 6-14 a times of 6 flavor medical material gross weights, extract 1-5h, filter, merge medicinal liquid and get ethanol extraction liquid, the thick paste that to be evaporated to 50 ℃ of relative densities be 1.28-1.35, dry, pulverize, get ethanol extraction;
(2) get Radix aconiti szechenyiani 10-18 weight portion, Tangut aconite 50-80 weight portion, Concha Margaritifera 28-42 weight portion, Os Draconis 90-135 weight portion, the mixing of sinter 9-18 weight portion, doubly measure to decoct with water by the 6-14 of 5 flavor medical material gross weights and extract 1-3h, add Parmelia saxatilis Ach. 9-18 weight portion, Lagotis brachystachya Maxim. 50-80 weight portion again, and add 6-14 times of water gaging of Parmelia saxatilis Ach., Lagotis brachystachya Maxim. 2 flavor medical material gross weights, decoct again and extract 2-4 time, decoct 2-4h, filter, merging filtrate, the thick paste that to be evaporated to 50 ℃ of relative densities be 1.28-1.35, drying is pulverized, and gets water extract;
(3) get Benzoinum 9-18 weight portion, Fel Ursi powder 3-10 weight portion 2 flavor medical materials, the 80-200 sieve is crossed in 10 ℃ of-30 ℃ of pulverizing, gets the medical material fine powder;
(4) the medical material fine powder that makes of the water extract that makes of the ethanol extraction that step (1) is made, step (2) and step (3) mixes, and promptly gets red imperial analgesic composition.
5. the preparation method of a kind of red imperial analgesic composition as claimed in claim 2 is characterized in that, step is as follows:
(1) gets Indian Herba Swertiae bimaculatae 67.0g, Flos Carthami 67.0g, Chrysosplenium nudicaule Bunge 14.0g, west szechwan pyrethrum 67.0g, Tangut Przewalskia 13.5g, Herpetospermum caudigerum Wall. 13.5g totally 6 flavor medical materials mixing, the alcoholic solution reflux, extract, of adding volumetric concentration 75% 2 times, the alcoholic acid amount that at every turn adds volumetric concentration 50-90% is 8 times of 6 flavor medical material gross weights, extract 3h, filter, merge medicinal liquid and get ethanol extraction liquid, be evaporated to 50 ℃ of relative densities and be 1.33 thick paste, drying is pulverized, and gets ethanol extraction;
(2) get Radix aconiti szechenyiani 14.0g, Tangut aconite 67.0g, Concha Margaritifera 35.0g, Os Draconis 112.0g, sinter 13.5g mixing, 10 times of amounts by 5 flavor medical material gross weights decoct with water extraction 2h, add Parmelia saxatilis Ach. 13.5g, Lagotis brachystachya Maxim. 67.0g again, and add 10 times of water gagings of Parmelia saxatilis Ach., Lagotis brachystachya Maxim. 2 flavor medical material gross weights, decoct again and extract 2 times, decoct for the first time 3h, 8 times of water gagings by 7 flavor medical material gross weights add for the second time, decoct 2h, filter merging filtrate, be evaporated to 50 ℃ of relative densities and be 1.33 thick paste, drying is pulverized, and gets water extract;
(3) get Benzoinum 13.0g, Fel Ursi powder 6.6g, 120 mesh sieves are crossed in 10 ℃ of-30 ℃ of pulverizing, get the medical material fine powder;
(4) the medical material fine powder that makes of the water extract that makes of the ethanol extraction that step (1) is made, step (2) and step (3) mixes, and promptly gets red imperial analgesic composition.
6. the application of a kind of red imperial analgesic composition as claimed in claim 1 or 2 in the medicine of preparation treatment migraine, angioneurotic headache.
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