CN102961437A - Pharmaceutical composition containing sophora alopecuroide oil and preparation method thereof - Google Patents

Pharmaceutical composition containing sophora alopecuroide oil and preparation method thereof Download PDF

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CN102961437A
CN102961437A CN2012104772774A CN201210477277A CN102961437A CN 102961437 A CN102961437 A CN 102961437A CN 2012104772774 A CN2012104772774 A CN 2012104772774A CN 201210477277 A CN201210477277 A CN 201210477277A CN 102961437 A CN102961437 A CN 102961437A
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oil
pharmaceutical composition
herba sophorae
sophorae alopecuroidis
sophora
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程先锋
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SUZHOU E-FAN PHARMACEUTICAL CO., LTD.
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XINJIANG XIWANG PHARMACEUTICAL CO Ltd
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Abstract

The invention relates to a pharmaceutical composition containing sophora alopecuroide oil and a preparation method thereof. The pharmaceutical composition provided by the invention is prepared from sophora alopecuroide and sophocarpidine which are used as raw materials. The preparation method of the pharmaceutical composition comprises the following steps of: performing destructive distillation on the sophora alopecuroide to obtain destructive distillation oil; mixing the sophocarpidine with the destructive distillation oil; adding polysorbate-80 into the mixture, stirring evenly, and then adding osmanthus flower fragrance, ethanol and a proper amount of water into the mixture, and then grinding the mixture through a colloid mill. The sophora-alopecuroide pharmaceutical composition provided by the invention has certain curative effects of detumescence, proliferation inhibition and the like on acute eczema, and is superior to the conventional sophora alopecuroide oil linimentum in anti-pruritus effect; the sophora-alopecuroide pharmaceutical composition also has certain curative effects of detumescence, proliferation inhibition and the like on chronic eczema; and besides, the sophora-alopecuroide pharmaceutical composition has certain antiphlogosis and skin tissue repair effects on dermatitis induced by the chronic eczema, and is superior to the sophora alopecuroide oil linimentum in curative effect.

Description

A kind of pharmaceutical composition that contains sophora alopecuroide oil and preparation method thereof
Technical field
The present invention relates to a kind of compound Chinese medicinal preparation, particularly relate to Chinese medicinal liniment of a kind of external preparation for skin medicine and preparation method thereof.
Background technology
The problems such as the medicine of the various common skin diseases of existing treatment all has poor effect on the market, and side effect is large.The sophora alopecuroide oil liniment is to adopt Xinjiang distinctive medium-height grass stype inferior (Herba Sophorae alopecuroidis) for feed purification forms, and Farsi " buy and close Zha Nuliadiwaya (medicine is complete works of) " and " Uygur medicine medicinal herbs most in use " all have the record of Herba Sophorae alopecuroidis treatment multiple dermatosis in ancient times.Modern medicine proves the dry seed of natural Herba Sophorae alopecuroidis, and the empyreumatic oil that obtains after dry distilling contains more than 10 and plants alkaloid, has antiinflammatory, anticancer and immunosuppressive action.The sophora alopecuroide oil liniment is that main dermatosis curative effect affirms that side effect is little to multiple epidermal hyperplasia.
Liu Jun etc. 1.Studies show that the contained alkaloidal pharmacological action of Herba Sophorae alopecuroidis is as follows
1. the central nervous system is acted on.Total alkaloid of sophora alopecuroide and monosomic alkali have certain inhibitory action to the laboratory animal maincenter, are embodied in calmness, analgesia and cooling etc.
2. to Cardiovascular System.Show as arrhythmia, to the protective effect of myocardial ischemia and myocardial infarction, decompressing effect.
3. antitumor action.
4. antiinflammatory and immunosuppressive action.
5. other pharmacological actions: antitussive and antiasthmatic, anticancer change protects the liver.
For the pharmacological action of above Herba Sophorae alopecuroidis, Development and Production goes out in the market: gram rushes down the medicines such as clever sheet, anti-inflammatory suppository for gynecopathy, Matrine Injection.The sophora alopecuroide oil liniment is according to the contained alkaloidal calmness of Herba Sophorae alopecuroidis, analgesia, protection blood vessel, antiinflammatory, a kind of preparation for external application to skin of the effect such as immunosuppressant research and development.The sophora alopecuroide oil liniment matter that can purify the blood is removed alkaline phlegmatic temperament, the detoxifcation heat clearing away, and killing parasites for relieving itching is used for the treatment of the damp and hot dermatitis caused diseases such as skin pruritus that cause of reason such as skin of accumulateing, such as eczema, chronic dermatitis, superficial skin fungus infection, psoriasis etc.Have evident in efficacy, the advantage such as untoward reaction is few and slight.
There is the correlational study of sophora alopecuroide oil liniment curative effect as follows, Gu Kefeng 2.Collect patients with chronic eczema 100 people, divide at random two groups, every group of 50 people, take the sophora alopecuroide oil liniment as treatment group, 17-hydroxy-11-dehydrocorticosterone hydrocortisone butyrate ointment (hydrocortisone butyrate) is matched group, treatment chronic eczema effect is carried out clinical observation, the result shows, use the cure rate of sophora alopecuroide oil liniment 2-4 after week and reach 59.2%, total effective rate is 81.6%, total effective rate is close with the matched group hydrocortisone butyrate, two groups of curative effects are without notable statistics difference (p<0.05), follow up a case by regular visits to demonstration after 3 months, the relapse rate of sophora alopecuroide oil liniment is starkly lower than hydrocortisone butyrate, and it is antipruritic to show that the sophora alopecuroide oil liniment has, antibiotic, the effects such as horny layer softening, treatment is with plumpness, the lichen sample becomes, it is the main intractables such as chronic eczema that play is itched, limitation dermatosis therapeutic effect is remarkable, and the recurrence that can avoid hormone therapy to exist, pigmentation, the shortcomings such as atrophoderma and the easy concurrent infection of prolonged application, curative effect tool clear superiority.
Matrine is alkaloidal Main Ingredients and Appearance in the cassia leguminous plants such as Radix Sophorae Flavescentis, root of subprostrate sophora.To in the matrine a large amount of pharmacology and clinical research, find that it has antiviral, antiinflammatory, antitumor action in recent years, the central nervous system is had the multiple pharmacological effect such as calmness, Antipyretic cooling effect and heart tonifying, blood pressure lowering, anti-arrhythmia.
Summary of the invention:
The purpose of this invention is to provide a kind of new pharmaceutical composition that contains sophora alopecuroide oil, to strengthen the curative effect of the various common skin diseases such as existing bean or pea oil liniment treated skin pruritus, hypertrophy.The present invention also provides the preparation method of this pharmaceutical composition.
For achieving the above object, a kind of sophora alopecuroide oil pharmaceutical composition provided by the invention, it is to make take Herba Sophorae alopecuroidis and matrine as crude drug.Preferably, the weight ratio of described Herba Sophorae alopecuroidis and matrine is 2000~3500: 0.5~5.More preferably, the weight ratio of described Herba Sophorae alopecuroidis and Radix Sophorae Flavescentis is 2800~3000: 1~3.
Particularly, pharmaceutical composition of the present invention is compound recipe sophora alopecuroide oil liniment, and it is made by following raw material: Herba Sophorae alopecuroidis 2000~3500g, matrine 0.5~5g, ethanol 100~500ml, Tween-80 50~70ml, osmanthus flower fragrance 20~30ml, purified water is an amount of, and the Herba Sophorae alopecuroidis dry distilling is got empyreumatic oil, and matrine and empyreumatic oil are mixed, add Tween-80, stir, add osmanthus flower fragrance, second alcohol and water to 1000ml, cross the colloid mill grinding and make.
The present invention also provides the preparation method of preparation aforementioned pharmaceutical compositions to be about to the Herba Sophorae alopecuroidis dry distilling and gets empyreumatic oil, and matrine and empyreumatic oil are mixed, and adds Tween-80, stirs, and adds osmanthus flower fragrance, ethanol and suitable quantity of water, crosses colloid mill and grinds and get final product.
Wherein, the method for described Herba Sophorae alopecuroidis empyreumatic oil is: take by weighing and select clean Herba Sophorae alopecuroidis oven dry, the Herba Sophorae alopecuroidis empyreumatic oil is collected in dry distilling more than 180 ℃.
Experiment shows, compound recipe sophora alopecuroide oil liniment of the present invention, the common sophora alopecuroide oil liniment than existing market, treatment skin pruritus, hyperkeratosis, the symptom dermatosiss such as lichenification, especially for acute and chronic eczema, dermatitis, have more antipruritic going and swell soon, antiinflammatory is effective, and zest is little, the characteristics such as few side effects.
The specific embodiment
Following examples further specify content of the present invention, but should not be construed as limitation of the present invention.Without departing from the spirit and substance of the case in the present invention, modification or replacement to the inventive method, step or condition are done all belong to scope of the present invention.
If do not specialize, the conventional means that used technological means is well known to those skilled in the art among the embodiment.
Embodiment 1
Prescription: Herba Sophorae alopecuroidis 2800g; Matrine 2g; Poly-Pyrusussuriensis fat 80 60ml; Ethanol 100ml osmanthus flower fragrance 25ml; Water adds to 1000ml.
Preparation method: the Herba Sophorae alopecuroidis of getting after the oven dry is inserted in the retort high-temperature retorting.Temperature to 180 degree is incubated 1 hour, collects the about 400ml of empyreumatic oil.Add matrine 2g, polyoxyethylene sorbitan monoleate 60ml after stirring, adds osmanthus flower fragrance 25ml, ethanol 100ml, adds water and is adjusted to 1000ml.Cross colloid mill and grind, and get final product.
Embodiment 2
Prescription: Herba Sophorae alopecuroidis 3000g; Matrine 1g; Poly-Pyrusussuriensis fat 80 50ml; Ethanol 200ml; Osmanthus flower fragrance 30ml; Water adds to 1000ml.
Preparation method: the Herba Sophorae alopecuroidis of getting after the oven dry is inserted in the retort high-temperature retorting.Collect the about 480ml of empyreumatic oil.Add matrine 1g, polyoxyethylene sorbitan monoleate 50ml after stirring, adds osmanthus flower fragrance 30ml, ethanol 200ml, adds water and is adjusted to 1000ml.Cross colloid mill and grind, and get final product.
Embodiment 3
Prescription: Herba Sophorae alopecuroidis 3500g, matrine 1.5g, ethanol 100ml, Tween-80 70ml, osmanthus flower fragrance 20ml, water adds to 1000ml.
Preparation method: the Herba Sophorae alopecuroidis of getting after the oven dry is inserted in the retort high-temperature retorting.Collect the about 560ml of empyreumatic oil.Add matrine 1.5g, polyoxyethylene sorbitan monoleate 70ml after stirring, adds osmanthus flower fragrance 20ml, ethanol 100ml, adds water and is adjusted to 1000ml.Cross colloid mill and grind, and get final product.
Embodiment 4
Prescription: Herba Sophorae alopecuroidis 3500g, matrine 3g, ethanol 100ml, Tween-80 70ml, osmanthus flower fragrance 20ml, water adds to 1000ml.
Preparation method: the Herba Sophorae alopecuroidis of getting after the oven dry is inserted in the retort high-temperature retorting.Collect the about 560ml of empyreumatic oil.Add matrine 5g, polyoxyethylene sorbitan monoleate 70ml after stirring, adds osmanthus flower fragrance 20ml, ethanol 100ml, adds water and is adjusted to 1000ml.Cross colloid mill and grind, and get final product.
Embodiment 5
Prescription: Herba Sophorae alopecuroidis 2000g, matrine 5g, ethanol 400ml, Tween-80 70ml, osmanthus flower fragrance 20ml, water adds to 1000ml.
Preparation method: the Herba Sophorae alopecuroidis of getting after the oven dry is inserted in the retort high-temperature retorting.Collect the about 160ml of empyreumatic oil.Add matrine 5g, polyoxyethylene sorbitan monoleate 50ml after stirring, adds osmanthus flower fragrance 20ml, ethanol 400ml, adds water and is adjusted to 1000ml.Cross colloid mill and grind, and get final product.
Embodiment 6
Prescription: Herba Sophorae alopecuroidis 2800g; Matrine 0.5g; Poly-Pyrusussuriensis fat 80 60ml; Ethanol 100ml; Osmanthus flower fragrance 25ml; Water adds to 1000ml.
Preparation method: the Herba Sophorae alopecuroidis of getting after the oven dry is inserted in the retort high-temperature retorting.Temperature to 180 degree is incubated 1 hour, collects the about 400ml of empyreumatic oil.Add matrine 2g, polyoxyethylene sorbitan monoleate 60ml after stirring, adds osmanthus flower fragrance 25ml, ethanol 100ml, adds water and is adjusted to 1000ml.Cross colloid mill and grind, and get final product.
Embodiment 7
Zoopery one:
Experimental agents: sophora alopecuroide oil liniment (Herba Sophorae alopecuroidis 2800g matrine 2g polyoxyethylene sorbitan monoleate 60ml ethanol 400ml osmanthus flower fragrance 25ml makes 1000ml), the present invention
Embodiment 1 compound recipe sophora alopecuroide oil liniment.
Laboratory animal: SPF level rat.
Experimental technique: get 30 of healthy rats, with 1%2,4-dinitrofluorobenzene acetone olive oil solution abdominal part sensitization, 1%2,4-dinitrofluorobenzene ear excites, and sets up acute allergic contact dermatitis model.Divide at random physiology saline group (A1 group), sophora alopecuroide oil liniment group (1 group of B), compound recipe sophora alopecuroide oil liniment group (C1 group), 10 every group, percutaneous dosing, three times on the one, administration 14 days.Method: measure two ear swelling thickness after 1.14 days, get its difference, 2. administration after three days, in 6:00 every day, 12:00,18:00,24:00 observed and recorded rat is added the precursor reactant number of times, each 2 minutes, get each group and, record data are a1, b1, c1.The results detailed in Table 1, table 2:
Table 1 acute eczema rat two ear swelling degree differences
Figure BSA00000809681600061
Figure BSA00000809681600071
Table 2 rat Licking response number of times experimental data
Figure BSA00000809681600072
By the above results as can be known:
1.C1 group ear swelling degree alleviates, and with A1 group comparing difference statistical significance (P0.05) is arranged, with B1 group comparing difference not statistically significant (P0.05).Show compound recipe sophora alopecuroide oil liniment, sophora alopecuroide oil liniment treated acute eczema all for curative effects such as certain detumescence, inhibition hypertrophy, and both curative effects are without significant difference.2. rat Licking response: b1/a1:44.2%, c1/a1:35.0%.Show that B1 group C1 group medicine all can reduce the rat Licking response, have certain antipruritic effect, and compound recipe sophora alopecuroide oil liniment itching-relieving action is better than the sophora alopecuroide oil liniment.
Zoopery two:
Get 30 of healthy rats, with 7%2,4-dinitrochlorobenzene acetone soln abdominal part sensitization, 0.3%2,4-dinitrochlorobenzene repeatedly ear excites, and sets up the chronic dermatitis Eczema Model, divides at random physiology saline group (A2 group), sophora alopecuroide oil liniment group (B2 group), compound recipe sophora alopecuroide oil liniment group (C2 group), 10 every group, three times on the one, percutaneous dosing, continuous 20 days.Rear observation chronic eczema mice skin lesion, ear swelling degree, the variation of number of inflammatory cells and histopathology form in the ear skin histology.The results detailed in Table 3:
Table 3 chronic eczema rat two ear swelling degree differences
Figure BSA00000809681600073
By the above results as can be known:
1.C2 group is compared the ear swelling degree and is alleviated more remarkable with A2 group, B2 group.Show that the effects such as the tool detumescence of compound recipe sophora alopecuroide oil liniment treated chronic eczema institute, inhibition hypertrophy are better than sophora alopecuroide oil liniment 2. histopathology forms and show, C2 group and B2 group all have clear improvement than the A2 group, and the inflammatory cell infiltration number minimizing degree of C2 group epidermis and corium and B2 group are compared more obvious, with A2 group comparing difference statistical significance (P0.05) are arranged.Show that compound recipe sophora alopecuroide oil liniment, sophora alopecuroide oil liniment have certain antiinflammatory and skin tissue recovering effect to chronic eczema is dermatitis caused, and compound recipe sophora alopecuroide oil liniment treated effect is better than the sophora alopecuroide oil liniment.The compound recipe sophora alopecuroide oil liniment that embodiment 2~6 makes has also been obtained similar effect.
List of references
(1) Liu Jun etc., Herba Sophorae alopecuroidis Recent Research (J), Xinjiang Chinese medicine, 2006,24 (6): 60-63.
(2) Gu Kefeng, sophora alopecuroide oil external curing eczema clinical observation (J), Chinese practical Chinese and western medicine magazine, 2008,21 (6): 493-494.

Claims (6)

1. pharmaceutical composition that contains sophora alopecuroide oil is characterized in that making take Herba Sophorae alopecuroidis and matrine as crude drug.
2. pharmaceutical composition according to claim 1, the weight ratio that it is characterized in that described Herba Sophorae alopecuroidis and matrine is 2000~3500: 0.5~5.
3. pharmaceutical composition according to claim 1, the weight ratio that it is characterized in that described Herba Sophorae alopecuroidis and matrine is 2800~3000: 1~3.
4. pharmaceutical composition according to claim 1 is characterized in that, is made by following raw material: Herba Sophorae alopecuroidis 2000~3500g, matrine 0.5~5g, ethanol 100~500ml, Tween-80 50~70ml, osmanthus flower fragrance 20~30ml, purified water is an amount of, and the Herba Sophorae alopecuroidis dry distilling is got empyreumatic oil, and matrine and empyreumatic oil are mixed, add Tween-80, stir, add osmanthus flower fragrance, second alcohol and water to 1000ml, cross the colloid mill grinding and make.
5. the preparation method of each described sophora alopecuroide oil pharmaceutical composition of claim 1~4: the Herba Sophorae alopecuroidis dry distilling is got empyreumatic oil, matrine and empyreumatic oil are mixed, add Tween-80, stir, add osmanthus flower fragrance, ethanol and suitable quantity of water, cross colloid mill and grind and get final product.
6. preparation method according to claim 5 is characterized in that, the method for described Herba Sophorae alopecuroidis empyreumatic oil is: take by weighing and select clean Herba Sophorae alopecuroidis oven dry, the Herba Sophorae alopecuroidis empyreumatic oil is collected in dry distilling more than 180 ℃.
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CN110885710A (en) * 2019-12-09 2020-03-17 杨振彪 Extraction device for sophora alopecuroide oil and use method thereof
CN111407770A (en) * 2020-05-25 2020-07-14 厦门大学 Composition for treating skin diseases and application thereof

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CN103285287A (en) * 2013-06-24 2013-09-11 新疆纳瓦依维吾尔医药开发有限公司 A combination drug for treating psoriasis and a preparation method thereof
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CN110885710A (en) * 2019-12-09 2020-03-17 杨振彪 Extraction device for sophora alopecuroide oil and use method thereof
CN111407770A (en) * 2020-05-25 2020-07-14 厦门大学 Composition for treating skin diseases and application thereof
CN111407770B (en) * 2020-05-25 2022-03-22 厦门大学 Composition for treating skin diseases and application thereof

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