CN101229224B - Chinese traditional medicine ointment preparation for curing vitligo and preparing method thereof - Google Patents
Chinese traditional medicine ointment preparation for curing vitligo and preparing method thereof Download PDFInfo
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Abstract
The invention relates to a Chinese medicine ointment preparation for external use and the preparation method thereof, in particular to a Chinese medicine ointment preparation for treating vitiligo andthe preparation method thereof. The Chinese medicine ointment preparation for treating vitiligo comprises extract with active component of Chinese medicine, auxiliary materials of ointment preparation, and adequate water; the extract with active component of Chinese medicine comprises psoralea fruit, angelica, and extract of pubescent angelica; wherein, every 1000g of Chinese medicine ointment preparation is extracted by the following weight of the psoralea fruit, the angelica, and the pubescent angelica: the psoralea fruit of 100 to 800g, the angelica of 100 to 600g, and the pubescent angelica of 100 to 600g. The Chinese medicine ointment preparation of the invention has significant content of effective components, excellent efficacy, and strong quality of safety. In addition, the invention discloses the preparation method of the Chinese medicine ointment preparation; the preparation method mainly adopts liquid extraction technique of supercritical CO2, the effective components in themedical materials are distilled (extracted) at relative low temperature, and the effective components are not destroyed.
Description
Technical field
The present invention relates to a kind of external traditional Chinese herb medicine preparation and preparation method thereof, relate in particular to leukodermic traditional Chinese herb medicine preparation of a kind of treatment and preparation method thereof.
Background technology
Vitiligo is one of difficult treatment, and sickness rate is about 1～2%, and the sickness rate of China is about 1%, and in rising trend, and sickness rate significantly increases in the flourishing densely populated areas of industry.This disease betides the skin exposure portion, influences attractive in appearancely, has a strong impact on patient's human communication and quality of life, brings great psychic trauma and psychic pain to the patient, therefore medicine that research treatment vitiligo is a new or method focus being field of medicaments.Leukodermic method of treatment and medicine mainly contain at present:
(1) western medicine and medical practitioners
A. photochemotherapy (also claiming PUVA), it is oral or photosensitizer such as external psoralen and cooperate long wave ultraviolet (or sunlight) irradiation, the course of treatment is long, general 12～18 months, but cure rate has only about 10%, part patient recurrence is arranged after stopping, and main medicine has Meladinine (methoxypsoralen), methoxsalen, khellin.
B.L-phenylalanine combined U VA compares with PVUA, and advantage is that skin increases the light toleration, can stop disease progression, but cure rate is also lower.
C. 17-hydroxy-11-dehydrocorticosterone is used, and mainly contains
Prednisone, to limitation, male, below 15 years old, the course of disease is better less than the patient's effect in 2 years.
Dexamethasone, low dose of flooding, the progressive stage state of an illness is stopped development certain effect, and the small number of patients pigment recovers to some extent.
Quiet of methylprednisolone can be used as progressive stage general property therapy for vitiligo, and side effect is more during the treatment.
D. melanocyte transplantation treatment expense makes us being difficult to accepting.
(2) for oral administration and the external combination or the combination of Chinese and Western medicine of Chinese medicine
The data of each family's report have big gap in the treatment by Chinese herbs vitiligo document, comprehensive relevant data and some AUTHORITATIVE DATA, and clinical cure rate is about 20%.
It is less to treat leukodermic Chinese patent medicine kind, mainly contains: white paralysed ball, vitiligo capsule, lose ball, Bailingding, Phaeolin injection, Methoxypsoralen pin, compound kaliziranding etc. in vain.
In addition, Chinese invention patent (application number is 03150215.6) discloses leukodermic medicine ' Baidianxiao ' for treating leukoderma Chinese medicine composition of a kind of treatment and preparation method thereof, comprises following component: Radix Serissae, Herba Siegesbeckiae, Fructus Atriplicis Sibiricae, Fructus Psoraleae, Periostracum Serpentis, Sal, Herba Portulacae, Sucus Zingberis, the Fructus Solani melongenae base of a fruit, Scorpio, Fructus Mume, Herba Macleayae Cordatae, white Serpentis, Nidus Vespae, the Radix Angelicae Dahuricae, Radix Angelicae Sinensis, boric acid, Flos Carthami, Herba Ecliptae, Fructus Lycii, Radix Polygoni Multiflori, Realgar, Lithargyrum, stone sulfur; Get the above-mentioned raw materials medicine, mix, add ethanol extraction, extracting liquid filtering, filtrate is put cold, adds Realgar, Lithargyrum, sulfur and soaks 5-10 days, filters, get filtrate routinely external preparation for skin pharmaceutical preparation method make various dosage forms promptly.
Chinese invention patent (application number is 200510022648.X) discloses leukodermic composition formula of treatment and preparation method thereof, and BAIDIANJING for oral administration mainly is made into by weight by following component: this composition formula is made up of the BAIDIANJING for oral administration and the purplish or white patches on the skin tincture that disappears of external; Wherein, BAIDIANJING for oral administration mainly is made into by weight by following component: Herba Xanthii grass 1000 grams, the Radix Astragali 600 grams, Fructus Atriplicis Sibiricae, Herba Siegesbeckiae, each 500 gram of Radix Pseudostellariae, Semen Astragali Complanati, Fructus Psoraleae, Rhizoma Wenyujin Concisum, Fructus Mori, Semen Sesami Nigrum, each 300 gram of Radix Polygoni Multiflori, Fructus Ligustri Lucidi, Herba Ecliptae, Pyritum, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Radix Codonopsis, Radix Rehmanniae Preparata, each 200 gram of GANQIZI, Radix Bupleuri (processed with vinegar), Rhizoma Et Radix Notopterygii, Poria, Semen Cuscutae, Radix Paeoniae Rubra, paddy, each 150 gram of Fructus Hordei Germinatus, duckweed spirodela, each 100 gram of the Rhizoma Atractylodis Macrocephalae, Rhizoma Chuanxiong, each 60 gram of the Radix Angelicae Dahuricae; The external purplish or white patches on the skin tincture that disappears mainly is made into by weight by following component: Semen Cuscutae 50 grams, Fructus Psoraleae 30 grams, Radix Angelicae Dahuricae (Radix Heraclei Scabridi), Herba Asari, each 20 gram of Realgar, Semen Oroxyli 15 grams.
Chinese invention patent (application number is 200710014223.3) discloses the leukodermic Chinese medicine composition of a kind of oral administration and externally used for curing, belongs to the field of Chinese medicines.The leukodermic Chinese medicine composition of this kind oral administration and externally used for curing, formulated by Radix Angelicae Sinensis, Rhizoma Chuanxiong, Fructus Ligustri Lucidi, Fructus Psoraleae, Radix Polygoni Multiflori, Fructus Atriplicis Sibiricae, Semen Sesami Nigrum, Radix Saposhnikoviae, the Rhizoma Atractylodis Macrocephalae, Fructus Lycii, Flos Carthami, Agkistrodon, Radix Clematidis, Herba Lysimachiae, Fructus Mori, Fructus Psoraleae, Semen Cuscutae, the Radix Angelicae Dahuricae and Borneolum Syntheticum by certain part by weight.Radix Angelicae Sinensis, Rhizoma Chuanxiong, Fructus Ligustri Lucidi, Fructus Psoraleae, Radix Polygoni Multiflori, Fructus Atriplicis Sibiricae, Semen Sesami Nigrum, Radix Saposhnikoviae, the Rhizoma Atractylodis Macrocephalae, Fructus Lycii, Flos Carthami, Agkistrodon, Radix Clematidis, Herba Lysimachiae and Fructus Mori are made decoction oral.With Fructus Psoraleae, Semen Cuscutae, the Radix Angelicae Dahuricae and Borneolum Syntheticum with the back external of 60 ° of soaking in Chinese liquor one week.
Chinese invention patent (application number is 93115622.X) discloses a kind of treatment leucoderma disease lotion, and it is that raw material adds water and is condensed into cream after removing slag and mixes the mixed water preparation that is mixed with of Borneolum Syntheticum, cetacort, iodine tincture, ethanol and distilled water again with frying in shallow oil with the Fructus Psoraleae and the Radix Angelicae Dahuricae.
Chinese invention patent (application number is 98113608.7) discloses the leukodermic Chinese medicine of a kind of treatment, mainly solves drawbacks such as present quasi-drugs costs an arm and a leg, curative effect is relatively poor.It is by oral medicine and apply medicinal lotion or ointment outward and form.The prescription of oral medicine is: Herba Ecliptae, the Radix Angelicae Dahuricae, Radix Polygoni Multiflori, SEMEN ASTRAGALI COMPLANATI, Fructus Tribuli, Radix Arnebiae (Radix Lithospermi), Rhizoma Paridis, Radix Salviae Miltiorrhizae, Radix Sophorae Flavescentis, Rhizoma Atractylodis.The prescription of applying medicinal lotion or ointment outward is: Fructus Psoraleae, the Radix Angelicae Dahuricae, Herba Portulacae, Cortex Cinnamomi, the Radix Stemonae, Flos Caryophylli.
The existing defective of the leukodermic Chinese patent medicine of existing treatment is: 1. curative effect is low; 2. preparation technology falls behind, and mostly is traditional handicraft greatly; 3. quality control is not tight, and the index composition is single; 4. external preparation mostly is tincture, and part patient has limited use to ethanol allergy; 5. medicine is formed too much, has increased preparation unstability and production cost.
Summary of the invention
In order to solve the technological deficiency that the leukodermic Chinese patent medicine of above-mentioned treatment exists, an object of the present invention is to provide the leukodermic traditional Chinese herb medicine preparation of a kind of treatment, it has good effect, no toxicity, technology advanced person, the characteristics that production cost is low.Another one purpose of the present invention provides the preparation method of above-mentioned traditional Chinese herb medicine preparation.
In order to realize first above-mentioned purpose, the present invention has adopted following technical scheme:
The leukodermic traditional Chinese herb medicine preparation of a kind of treatment, form by the extracting solution of Chinese medicine material composition, the adjuvant of ointment formulation and an amount of water, Chinese medicine material composition extracting solution comprises the extracting solution of Fructus Psoraleae, the Radix Angelicae Dahuricae and Radix Angelicae Pubescentis, wherein, every 1000g traditional Chinese herb medicine preparation adopts Fructus Psoraleae, the Radix Angelicae Dahuricae and the Radix Angelicae Pubescentis of following weight to extract:
Fructus Psoraleae 100～800g Radix Angelicae Dahuricae 100～600g Radix Angelicae Pubescentis 100～600g.
As preferably, above-mentioned every 1000g traditional Chinese herb medicine preparation adopts Fructus Psoraleae, the Radix Angelicae Dahuricae and the Radix Angelicae Pubescentis of following weight to extract:
Fructus Psoraleae 200～600g Radix Angelicae Dahuricae 200～500g Radix Angelicae Pubescentis 200～500g.
As most preferably, above-mentioned every 1000g traditional Chinese herb medicine preparation adopts Fructus Psoraleae, the Radix Angelicae Dahuricae and the Radix Angelicae Pubescentis of following weight to extract:
Fructus Psoraleae 400g Radix Angelicae Dahuricae 300g Radix Angelicae Pubescentis 300g.
As preferably, the adjuvant of above-mentioned ointment formulation comprises the following composition of percentage ratio that accounts for gross weight:
Stearic acid 2～5% octadecanol 3～8% azones 0.5～2%
Ethyl hydroxybenzoate 0.05～0.2% anethole 0.05～0.15% span 20 0.5～3%
Tween 80 0.5～3% propylene glycol 3～8% glycerol 3～8%.
As most preferably, the adjuvant of above-mentioned ointment formulation comprises the following composition of percentage ratio that accounts for gross weight:
Stearic acid 3.5% octadecanol 5% azone 1%
Ethyl hydroxybenzoate 0.1% anethole 0.12% span 20 1.5%
Tween 80 1.5% propylene glycol 5% glycerol 5%.
As preferably, the extracting solution of above-mentioned Chinese medicine material composition Fructus Psoraleae, the Radix Angelicae Dahuricae and Radix Angelicae Pubescentis is for adopting supercritical CO
2The extract of extraction.
In order to realize second purpose, the present invention has adopted following technical scheme:
The leukodermic traditional Chinese herb medicine preparation process thereof of above-mentioned treatment comprises the steps:
(1) prescription Chinese medicine material composition is smashed, sieved, adopt supercritical CO
2Abstraction technique carries out supercritical CO by following condition
2The fluid cycling extraction is collected extract: the extraction kettle temperature is 40～60 ℃, and pressure is 15～25MPa, and the temperature of separation reactor I is 40～45 ℃, and pressure is 7～7.5MPa, 30～40 ℃ of the temperature of separation reactor I I, and pressure is 5.5～6MPa;
(2) adjuvant oil phase and water are heated to 80 ℃～85 ℃ respectively,, then oil phase are added aqueous phase, stir evenly stirring evenly in the above-mentioned extract adding adjuvant oil phase, high-speed stirred emulsifying again, homogenizing, the degassing promptly gets described traditional Chinese herb medicine preparation.
As preferably, in the above-mentioned step (1): the extraction kettle temperature is 50 ℃, and pressure is 20MPa, and the temperature of separation reactor I is 42 ℃, and pressure is 7～7.5MPa, 35 ℃ of the temperature of separation reactor I I, and pressure is 5.5～6MPa.
The present invention is owing to adopted above technical scheme, and beneficial effect is as follows:
(1) prescription adopts Fructus Psoraleae, the Radix Angelicae Dahuricae, Radix Angelicae Pubescentis three flavor couplings, and this three flavors Chinese medicine all contains and vitiligo is activated melanocyte produces the effective tonkabean spermin of melanin constituents, helps improving the curative effect of said preparation.
(2) adopt supercritical CO
2Fluid extraction technology substitutes traditional extraction process, and (extraction) comes out to make that effective ingredient is extracted at a lower temperature in the medical material, and effective ingredient is not destroyed.
(3) active constituent content height in the manufactured goods, raising curative effect that can be by a relatively large margin, according to preliminary test to the right side of fifty, the course of disease is below 5 years, in, the obvious effective rate of the patients with vitiligo of small size reaches more than 80%, total effective rate reaches more than 90%, is better than the leukodermic Chinese medicine for external application of the existing treatment in market.
(4) this preparation adopts soft (frost) paste formulation of oil-in-water type, high safety, overcomes existing external curing vitiligo Chinese medicine preparation and be tincture and part ethanol autopath is easily caused defective hypersensitive, and this product is the oil-in-water type ointment that pair advantage of skin moisturizing maintenance action is arranged.
The specific embodiment
Embodiment 1
Prescription: Fructus Psoraleae 400g, Radix Angelicae Dahuricae 300g, Radix Angelicae Pubescentis 300g.
Adjuvant: stearic acid 35g, octadecanol 50g, azone 10g, ethyl hydroxybenzoate 1g, anethole 1.2g, span 20 15g, Tween 80 15g, propylene glycol 50g, glycerol 50g, distilled water is an amount of, makes 1000g.
Preparation technology:
(1) prescription Chinese medicine material composition is smashed, crossed 30 orders, adopt supercritical CO
2Abstraction technique carries out supercritical CO by following condition
2The fluid cycling extraction is collected extract: the extraction kettle temperature is 50 ℃, and pressure is 20MPa, and the temperature of separation reactor I is 42 ℃, and pressure is 7～7.5MPa, 35 ℃ of the temperature of separation reactor I I, and pressure is 5.5～6MPa.
(2) adjuvant oil phase and water are heated to 80 ℃ and 85 ℃ respectively,, under agitation oil phase are added aqueous phase then, stir evenly stirring evenly in the above-mentioned extract adding adjuvant oil phase, high-speed stirred emulsifying again, homogenizing, the degassing promptly gets described traditional Chinese herb medicine preparation.
Embodiment 2
Prescription: Fructus Psoraleae 200g, Radix Angelicae Dahuricae 150g, Radix Angelicae Pubescentis 150g.
Adjuvant: stearic acid 40g, octadecanol 62g, azone 15g, ethyl hydroxybenzoate 1.5g, anethole 1.5g, span 20 10g, Tween 80 20g, propylene glycol 60g, glycerol 40g, distilled water is an amount of, makes 1000g.
Preparation technology such as embodiment 1.
Embodiment 3
Prescription: Fructus Psoraleae 600g, Radix Angelicae Dahuricae 400g, Radix Angelicae Pubescentis 400g.
Adjuvant: stearic acid 35g, octadecanol 50g, azone 10g, ethyl hydroxybenzoate 1g, anethole 1.2g, span 20 15g, Tween 80 20g, propylene glycol 60g, glycerol 40g, distilled water is an amount of, makes 1000g.
Preparation technology such as embodiment 1.
Model case:
Case one: Wu * *, the man, 41 years old, 3 years medical histories, disease sites: forehead, around the lip, the irregular type white macula is always suffered from the about 15CM of area
2, multi-treatment 3 years is invalid.The traditional Chinese herb medicine preparation of the back external embodiment of the invention 1, exterior coating treatment are after 30 days, and the pigment island is born in the affected part, use continuously 2 months again, and the white macula of having suffered from disappears, and the illing skin color restoration is normal.After the drug withdrawal one month, the Chinese medicine ointment that re-uses in the embodiments of the invention 1 was consolidated curative effect in one month.Follow up a case by regular visits to after 1 year, do not see recurrence.
Case two: permitted * *, man 50 years old, medical history 10 years is surplus, disease sites: forehead, face, wing of nose both sides, around the lip, the equal symmetry of both hands and arm suffers from irregular shape white macula, suffers from the about 80CM of the white macula gross area
2, there is not positive effect through multi-treatment, the traditional Chinese herb medicine preparation of the embodiment of the invention 1 is used in the back, and behind the external curing two weeks, increase is significantly increased on the pigment island, continues to use three months, and illing skin is normal substantially, renews with one month, and the colour of skin is normal, clinical cure.Follow up a case by regular visits to and do not see recurrence.
Case three: Lee *, the woman, 22 years old, the course of disease 3 years was surplus, and the affected part is: the back cervical region, forehead eyebrow place, around the lip, the both hands back, chest is irregular white macula, always suffering from area is 30CM
2Do not have positive effect through multi-treatment, the traditional Chinese herb medicine preparation of the embodiment of the invention 1 is used in the back, and through the external curing two weeks, pigment island, affected part generates, and continues to use 2 months, and white macula disappears, and it is normal that the illing skin colour of skin is recovered, and do not see recurrence so far.
Case four: old * *, man 35 years old, it is surplus to suffer from vitiligo 3 years, and the affected part is: the back cervical region, forehead eyebrow place, around the lip, chest is irregular shape white macula, area is about 20CM
2, to control for a long time and fail to take effect, the Chinese medicine ointment in the embodiments of the invention 1 is used in the back, uses continuously three months, and white macula disappears, and it is normal that the illing skin colour of skin is recovered, and follows up a case by regular visits to and do not see recurrence.
Claims (8)
1. treat leukodermic traditional Chinese herb medicine preparation for one kind, form by the extracting solution of Chinese medicine material composition, the adjuvant of ointment formulation and an amount of water, it is characterized in that Chinese medicine material composition extracting solution comprises the extracting solution of Fructus Psoraleae, the Radix Angelicae Dahuricae and Radix Angelicae Pubescentis, wherein every 1000g traditional Chinese herb medicine preparation adopts Fructus Psoraleae, the Radix Angelicae Dahuricae and the Radix Angelicae Pubescentis of following weight to extract:
Fructus Psoraleae 100～800g Radix Angelicae Dahuricae 100～600g Radix Angelicae Pubescentis 100～600g.
2. the leukodermic traditional Chinese herb medicine preparation of a kind of treatment according to claim 1 is characterized in that every 1000g traditional Chinese herb medicine preparation adopts Fructus Psoraleae, the Radix Angelicae Dahuricae and the Radix Angelicae Pubescentis of following weight to extract:
Fructus Psoraleae 200～600g Radix Angelicae Dahuricae 200～500g Radix Angelicae Pubescentis 200～500g.
3. the leukodermic traditional Chinese herb medicine preparation of a kind of treatment according to claim 2 is characterized in that every 1000g traditional Chinese herb medicine preparation adopts Fructus Psoraleae, the Radix Angelicae Dahuricae and the Radix Angelicae Pubescentis of following weight to extract:
Fructus Psoraleae 400g Radix Angelicae Dahuricae 300g Radix Angelicae Pubescentis 300g.
4. according to claim 1 or the leukodermic traditional Chinese herb medicine preparation of 2 or 3 described a kind of treatments, it is characterized in that the adjuvant of ointment formulation comprises the following composition of percentage ratio that accounts for gross weight:
Stearic acid 2～5% octadecanol 3～8% azones 0.5～2%
Ethyl hydroxybenzoate 0.05～0.2% anethole 0.05～0.15% span 20 0.5～3%
Tween 80 0.5～3% propylene glycol 3～8% glycerol 3～8%.
5. the leukodermic traditional Chinese herb medicine preparation of a kind of treatment according to claim 4 is characterized in that the adjuvant of ointment formulation comprises the following composition of percentage ratio that accounts for gross weight:
Stearic acid 3.5% octadecanol 5% azone 1%
Ethyl hydroxybenzoate 0.1% anethole 0.12% span 20 1.5%
Tween 80 1.5% propylene glycol 5% glycerol 5%.
6. according to claim 1 or the leukodermic traditional Chinese herb medicine preparation of 2 or 3 described a kind of treatments, the extracting solution that it is characterized in that Chinese medicine material composition Fructus Psoraleae, the Radix Angelicae Dahuricae and Radix Angelicae Pubescentis is for adopting supercritical CO
2The extract of extraction.
7. according to claim 1 or the leukodermic traditional Chinese herb medicine preparation process thereof of 2 or 3 described a kind of treatments, it is characterized in that comprising the steps:
(1) prescription Chinese medicine material composition is smashed, sieved, adopt supercritical CO
2Abstraction technique carries out supercritical CO by following condition
2The fluid cycling extraction is collected extract: the extraction kettle temperature is 40～60 ℃, and pressure is 15～25MPa, and the temperature of separation reactor I is 40～45 ℃, and pressure is 7～7.5MPa, 30～40 ℃ of the temperature of separation reactor I I, and pressure is 5.5～6MPa;
(2) adjuvant oil phase and water are heated to 80 ℃～85 ℃ respectively,, then oil phase are added aqueous phase, stir evenly stirring evenly in the above-mentioned extract adding adjuvant oil phase, high-speed stirred emulsifying again, homogenizing outgases, promptly gets described traditional Chinese herb medicine preparation.
8. the leukodermic traditional Chinese herb medicine preparation process thereof of a kind of treatment according to claim 7, it is characterized in that in the step (1): the extraction kettle temperature is 50 ℃, pressure is 20MPa, the temperature of separation reactor I is 42 ℃, pressure is 7～7.5MPa, 35 ℃ of the temperature of separation reactor I I, pressure are 5.5～6MPa.
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| CN2008100591222A CN101229224B (en) | 2008-01-14 | 2008-01-14 | Chinese traditional medicine ointment preparation for curing vitligo and preparing method thereof |
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| CN105998166A (en) * | 2016-06-20 | 2016-10-12 | 中国人民解放军空军总医院 | Compound skin cream for treating leucoderma and preparation method thereof |
| CN108938816A (en) * | 2018-10-17 | 2018-12-07 | 吕梁学院 | Chinese medicine composition, ointment and preparation method thereof for covering and treating leucoderma |
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