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CN104257786B - A kind of coptis external preparation, preparation method and applications - Google Patents

A kind of coptis external preparation, preparation method and applications Download PDF

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CN104257786B
CN104257786B CN201410557095.7A CN201410557095A CN104257786B CN 104257786 B CN104257786 B CN 104257786B CN 201410557095 A CN201410557095 A CN 201410557095A CN 104257786 B CN104257786 B CN 104257786B
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coptis
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coptis chinensis
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杨大坚
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
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Abstract

本发明提供了一种黄连外用制剂,由黄连提取物、收敛剂和表面活性剂组成;本发明、解决了黄连水提取液粘度较差,难以附着在皮肤表面容易出现流淌的问题,增加了患者使用的舒适感;并且相比较黄连单方水提液,黄连外用制剂的消炎效果更好,对湿疹和痤疮具有良好的治疗作用;本制剂具有消除疤痕的作用,对于痤疮产生的疤痕具有良好的消减作用。The invention provides an external preparation of Coptidis rhizome, which is composed of Coptidis rhizome extract, astringent and surfactant; the invention solves the problem that the water extract of Coptidis rhizome has poor viscosity, is difficult to attach to the skin surface and tends to flow, and increases the number of patients. Comfortable to use; and compared with the unilateral water extract of Coptis chinensis, the anti-inflammatory effect of Coptis chinensis external preparation is better, and it has a good therapeutic effect on eczema and acne; effect.

Description

一种黄连外用制剂、制备方法及其应用Coptis rhizome external preparation, preparation method and application thereof

技术领域technical field

本发明涉及一种中药外用制剂,更具体的说是涉及黄连外用制剂、制备方法及其应用。The invention relates to an external preparation of traditional Chinese medicine, and more specifically relates to an external preparation of Coptis rhizome, a preparation method and application thereof.

技术背景technical background

黄连清热燥湿,泻火解毒。用于湿热痞满,呕吐吞酸,泻痢,黄疸,高热神昏,心火亢盛,心烦不寐,血热吐衄,目赤,牙痛,消渴,痈肿疔疮;外治湿疹,湿疮,耳道流脓。酒黄连善清上焦火热。用于目赤,口疮。李辉等报道了黄连解毒汤坐浴治疗肛门湿疹的效果,表明本组治疗最短6天,最长27天,平均9~18天,结果痊愈112例,好转44例,无效12例。黄连解毒汤坐浴治疗肛门湿疹效果满意。王淑忠等报道了黄连素湿敷联合丁酸氢化可的松软膏治疗婴儿急性渗出型湿疹的临床疗效和安全性。方法:78例婴儿急性渗出型湿疹门诊患儿随机分为观察组42例和对照组36例。观察组采用黄连素溶液冷湿敷,bid;对照组采用2%硼酸冷湿敷,bid。均5d为1疗程。皮损干燥后,两组患儿均外涂丁酸氢化可的松软膏,bid,5d为1疗程。总疗程为10d。结果:观察组总有效率90.47%,对照组为69.44%,两组比较,差异有统计学意义(P<0.01);观察组痊愈率50.00%,对照组为38.89%,两组比较,差异有统计学意义(P<0.05)。结论:黄连素溶液联合丁酸氢化可的松软膏治疗婴儿急性渗出型湿疹有效,安全性好,值得临床推广应用。Coptis chinensis clears heat and dries dampness, purifies fire and detoxifies. For damp and hot fullness, vomiting and acid regurgitation, diarrhea, jaundice, high fever and coma, hyperactivity of heart fire, upset and insomnia, vomiting of blood heat, red eyes, toothache, thirst, carbuncle and furuncle; external treatment of eczema, Eczema, ear canal discharge pus. The wine Coptis chinensis is scorched hot. For red eyes, aphtha. Li Hui et al. reported the effect of sitz bath of Huanglian Jiedu Decoction on anal eczema, showing that the shortest 6 days of treatment in this group, the longest 27 days, with an average of 9 to 18 days, resulted in 112 cases of recovery, 44 cases of improvement, and 12 cases of ineffectiveness. Coptidis Jiedu Decoction has satisfactory effect in treating anal eczema with sitz bath. Wang Shuzhong et al. reported the clinical efficacy and safety of berberine wet compress combined with hydrocortisone butyrate ointment in the treatment of acute exudative eczema in infants. Methods: 78 outpatients with acute exudative eczema in infants were randomly divided into an observation group of 42 cases and a control group of 36 cases. The observation group was treated with berberine solution cold wet compress, bid; the control group was treated with 2% boric acid cold wet compress, bid. 5 days each is a course of treatment. After the skin lesions were dry, both groups of children were externally applied hydrocortisone butyrate ointment, bid, 5 days as a course of treatment. The total course of treatment is 10d. Results: The total effective rate of the observation group was 90.47%, and that of the control group was 69.44%. The difference between the two groups was statistically significant (P<0.01); the recovery rate of the observation group was 50.00%, and that of the control group was 38.89%. Statistically significant (P<0.05). Conclusion: Berberine solution combined with hydrocortisone butyrate ointment is effective and safe in the treatment of acute exudative eczema in infants, and it is worthy of clinical application.

中医认为痤疮是湿热火毒内生,内郁湿火,或七情内郁,气郁化火,水不济火,火邪炽盛,而蕴于皮肤而成。我们应用黄连素是因它具有清热燥湿、解毒、凉血、泻火、消炎等功效。黄连素可以抑制痤疮的繁殖,使皮脂中的游离脂肪酸减少。李春生等报道了应用黄连解毒汤合枇杷叶丸治疗寻常痤疮的临床疗效。方法:用黄连解毒汤合枇杷叶丸治疗60例寻常痤疮患者,记录其服药前后局部和全身症状的变化,并评价其疗效,强调饮食禁忌。结果:60例患者中临床治愈9例(15%),显效39例(65%),好转7例(11.67%),未愈5例(8.33%)。显效率80%,总有效率91.67%,复发率11.1%。结论:黄连解毒汤合枇杷叶丸是治疗寻常痤疮的有效方剂之一。治疗期间禁食奶制品,减少糖类摄入,有益于本病的治愈。Traditional Chinese medicine believes that acne is caused by endogenous damp heat and fire poison, internal stagnation of damp fire, or internal stagnation of seven emotions, stagnation of qi turning into fire, water deficiency of fire, and flaming fire evil, which accumulate in the skin. We use berberine because it has the functions of clearing heat and dampness, detoxifying, cooling blood, purging fire, and reducing inflammation. Berberine can inhibit the reproduction of acne and reduce the free fatty acids in sebum. Li Chunsheng et al. reported the clinical efficacy of Huanglianjiedu Decoction combined with Loquat Leaf Pills in the treatment of acne vulgaris. Method: Treat 60 patients with acne vulgaris with Huanglian Jiedu Decoction and Pipaye Pills, record the changes of local and systemic symptoms before and after taking the medicine, and evaluate its curative effect, emphasizing dietary taboos. Results: Of the 60 patients, 9 were cured (15%), markedly effective in 39 (65%), improved in 7 (11.67%), and unhealed in 5 (8.33%). The effective rate is 80%, the total effective rate is 91.67%, and the recurrence rate is 11.1%. Conclusion: Huanglian Jiedu Decoction combined with Pipaye Pills is one of the effective prescriptions for acne vulgaris. Fasting of dairy products and reducing sugar intake during treatment are beneficial to the cure of this disease.

发明内容Contents of the invention

本发明了提供了一种以黄连提取物为主的用于治疗湿疹和痤疮的黄连外用制剂。The invention provides a Coptis rhizome external preparation for treating eczema and acne, which is mainly composed of Coptis chinensis extract.

一种黄连外用制剂,所述外用制剂由黄连提取物、收敛剂和表面活性剂组成。The external preparation of Coptidis rhizome is composed of Coptidis rhizome extract, astringent and surfactant.

所述的黄连外用制剂,其特征在于:所述收敛剂为鞣酸,表面活性剂为大豆卵磷脂组成。The external preparation of Coptis rhizome is characterized in that: the astringent is tannic acid, and the surfactant is composed of soybean lecithin.

所述的黄连外用制剂,其特征在于:所述黄连提取物的原药材、鞣酸和大豆卵磷脂的重量比为15-30:0.3-0.6:0.7-1.2。The external preparation of Coptis chinensis is characterized in that the weight ratio of the original medicinal material of the Coptis chinensis extract, tannic acid and soybean lecithin is 15-30:0.3-0.6:0.7-1.2.

所述的黄连外用制剂,其特征在于:所述外用制剂中的黄连原药材、鞣酸和大豆卵磷脂的重量比为20:0.5:0.9;The external preparation of Coptis chinensis is characterized in that: the weight ratio of the original medicinal material of Coptis chinensis, tannic acid and soybean lecithin in the external preparation is 20:0.5:0.9;

所述的黄连外用制剂,其特征在于:所述外用制剂每100ml含有原药材重20g的黄连提取物、0.5g鞣酸和0.9g大豆卵磷脂;The external preparation of Coptis rhizome is characterized in that: every 100ml of the external preparation contains Coptis chinensis extract weighing 20g of the original medicinal material, 0.5g of tannic acid and 0.9g of soybean lecithin;

所述的外用制剂的溶剂为2-5%的乙醇;可制成搽剂、喷雾剂、气雾剂中的一种。The solvent of the external preparation is 2-5% ethanol; it can be made into one of liniment, spray and aerosol.

所述的黄连外用制剂,其特征在于:The external preparation of Coptis rhizome is characterized in that:

所述外用制剂可支撑乳膏,其中油相的基质为硬脂酸、单双硬脂酸甘油酯、白凡士林、羊毛脂和十六醇的混合物;水相基质为在水中加入甘油、十二烷基酸钠、羟苯乙酯和氮酮的混合溶液。The external preparation can support cream, wherein the base of the oil phase is a mixture of stearic acid, glyceryl monostearate, white petrolatum, lanolin and cetyl alcohol; the base of the water phase is a mixture of glycerin, lauryl A mixed solution of sodium alkanoate, ethylparaben and azone.

上述所述剂型为搽剂、喷雾剂、气雾剂的黄连外用制剂的制备方法,其特征在于:包括以下步骤:The above-mentioned preparation method of Coptis rhizome external preparations in the form of liniment, spray and aerosol is characterized in that it comprises the following steps:

1)粉碎黄连药材,过筛;1) Pulverize Coptidis medicinal material, sieve;

2)以水回流提取黄连药材,冷却,除去杂质,浓缩至30g原药材/100ml,静置冷却,过滤沉淀,得到黄连水提取液;2) extracting Coptis chinensis medicinal material with water reflux, cooling, removing impurities, concentrating to 30g of the original medicinal material/100ml, standing for cooling, filtering the precipitate, and obtaining Coptis chinensis water extract;

5)黄连提取液采用UTA专用壳聚糖进行二次澄清处理;5) Coptis chinensis extract is clarified twice with UTA-specific chitosan;

3)在黄连水提取液加入乙醇,调整醇浓度为50-60%,静置过滤沉淀,得到黄连澄清液;3) adding ethanol to the water extract of Coptidis rhizome, adjusting the alcohol concentration to 50-60%, standing and filtering the precipitate to obtain the clarified solution of Coptidis rhizome;

4)回收乙醇加入水和乙醇溶液调整溶剂乙醇浓度为2-5%,每100ml含有15-20g黄连原药材提取物,得到黄连提取液;4) recover ethanol and add water and ethanol solution to adjust solvent ethanol concentration to 2-5%, and each 100ml contains 15-20g Coptidis rhizome extract, to obtain Coptidis rhizome extract;

5)加入鞣酸和大豆卵磷脂,制备得到黄连外用制剂。5) adding tannic acid and soybean lecithin to prepare a Coptis rhizome external preparation.

上述所述剂型为乳膏的黄连外用制剂的制备方法,包括以下步骤:The above-mentioned formulation is the preparation method of the Coptis rhizome external preparation of emulsifiable paste, comprises the following steps:

1)粉碎黄连药材,过筛;1) Pulverize Coptidis medicinal material, sieve;

2)以水回流提取黄连药材,冷却,除去杂质,浓缩至30g原药材/100ml,静置冷却,过滤沉淀,得到黄连水提取液;2) extracting Coptis chinensis medicinal material with water reflux, cooling, removing impurities, concentrating to 30g of the original medicinal material/100ml, standing for cooling, filtering the precipitate, and obtaining Coptis chinensis water extract;

3)浓缩黄连水提取液,加入水相基质;3) Concentrating the water extract of Coptidis rhizome, adding the aqueous matrix;

4)将鞣酸和大豆卵磷脂一起加入油相基质;4) adding tannic acid and soybean lecithin to the oil phase matrix;

5)混合水相基质和油相基质,得到用于治疗痤疮的丹参组合药物乳膏。5) Mixing the water phase base and the oil phase base to obtain the Danshen combination medicine cream for treating acne.

所述的黄连外用制剂在制备治疗湿疹药物中的应用。Application of the external preparation of Coptis rhizome in preparation of medicine for treating eczema.

所述的黄连外用制剂在制备治疗痤疮药物中的应用。Application of the external preparation of Coptidis rhizoma in preparation of medicine for treating acne.

本发明的有益技术效果是:The beneficial technical effect of the present invention is:

第一,黄连外用剂型的水剂型解决了黄连水提取液粘度较差,难以附着在皮肤表面容易出现流淌的问题,增加了患者使用的舒适感;First, the aqueous formulation of Coptidis rhizome for external use solves the problem that the water extract of Coptis chinensis has poor viscosity and is difficult to adhere to the skin surface and is prone to flow, which increases the comfort of patients;

第二,相比较黄连单方水提液,黄连外用制剂的消炎效果更好,对湿疹和痤疮具有良好的治疗作用;Second, compared with the unilateral water extract of Coptis chinensis, the anti-inflammatory effect of Coptis chinensis topical preparation is better, and it has a good therapeutic effect on eczema and acne;

第三,本制剂具有消除疤痕的作用,对于痤疮产生的疤痕具有良好的消减作用。Thirdly, the preparation has the effect of eliminating scars, and has a good reducing effect on the scars produced by acne.

具体实施方式detailed description

实施例1不同澄清处理对黄连外用制剂的影响Example 1 Effects of Different Clarification Treatments on Coptis Rhizoma External Preparations

(一)黄连提取液的制备(1) Preparation of Coptis Rhizoma Extract

粉碎黄连药材,过筛,分为3组,每组3份,每份100g;以5倍、3倍、3倍的水回流提取各份黄连药材,每次30min,冷却,除去杂质,浓缩至30g原药材/100ml,静置冷却,过滤沉淀,得到黄连水提取液;在黄连水提取液加入乙醇,调整醇浓度大于60%,静置过滤沉淀,得到黄连澄清液;回收乙醇加入水和乙醇溶液调整溶剂乙醇浓度为2-5%,每100ml含有30g黄连原药材提取物,得到黄连提取液。Crush Coptidis medicinal material, sieve, divide into 3 groups, each group has 3 parts, each part is 100g; extract each part of Coptidis medicinal material with 5 times, 3 times and 3 times of water reflux, each time for 30min, cool, remove impurities, concentrate to 30g of raw medicinal materials/100ml, let it stand for cooling, filter the precipitate to obtain the water extract of Coptis chinensis; add ethanol to the water extract of Coptis chinensis, adjust the alcohol concentration to be greater than 60%, leave it to stand and filter the precipitate to obtain the clarified solution of Coptis chinensis; recover the ethanol and add water and ethanol The solution adjusts the solvent ethanol concentration to 2-5%, and every 100ml contains 30g of Coptis chinensis original medicinal material extract to obtain Coptis chinensis extract.

(二)澄清方法的考察(2) Investigation of clarification methods

1、壳聚糖二次澄清1. Second clarification of chitosan

称取壳聚糖1g,加1%醋酸100mL,磁力搅拌混匀后静置24h,备用;Weigh chitosan 1g, add 1% acetic acid 100mL, stir magnetically and let stand for 24h, set aside;

取上述步骤得到的黄连提取液1组(3份)黄连澄清液,加热至50℃,每份按药液体积的5%、10%、20%的量分别加入壳聚糖澄清剂,边加入边以100r·min-1搅拌10min,溶液放冷后静置12h,10000r·min-1离心,过滤,挥去醋酸,得到壳聚糖处理组。Take 1 group (3 parts) of the Coptidis Rhizoma extract obtained in the above steps, heat it to 50°C, add chitosan clarifying agent to each part according to the amount of 5%, 10%, and 20% of the volume of the medicinal solution, and add While stirring at 100r·min -1 for 10min, the solution was allowed to cool and then allowed to stand for 12h, centrifuged at 10000r·min -1 , filtered, and the acetic acid was evaporated to obtain the chitosan treatment group.

2、ZTC 1+1-Ⅲ澄清剂二次澄清2. ZTC 1+1-Ⅲ clarifier secondary clarification

A组分(白色至微黄色粉末)1g,加少量蒸馏水,搅拌成糊状,然后加蒸馏水至足量,溶胀24h,搅拌,配成1%溶液。B组分(微黄色至浅黄色粉末)1g,加少量1%醋酸溶液,搅拌成糊状,加1%醋酸溶液至足量,溶胀24h,配成1%溶液,备用;A component (white to light yellow powder) 1g, add a small amount of distilled water, stir to form a paste, then add distilled water to a sufficient amount, swell for 24 hours, stir to make a 1% solution. Component B (light yellow to light yellow powder) 1g, add a small amount of 1% acetic acid solution, stir to form a paste, add 1% acetic acid solution to a sufficient amount, swell for 24 hours, make a 1% solution, and set aside;

取上述步骤得到的黄连提取液1组(3份)黄连澄清液,加热至70℃,按药液体积的5%、10%、20%的量加入ZTC1+1-Ⅲ澄清剂,样品液先加B组分后加A组分,边加入边以100r·min-1搅拌10min,溶液放冷后静置12h,10000r·min-1离心,过滤,挥去醋酸,得到ZTC处理组。Take 1 group (3 parts) of Coptidis Rhizoma extract obtained in the above steps, heat it to 70°C, add ZTC1+1-Ⅲ clarifying agent according to the amount of 5%, 10%, and 20% of the volume of the medicinal solution, and the sample solution is first After adding component B, add component A, stir at 100r·min -1 for 10min while adding, let the solution cool down and let it stand for 12h, centrifuge at 10000r·min -1 , filter, and evaporate the acetic acid to obtain the ZTC treatment group.

(三)不同澄清方法对黄连外用制剂的影响(3) Effects of different clarification methods on Coptis rhizome external preparations

将未处理的黄连提取液、壳聚糖处理组和ZTC处理组,添加水和乙醇,每100ml含有原药材重20g的黄连提取物、0.5g鞣酸和0.9g大豆卵磷脂,乙醇浓度为3-4%。常温贮藏10d;考察澄清效果;具体如表1所示。Add water and ethanol to the untreated Coptidis Rhizoma extract, chitosan treatment group and ZTC treatment group, and every 100ml contains Coptidis Rhizoma extract weighing 20g of the original medicinal material, 0.5g tannic acid and 0.9g soybean lecithin, and the ethanol concentration is 3 -4%. Store at room temperature for 10 days; investigate the clarification effect; details are shown in Table 1.

表1不同二次澄清方法对黄连外用制剂的影响Table 1 Effects of different secondary clarification methods on Coptis rhizome topical preparations

黄连提取液中含有大量微细粒子、黏液质、蛋白质、果胶、淀粉等复杂成分,这些物质共同形成1~100nm的胶体分散体系,采用水提醇沉体系,很难将上述物质除去。在黄连提取液中添加如鞣酸以后,会导致出现大量的沉淀,严重影响黄连外用制剂的使用,因此对黄连提取液进行二次澄清处理非常有必要。Coptis chinensis extract contains a large number of complex components such as fine particles, mucus, protein, pectin, starch, etc. These substances together form a colloidal dispersion system of 1-100nm, and it is difficult to remove the above-mentioned substances by using a water extraction and alcohol precipitation system. Adding tannic acid to the extract of Coptidis rhizome will lead to a large amount of precipitation, which will seriously affect the use of external preparations of Coptis chinensis. Therefore, it is very necessary to carry out secondary clarification treatment on the extract of Coptis chinensis.

将上述液体装瓶制成喷雾剂、搽剂或气雾剂中的一种。The above liquid is bottled to make one of spray, liniment or aerosol.

黄连外用制剂乳膏剂的制备方法Preparation method of coptis external preparation cream

称取黄连药材200g,粉碎黄连药材,过筛;以5倍、3倍、3倍的水回流提取各份黄连药材,每次30min,冷却,除去杂质,浓缩至30g原药材/100ml,静置冷却,过滤沉淀,得到黄连水提取液;浓缩至稠膏,加入水相基质(适量水中加入甘油117g、十二烷基酸钠18g、羟苯乙酯1.8g、氮酮20g)溶解,于80℃保温,备用;Weigh 200g of Coptis chinensis, crush the Coptis chinensis, and sieve; extract each portion of Coptis chinensis with 5 times, 3 times, and 3 times of water reflux, each time for 30min, cool, remove impurities, concentrate to 30g of the original drug/100ml, and let it stand Cool and filter the precipitate to obtain the water extract of Coptis chinensis; concentrate to a thick paste, add water phase matrix (117g of glycerin, 18g of sodium laurylate, 1.8g of ethylparaben, and 20g of azone are added to an appropriate amount of water) to dissolve, and dissolve at 80 ℃ heat preservation, spare;

将5g鞣酸和9g大豆卵磷脂一起加入油相基质(硬脂酸9g、单双硬脂酸甘油酯36g、白凡士林90g、羊毛脂72g、十六醇72g)充分搅匀,于80℃保温,备用;Add 5g of tannic acid and 9g of soybean lecithin into the oil phase base (9g of stearic acid, 36g of glyceryl monostearate, 90g of white petrolatum, 72g of lanolin, and 72g of cetyl alcohol), stir well, and keep warm at 80°C ,spare;

将上述油相基质缓慢加入水相基质中,边加边搅拌1000r/min,80℃保持15min,制成乳膏,降至室温,制备得到乳膏剂。Slowly add the above-mentioned oil phase base into the water phase base, stir 1000r/min while adding, keep at 80°C for 15min, make a cream, cool down to room temperature, and prepare a cream.

实施例3不同的乳化剂对兔耳痤疮实验模型抗角化作用Embodiment 3 Different emulsifiers have anti-keratinization effect on rabbit ear acne experimental model

实验样品的制备Preparation of experimental samples

粉碎黄连药材,过筛,分为5组,每组3份,每份100g;以5倍、3倍、3倍的水回流提取各份黄连药材,每次30min,冷却,除去杂质,浓缩至30g原药材/100ml,静置冷却,过滤沉淀,得到黄连水提取液;在黄连水提取液加入乙醇,调整醇浓度为50-60%,静置过滤沉淀,得到黄连澄清液;回收乙醇加入水和乙醇溶液调整溶剂乙醇浓度为2-5%,每100ml含有30g黄连原药材提取物,得到黄连提取液。各份黄连提取液加热至50℃,每份按药液体积的5%加入壳聚糖澄清剂,边加入边以100r·min-1搅拌10min,溶液放冷后静置12h,10000r·min-1离心,过滤,挥去醋酸,得到壳聚糖处理液。Crush Coptis chinensis, sieve, divide into 5 groups, 3 parts in each group, 100g each; extract each part of Coptis chinensis with 5 times, 3 times, 3 times of water reflux, each time for 30min, cool, remove impurities, concentrate to 30g of raw medicinal materials/100ml, let it stand for cooling, filter the precipitate to obtain the water extract of Coptis chinensis; add ethanol to the water extract of Coptis chinensis, adjust the alcohol concentration to 50-60%, let it stand and filter the precipitate to obtain the clarified solution of Coptis chinensis; recover the ethanol and add water and the ethanol solution to adjust the ethanol concentration of the solvent to 2-5%, and each 100ml contains 30g of Coptis chinensis original medicinal material extract to obtain Coptis chinensis extract. Heat each portion of Coptis chinensis extract to 50°C, add chitosan clarifier to each portion according to 5% of the volume of the liquid medicine, stir at 100r·min -1 for 10min while adding, let the solution cool down and let it stand for 12h , 10000r·min -1 1. Centrifuge, filter, and wave off acetic acid to obtain chitosan treatment liquid.

将壳聚糖处理液添加水,使每100ml含有20g黄连原药材的提取物,得到黄连提取液组。Water was added to the chitosan-treated liquid so that 20 g of the extract of the original medicinal material of Coptidis Rhizoma was contained per 100 ml, and the extract of Coptidis Rhizoma was obtained.

取其中一组壳聚糖处理液添加水、乙醇鞣酸和大豆卵磷脂,使每100ml含有20g黄连原药材的提取物、0.5g鞣酸和0.9g大豆卵磷脂,溶剂乙醇的浓度为2-5%;得到实验Ⅰ组。Get wherein one group of chitosan treatment liquids add water, ethanol tannic acid and soybean lecithin, make every 100ml contain the extract of 20g Coptidis rhizome former medicinal material, 0.5g tannic acid and 0.9g soybean lecithin, the concentration of solvent ethanol is 2- 5%; experimental group I was obtained.

取其中一组壳聚糖处理液添加水、乙醇鞣酸和吐温-80,使每100ml含有20g黄连原药材的提取物、0.5g鞣酸和0.9g吐温-80,溶剂乙醇的浓度为2-5%;得到实验Ⅱ组。Get wherein one group of chitosan treatment liquids add water, ethanol tannic acid and Tween-80, make every 100ml contain the extract of 20g Coptidis rhizome former medicinal material, 0.5g tannic acid and 0.9g Tween-80, the concentration of solvent ethanol is 2-5%; experimental group II was obtained.

取其中一组壳聚糖处理液添加水、乙醇鞣酸和月桂酸单甘油酯,使每100ml含有20g黄连原药材的提取物、0.5g鞣酸和0.9g吐温-80,溶剂乙醇的浓度为2-5%;得到实验Ⅲ组。Get wherein one group of chitosan treatment liquids add water, ethanol tannic acid and lauric monoglyceride, make every 100ml contain the extract of 20g Coptidis rhizome original medicinal material, 0.5g tannic acid and 0.9g Tween-80, the concentration of solvent ethanol 2-5%; the experimental group III was obtained.

取其中一组壳聚糖处理液添加水和乙醇鞣酸,使每100ml含有20g黄连原药材的提取物和0.5g鞣酸,不含有黄连提取物,溶剂乙醇的浓度为2-5%;得到实验Ⅳ组。Get wherein one group of chitosan treatment liquids add water and ethanol tannic acid, make every 100ml contain the extract of 20g Coptidis Rhizoma former medicinal material and 0.5g tannic acid, do not contain Coptidis Rhizoma extract, the concentration of solvent ethanol is 2-5%; Obtain Experiment IV group.

健康白色雄兔,体重2000~2500g,0.1%维A酸乳膏(,《中国药典》2010年版二部);煤焦油,为黑色、糊状。Healthy white male rabbits, body weight 2000~2500g, 0.1% retinoic acid cream (, "Chinese Pharmacopoeia" 2010 edition part two); coal tar, black, paste.

分组将24只健康雄性白兔随机分为8组;分别为正常对照组、模型对照组、阳性药对照组、黄连提取液组、实验Ⅰ组、实验Ⅱ组、实验Ⅲ组及实验Ⅳ组。Grouping 24 healthy male white rabbits were randomly divided into 8 groups: normal control group, model control group, positive drug control group, coptis extract group, experiment Ⅰ group, experiment Ⅱ group, experiment Ⅲ group and experiment Ⅳ group.

造模除对正常对照组白兔不做任何处理外,其余7组白兔,分别在每只白兔左右耳内侧耳管开口处2cm×2cm范围内,每天外涂煤焦油1次,每次涂0.25ml。连续2周。于第14d。随机取2只造模白兔进行皮肤活检,证实已造模成功。Except for the white rabbits in the normal control group without any treatment for modeling, the white rabbits in the other 7 groups were coated with coal tar once a day in the range of 2 cm × 2 cm at the opening of the inner ear canal of the left and right ears of each white rabbit. Apply 0.25ml. 2 weeks in a row. at 14d. Two model-making white rabbits were randomly selected for skin biopsy, which confirmed that the model was successfully established.

用药采用外用给药法。分别在模型对照组、阳性药对照组、黄连提取液组、实验Ⅰ组、实验Ⅱ组、实验Ⅲ组及实验Ⅳ组各组白兔左右耳造模部位分别涂生理盐水0.1ml、0.1%维A酸乳膏0.1g、实验Ⅰ组制剂0.1ml、实验Ⅱ组0.1ml、实验Ⅲ组0.1ml及实验Ⅳ组0.1ml,每日2次,连续2周。正常对照组仍不做任何处理。Medication adopts external administration method. Apply normal saline 0.1ml, 0.1% vitamin C to the model-making parts of the left and right ears of white rabbits in the model control group, positive drug control group, Coptidis extract group, experimental group I, experimental group II, experimental group III and experimental group IV respectively. A acid cream 0.1g, experimental group I preparation 0.1ml, experimental group II 0.1ml, experimental group III 0.1ml and experimental group IV 0.1ml, 2 times a day for 2 consecutive weeks. The normal control group still did not receive any treatment.

取材与其组织病理改变级别的判定于末次给药24h后,用3mm打孔器在兔耳涂药处打孔取材.制作耳片标本(皮肤全层)。以10%福尔马林固定后并送病理,HE染色后.光镜下观察病理组织学改变。按其表皮增厚及毛囊口扩张程度和角化物多少将标本的病理变化分为4级:“0”为无粉刺;“+”为毛囊漏斗部可见少量致密角化物;“++”为毛囊漏斗部可见中等量角化物,并向皮脂腺延伸;“+++”为扩张的毛囊内有广泛的角化物。24 hours after the last drug administration, a 3mm hole punch was used to punch a hole in the drug-applied rabbit ear to make a specimen of the ear piece (full-thickness skin). After being fixed with 10% formalin and sent to pathology, after HE staining, the histopathological changes were observed under light microscope. According to the thickening of the epidermis, the expansion degree of the hair follicle opening and the amount of keratin, the pathological changes of the specimen were divided into 4 grades: "0" means no acne; "+" means a small amount of dense keratin in the infundibulum of the hair follicle; A moderate amount of keratinization can be seen in the infundibulum, extending toward the sebaceous gland; "+++" means extensive keratinization in the expanded hair follicle.

统计学方法本实验通过对各组实验标本的病理组织学改变进行分级后.采用秩和检验法比较各组间差异。Statistical method In this experiment, after grading the pathological and histological changes of the experimental specimens in each group, the rank sum test was used to compare the differences among the groups.

给药后各组兔耳肉眼观察After administration, the rabbit ears of each group were observed with naked eyes

正常对照组:兔耳菲薄柔软.可见清晰毛细血管.兔耳耳管开口处可见毛囊排列整齐。大小均匀。模型对照组:涂煤焦油1周后。可见造模区耳部厚度增加、变硬,毛囊口有黑色角栓。涂煤焦油2周后,可见造模部位毛囊口有明显角栓,呈黑头粉刺状毛囊口隆起呈丘疹状,整个兔耳表面粗糙。又经过2周外涂生理盐水后,造模部位耳部仍可见明显的毛囊角栓。Normal control group: the rabbit ears are thin and soft. Clear capillaries can be seen. The hair follicles can be seen in neat arrangement at the opening of the ear canal of the rabbit ears. Uniform size. Model control group: 1 week after applying coal tar. It can be seen that the thickness of the ears in the modeling area increases and becomes hard, and there are black horn plugs at the hair follicle mouth. After 2 weeks of coal tar application, it can be seen that the hair follicle mouth of the modeling site has obvious horn plugs, and the hair follicle mouth is raised in the form of blackheads and papules, and the surface of the entire rabbit ear is rough. After another 2 weeks of external application of physiological saline, obvious hair follicle angle plugs can still be seen in the ears of the modeling site.

阳性药对照组和实验Ⅰ组经给药2周治疗后。耳部增厚不同程度减轻,局部毛囊角栓减少;部分角栓脱落后遗只有较少的留点状凹陷毛囊,丘疹变平、减少。实验Ⅲ组及实验Ⅳ组角栓多数脱落,但是脱落位置遗留较多的点状凹陷毛囊。黄连提取液组和实验Ⅱ组仍可见明显的毛囊角栓。Positive drug control group and experimental group Ⅰ after 2 weeks of treatment. The thickening of the ears is alleviated to varying degrees, and the local hair follicle horn plugs are reduced; after some horn plugs fall off, there are only a few punctate depressed hair follicles, and the papules become flat and reduced. Most of the horn plugs in experimental group III and experimental group IV fell off, but there were many point-shaped depressed hair follicles left at the position of the falling off. Obvious hair follicle angle plugs can still be seen in the Coptis chinensis extract group and the experimental group Ⅱ.

给药后各组兔耳光镜下组织学观察Histological observation of rabbits in each group after administration

正常对照组:表皮较薄,表皮、真皮交界清楚,可见毛囊。模型对照组:可见表皮及毛囊上皮不规则增生,角化过度。毛孔扩张,其中充满角化物质。相邻的毛囊相互融合,毛囊漏斗部扩大如壶状。Normal control group: the epidermis is thinner, the junction between epidermis and dermis is clear, and hair follicles can be seen. Model control group: irregular hyperplasia and hyperkeratosis of epidermis and hair follicle epithelium can be seen. Pores are dilated and filled with keratinized substances. Adjacent hair follicles fuse with each other, and the infundibulum of the hair follicle expands like a pot.

实验Ⅰ组经给药2周治疗后,表皮增厚消除,无毛囊口扩张。阳性药对照组、实验Ⅲ组及实验Ⅳ组:表皮增厚不同程度减轻,无毛囊口扩张或部分毛囊口轻度扩张;有极少量到少量疏松角化物质充填,未见毛囊漏斗部扩大如壶状。黄连提取液组实验Ⅱ组毛囊扩张及角化物质充填程度稍有减轻,但不明显。In the experimental group Ⅰ, after 2 weeks of treatment, the thickening of the epidermis was eliminated, and there was no expansion of the hair follicle orifice. Positive drug control group, experimental group Ⅲ and experimental group Ⅳ: epidermis thickening alleviated to varying degrees, no hair follicle orifice dilated or some hair follicle orifices slightly dilated; a very small amount to a small amount of loose keratinized material filled, no hair follicle infundibulum enlarged such as Pot-shaped. In the Coptidis extract group, the expansion of hair follicles and the filling degree of keratinized substances in the experimental group II were slightly reduced, but not obvious.

组织病理检查的分级结果见表2所示。The grading results of histopathological examination are shown in Table 2.

表2黄连外用制剂不同乳化剂对兔耳实验性角化模型的影响Table 2 Effects of different emulsifiers of Coptis rhizome external preparations on rabbit ear experimental keratosis model

注:与模型组相比较,*P﹤0.05,**P﹤0.01;ΔP﹥0.05。Note: Compared with the model group, * P﹤0.05, ** P﹤0.01; ΔP ﹥0.05.

从上述数据可知,采用黄连提取液、卵磷脂和鞣酸的组合可以有效的消除皮肤毛囊皮脂腺导管的过度角化的问题。但是黄连提取液、月桂酸单甘油酯和鞣酸的组合以及黄连提取液和鞣酸的组合对于对于角化的问题改善不明显。黄连提取液、吐温-80和鞣酸的组合,不具有消除角质化的作用。黄连药材的提取液也不具有消除角质化的作用。From the above data, it can be known that the combination of Coptidis Rhizome extract, lecithin and tannic acid can effectively eliminate the problem of hyperkeratosis of skin pilosebaceous gland ducts. However, the combination of Coptidis rhizome extract, lauric monoglyceride and tannic acid and the combination of Coptidis rhizome extract and tannic acid did not significantly improve the problem of keratosis. The combination of Coptis chinensis extract, Tween-80 and tannic acid does not have the effect of eliminating keratinization. The extract of Coptidis Rhizoma also does not have the effect of eliminating keratinization.

实施例4黄连外用制剂对湿疹的作用The effect of embodiment 4 coptis external preparations on eczema

样品的制备sample preparation

粉碎黄连药材,过筛,分为3组,每组3份,每份100g;以5倍、3倍、3倍的水回流提取各份黄连药材,每次30min,冷却,除去杂质,浓缩至30g原药材/100ml,静置冷却,过滤沉淀,得到黄连水提取液;在黄连水提取液加入乙醇,调整醇浓度为50-60%,静置过滤沉淀,得到黄连澄清液;回收乙醇加入水和乙醇溶液调整溶剂乙醇浓度为2-5%,每100ml含有30g黄连原药材提取物,得到黄连提取液。各份黄连提取液加热至50℃,每份按药液体积的5%加入壳聚糖澄清剂,边加入边以100r·min-1搅拌10min,溶液放冷后静置12h,10000r·min-1离心,过滤,挥去醋酸,得到壳聚糖处理液。Crush Coptidis medicinal material, sieve, divide into 3 groups, each group has 3 parts, each part is 100g; extract each part of Coptidis medicinal material with 5 times, 3 times and 3 times of water reflux, each time for 30min, cool, remove impurities, concentrate to 30g of raw medicinal materials/100ml, let it stand for cooling, filter the precipitate to obtain the water extract of Coptis chinensis; add ethanol to the water extract of Coptis chinensis, adjust the alcohol concentration to 50-60%, let it stand and filter the precipitate to obtain the clarified solution of Coptis chinensis; recover the ethanol and add water and the ethanol solution to adjust the ethanol concentration of the solvent to 2-5%, and each 100ml contains 30g of Coptis chinensis original medicinal material extract to obtain Coptis chinensis extract. Heat each portion of Coptis chinensis extract to 50°C, add chitosan clarifier to each portion according to 5% of the volume of the liquid medicine, stir at 100r·min -1 for 10min while adding, let the solution cool down and let it stand for 12h , 10000r·min -1 1. Centrifuge, filter, and wave off acetic acid to obtain chitosan treatment liquid.

取其中一组壳聚糖处理液添加水、乙醇鞣酸和大豆卵磷脂,使每100ml含有15g黄连原药材的提取物、0.6g鞣酸和1.2g大豆卵磷脂,溶剂乙醇的浓度为2-5%;到时实验Ⅴ组。Get wherein one group of chitosan treatment liquids add water, ethanol tannic acid and soybean lecithin, make every 100ml contain the extract of 15g Coptidis rhizome former medicinal material, 0.6g tannic acid and 1.2g soybean lecithin, the concentration of solvent ethanol is 2- 5%; when the time comes for the experimental group V.

取其中一组壳聚糖处理液添加水、乙醇鞣酸和大豆卵磷脂,使每100ml含有30g黄连原药材的提取物、0.3g鞣酸和0.7g大豆卵磷脂,溶剂乙醇的浓度为2-5%;到时实验Ⅵ组。Get wherein one group of chitosan treatment liquids add water, ethanol tannic acid and soybean lecithin, make every 100ml contain the extract of 30g Coptidis rhizome former medicinal material, 0.3g tannic acid and 0.7g soybean lecithin, the concentration of solvent ethanol is 2- 5%; when the experimental group VI.

制备一组每100ml含有0.5g鞣酸和0.9g大豆卵磷脂,不含有黄连提取物,溶剂乙醇的浓度为2-5%;得到基质对照组。Prepare a group containing 0.5g tannic acid and 0.9g soybean lecithin per 100ml, not containing Coptidis rhizome extract, and the concentration of solvent ethanol is 2-5%; obtain matrix control group.

对湿疹的作用考察Effect on eczema

对二甲苯致小鼠耳廓肿胀的影响考察Effects of p-xylene on mouse auricle swelling

70只雄性小鼠,随机分为模型对照组、基质对照组、醋酸地塞米松乳膏组、黄连提取液组、实验Ⅰ组、实验Ⅴ组和实验Ⅵ组,每组10只。除模型对照组外,各组分别用凡士林、醋酸地塞米松乳膏、黄连提取液组、实验Ⅰ组、实验Ⅴ组和实验Ⅵ组制备的药液,均匀涂抹于小鼠左右耳廓,2.5g/kg,每天1次,连续4d。于末次涂药后1h,以蒸馏水洗去药物,用干棉球擦净。将0.04ml二甲苯滴于小鼠右耳耳廓,1.5h后脱臼处死,用9mm打孔器分别在每只小鼠同一部位摘取小鼠双耳片,称重,求两耳片之差值,即为耳廓肿胀度。Seventy male mice were randomly divided into model control group, matrix control group, dexamethasone acetate cream group, Coptis chinensis extract group, experimental group I, experimental group V and experimental group VI, with 10 mice in each group. In addition to the model control group, each group used petroleum jelly, dexamethasone acetate cream, Coptis chinensis extract group, experimental group I, experimental group V and experimental group VI to prepare the liquid, and evenly applied to the left and right auricles of the mice, 2.5 g/kg, once a day for 4 consecutive days. One hour after the last application, wash off the drug with distilled water and wipe it off with a dry cotton ball. Drop 0.04ml of xylene on the auricle of the right ear of the mouse, dislocate and kill the mouse after 1.5h, use a 9mm puncher to remove the two ear slices from the same part of each mouse, weigh them, and calculate the difference between the two ear slices The value is the swelling degree of the auricle.

对右旋糖酐40诱发小鼠搔抓反应的影响Effects on Dextran 40-induced Scratch Response in Mice

70只小鼠,雌雄各半,先在小鼠颈背部2cm×2cm脱毛,如上随机分为模型对照组、基质对照组、醋酸地塞米松乳膏组、黄连提取液组、实验Ⅰ组、实验Ⅴ组和实验Ⅵ组,各组分别用凡士林、醋酸地塞米松乳膏、黄连提取液组、实验Ⅰ组、实验Ⅴ组和实验Ⅵ组制备的药液,均匀涂抹于小鼠左右耳廓,2.5g/kg,每天1次,连续4d。末次给药1h后,每只小鼠尾静脉注射0.025%低分子右旋糖酐5ml/kg(1.25mg/kg)。注射后观察并记录每只小鼠的搔抓潜伏期以及30min内各组小鼠的搔抓次数。70 mice, half male and half male, were first depilated on the back of the neck at 2cm×2cm, and randomly divided into model control group, matrix control group, dexamethasone acetate cream group, Coptidis extract group, experimental group I, and experimental group as above. In group V and group VI, each group used vaseline, dexamethasone acetate cream, Coptis chinensis extract group, group I, group V and group VI, and applied them evenly to the left and right auricles of the mice. 2.5g/kg, once a day, for 4 consecutive days. One hour after the last administration, each mouse was injected with 0.025% low molecular weight dextran 5ml/kg (1.25mg/kg) through the tail vein. After injection, the scratching latency of each mouse and the number of scratching times of mice in each group within 30 min were observed and recorded.

黄连外用制剂治疗慢性湿疹的实验研究Experimental Study on Treatment of Chronic Eczema with Coptidis External Preparation

70只豚鼠,雌雄各半,随机分为模型对照组、基质对照组、醋酸地塞米松乳膏组、黄连提取液组、实验Ⅰ组、实验Ⅴ组和实验Ⅵ组。每只豚鼠颈背部剪毛2cm×2cm大小,以5%DNCB丙酮溶液25l外涂致敏,2周后,外涂0.1%DNCB丙酮溶液100l于豚鼠右耳内侧激发,每周激发1次,连续4周。在第4次激发后72h,除模型对照组外,各组分别用凡士林、醋酸地塞米松乳膏、甘草酸高、中、低剂量软膏,均涂抹于小鼠两耳廓两面,2.5g/kg,每天1次,连续10d。给药10d后,停药1d,用游标卡尺测定每只豚鼠左、右耳中部厚度,计算其差值,即为肿胀度。处死豚鼠,取右耳皮肤组织10mm×2mm,4%甲醛固定,石蜡包埋、切片,苏木精-伊红(HE)染色,光镜下观察耳部皮肤病理变化。Seventy guinea pigs, half male and half male, were randomly divided into model control group, matrix control group, dexamethasone acetate cream group, Coptis chinensis extract group, experimental group I, experimental group V and experimental group VI. Each guinea pig’s nape was cut to a size of 2cm×2cm, and sensitized with 25l of 5% DNCB acetone solution. After 2 weeks, 100l of 0.1% DNCB acetone solution was applied to the inner side of the right ear of the guinea pig for stimulation once a week for 4 consecutive weeks. At 72 hours after the fourth challenge, except for the model control group, each group applied vaseline, dexamethasone acetate cream, high-dose, medium-dose, and low-dose ointment of glycyrrhizinic acid, all of which were applied to the two auricles of the mice, 2.5g/ kg, once a day for 10 consecutive days. After 10 days of administration, stop the drug for 1 day, measure the thickness of the middle part of the left and right ears of each guinea pig with a vernier caliper, and calculate the difference, which is the degree of swelling. The guinea pigs were sacrificed, and the right ear skin tissue was taken 10mm×2mm, fixed in 4% formaldehyde, embedded in paraffin, sectioned, stained with hematoxylin-eosin (HE), and the pathological changes of the ear skin were observed under a light microscope.

对上述给实验组的统计学方法:利用SPSS15.0统计软件包,采用单因素方差分析进行统计分析,P<0.05为差异有统计学意义。具体见表3示。Statistical method for the above-mentioned experimental group: using SPSS15.0 statistical software package, using one-way analysis of variance for statistical analysis, P<0.05 means the difference is statistically significant. See Table 3 for details.

表3黄连外用制剂对小鼠耳廓肿胀和搔抓反应以及豚鼠耳廓肿胀的影响Table 3 Effects of external preparations of Coptidis rhizome on mouse auricle swelling and scratching response and guinea pig auricle swelling

注:与模型组向比较,**P﹤0.05;*P﹤0.01。Note: Compared with the model group, ** P﹤0.05; * P﹤0.01.

上述实验数据表明,在考察黄连外用制剂对二甲苯致小鼠耳廓肿胀的影响中,模型对照组小鼠造模后1.5h,耳廓肿胀明显。醋酸地塞米松乳膏组、实验Ⅰ组、实验Ⅴ组和实验Ⅵ组耳廓肿胀度显著减轻,与模型对照组比较,差异有统计学意义(P<0.05或<0.01)。黄连提取液组和基质对照组也能减轻耳廓肿胀度(P<0.05)。The above experimental data showed that in the investigation of the effect of the external preparation of Coptidis rhizome on the swelling of the auricles of mice induced by xylene, the swelling of the auricles of the mice in the model control group was obvious 1.5 hours after the model was established. The dexamethasone acetate cream group, experimental group Ⅰ, experimental group Ⅴ and experimental group Ⅵ significantly reduced the ear swelling, compared with the model control group, the difference was statistically significant (P<0.05 or <0.01). Coptis chinensis extract group and matrix control group can also reduce auricle swelling (P<0.05).

在考察黄连外用制剂对右旋糖酐40诱发小鼠搔抓反应的影响中,模型对照组小鼠造模后有瘙痒症状,表现为频繁的搔抓。醋酸地塞米松乳膏组、实验Ⅰ组、实验Ⅴ组和实验Ⅵ组搔抓潜伏期明显延长,醋酸地塞米松乳膏组、基质对照、实验Ⅰ组、实验Ⅴ组组30min内搔抓次数明显减少,与模型对照组比较差异均有统计学意义(P<0.O5)。黄连提取液组和实验Ⅵ组也能减轻30min内搔抓次数。In the investigation of the effect of Coptis rhizome external preparations on the scratching response of mice induced by dextran 40, the mice in the model control group had pruritus symptoms after modeling, which manifested as frequent scratching. The dexamethasone acetate cream group, experimental group Ⅰ, experimental group Ⅴ and experimental group Ⅵ significantly prolonged the scratching latency, and the dexamethasone acetate cream group, matrix control, experimental group Ⅰ, and experimental group Ⅴ had significant scratching times within 30 minutes. Compared with the model control group, the difference was statistically significant (P<0.05). Coptidis extract group and experimental group Ⅵ can also reduce the number of scratching within 30 minutes.

在考察黄连外用制剂治疗慢性湿疹的实验研究中,醋酸地塞米松乳膏组、实验Ⅰ组、实验Ⅴ组和实验Ⅵ组均能明显抑制慢性湿疹豚鼠耳廓肿胀,与模型对照组比较,差异均有统计学意义(P<0.01)。黄连提取液组和基质对照组也能(P<0.05)。In the experimental study on the treatment of chronic eczema with external preparations of Coptis chinensis, the dexamethasone acetate cream group, experimental group Ⅰ, experimental group Ⅴ and experimental group Ⅵ could significantly inhibit the ear swelling of guinea pigs with chronic eczema. Compared with the model control group, the difference Both were statistically significant (P<0.01). Coptidis extract group and matrix control group also can (P<0.05).

Claims (5)

1.一种黄连外用制剂,其特征在于:所述外用制剂由黄连提取物、收敛剂和表面活性剂组成;所述收敛剂为鞣酸,表面活性剂为大豆卵磷脂组成;所述黄连提取物的原药材、鞣酸和大豆卵磷脂的重量比为15-30:0.3-0.6:0.7-1.2;1. A coptis external preparation, characterized in that: said external preparation is composed of Coptidis extract, astringent and surfactant; said astringent is tannic acid, and surfactant is composed of soybean lecithin; said Coptidis extract The weight ratio of the original medicinal material, tannic acid and soybean lecithin of the product is 15-30:0.3-0.6:0.7-1.2; 所述的黄连外用制剂的制备方法,包括以下步骤:The preparation method of described coptis external preparation, comprises the following steps: 1)粉碎黄连药材,过筛;1) Pulverize Coptidis Rhizoma medicinal material, sieve; 2)以水回流提取黄连药材,冷却,除去杂质,浓缩至30g原药材/100ml,静置冷却,过滤沉淀,得到黄连水提取液;2) extracting Coptis chinensis medicinal material with water reflux, cooling, removing impurities, concentrating to 30g of the original medicinal material/100ml, standing for cooling, filtering the precipitate, and obtaining Coptis chinensis water extract; 3)黄连提取液采用UTA专用壳聚糖进行二次澄清处理;3) Coptis chinensis extract is clarified twice with UTA-specific chitosan; 4)在黄连水提取液加入乙醇,调整醇浓度为50-60%,静置过滤沉淀,得到黄连澄清液;4) adding ethanol to the water extract of Coptidis rhizome, adjusting the alcohol concentration to 50-60%, standing and filtering the precipitate to obtain the clarified solution of Coptidis rhizome; 5)回收乙醇加入水和乙醇溶液调整溶剂乙醇浓度为2-5%,每100ml含有15-20g黄连原药材提取物,得到黄连提取物;5) Recover ethanol and add water and ethanol solution to adjust the solvent ethanol concentration to 2-5%, and each 100ml contains 15-20g of Coptis chinensis original medicinal material extract to obtain Coptis chinensis extract; 6)加入鞣酸和大豆卵磷脂,制备得到黄连外用制剂。6) adding tannic acid and soybean lecithin to prepare a Coptis rhizome external preparation. 2.根据权利要求1所述的黄连外用制剂,其特征在于:所述外用制剂中的黄连原药材、鞣酸和大豆卵磷脂的重量比为20:0.5:0.9。2. The external preparation of Coptis chinensis according to claim 1, characterized in that: the weight ratio of the original medicinal material of Coptis chinensis, tannic acid and soybean lecithin in the external preparation is 20:0.5:0.9. 3.根据权利要求2所述的黄连外用制剂,其特征在于:所述外用制剂每100ml含有原药材重20g的黄连提取物、0.5g鞣酸和0.9g大豆卵磷脂;3. The external preparation of Coptis chinensis according to claim 2, characterized in that: every 100ml of said external preparation contains Coptis chinensis extract weighing 20g of the original medicinal material, 0.5g of tannic acid and 0.9g of soybean lecithin; 所述的外用制剂的溶剂为2-5%的乙醇;制成搽剂、喷雾剂或气雾剂中的一种。The solvent of the external preparation is 2-5% ethanol; it is made into one of liniment, spray or aerosol. 4.权利要求1-3任一项所述的黄连外用制剂在制备治疗湿疹药物中的应用。4. The application of the Coptis rhizome external preparation described in any one of claims 1-3 in the preparation of medicine for treating eczema. 5.权利要求1-3任一项所述的黄连外用制剂在制备治疗痤疮药物中的应用。5. The application of the Coptis rhizome external preparation described in any one of claims 1-3 in the preparation of a medicament for treating acne.
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