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CN101843821B - Chinese medicinal composition for treating chromatosis and preparation thereof - Google Patents

Chinese medicinal composition for treating chromatosis and preparation thereof Download PDF

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CN101843821B
CN101843821B CN2010101892224A CN201010189222A CN101843821B CN 101843821 B CN101843821 B CN 101843821B CN 2010101892224 A CN2010101892224 A CN 2010101892224A CN 201010189222 A CN201010189222 A CN 201010189222A CN 101843821 B CN101843821 B CN 101843821B
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廖万清
康善珠
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Second Military Medical University SMMU
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Abstract

本发明涉及一种治疗色素沉着的中药组合物及其制剂。色素沉着可见于许多皮肤病,其成因通常受阳光、紫外线辐射或化妆品、药物及其它物质刺激后,形成黑色的皮肤色素沉积而成,一部分随着角质层脱落;一部分沉淀于底层,通过血液循环排出体外,以上功能一旦失调,便形成了色素沉着。本发明的中药组合物配方以党参、黄芪、白术、土茯苓等补中益气,健脾益肺中成药为主,辅以补血活血的当归,健脾固肾润肺、益脑填精养颜的怀山药,养血柔肝的白芍,清热凉血、活血化瘀的赤芍,去瘀生新、活血调经的益母草,补脾益气、清热解毒的生甘草,加工成为补中益气、健脾益肺、活血化瘀的口服制剂,经数十年的临床应用证实,对治疗色素沉着有着良好的功效。The invention relates to a traditional Chinese medicine composition for treating pigmentation and its preparation. Pigmentation can be seen in many skin diseases. It is usually caused by the stimulation of sunlight, ultraviolet radiation or cosmetics, drugs and other substances to form black skin pigmentation. Part of it falls off with the stratum corneum; Excreted from the body, once the above functions are out of balance, pigmentation will be formed. The formula of the traditional Chinese medicine composition of the present invention mainly uses Codonopsis radix, Astragalus root, Atractylodes macrocephala, Smilax tuckahoe, etc. to invigorate the middle and replenish qi, invigorate the spleen and benefit the lung, supplemented with angelica that invigorates blood and activates blood, invigorates the spleen, strengthens the kidney and moistens the lung, nourishes the brain, replenishes essence and beautifies the face. Chinese yam, white peony root for nourishing blood and softening liver, red peony root for clearing heat and cooling blood, promoting blood circulation and removing blood stasis, motherwort for removing blood stasis, promoting blood circulation and regulating menstruation, raw licorice for nourishing spleen and replenishing qi, clearing away heat and detoxification, processed into nourishing middle and nourishing qi , invigorating the spleen and benefiting the lungs, promoting blood circulation and removing blood stasis, the oral preparation has been proved by decades of clinical application to have a good effect on the treatment of pigmentation.

Description

一种治疗色素沉着的中药组合物及其制剂A kind of traditional Chinese medicine composition and its preparation for treating pigmentation

技术领域: Technical field:

本发明涉及医药技术领域,具体涉及一种治疗色素沉着的中药组合物及其制剂。The invention relates to the technical field of medicine, in particular to a traditional Chinese medicine composition for treating pigmentation and its preparation.

背景技术: Background technique:

色素沉着可见于许多皮肤病,皮肤病学把以皮肤色素沉着为主要表现的疾病统称为皮肤色素沉着过度性疾病。色素沉着的成因,通常受阳光、紫外线辐射或化妆品、药物及其它物质刺激后,形成黑色的皮肤色素沉积而成,一部分随着角质层脱落;一部分沉淀于底层,通过血液循环排出体外,以上功能一旦失调,便形成了色素沉着。临床上比较常见的是黄褐斑。Hyperpigmentation can be seen in many skin diseases, and dermatology refers to diseases with skin pigmentation as the main manifestation as skin hyperpigmentation diseases. The cause of pigmentation is usually stimulated by sunlight, ultraviolet radiation or cosmetics, drugs and other substances to form black skin pigmentation, part of which falls off with the stratum corneum; part of it precipitates at the bottom and is excreted through blood circulation. Once out of balance, pigmentation is formed. Melasma is the most common clinically.

中医理论认为本病的形成,多与肝、脾、肾功能失调有关,情志失畅,肝气郁结,使气血瘀滞于颜面;脾虚气弱,运化无力,气血不能上荣于面;肾阳不足,肾阴弥漫,使颜面气血失和;肾阴不足,肾水不能上承。病程日久,均可导致血瘀,因此黑斑、褐斑颜色也随之加深。《诸病源候论》云:“五脏六腑十二经血,皆上于面,夫血之行俱荣表里,人或痰饮渍脏,或腠理受风,致气血不和,或涩或浊,不能荣于皮肤,故发生黑皯”精确地论述了面部色素沉着的病因病机。黑色从五行归属于肾,肾病可见肤色黧黑。肾病所致的黧黑,并非外邪湿热所作祟,不论肾阳不足或肾精不足,皆是本虚,或为气虚寒凝或精亏津涸,而非污垢邪浊。The theory of traditional Chinese medicine believes that the formation of this disease is mostly related to the dysfunction of the liver, spleen, and kidney. The emotional disturbance, the stagnation of liver qi, and the stagnation of qi and blood on the face; ; Insufficient kidney yang, diffuse kidney yin, disharmony of Qi and blood in the face; With the passing of time, all can cause blood stasis, so dark spot, brown spot color also deepens thereupon. "On the Causes and Symptoms of Various Diseases" says: "The blood of the five viscera, six fu-organs, six fu-organs, and twelve meridians are all on the face. Or turbidity, can not be honored on the skin, so black pox occurs "accurately discusses the etiology and pathogenesis of facial pigmentation. Black belongs to the kidney from the five elements, and kidney disease can show dark skin. Darkness caused by kidney disease is not caused by exogenous pathogenic dampness and heat. Regardless of deficiency of kidney yang or deficiency of kidney essence, it is all due to deficiency, or it is due to deficiency of qi and coldness or depletion of essence and body fluid, rather than dirt and evil turbidity.

发明内容: Invention content:

本发明的目的在于提供一种治疗色素沉着的中药组合物及其制剂。The object of the present invention is to provide a Chinese medicine composition for treating pigmentation and its preparation.

本发明提供一种治疗色素沉着的中药组合物,该组合物由下述重量份配比的原料药制成:The invention provides a traditional Chinese medicine composition for treating pigmentation. The composition is made of the following raw materials in proportions by weight:

党参8-12份    黄芪8-12份       白术8-12份    土茯苓16-24份Codonopsis 8-12 parts Astragalus 8-12 parts Atractylodes 8-12 parts Smilax 16-24 parts

当归7-11份    怀山药12-18份    赤芍4-8份     白芍4-8份7-11 parts of angelica 12-18 parts of Chinese yam 4-8 parts of red peony root 4-8 parts of white peony root

益母草7-11份  生甘草9-15份。Motherwort 7-11 parts Raw licorice 9-15 parts.

优选的,各组分的重量份是:Preferably, the parts by weight of each component are:

党参10份      黄芪10份         白术10份      土茯苓20份Codonopsis 10 parts Astragalus 10 parts Atractylodes macrocephala 10 parts Smilax tuckahoe 20 parts

当归9份       怀山药15份       赤芍6份       白芍6份Angelica 9 parts Huayam 15 parts Radix Paeoniae Rubra 6 parts Paeoniae Alba 6 parts

益母草9份     生甘草12份。Motherwort 9 parts, raw licorice 12 parts.

本发明还提供了上述治疗色素沉着的中药组合物的口服制剂,是医学上可接受的各种口服剂型,如颗粒剂、片剂、胶囊剂、口服液或糖浆。The present invention also provides oral preparations of the above-mentioned traditional Chinese medicine composition for treating pigmentation, which are in various oral dosage forms acceptable to medicine, such as granules, tablets, capsules, oral liquids or syrups.

本发明还提供了上述治疗色素沉着的中药组合物的口服制剂的制备方法,该方法包括:The present invention also provides a preparation method of the oral preparation of the above-mentioned traditional Chinese medicine composition for treating pigmentation, the method comprising:

(I)活性成分提取物的制备(1) Preparation of active ingredient extract

将上述重量配比的党参、黄芪、白术、土茯苓、当归、怀山药、赤芍、白芍、益母草、生甘草药材,先以3倍水量浸泡2-8小时,再以10倍水量煎煮2次,每次1小时,煎液滤过,滤液合并,浓缩至相对密度为1.3~1.35(50℃)的清膏,加2倍量乙醇,搅匀,静置24小时,上清液回收乙醇;Soak Codonopsis pilosula, Radix Astragali, Atractylodes macrocephala, Smilax cocos, Angelica sinensis, Chinese yam, Radix Paeoniae Rubra, Radix Paeoniae Alba, Motherwort, and Raw Licorice in the above weight ratio, firstly soak in 3 times the amount of water for 2-8 hours, and then decoct in 10 times the amount of water 2 times, 1 hour each time, filter the decoction, combine the filtrates, concentrate to a clear paste with a relative density of 1.3-1.35 (50°C), add 2 times the amount of ethanol, stir well, let stand for 24 hours, and recover the supernatant ethanol;

(II)口服制剂的制备(II) Preparation of oral preparations

将(I)活性成分提取物,按常规方法与药用辅料制成液体口服制剂或固体口服制剂。The (I) active ingredient extract is prepared into a liquid oral preparation or a solid oral preparation with pharmaceutical adjuvants according to a conventional method.

本发明还提供了上述治疗色素沉着的中药组合物的糖浆。步骤(II)具体是:将(I)活性成分提取物,加白糖水200ml,加水至1000ml,搅匀,冷藏24h,滤过,灌装,灭菌,即得糖浆。The present invention also provides the syrup of the above-mentioned traditional Chinese medicine composition for treating pigmentation. Step (II) is specifically: add (I) active ingredient extract, add 200ml of sugar water, add water to 1000ml, stir well, refrigerate for 24h, filter, fill, and sterilize to obtain syrup.

本发明还提供了上述治疗色素沉着的中药组合物的颗粒冲剂。步骤(II)具体是:将(I)活性成分提取物,加水至1000ml,搅匀,冷藏24h,滤过,灌装,灭菌,即得浸膏。在所得浸膏中加入10~40g的糊精和一定量的蔗糖,过16目标准筛,制得颗粒冲剂,80℃恒温干燥。其中浸膏10g时加入40g糊精,干燥速度最快。The present invention also provides the granular granule of the above-mentioned traditional Chinese medicine composition for treating pigmentation. The step (II) is specifically: add water to the active ingredient extract of (I) to 1000ml, stir well, refrigerate for 24 hours, filter, fill, and sterilize to obtain the extract. Add 10-40 g of dextrin and a certain amount of sucrose to the obtained extract, pass through a 16-mesh standard sieve to prepare granules, and dry at a constant temperature of 80°C. Add 40g of dextrin to 10g of extract, and the drying speed is the fastest.

本发明的中药组合物,配方以党参、黄芪、白术、土茯苓等补中益气,健脾益肺中成药为主,辅以补血活血的当归,健脾固肾润肺、益脑填精养颜的怀山药,养血柔肝的白芍,清热凉血、活血化瘀的赤芍,去瘀生新、活血调经的益母草,补脾益气、清热解毒的生甘草,以精良的工艺加工成为补中益气、健脾益肺、活血化瘀的口服制剂,经数十年的临床应用证实,对治疗色素沉着有着良好的功效。The traditional Chinese medicine composition of the present invention is formulated with codonopsis, astragalus, atractylodes macrocephala, Smilax tuckahoe, etc. to invigorate the middle and replenish qi, invigorate the spleen and benefit the lung as the main Chinese patent medicine, supplemented with angelica that invigorates blood and activates blood, invigorates the spleen, strengthens the kidney and moistens the lung, and nourishes the brain and replenishes essence. Chinese yam for beauty, white peony root for nourishing blood and liver, red peony root for clearing heat and cooling blood, promoting blood circulation and removing blood stasis, motherwort for removing blood stasis, promoting blood circulation and regulating menstruation, raw licorice for nourishing spleen and Qi, clearing heat and detoxifying, processed with sophisticated technology It has become an oral preparation for invigorating the middle and replenishing Qi, invigorating the spleen and benefiting the lungs, promoting blood circulation and removing blood stasis. After decades of clinical application, it has been proved that it has a good effect on the treatment of pigmentation.

具体实施方式: Detailed ways:

下面结合实施例对本发明作进一步描述,但本发明的实施不仅限于此:The present invention will be further described below in conjunction with embodiment, but the implementation of the present invention is not limited thereto:

实施例1:Example 1:

配方:党参10.0g    黄芪10.0g    白术10.0g    土茯苓20.0gRecipe: Codonopsis 10.0g Astragalus 10.0g Atractylodes macrocephala 10.0g Smilax 20.0g

      当归9.0g     怀山药15.0g  赤芍6.0g     白芍6.0g  Angelica 9.0g   Huai Yam 15.0g Radix Paeoniae Rubra 6.0g   White Peony Root 6.0g

      益母草9.0g   生甘草12.0g。  Motherwort 9.0g Raw licorice 12.0g.

制备方法:Preparation:

取配方中10味药材,先以3倍水量浸泡6h,,再以10倍水量煎煮2次,每次1小时,煎液滤过,滤液合并,浓缩至相对密度为1.3~1.35(50℃)的清膏,加2倍量乙醇,搅匀,静置24h,上清液回收乙醇,加白糖水200ml,加水至1000ml,搅匀,冷藏24h,滤过,灌装,灭菌,即得。Take 10 medicinal materials in the formula, first soak them in 3 times the amount of water for 6 hours, then decoct them twice with 10 times the amount of water, 1 hour each time, filter the decoction, combine the filtrates, concentrate to a relative density of 1.3-1.35 (50°C ) clear cream, add 2 times the amount of ethanol, stir well, let it stand for 24h, recover ethanol from the supernatant, add 200ml of sugar water, add water to 1000ml, stir well, refrigerate for 24h, filter, fill, sterilize, and get .

实施例2:药物活性试验Embodiment 2: drug activity test

一、资料与方法1. Materials and methods

1、病例:200名女性患者均来自门诊,病程6个月~5年,年龄20岁~50岁,其中,黄褐斑72例,雀斑48例,皮肤色素沉着80例。1. Cases: 200 female patients were all from outpatient clinics. The course of disease was 6 months to 5 years, aged 20 to 50 years. Among them, there were 72 cases of chloasma, 48 cases of freckles, and 80 cases of skin pigmentation.

1、实验组:102例,年龄21~47岁,平均36.5岁1. Experimental group: 102 cases, aged 21 to 47 years old, with an average of 36.5 years old

2、对照组:98例,年龄20~50岁,平均38.6岁2. Control group: 98 cases, aged 20 to 50 years old, with an average of 38.6 years old

3、治疗方法:3. Treatment method:

实验组:口服由实施例1制成的糖浆(A-斑糖浆)每日2次,对照组:口服维生素E,观察期间停用其它内服及外用药物。总疗程8周,每7天观察一次,记录疗效及副作用。Experimental group: oral administration of the syrup made in Example 1 (A-spot syrup) twice a day, control group: oral administration of vitamin E, and other internal and external drugs were stopped during the observation period. The total course of treatment was 8 weeks, and the patients were observed every 7 days, and the curative effect and side effects were recorded.

三、疗效评定标准3. Evaluating Criteria for Efficacy

显效:治疗一个疗程后,色素沉着部分淡化明显,皮肤恢复光泽。Significant effect: After a course of treatment, the pigmentation part is obviously lightened, and the skin regains its luster.

有效:治疗一个疗程后,色素沉着部分淡化,仍有一些色素沉着,皮肤光泽度尚可。Effective: After a course of treatment, the pigmentation part fades, some pigmentation remains, and the skin gloss is acceptable.

无效:治疗一个疗程后,色素撑着部分无淡化。Ineffective: After a course of treatment, the pigmented part has not faded.

四、观察结果:治疗组与对照组一般情况,无显著差异,符合可比性。两组治疗结果见表1,显效加有效为有效率,两组的总有效率分别为89.12%和62.24%,经统计学处理有显著差异(P<0.05),说明治疗组疗效明显高于对照组。4. Observation results: There was no significant difference in the general condition between the treatment group and the control group, which was comparable. The results of the two groups of treatments are shown in Table 1. Markedly effective plus effective is the effective rate. The total effective rates of the two groups are 89.12% and 62.24% respectively, and there is a significant difference through statistical processing (P<0.05), indicating that the curative effect of the treatment group is significantly higher than that of the control group. Group.

表1实验组与对照组疗效比较Table 1 Comparison of curative effect between experimental group and control group

  组别 group   例数 Number of cases   显效 Significantly effective   有效 efficient   无效 invalid   总有效率 total effective rate   治疗组 therapy group   102 102   53(51.96) 53(51.96)   38(37.22) 38(37.22)   11(10.78) 11(10.78)   89.21% 89.21%   对照组 control group   98 98   45(45.91) 45(45.91)   16(16.32) 16(16.32)   23(23.47) 23(23.47)   62.24% 62.24%

毒副作用观察结果:102例实验组观察患者均未出现任何皮肤过敏、身体不适等不良反应,说明本发明中药组合物临床使用安全。Observation results of toxic and side effects: 102 patients in the experimental group did not have any adverse reactions such as skin allergies and physical discomfort, indicating that the Chinese medicine composition of the present invention is safe for clinical use.

经对102例面部皮肤病患者观察结果表明,本发明药物对于黄褐斑、雀斑等皮肤色素沉着等面部皮肤色素沉着性疾病均有显著的疗效,临床观察未见任何不良反应,说明本发明中药组合物是一种治疗面部皮肤病的安全而有效的药物。The observation results of 102 routine facial skin disease patients show that the medicine of the present invention has a significant curative effect on facial skin pigmentation diseases such as chloasma, freckles and other skin pigmentation, and no adverse reactions are seen in clinical observation, which shows that the Chinese medicine of the present invention The composition is a safe and effective medicine for treating facial skin diseases.

Claims (5)

1.一种治疗色素沉着的中药组合物,其特征在于该组合物由下述重量份配比的原料药制成:1. a Chinese medicine composition for the treatment of pigmentation, characterized in that the composition is made from the bulk drug of the following parts by weight ratio: 党参8-12份   黄芪8-12份     白术8-12份   土茯苓16-24份Codonopsis 8-12 parts Astragalus 8-12 parts Atractylodes 8-12 parts Smilax 16-24 parts 当归7-11份   怀山药12-18份  赤芍4-8份    白芍4-8份Angelica 7-11 parts Chinese yam 12-18 parts red peony root 4-8 parts white peony root 4-8 parts 益母草7-11份 生甘草9-15份。Motherwort 7-11 parts Raw licorice 9-15 parts. 2.根据权利要求1所述的一种治疗色素沉着的中药组合物,其特征在于该组合物由下述重量份配比的原料药制成:2. a kind of Chinese medicine composition for the treatment of pigmentation according to claim 1, is characterized in that this composition is made of the bulk drug of following weight portion proportioning: 党参10份   黄芪10份    白术10份   土茯苓20份Codonopsis 10 parts Astragalus 10 parts Atractylodes macrocephala 10 parts Smilax cocos 20 parts 当归9份    怀山药15份  赤芍6份    白芍6份9 parts of Angelica, 15 parts of Chinese Yam, 6 parts of Radix Paeoniae Alba, 6 parts of Paeoniae Alba 益母草9份  生甘草12份。Motherwort 9 parts Raw licorice 12 parts. 3.根据权利要求1或2所述的一种治疗色素沉着的中药组合物,其特征该中药组合物和常规药用辅料制成口服制剂。3. A kind of Chinese medicine composition for treating pigmentation according to claim 1 or 2, characterized in that the Chinese medicine composition and conventional pharmaceutical adjuvants are made into oral preparations. 4.根据权利要求3所述的一种治疗色素沉着的中药组合物,其特征该中药组合物和常规药用辅料制成的口服制剂是糖浆或颗粒冲剂。4. A Chinese medicine composition for treating pigmentation according to claim 3, characterized in that the oral preparation made from the Chinese medicine composition and conventional pharmaceutical adjuvants is syrup or granule. 5.一种制备治疗色素沉着的中药组合物的口服制剂的方法,该方法包括:5. A method for preparing an oral preparation of a Chinese medicine composition for the treatment of pigmentation, the method comprising: (I)活性成分提取物的制备(1) preparation of active ingredient extract 将下述重量份配比的药材:With the medicinal material of following weight portion proportioning: 党参8-12份   黄芪8-12份   白术8-12份   土茯苓16-24份Codonopsis 8-12 parts Astragalus 8-12 parts Atractylodes 8-12 parts Smilax 16-24 parts 当归7-11份   怀山药12-18  份赤芍4-8份  白芍4-8份7-11 parts of angelica, 12-18 parts of Chinese yam, 4-8 parts of red peony, 4-8 parts of white peony 益母草7-11份 生甘草9-15份,Motherwort 7-11 parts Raw licorice 9-15 parts, 先以3倍水量浸泡2-8小时,再以10倍水量煎煮2次,每次1小时,煎液滤过,滤液合并,浓缩至50℃相对密度为1.3~1.35的清膏,加2倍量乙醇,搅匀,静置24小时,上清液回收乙醇;First soak in 3 times the amount of water for 2-8 hours, then decoct twice with 10 times the amount of water, 1 hour each time, filter the decoction, combine the filtrates, concentrate to a clear paste with a relative density of 1.3 to 1.35 at 50°C, add 2 Double the amount of ethanol, stir well, let it stand for 24 hours, and recover ethanol from the supernatant; (II)口服制剂的制备(II) Preparation of oral preparations 将(I)活性成分提取物,按常规方法与药用辅料制成液体口服制剂或固体口服制剂。The (I) active ingredient extract is prepared into a liquid oral preparation or a solid oral preparation with pharmaceutical adjuvants according to a conventional method.
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