CN107468858B - A kind of Chinese medicinal ointment and preparation method thereof for treating stagnation of QI due to depression of the liver psoriasis pustulosa - Google Patents
A kind of Chinese medicinal ointment and preparation method thereof for treating stagnation of QI due to depression of the liver psoriasis pustulosa Download PDFInfo
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- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
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- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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Abstract
本发明属于医药领域,特别涉及一种治疗肝郁气滞型银屑病的中药膏剂。该药物组合物的中药材组方按照重量份比计算为:粉萆薢27~36重量份、南鹤虱16~20重量份、土鳖虫11~15重量份、冰片9~12重量份、钻地风1~4重量份、酢浆草1~4重量份、醉魂藤1~4重量份制成。该治疗肝郁气滞型银屑病的中药膏剂采用乙醇提取,浓缩为浸膏后与膏剂的油相辅料以及水相辅料混合,乳化后制得。The invention belongs to the field of medicine, in particular to a traditional Chinese medicinal ointment for treating psoriasis of liver depression and qi stagnation type. The traditional Chinese medicinal material prescription of the pharmaceutical composition is calculated according to the weight ratio: 27-36 parts by weight of fennel, 16-20 parts by weight of southern crane louse, 11-15 parts by weight of ground beetle, 9-12 parts by weight of borneol, It is prepared by 1-4 parts by weight of wind, 1-4 parts by weight of sorrel and 1-4 parts by weight of drunken vine. The traditional Chinese medicine ointment for treating psoriasis of liver depression and qi stagnation type is extracted by ethanol, concentrated into extractum, mixed with oil phase auxiliary materials and water phase auxiliary materials of the ointment, and emulsified.
Description
技术领域technical field
本发明属于医药领域,具体涉及一种治疗肝郁气滞型银屑病的中药膏剂及其制备方法。The invention belongs to the field of medicine, and in particular relates to a traditional Chinese medicinal ointment for treating psoriasis of liver depression and qi stagnation type and a preparation method thereof.
背景技术Background technique
在银屑病是一种常见的慢性复发性皮肤病。根据临床特征,可分为寻常型、关节型、脓疱型、红皮病型。其中寻常型银屑病最常见,占 90%以上。银屑病皮损为红色丘疹或红斑上覆盖厚厚的银白色鳞屑,具有“薄膜现象、蜡滴现象、点状出血”的特点;多发于全身,对称分布于头皮、四肢伸侧及骶尾部,常伴有不同程度瘙痒。Psoriasis is a common chronic relapsing skin disease. According to clinical features, it can be divided into vulgar, joint, pustular, and erythrodermic types. Among them, psoriasis vulgaris is the most common, accounting for more than 90%. Psoriatic lesions are red papules or erythema covered with thick silvery-white scales, with the characteristics of "film phenomenon, wax drop phenomenon, and spotting"; they mostly occur in the whole body, and are symmetrically distributed on the scalp, extensor sides of limbs, and sacrum , often accompanied by varying degrees of itching.
现代医学对于银屑病的发病原因尚未研究清楚。目前研究认为该病与遗传、环境等多种因素有关,并与免疫介导的角质形成细胞增殖有关。化学药物治疗多采用免疫抑制药物、肾上腺皮质激素类、抗生素等,因其反复发作,化学药物副作用较大且效果不太理想,限制了其临床应用。The pathogenesis of psoriasis has not been studied clearly in modern medicine. Current studies suggest that the disease is related to multiple factors such as genetics and environment, and is related to immune-mediated keratinocyte proliferation. Chemotherapy mostly uses immunosuppressive drugs, adrenal cortex hormones, antibiotics, etc. Because of its recurrent attacks, the side effects of chemical drugs are relatively large and the effect is not ideal, which limits its clinical application.
银屑病在中医文献中也称为“白疤”、“干癣”、“松皮癣”、“白壳疮”、“蛇虱” 等。祖国医学通过长期的临床实践与摸索,在治疗银屑病的方面形成了一些系统的理论和方法,并取得了一定疗效。在中医治疗方面,银屑病的证型主要为血热型、血瘀型、血燥型、血虚型,其他证型如湿热型、 风热型、风寒型、肝肾不足型、肝郁气滞型、脾肾亏虚型、冲任不调证型相较少。因此在辨证论治的基础上,目前治疗银屑病主要采用补血、凉血、活血药物。最常用的是包括生地、当归、丹皮、甘草、赤芍、丹参、白鲜皮、土茯苓、紫草,其他药物的使用主要为清热解毒药、活血化瘀药、补虚药。药对配伍以生地+牡丹皮、当归+川芎、熟地+当归使用频次最多,形成以清热解毒、活血化瘀、补虚为特点的基本治则。而对于肝郁气滞型银屑病目前尚未见理想的治疗方剂。Psoriasis is also called " white scar ", " psoriasis ", " pine skin tinea ", " white shell sore ", " snake lice " etc. in Chinese medicine literature. Through long-term clinical practice and exploration, Chinese medicine has formed some systematic theories and methods in the treatment of psoriasis, and has achieved certain curative effects. In terms of TCM treatment, the syndrome types of psoriasis are mainly blood-heat type, blood stasis type, blood-dryness type, and blood-deficiency type, and other syndrome types such as damp-heat type, wind-heat type, wind-cold type, liver-kidney deficiency type, Qi stagnation type, spleen and kidney deficiency type, and Chong-ren imbalance syndrome type are less. Therefore, on the basis of syndrome differentiation and treatment, the current treatment of psoriasis mainly adopts blood-enriching, blood-cooling and blood-activating drugs. The most commonly used ones include rehmannia root, angelica, paeonol, licorice, red peony root, salvia miltiorrhiza, white fresh skin, smilax cocos, and comfrey. Other drugs are mainly heat-clearing and detoxifying drugs, blood-activating and stasis-removing drugs, and deficiency-reinforcing drugs. For the compatibility of medicine pairs, Shengdi + Cortex Moutan, Angelica + Chuanxiong, and Rehmannia + Angelica are used most frequently, forming a basic treatment principle characterized by clearing away heat and detoxification, promoting blood circulation and removing blood stasis, and tonifying deficiency. For psoriasis of liver depression and qi stagnation type, there is no ideal treatment prescription at present.
因此,目前仍需要对肝郁气滞型银屑病的中药组方进行筛选和药效研究,以便为临床治疗提供治疗选择。Therefore, it is still necessary to screen and study the efficacy of traditional Chinese medicine prescriptions for psoriasis with liver depression and qi stagnation, so as to provide treatment options for clinical treatment.
发明内容Contents of the invention
针对上述现有技术,本发明的目的之一是提供一种治疗肝郁气滞型银屑病的中药膏剂,为实现上述目的,本发明采用的技术方案如下:For above-mentioned prior art, one of purpose of the present invention is to provide a kind of Chinese medicinal ointment for the treatment of psoriasis of stagnation of liver-QI stagnation type, for realizing above-mentioned purpose, the technical scheme that the present invention adopts is as follows:
一种治疗肝郁气滞型银屑病的中药膏剂,由以下重量份比的中药材作为原料制成粉萆薢A traditional Chinese medicine ointment for treating psoriasis of liver depression and qi stagnation type, which is made of Chinese medicinal materials in the following weight ratios as raw materials
27~36重量份、南鹤虱16~20重量份、土鳖虫11~15重量份、冰片9~12重量份、钻地风1~4重量份、酢浆草1~4重量份、醉魂藤1~4重量份。27-36 parts by weight, 16-20 parts by weight of southern crane lice, 11-15 parts by weight of ground beetle, 9-12 parts by weight of borneol, 1-4 parts by weight of earth-boring wind, 1-4 parts by weight of sorrel, drunk soul Rattan 1-4 parts by weight.
在一个优选的技术方案中,所述中药膏剂由以下重量份比的中药材作为原料制成:粉萆薢31重量份、南鹤虱17重量份、土鳖虫14重量份、冰片10重量份、钻地风3重量份、酢浆草2重量份、醉魂藤2重量份。In a preferred technical solution, the traditional Chinese medicine ointment is made of the following Chinese medicinal materials in parts by weight as raw materials: 31 parts by weight of Rhododendron chinensis, 17 parts by weight of Southern crane lice, 14 parts by weight of ground beetle, 10 parts by weight of borneol, 3 parts by weight of ground wind, 2 parts by weight of sorrel, and 2 parts by weight of drunken vine.
在另一个优选的技术方案中,所述中药膏剂由以下重量份比的中药材作为原料制成:粉萆薢35重量份、南鹤虱19重量份、土鳖虫12重量份、冰片11重量份、钻地风2重量份、酢浆草3重量份、醉魂藤3重量份。In another preferred technical solution, the traditional Chinese medicine ointment is made of the following Chinese medicinal materials in parts by weight as raw materials: 35 parts by weight of Rhododendron chinensis, 19 parts by weight of southern crane louse, 12 parts by weight of wood beetle, 11 parts by weight of borneol, 2 parts by weight of earth-boring wind, 3 parts by weight of wood sorrel, and 3 parts by weight of drunken vine.
在另一个优选的技术方案中,所述中药膏剂由以下重量份比的中药材作为原料制成粉萆薢28重量份、南鹤虱18重量份、土鳖虫13重量份、冰片11重量份、钻地风3重量份、酢浆草3重量份、醉魂藤3重量份。In another preferred technical solution, the traditional Chinese medicine ointment is made of the following Chinese medicinal materials in the following weight ratios as raw materials: 28 parts by weight of fennel, 18 parts by weight of southern crane louse, 13 parts by weight of ground beetle, 11 parts by weight of borneol, 3 parts by weight of ground wind, 3 parts by weight of sorrel, and 3 parts by weight of drunken vine.
优选的,上述中药膏剂为软膏剂、乳膏剂中的一种。Preferably, the above-mentioned traditional Chinese medicine ointment is one of ointment and cream.
优选的,上述中药膏剂还含有医药学上可接受的药用辅料。Preferably, the above-mentioned traditional Chinese medicine ointment also contains pharmaceutically acceptable pharmaceutical excipients.
优选的,上述医药学上可接受的药用辅料包括硬脂酸、单硬脂酸甘油脂、液体石蜡、凡士林、羊毛脂,三乙醇胺、尼泊金乙酯、氮酮和去离子水。Preferably, the pharmaceutically acceptable excipients include stearic acid, glycerol monostearate, liquid paraffin, petrolatum, lanolin, triethanolamine, ethylparaben, azone and deionized water.
本发明的另一方面提供了上述治疗肝郁气滞型银屑病的中药膏剂的制备方法,包括以下步骤:Another aspect of the present invention provides the preparation method of the above-mentioned traditional Chinese medicine ointment for the treatment of liver depression and qi stagnation type psoriasis, comprising the following steps:
1)取处方量粉萆薢、南鹤虱、土鳖虫、钻地风、酢浆草、醉魂藤分别粉碎,过70目筛,1) Take the prescribed amount of fenugreek, southern crane lice, ground beetle, earth-burrowing wind, wood sorrel, and drunken vine, and crush them separately, and pass through a 70-mesh sieve.
混合得药材粉末;Mixed medicinal powder;
2)按照料液比为1:3~1:6的比例向步骤1)所得要药材粉末中加入浓度为60%~70%2) According to the ratio of solid-liquid ratio of 1:3 to 1:6, add the concentration of 60% to 70% to the medicinal powder obtained in step 1).
的乙醇浸泡2~4h,然后70℃下恒温水浴回流提取4h,放冷过滤,得药材醇提液;Soak in ethanol for 2 to 4 hours, then reflux extraction in a constant temperature water bath at 70°C for 4 hours, let it cool and filter, and obtain the alcoholic extract of the medicinal material;
3)将步骤2)所得药材醇提液蒸发浓缩至相对密度为1.15~1.35,冷却后加入处方量的3) Evaporate and concentrate the alcoholic extract of medicinal materials obtained in step 2) to a relative density of 1.15-1.35, add the prescribed amount of
冰片,搅拌均匀得药材浸膏;Borneol, stirred evenly to obtain medicinal material extract;
4)将步骤3)所得浸膏与医药学上可接受的要用辅料混合制备成中药膏剂。4) Mix the extract obtained in step 3) with pharmaceutically acceptable auxiliary materials to prepare a traditional Chinese medicine ointment.
优选的,步骤2)中所述料液比为1:4,乙醇浓度为65%,乙醇浸泡时间为3.5h;步骤3)中所述药材醇提液蒸发浓缩至相对密度为1.32。Preferably, the solid-to-liquid ratio in step 2) is 1:4, the ethanol concentration is 65%, and the soaking time in ethanol is 3.5 hours; the alcohol extract of medicinal materials in step 3) is evaporated and concentrated to a relative density of 1.32.
优选的,上述步骤4)包括以下步骤:Preferably, the above step 4) includes the following steps:
a、取药材浸膏重量50%的硬脂酸、药材浸膏重量12%的单硬脂酸甘油脂、药材浸膏重量20%的液体石蜡、药材浸膏重量8%的凡士林、药材浸膏重量20%的羊毛脂和药材浸膏重量4%的氮酮置于容器中,水浴加热熔化,搅拌均匀,作为油相,70℃恒温保存备用;a, get the stearic acid of medicinal material extract weight 50%, the glyceryl monostearate of medicinal material extract weight 12%, the liquid paraffin of medicinal material extract weight 20%, the vaseline of medicinal material extract weight 8%, medicinal material extract 20% by weight of lanolin and 4% by weight of medicinal extracts of azone are placed in a container, heated and melted in a water bath, stirred evenly, used as an oil phase, and kept at a constant temperature of 70°C for later use;
b、取药材浸膏重量2.8%的三乙醇胺、药材浸膏重量2%的尼泊金乙酯和药材浸膏重量191%的去离子水置于另一容器中,加热至完全溶解,作为水相;B, get the triethanolamine of medicinal material extract weight 2.8%, the paraben ethyl ester of medicinal material extract weight 2% and the deionized water of medicinal material extract weight 191% are placed in another container, be heated to dissolving completely, as water Mutually;
c、将水相缓慢倒入油相中,搅拌均匀后加入步骤3)所得药材浸膏,边加入边搅拌,至乳化完全,放冷后灌装即得软膏剂。c. Slowly pour the water phase into the oil phase, stir evenly, add the medicinal material extract obtained in step 3), stir while adding, until the emulsification is complete, let it cool, and then fill it to obtain an ointment.
本发明技术方案中所述的粉萆薢为薯蓣科植物粉背薯蓣Dioscorea hypoglaucaPalibin的干燥根茎。 苦,平。归肾、胃经。功效为利湿去浊、祛风除痹。其来源及药材标准收录于中国药典2015版。Dioscorea hypoglauca Palibin described in the technical solution of the present invention is the dry rhizome of Dioscorea hypoglauca Palibin. Bitter, flat. Return kidney, stomach warp. Efficacy is dampness removing turbidity, dispelling wind and removing numbness. Its source and medicinal material standards are included in the Chinese Pharmacopoeia 2015 edition.
本发明技术方案中所述的南鹤虱为伞形科植物野胡萝卜DaucuscarotaL.的干燥成熟果实。苦、辛,平;有小毒。归脾、胃经。功效为杀虫消积。其来源及药材标准收录于中国药典2015版。The southern crane lice described in the technical solution of the present invention is the dry and mature fruit of the wild carrot Daucuscarota L. of the Umbelliferae plant. Bitter, pungent, flat; slightly poisonous. Return spleen, stomach warp. The effect is to kill insects and eliminate accumulation. Its source and medicinal material standards are included in the Chinese Pharmacopoeia 2015 edition.
本发明技术方案中所述的土鳖虫为鳖蠊科昆虫地鳖EupolyphagaSinesisWalker或冀地鳖Steleophagaplancyi(Boleny)的雌虫干燥体。咸,寒;有小毒。归肝经。功效为破血逐瘀,续筋接骨。其来源及药材标准收录于中国药典2015版。The ground beetle described in the technical solution of the present invention is the dried female body of Eupolyphaga Sinesis Walker or Steleophaga plancyi (Boleny), an insect of the cockroach family Eupolyphaga Sinesis Walker. Salty, cold; slightly poisonous. Return liver channel. Efficacy is breaking blood and removing blood stasis, renewing tendons and bones. Its source and medicinal material standards are included in the Chinese Pharmacopoeia 2015 edition.
本发明技术方案中所述的钻地风为虎耳草科植物钻地风Schizophragmaintegrifolium(Franch.)Oliv.的根及茎藤。性凉,味淡,入脾经。功效为祛风除湿,其来源及性状收录于《中药大辞典》。The ground-boring wind described in the technical solution of the present invention is the root and stem of the saxifrage plant Schizophragmaintegrifolium (Franch.) Oliv. Cool in nature, mild in taste, enters the spleen meridian. The effect is to dispel wind and dampness, and its source and properties are included in the "Dictionary of Chinese Medicine".
本发明技术方案中所述的酢浆草为酢浆草科植物酢浆草 Oxalis corniculataLinnaeus 的干燥全草。酸,寒。入肝、肺、膀胱经。功效为清热利湿、凉血散瘀、消肿解毒。The wood sorrel described in the technical solution of the present invention is the dry whole grass of Oxalis corniculata Linnaeus of Oxalis family plant. sour, cold. Go into liver, lung, urinary bladder channel. Efficacy is clearing heat and dampness, cooling blood and dissipating blood stasis, reducing swelling and detoxification.
本发明技术方案中所述的醉魂藤为萝藦科醉魂藤Heterostemma alatum Wight的根,苦;平。入肝、肾经。功效为宣壅逐湿;辟秽疗疟。The drunken vine described in the technical solution of the present invention is the root of Heterostemma alatum Wight, bitter; flat. Go into liver, kidney channel. The effect is to dispel stagnation and eliminate dampness; to ward off filth and treat malaria.
本发明的发明人经过大量处方筛选发现,粉萆薢、南鹤虱、土鳖虫、冰片组合物外用对肝郁气滞型银屑病治疗效果较差,钻地风、酢浆草组合物外用对肝郁气滞型银屑病无显著治疗效果,但上述中药按特定比例组合,并与醉魂藤按特定比例合并使用时,外用对肝郁气滞型银屑病具有出乎意料的治疗效果,且成本较低,药效发挥更快。The inventors of the present invention have found through a large number of prescription screenings that the external application of the composition of fenugreek, southern crane louse, wood beetle, and borneol has poor therapeutic effect on psoriasis of liver depression and qi stagnation type. There is no significant therapeutic effect on psoriasis of stagnation of liver and qi stagnation, but when the above-mentioned traditional Chinese medicine is combined in a specific proportion and used in combination with Drunken Soul Vine in a specific proportion, the external application has an unexpected therapeutic effect on psoriasis of stagnation of liver and qi stagnation , and the cost is lower, and the efficacy of the drug is exerted faster.
具体实施方式Detailed ways
下面结合实施例对本发明作进一步的解释。应当理解的是,以下实施例仅用于解释本发明,而不是限制本发明的保护范围。Below in conjunction with embodiment the present invention is further explained. It should be understood that the following examples are only used to explain the present invention, rather than limit the protection scope of the present invention.
实施例1 治疗肝郁气滞型银屑病的中药膏剂及其制备Example 1 Traditional Chinese Medicine Ointment for Treating Liver Qi Stagnation Type Psoriasis and Its Preparation
治疗肝郁气滞型银屑病的中药膏剂的组方见下表:The prescription of traditional Chinese medicine ointment for treating psoriasis of stagnation of liver stagnation and qi stagnation is shown in the table below:
制备方法:Preparation:
1)取处方量粉萆薢、南鹤虱、土鳖虫、钻地风、酢浆草、醉魂藤分别粉碎,过70目筛,1) Take the prescribed amount of fenugreek, southern crane lice, ground beetle, earth-burrowing wind, wood sorrel, and drunken vine, and crush them separately, and pass through a 70-mesh sieve.
混合得药材粉末;Mixed medicinal powder;
2)按照料液比为1:4的比例向步骤1)所得要药材粉末中加入浓度为65%的乙醇浸泡2) According to the ratio of solid to liquid of 1:4, add 65% ethanol to the medicinal material powder obtained in step 1) to soak
3.5h,然后70℃下恒温水浴回流提取4h,放冷过滤,得药材醇提液;3.5h, then reflux extraction in a constant temperature water bath at 70°C for 4h, let it cool and filter to obtain the alcoholic extract of medicinal materials;
3)将步骤2)所得药材醇提液蒸发浓缩至相对密度为1.32,冷却后加入处方量的冰片,3) Evaporate and concentrate the medicinal material alcohol extract obtained in step 2) to a relative density of 1.32, add the prescribed amount of borneol after cooling,
搅拌均匀得药材浸膏;Stir evenly to obtain medicinal material extract;
4)取药材浸膏重量50%的硬脂酸、药材浸膏重量12%的单硬脂酸甘油脂、药材浸膏重量20%的液体石蜡、药材浸膏重量8%的凡士林、药材浸膏重量20%的羊毛脂和药材浸膏重量4%的氮酮置于容器中,水浴加热熔化,搅拌均匀,作为油相,70℃恒温保存备用;4) Take stearic acid with 50% weight of medicinal material extract, glyceryl monostearate with 12% weight of medicinal material extract, liquid paraffin with 20% weight of medicinal material extract, vaseline with 8% weight of medicinal material extract, and medicinal material extract 20% by weight of lanolin and 4% by weight of medicinal extracts of azone are placed in a container, heated and melted in a water bath, stirred evenly, used as an oil phase, and kept at a constant temperature of 70°C for later use;
取药材浸膏重量2.8%的三乙醇胺、药材浸膏重量2%的尼泊金乙酯和药材浸膏重量191%的去离子水置于另一容器中,加热至完全溶解,作为水相;Get the triethanolamine of medicinal material extract weight 2.8%, the paraben ethyl ester of medicinal material extract weight 2% and the deionized water of medicinal material extract weight 191% are placed in another container, be heated to completely dissolving, as water phase;
将水相缓慢倒入油相中,搅拌均匀后加入步骤3)所得药材浸膏,边加入边搅拌,至乳化完全,放冷后灌装得软膏剂。Slowly pour the water phase into the oil phase, stir evenly, add the medicinal material extract obtained in step 3), stir while adding, until the emulsification is complete, let it cool, and then fill it to obtain an ointment.
实施例2 治疗肝郁气滞型银屑病的中药膏剂及其制备Example 2 Chinese medicine ointment for treating psoriasis of stagnation of liver stagnation and qi stagnation and its preparation
治疗肝郁气滞型银屑病的中药膏剂的组方见下表:The prescription of traditional Chinese medicine ointment for treating psoriasis of stagnation of liver stagnation and qi stagnation is shown in the table below:
制备方法:Preparation:
1)取处方量粉萆薢、南鹤虱、土鳖虫、钻地风、酢浆草、醉魂藤分别粉碎,过70目筛,1) Take the prescribed amount of fenugreek, southern crane lice, ground beetle, earth-burrowing wind, wood sorrel, and drunken vine, and crush them separately, and pass through a 70-mesh sieve.
混合得药材粉末;Mixed medicinal powder;
2)按照料液比为1:5的比例向步骤1)所得要药材粉末中加入浓度为70%的乙醇浸泡2) Add 70% ethanol to the medicinal material powder obtained in step 1) according to the ratio of solid to liquid: 1:5 for soaking
3.0h,然后70℃下恒温水浴回流提取4h,放冷过滤,得药材醇提液;3.0h, then reflux extraction in a constant temperature water bath at 70°C for 4h, let it cool and filter to obtain the alcoholic extract of medicinal materials;
3)将步骤2)所得药材醇提液蒸发浓缩至相对密度为1.35,冷却后加入处方量的冰片,3) Evaporate and concentrate the medicinal material alcohol extract obtained in step 2) to a relative density of 1.35, add the prescribed amount of borneol after cooling,
搅拌均匀得药材浸膏;Stir evenly to obtain medicinal material extract;
4)取药材浸膏重量50%的硬脂酸、药材浸膏重量12%的单硬脂酸甘油脂、药材浸膏重量20%的液体石蜡、药材浸膏重量8%的凡士林、药材浸膏重量20%的羊毛脂和药材浸膏重量4%的氮酮置于容器中,水浴加热熔化,搅拌均匀,作为油相,70℃恒温保存备用;4) Take stearic acid with 50% weight of medicinal material extract, glyceryl monostearate with 12% weight of medicinal material extract, liquid paraffin with 20% weight of medicinal material extract, vaseline with 8% weight of medicinal material extract, and medicinal material extract 20% by weight of lanolin and 4% by weight of medicinal extracts of azone are placed in a container, heated and melted in a water bath, stirred evenly, used as an oil phase, and kept at a constant temperature of 70°C for later use;
取药材浸膏重量2.8%的三乙醇胺、药材浸膏重量2%的尼泊金乙酯和药材浸膏重量191%的去离子水置于另一容器中,加热至完全溶解,作为水相;Get the triethanolamine of medicinal material extract weight 2.8%, the paraben ethyl ester of medicinal material extract weight 2% and the deionized water of medicinal material extract weight 191% are placed in another container, be heated to completely dissolving, as water phase;
将水相缓慢倒入油相中,搅拌均匀后加入步骤3)所得药材浸膏,边加入边搅拌,至乳化完全,放冷后灌装得软膏剂。Slowly pour the water phase into the oil phase, stir evenly, add the medicinal material extract obtained in step 3), stir while adding, until the emulsification is complete, let it cool, and then fill it to obtain an ointment.
实施例3 治疗肝郁气滞型银屑病的中药膏剂的临床前药效学研究Example 3 Preclinical Pharmacodynamics Study of Traditional Chinese Medicine Ointment for Treatment of Liver Qi Stagnation Type Psoriasis
药物及其制备:实验采用实施例1组方3、组方4、组方5制备的中药膏剂作为实验药物;为对比药物效果,特制备以下6种对比药物作为阳性对照:Medicines and their preparation: The traditional Chinese medicine ointments prepared by prescription 3, prescription 4, and prescription 5 of Example 1 were used in the experiment as experimental medicines; in order to compare the effects of medicines, the following 6 kinds of comparative medicines were specially prepared as positive controls:
对比例1:组方配比为粉萆薢360g、南鹤虱200 g、土鳖虫150 g、冰片120 g。制备方法如下:Comparative example 1: The formula ratio is 360 g of fennel, 200 g of southern crane louse, 150 g of ground beetle, and 120 g of borneol. The preparation method is as follows:
1)取处方量粉萆薢、南鹤虱、土鳖虫分别粉碎,过70目筛,混合得药材粉末;1) Take the prescribed amount of fennel, southern crane lice, and ground beetle, grind them separately, pass through a 70-mesh sieve, and mix to obtain medicinal powder;
2)按照料液比为1:4的比例向步骤1)所得要药材粉末中加入浓度为65%的乙醇浸泡2) According to the ratio of solid to liquid of 1:4, add 65% ethanol to the medicinal material powder obtained in step 1) to soak
3.5h,然后70℃下恒温水浴回流提取4h,放冷过滤,得药材醇提液;3.5h, then reflux extraction in a constant temperature water bath at 70°C for 4h, let it cool and filter to obtain the alcoholic extract of medicinal materials;
3)将步骤2)所得药材醇提液蒸发浓缩至相对密度为1.32,冷却后加入处方量的冰片,3) Evaporate and concentrate the medicinal material alcohol extract obtained in step 2) to a relative density of 1.32, add the prescribed amount of borneol after cooling,
搅拌均匀得药材浸膏;Stir evenly to obtain medicinal material extract;
4)取药材浸膏重量50%的硬脂酸、药材浸膏重量12%的单硬脂酸甘油脂、药材浸膏重量20%的液体石蜡、药材浸膏重量8%的凡士林、药材浸膏重量20%的羊毛脂和药材浸膏重量4%的氮酮置于容器中,水浴加热熔化,搅拌均匀,作为油相,70℃恒温保存备用;4) Take stearic acid with 50% weight of medicinal material extract, glyceryl monostearate with 12% weight of medicinal material extract, liquid paraffin with 20% weight of medicinal material extract, vaseline with 8% weight of medicinal material extract, and medicinal material extract 20% by weight of lanolin and 4% by weight of medicinal extracts of azone are placed in a container, heated and melted in a water bath, stirred evenly, used as an oil phase, and kept at a constant temperature of 70°C for later use;
取药材浸膏重量2.8%的三乙醇胺、药材浸膏重量2%的尼泊金乙酯和药材浸膏重量191%的去离子水置于另一容器中,加热至完全溶解,作为水相;Get the triethanolamine of medicinal material extract weight 2.8%, the paraben ethyl ester of medicinal material extract weight 2% and the deionized water of medicinal material extract weight 191% are placed in another container, be heated to completely dissolving, as water phase;
将水相缓慢倒入油相中,搅拌均匀后加入步骤3)所得药材浸膏,边加入边搅拌,至乳化完全,放冷后灌装得软膏剂。Slowly pour the water phase into the oil phase, stir evenly, add the medicinal material extract obtained in step 3), stir while adding, until the emulsification is complete, let it cool, and then fill it to obtain an ointment.
对比例2:组方配比为钻地风400g、酢浆草400g。制备方法如下:Comparative example 2: The prescription ratio is 400g of ground-boring wind and 400g of sorrel. The preparation method is as follows:
1)取处方量钻地风、酢浆草分别粉碎,过70目筛,混合得药材粉末;1) Take the prescription amount of the ground wind and wood sorrel, grind them separately, pass through a 70-mesh sieve, and mix to obtain medicinal powder;
2)按照料液比为1:4的比例向步骤1)所得要药材粉末中加入浓度为65%的乙醇浸泡2) According to the ratio of solid to liquid of 1:4, add 65% ethanol to the medicinal material powder obtained in step 1) to soak
3.5h,然后70℃下恒温水浴回流提取4h,放冷过滤,得药材醇提液;3.5h, then reflux extraction in a constant temperature water bath at 70°C for 4h, let it cool and filter to obtain the alcoholic extract of medicinal materials;
3)将步骤2)所得药材醇提液蒸发浓缩至相对密度为1.32得药材浸膏;3) Evaporate and concentrate the medicinal material alcohol extract obtained in step 2) to a relative density of 1.32 to obtain medicinal material extract;
4)取药材浸膏重量50%的硬脂酸、药材浸膏重量12%的单硬脂酸甘油脂、药材浸膏重量20%的液体石蜡、药材浸膏重量8%的凡士林、药材浸膏重量20%的羊毛脂和药材浸膏重量4%的氮酮置于容器中,水浴加热熔化,搅拌均匀,作为油相,70℃恒温保存备用;4) Take stearic acid with 50% weight of medicinal material extract, glyceryl monostearate with 12% weight of medicinal material extract, liquid paraffin with 20% weight of medicinal material extract, vaseline with 8% weight of medicinal material extract, and medicinal material extract 20% by weight of lanolin and 4% by weight of medicinal extracts of azone are placed in a container, heated and melted in a water bath, stirred evenly, used as an oil phase, and kept at a constant temperature of 70°C for later use;
取药材浸膏重量2.8%的三乙醇胺、药材浸膏重量2%的尼泊金乙酯和药材浸膏重量191%的去离子水置于另一容器中,加热至完全溶解,作为水相;Get the triethanolamine of medicinal material extract weight 2.8%, the paraben ethyl ester of medicinal material extract weight 2% and the deionized water of medicinal material extract weight 191% are placed in another container, be heated to completely dissolving, as water phase;
将水相缓慢倒入油相中,搅拌均匀后加入步骤3)所得药材浸膏,边加入边搅拌,至乳化完全,放冷后灌装得软膏剂。Slowly pour the water phase into the oil phase, stir evenly, add the medicinal material extract obtained in step 3), stir while adding, until the emulsification is complete, let it cool, and then fill it to obtain an ointment.
对比例3:组方配比为醉魂藤800g,制备方法如下:Comparative example 3: The prescription ratio is 800g of Drunken Soul Vine, and the preparation method is as follows:
1)取处方量醉魂藤粉碎,过70目筛,得药材粉末;1) Take the prescription amount of Drunken Soul Vine, crush it, and pass it through a 70-mesh sieve to obtain medicinal powder;
2)按照料液比为1:4的比例向步骤1)所得要药材粉末中加入浓度为65%的乙醇浸泡2) According to the ratio of solid to liquid of 1:4, add 65% ethanol to the medicinal material powder obtained in step 1) to soak
3.5h,然后70℃下恒温水浴回流提取4h,放冷过滤,得药材醇提液;3.5h, then reflux extraction in a constant temperature water bath at 70°C for 4h, let it cool and filter to obtain the alcoholic extract of medicinal materials;
3)将步骤2)所得药材醇提液蒸发浓缩至相对密度为1.32得药材浸膏;3) Evaporate and concentrate the medicinal material alcohol extract obtained in step 2) to a relative density of 1.32 to obtain medicinal material extract;
4)取药材浸膏重量50%的硬脂酸、药材浸膏重量12%的单硬脂酸甘油脂、药材浸膏重量20%的液体石蜡、药材浸膏重量8%的凡士林、药材浸膏重量20%的羊毛脂和药材浸膏重量4%的氮酮置于容器中,水浴加热熔化,搅拌均匀,作为油相,70℃恒温保存备用;4) Take stearic acid with 50% weight of medicinal material extract, glyceryl monostearate with 12% weight of medicinal material extract, liquid paraffin with 20% weight of medicinal material extract, vaseline with 8% weight of medicinal material extract, and medicinal material extract 20% by weight of lanolin and 4% by weight of medicinal extracts of azone are placed in a container, heated and melted in a water bath, stirred evenly, used as an oil phase, and kept at a constant temperature of 70°C for later use;
取药材浸膏重量2.8%的三乙醇胺、药材浸膏重量2%的尼泊金乙酯和药材浸膏重量191%的去离子水置于另一容器中,加热至完全溶解,作为水相;Get the triethanolamine of medicinal material extract weight 2.8%, the paraben ethyl ester of medicinal material extract weight 2% and the deionized water of medicinal material extract weight 191% are placed in another container, be heated to completely dissolving, as water phase;
将水相缓慢倒入油相中,搅拌均匀后加入步骤3)所得药材浸膏,边加入边搅拌,至乳化完全,放冷后灌装得软膏剂。Slowly pour the water phase into the oil phase, stir evenly, add the medicinal material extract obtained in step 3), stir while adding, until the emulsification is complete, let it cool, and then fill it to obtain an ointment.
对比例4:组方配比为粉萆薢360g、南鹤虱200 g、土鳖虫150 g、冰片120 g、钻地风40g、酢浆草40g。制备方法如下:Comparative example 4: The formula ratio is 360g of fenugreek, 200g of southern crane lice, 150g of ground beetle, 120g of borneol, 40g of earth-boring wind, and 40g of sorrel. The preparation method is as follows:
1)取处方量粉萆薢、南鹤虱、土鳖虫、钻地风、酢浆草。分别粉碎,过70目筛,混合得药材粉末;1) Take the prescribed amount of fennel, southern crane lice, ground beetle, ground borer, and wood sorrel. Pulverize respectively, cross 70 mesh sieves, and mix to obtain medicinal material powder;
2)按照料液比为1:4的比例向步骤1)所得要药材粉末中加入浓度为65%的乙醇浸泡2) According to the ratio of solid to liquid of 1:4, add 65% ethanol to the medicinal material powder obtained in step 1) to soak
3.5h,然后70℃下恒温水浴回流提取4h,放冷过滤,得药材醇提液;3.5h, then reflux extraction in a constant temperature water bath at 70°C for 4h, let it cool and filter to obtain the alcoholic extract of medicinal materials;
3)将步骤2)所得药材醇提液蒸发浓缩至相对密度为1.32,冷却后加入处方量的冰片,3) Evaporate and concentrate the medicinal material alcohol extract obtained in step 2) to a relative density of 1.32, add the prescribed amount of borneol after cooling,
搅拌均匀得药材浸膏;Stir evenly to obtain medicinal material extract;
4)取药材浸膏重量50%的硬脂酸、药材浸膏重量12%的单硬脂酸甘油脂、药材浸膏重量20%的液体石蜡、药材浸膏重量8%的凡士林、药材浸膏重量20%的羊毛脂和药材浸膏重量4%的氮酮置于容器中,水浴加热熔化,搅拌均匀,作为油相,70℃恒温保存备用;4) Take stearic acid with 50% weight of medicinal material extract, glyceryl monostearate with 12% weight of medicinal material extract, liquid paraffin with 20% weight of medicinal material extract, vaseline with 8% weight of medicinal material extract, and medicinal material extract 20% by weight of lanolin and 4% by weight of medicinal extracts of azone are placed in a container, heated and melted in a water bath, stirred evenly, used as an oil phase, and kept at a constant temperature of 70°C for later use;
取药材浸膏重量2.8%的三乙醇胺、药材浸膏重量2%的尼泊金乙酯和药材浸膏重量191%的去离子水置于另一容器中,加热至完全溶解,作为水相;Get the triethanolamine of medicinal material extract weight 2.8%, the paraben ethyl ester of medicinal material extract weight 2% and the deionized water of medicinal material extract weight 191% are placed in another container, be heated to completely dissolving, as water phase;
将水相缓慢倒入油相中,搅拌均匀后加入步骤3)所得药材浸膏,边加入边搅拌,至乳化完全,放冷后灌装得软膏剂。Slowly pour the water phase into the oil phase, stir evenly, add the medicinal material extract obtained in step 3), stir while adding, until the emulsification is complete, let it cool, and then fill it to obtain an ointment.
对比例5:组方配比为粉萆薢360g、南鹤虱200 g、土鳖虫150 g、冰片120 g、醉魂藤40g。制备方法如下:Comparative example 5: The formula ratio is 360g of fennel, 200g of southern crane louse, 150g of ground beetle, 120g of borneol, and 40g of drunken vine. The preparation method is as follows:
1)取处方量粉萆薢、南鹤虱、土鳖虫、醉魂藤。分别粉碎,过70目筛,混合得药材粉末;1) Take the prescribed amount of fenugreek, southern crane lice, ground beetle, and drunken vine. Pulverize respectively, cross 70 mesh sieves, and mix to obtain medicinal material powder;
2)按照料液比为1:4的比例向步骤1)所得要药材粉末中加入浓度为65%的乙醇浸泡2) According to the ratio of solid to liquid of 1:4, add 65% ethanol to the medicinal material powder obtained in step 1) to soak
3.5h,然后70℃下恒温水浴回流提取4h,放冷过滤,得药材醇提液;3.5h, then reflux extraction in a constant temperature water bath at 70°C for 4h, let it cool and filter to obtain the alcoholic extract of medicinal materials;
3)将步骤2)所得药材醇提液蒸发浓缩至相对密度为1.32,冷却后加入处方量的冰片,3) Evaporate and concentrate the medicinal material alcohol extract obtained in step 2) to a relative density of 1.32, add the prescribed amount of borneol after cooling,
搅拌均匀得药材浸膏;Stir evenly to obtain medicinal material extract;
4)取药材浸膏重量50%的硬脂酸、药材浸膏重量12%的单硬脂酸甘油脂、药材浸膏重量20%的液体石蜡、药材浸膏重量8%的凡士林、药材浸膏重量20%的羊毛脂和药材浸膏重量4%的氮酮置于容器中,水浴加热熔化,搅拌均匀,作为油相,70℃恒温保存备用;4) Take stearic acid with 50% weight of medicinal material extract, glyceryl monostearate with 12% weight of medicinal material extract, liquid paraffin with 20% weight of medicinal material extract, vaseline with 8% weight of medicinal material extract, and medicinal material extract 20% by weight of lanolin and 4% by weight of medicinal extracts of azone are placed in a container, heated and melted in a water bath, stirred evenly, used as an oil phase, and kept at a constant temperature of 70°C for later use;
取药材浸膏重量2.8%的三乙醇胺、药材浸膏重量2%的尼泊金乙酯和药材浸膏重量191%的去离子水置于另一容器中,加热至完全溶解,作为水相;Get the triethanolamine of medicinal material extract weight 2.8%, the paraben ethyl ester of medicinal material extract weight 2% and the deionized water of medicinal material extract weight 191% are placed in another container, be heated to completely dissolving, as water phase;
将水相缓慢倒入油相中,搅拌均匀后加入步骤3)所得药材浸膏,边加入边搅拌,至乳化完全,放冷后灌装得软膏剂。Slowly pour the water phase into the oil phase, stir evenly, add the medicinal material extract obtained in step 3), stir while adding, until the emulsification is complete, let it cool, and then fill it to obtain an ointment.
对比例6:组方配比为钻地风400g、酢浆草400g、醉魂藤400g。制备方法如下:Comparative example 6: The prescription ratio is 400g of ground-boring wind, 400g of sorrel, and 400g of drunken vine. The preparation method is as follows:
1)取处方量钻地风、酢浆草、醉魂藤分别粉碎,过70目筛,混合得药材粉末;1) Take the prescription amount of ground wind, wood sorrel, and drunken vine, grind them separately, pass through a 70-mesh sieve, and mix to obtain medicinal powder;
2)按照料液比为1:4的比例向步骤1)所得要药材粉末中加入浓度为65%的乙醇浸泡2) According to the ratio of solid to liquid of 1:4, add 65% ethanol to the medicinal material powder obtained in step 1) to soak
3.5h,然后70℃下恒温水浴回流提取4h,放冷过滤,得药材醇提液;3.5h, then reflux extraction in a constant temperature water bath at 70°C for 4h, let it cool and filter to obtain the alcoholic extract of medicinal materials;
3)将步骤2)所得药材醇提液蒸发浓缩至相对密度为1.32得药材浸膏;3) Evaporate and concentrate the medicinal material alcohol extract obtained in step 2) to a relative density of 1.32 to obtain medicinal material extract;
4)取药材浸膏重量50%的硬脂酸、药材浸膏重量12%的单硬脂酸甘油脂、药材浸膏重量20%的液体石蜡、药材浸膏重量8%的凡士林、药材浸膏重量20%的羊毛脂和药材浸膏重量4%的氮酮置于容器中,水浴加热熔化,搅拌均匀,作为油相,70℃恒温保存备用;4) Take stearic acid with 50% weight of medicinal material extract, glyceryl monostearate with 12% weight of medicinal material extract, liquid paraffin with 20% weight of medicinal material extract, vaseline with 8% weight of medicinal material extract, and medicinal material extract 20% by weight of lanolin and 4% by weight of medicinal extracts of azone are placed in a container, heated and melted in a water bath, stirred evenly, used as an oil phase, and kept at a constant temperature of 70°C for later use;
取药材浸膏重量2.8%的三乙醇胺、药材浸膏重量2%的尼泊金乙酯和药材浸膏重量191%的去离子水置于另一容器中,加热至完全溶解,作为水相;Get the triethanolamine of medicinal material extract weight 2.8%, the paraben ethyl ester of medicinal material extract weight 2% and the deionized water of medicinal material extract weight 191% are placed in another container, be heated to completely dissolving, as water phase;
将水相缓慢倒入油相中,搅拌均匀后加入步骤3)所得药材浸膏,边加入边搅拌,至乳化完全,放冷后灌装得软膏剂。Slowly pour the water phase into the oil phase, stir evenly, add the medicinal material extract obtained in step 3), stir while adding, until the emulsification is complete, let it cool, and then fill it to obtain an ointment.
动物模型及分组给药:SPF级雄性BALB /c小鼠,体重18~20 g,购自北京华阜康生物科技股份有限公司,饲养于SPF 级动物室。实验前适应性饲养1周。小鼠以戊巴比妥钠80mg /kg腹腔注射麻醉。每只小鼠刮除背部毛发,形成面积为2 cm×3cm 大小的暴露区域。每日在小鼠背部裸露区域涂抹5% 咪喹莫特乳膏200mg /kg,连续涂抹14日造模;造模过程中小鼠均单笼饲养,每日夜间将小鼠装入不锈钢小鼠固定器中(北京合力科创科技发展有限公司)束缚过夜。以裸露区域皮肤出现皮损、红斑、鳞屑、浸润为造模成功。随机取造模成功小鼠60只,随机分为10组,每组6只。Animal model and group administration: SPF-grade male BALB/c mice, weighing 18-20 g, were purchased from Beijing Huafukang Biotechnology Co., Ltd., and were raised in an SPF-grade animal room. Adaptive feeding for 1 week before the experiment. Mice were anesthetized by intraperitoneal injection of pentobarbital sodium 80 mg/kg. The back hair of each mouse was shaved to form an exposed area with an area of 2 cm×3 cm. Apply 5% imiquimod cream 200mg/kg on the exposed area of the back of the mouse every day, and apply it continuously for 14 days to build the model; during the model making process, the mice were kept in single cages, and the mice were fixed in stainless steel mice every night The instrument (Beijing Heli Science and Technology Development Co., Ltd.) was restrained overnight. The skin lesions, erythema, scales, and infiltration in the exposed area were regarded as successful modeling. 60 mice successfully modeled were randomly selected and divided into 10 groups with 6 mice in each group.
第1组为阴性对照组,于造模区域皮肤涂抹生理盐水,每日1次,共涂抹14日;Group 1 was the negative control group, and normal saline was applied to the skin of the modeling area once a day for a total of 14 days;
第2-4组为实验组,分别于造模区域皮肤涂抹实施例1组方3、组方4、组方5制备的中药膏剂,以粉萆薢生药材计算给药剂量为3g/只/日,共涂抹14日。The 2nd to 4th groups are the experimental group, apply the traditional Chinese medicine ointment prepared by the formula 3, the formula 4 and the formula 5 of the embodiment 1 respectively on the skin of the modeling area, and the dosage is calculated as 3g/piece/day based on the medicinal materials of the powdered scorpion. , a total of 14 days.
第5-7组属于阳性对照组,分别于造模区域皮肤涂抹对比例1、4、5制备的中药膏剂,以粉萆薢生药材计算给药剂量为3g/只/日,共涂抹14日。Groups 5-7 belonged to the positive control group, and the traditional Chinese medicine ointments prepared in Comparative Examples 1, 4, and 5 were applied to the skin of the modeling area, and the dosage was calculated as 3 g/piece/day based on the raw medicinal materials of fennel, for a total of 14 days.
第8、9组属于阳性对照组,分别于造模区域皮肤涂抹对比例2、6制备的中药膏剂,以钻地风生药材计算给药剂量为0.45g/只/日,共涂抹14日。Groups 8 and 9 belonged to the positive control group. The traditional Chinese medicine ointments prepared in Comparative Examples 2 and 6 were applied to the skin of the modeling area, and the dosage was calculated as 0.45 g/piece/day based on the medicinal materials of the earth-burrowing wind, for a total of 14 days.
第10组属于阳性对照组,分别于造模区域皮肤涂抹对比例3制备的中药膏剂,以醉魂藤生药材计算给药剂量为0.45g/只/日,共涂抹14日。Group 10 belonged to the positive control group. The traditional Chinese medicine ointment prepared in Comparative Example 3 was applied to the skin of the modeling area, and the dosage was calculated as 0.45 g/piece/day based on the medicinal material of Drunken Vine, for a total of 14 days.
考察指标:自首次给药之日开始至给药结束后第7日,每日数码照相观察小鼠造模区域皮肤。观察皮损面积红斑、浸润、脱屑情况,根据银屑病皮损面积和严重度积分(PASI积分) 评价各组大鼠银屑病严重程度,根据严重程度将红斑、浸润、脱屑三项指标分别赋予0-4分(0无症状、1轻度、2中度、3重度、4极其严重),将三者积分相加得PASI总积分(0-12分)。各组动物根据每只动物的PASI总积分计算均值和标准差进行比较。两组间采用t检验进行对比。p<0.05视为差异显著, p<0.01视为差异极其显著。Investigation indicators: From the day of the first administration to the 7th day after the end of the administration, the skin of the mouse modeling area was observed by digital photography every day. Observe the erythema, infiltration and desquamation of the skin lesion area, evaluate the psoriasis severity of rats in each group according to the psoriasis lesion area and severity score (PASI score), and divide the three items of erythema, infiltration and desquamation according to the severity. Indexes are assigned 0-4 points (0 asymptomatic, 1 mild, 2 moderate, 3 severe, 4 extremely severe), and the total PASI score (0-12 points) is obtained by adding the three points. Animals in each group were compared by calculating the mean and standard deviation based on the total PASI integral of each animal. The t test was used for comparison between the two groups. P<0.05 was regarded as significant difference, and p<0.01 was regarded as extremely significant difference.
结果:给药结束后第7日,各组小鼠造模部位红斑、浸润、脱屑程度PASI总积分结果见下表:Results: On the 7th day after the end of the administration, the total PASI score results of the erythema, infiltration, and desquamation degree of the mice in each group are shown in the table below:
与阴性对照组相比a:p<0.05, b:p<0.01;与对比例1阳性对照组相比c:p<0.05,d:p<0.01。Compared with negative control group a: p<0.05, b: p<0.01; compared with comparative example 1 positive control group c: p<0.05, d: p<0.01.
由上表可见,在粉萆薢给药剂量等同的情况下,组方3、4、5给药14日后,小鼠PASI总积分极显著低于阴性对照组(p<0.01),对比例1阳性对照组PASI总积分显著低于阴性对照组(p<0.05);组方3、4、5给药后PASI总积分均极显著低于对比例1阳性对照组(p<0.01)。说明组方3、4、5对肝郁气滞型银屑病小鼠的症状改善作用极显著优于对比例1的中药膏剂(粉萆薢、南鹤虱、土鳖虫、冰片组方)。It can be seen from the above table that, under the condition of the same dosage of fenugreek, after 14 days of administration of prescriptions 3, 4, and 5, the total PASI score of the mice was extremely significantly lower than that of the negative control group (p<0.01), and the comparative example 1 was positive. The total PASI score of the control group was significantly lower than that of the negative control group (p<0.05); the total PASI score of prescriptions 3, 4, and 5 after administration was significantly lower than that of the positive control group of comparative example 1 (p<0.01). It shows that prescriptions 3, 4, and 5 can improve the symptoms of psoriasis mice with liver depression and qi stagnation type significantly better than the traditional Chinese medicine ointment of comparative example 1.
对比例2阳性对照组、对比例3阳性对照组及对比例6阳性对照组小鼠PASI总积分与阴性对照组无显著差异(p>0.05),说明对比例2(钻地风、酢浆草组方)、对比例3(醉魂藤组方)、对比例6(钻地风、酢浆草、醉魂藤组方)的中药膏剂对肝郁气滞型银屑病小鼠的症状改善作用与生理盐水无显著差异。There was no significant difference in the total PASI score of mice in the positive control group of Comparative Example 2, the positive control group of Comparative Example 3 and the positive control group of Comparative Example 6 and the negative control group (p>0.05), indicating that Comparative Example 2 (earth-boring wind, wood sorrel Recipe), Comparative Example 3 (Zuihunteng prescription), Comparative Example 6 (Zidifeng, Sorrel, Zuixunteng prescription) improved the symptoms of psoriasis mice with liver depression and qi stagnation The effect was not significantly different from that of normal saline.
对比例4阳性对照组及对比例5阳性对照组小鼠PASI总积分显著低于阴性对照组(p<0.05),但与对比例1阳性对照组相比无显著差异(p>0.05),说明钻地风、酢浆草两味中药或醉魂藤单味中药对粉萆薢、南鹤虱、土鳖虫、冰片组方无显著增效作用。The total PASI score of mice in the positive control group of Comparative Example 4 and the positive control group of Comparative Example 5 was significantly lower than that of the negative control group (p<0.05), but there was no significant difference compared with the positive control group of Comparative Example 1 (p>0.05), indicating that There was no significant synergistic effect of the two Chinese medicines of Zundifeng and Sorrel or the single Chinese medicine of Zuixunteng on the prescriptions of Fleuria spp.
综上可见,钻地风、酢浆草、醉魂藤三味中药合用对粉萆薢、南鹤虱、土鳖虫、冰片组方具有显著的增效作用,对郁气滞型银屑病小鼠的皮损症状具有显著改善作用。In summary, the combined use of the three traditional Chinese medicines of burrowing wind, wood sorrel, and drunken vine has a significant synergistic effect on the prescriptions of A. The symptoms of skin lesions can be significantly improved.
此外,应当理解,虽然本说明书按照实施方式加以描述,但并非每个实施方式仅包含一个独立的技术方案,说明书的叙述方式仅仅是为清楚起见,本领域技术人员应当将说明书作为一个整体,各实施例中的技术方案也可以适当组合,形成本领域技术人员可以理解的其他实施方式。In addition, it should be understood that although this specification is described according to implementation modes, not each implementation mode only includes an independent technical solution, and the narration method of the specification is only for clarity, and those skilled in the art should take the specification as a whole, and each The technical solutions in the embodiments can also be properly combined to form other implementations that can be understood by those skilled in the art.
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