CN104225471B - A kind of compound preparation and preparation method for the treatment of oral lichen planus - Google Patents
A kind of compound preparation and preparation method for the treatment of oral lichen planus Download PDFInfo
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- CN104225471B CN104225471B CN201410458321.6A CN201410458321A CN104225471B CN 104225471 B CN104225471 B CN 104225471B CN 201410458321 A CN201410458321 A CN 201410458321A CN 104225471 B CN104225471 B CN 104225471B
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Abstract
The invention discloses a kind of compound preparation for the treatment of oral lichen planus, this compound preparation is made up of the raw material of following ratio of weight and number: Radix Curcumae 10-100 part, Rhizoma Chuanxiong 10-100 part, Talcum 10-100 part, roud cardamon seed 8-80 part, Semen Armeniacae Amarum 8-80 part, Semen Coicis 8-80 part, Herba Artemisiae Scopariae 6-60 part, Cortex Magnoliae Officinalis 6-60 part, Herba Pogostemonis 6-60 part, Radix Sophorae Flavescentis 3-30 part, Radix Arnebiae (Radix Lithospermi) 3-30 part.The present invention further discloses the preparation method of this compound preparation.Prove that compound preparation of the present invention has good therapeutical effect to oral lichen planus by experiment, compound preparation of the present invention can significantly improve the immunologic function of human body simultaneously.Novel formula of the present invention, composition is simple, and all inexpensively, drug cost is comparatively cheap, and preparation method of the present invention is simple to operate, is applicable to suitability for industrialized production for each taste principal agent price.
Description
Technical field
The present invention relates to a kind of compound preparation for the treatment of oral disease, especially relate to a kind of compound preparation for the treatment of oral lichen planus and preparation method thereof.
Background technology
Oral lichen planus (OralLichenPanus, OLP) is common non-infectious Oral mucosal lesion, and have that sickness rate is high, course of disease delay, have cAMP content feature, its cause of disease is complicated, be still not clear so far, and the course of disease is long.The typical pathologic of oral lichen planus (OLP) shows as epithelium hyperparakeratosis, basal layer liquefactive degeneration and lamina propria has intensive lymphocyte to be band-like infiltration.In the etiologic etiological research of oral lichen planus, the relation of candidiasis and lichen planus obtains the concern of Chinese scholars very early, but can not be still that fungal component or initiating pathogenic bacterium are drawn a conclusion to candidiasis so far.Clear and definite research is carried out to the candidiasis of oral lichen planus, thus prevention and therapy diseases of oral mucosa effectively, first need the method for strain identification classification accurately, particularly between bacterial strain, the analysis of relation judges.Though traditional Phenotype typing has certain researching value, there is the limitation such as distinguishing ability is weak, poor repeatability, instability.Along with the fast development of modern biotechnology molecular engineering, from gene level to candidiasis carry out typing become may and inevitable.Therefore, concrete to it pathogenetic discussion is one of stomatologic study hotspot always.
At present, the treatment of doctor trained in Western medicine to primary disease adopts glucocorticoid, immunostimulant, vitamin etc. more, but to hyperkeratosis without effect, curative effect is indefinite, and long-term taking can produce larger side effect.In recent years, Chinese medicine achieves initial achievements in the research of OLP.In determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, Song Minhua etc. according to The mouth is the body opening or window of the spleen, the tongue is the orifice to the heart, gingiva belongs to taste, kidney channel row tongue both sides, by dialectical for OLP be stagnation of QI due to depression of the liver, deficiency of the liver and kindey, deficiency of both QI and blood, damp-heat brewing internally.Huang Qiuqin according to the clinical manifestation of patient and tongue fur, body of the tongue, pulse condition is dialectical is divided into Qi deficiency blood stasis type, Splenic asthenia and obstruction of dampness, type of hyperactivity of fire caused by deficiency of YIN, control with benefiting QI for activating blood circulation, eliminating blood stasis and removing ecchymoses, invigorating the spleen for eliminating dampness, let out turbid speckle removing, heat-clearing and toxic substances removing, blood cooling and ecchymoses removing, gives BUYANG HUANWU TANG, Pingwei San, Zengye Tang or ZHIBAI DIHUANG WAN respectively and treats.Wei Shuhua etc., by dialectical to OLP patient, control with clearing stomach activating the spleen, removing dampness speckle removing, depressed liver-energy dispersing and QI regulating, dissipating depression of QI speckle removing, supplementing QI and nourishing YIN, dampness removing speckle removing, warming YANG and invigorating QI, and achieve good clinical efficacy.Chinese patent 200610043058.X discloses a kind of Chinese medicine for the treatment of oral lichen planus, and this Chinese medicine is made up of Flos Lonicerae 30-50 part, Caulis Spatholobi 30-50 part, Radix Salviae Miltiorrhizae 30-50 part, Cortex Magnoliae Officinalis 15-25 part, raw Talcum 50-150 part, Rhizoma Smilacis Glabrae 30-50 part, Radix Gentianae 10-20 part, Radix Rehmanniae 10-30 part, Semen Coicis 30-50 part, Rhizoma Atractylodis 15-20 part, Radix Scrophulariae 15-30 part, Radix Bupleuri 10-15 part, Radix Achyranthis Bidentatae 10-15 part, Cortex Dictamni 10-15 part and Radix Glycyrrhizae 10-15 part.Chinese patent 201210114967.3 discloses a kind of compound preparation for the treatment of oral lichen planus, said preparation is by Herba Lophatheri 16-28 part, Radix Sophorae Flavescentis 16-28 part, toad clothing 16-28 part, Rhizoma Coptidis 16-28 part, Radix rosae multiflorae 16-28 part, mountain vitriol 16-28 part, Fructus Amomi 12-25 part, Oletum Trogopterori 12-25 part, Radix Aucklandiae 12-25 part, Chrysosplenium grayanum Maxim. 12-25 part, Hericium erinaceus (Bull. Ex Fr.) Pers. 12-25 part, Mylabris 12-25 part, Radix Notoginseng 6-18 part, Stamen Nelumbinis 6-18 part, Radix Solani Melongenae 6-18 part, Cortex Myricae Rubrae 6-18 part, artificial Calculus Bovis 6-18 part, vitamin C 6-18 part, Fructus Choerospondiatis 1-12 part, Stigma Croci 1-12 part, Flos Ginseng 1-12 part, Semen Gleditsiae 1-12 part, Folium Eriobotryae 1-12 part, Corm Eleocharitis 1-12 part forms.Above-mentioned disclosed patent has certain clinical efficacy at treatment oral lichen planus, but in the patent of above-mentioned announcement, taste of Chinese medicine number is more, contains multiple rare Chinese medicine, and its drug cost is higher, and more difficultly realizes industrialized great production.
Summary of the invention
One object of the present invention is to overcome the deficiencies in the prior art, there is provided a kind of composition simple, novel formula, a kind of compound preparation for the treatment of oral lichen planus of determined curative effect, this compound preparation has that cost is low, good effect, have no side effect, not easily produce toleration, take and the advantage such as easy to carry.
Another object of the present invention is to provide a kind of preparation method for the treatment of the compound preparation of oral lichen planus, and this preparation method is simple to operate, is applicable to suitability for industrialized production.
The object of the invention is to be achieved through the following technical solutions: a kind of compound preparation for the treatment of oral lichen planus, is characterized in that: it is made up of the raw material of following ratio of weight and number: Radix Curcumae 10-100 part, Rhizoma Chuanxiong 10-100 part, Talcum 10-100 part, roud cardamon seed 8-80 part, Semen Armeniacae Amarum 8-80 part, Semen Coicis 8-80 part, Herba Artemisiae Scopariae 6-60 part, Cortex Magnoliae Officinalis 6-60 part, Herba Pogostemonis 6-60 part, Radix Sophorae Flavescentis 3-30 part, Radix Arnebiae (Radix Lithospermi) 3-30 part.
Preferably, the ratio of weight and number of described each raw material is: Radix Curcumae 20-80 part, Rhizoma Chuanxiong 20-80 part, Talcum 20-80 part, roud cardamon seed 15-60 part, Semen Armeniacae Amarum 15-60 part, Semen Coicis 15-60 part, Herba Artemisiae Scopariae 10-40 part, Cortex Magnoliae Officinalis 10-40 part, Herba Pogostemonis 10-40 part, Radix Sophorae Flavescentis 8-20 part, Radix Arnebiae (Radix Lithospermi) 8-20 part.
Preferably, the ratio of weight and number of described each raw material is: Radix Curcumae 40-60 part, Rhizoma Chuanxiong 40-60 part, Talcum 40-60 part, roud cardamon seed 30-50 part, Semen Armeniacae Amarum 30-50 part, Semen Coicis 30-50 part, Herba Artemisiae Scopariae 20-30 part, Cortex Magnoliae Officinalis 20-30 part, Herba Pogostemonis 20-30 part, Radix Sophorae Flavescentis 10-15 part, Radix Arnebiae (Radix Lithospermi) 10-15 part.
Preferably, the ratio of weight and number of described each raw material is: Radix Curcumae 30 parts, Rhizoma Chuanxiong 20 parts, 20 parts, Talcum, roud cardamon seed 12 parts, Semen Armeniacae Amarum 12 parts, Semen Coicis 12 parts, Herba Artemisiae Scopariae 8 parts, Cortex Magnoliae Officinalis 8 parts, Herba Pogostemonis 8 parts, Radix Sophorae Flavescentis 5 parts, Radix Arnebiae (Radix Lithospermi) 5 parts.
Prepare a kind of method for the treatment of the compound preparation of oral lichen planus described in above-mentioned any one, it is characterized in that: it comprises the following steps:
S1: take roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi) by weight, with extraction by steam distillation roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi) volatile oil, collect volatile oil and carry out enclose with 2 ~ 4 times amount β – cyclodextrin and cross 60 ~ 80 mesh sieves after porphyrize being prepared into roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi) volatile oil clathrate compound, medicinal residues are for subsequent use;
S2: take after Talcum mixes with the medicinal residues of S1 step by weight, add the soak by water 1 ~ 1.5 hour of medical material 3 ~ 5 times amount, filter and obtain decocting liquid, medicinal residues discard;
S3: take Radix Curcumae, Rhizoma Chuanxiong, Herba Artemisiae Scopariae, Cortex Magnoliae Officinalis, Herba Pogostemonis, Radix Sophorae Flavescentis by weight, adds the water soaking 0.5 ~ 1 hour of medical material 4 ~ 6 times amount, decocts 0.5 ~ 1 hour subsequently after mixing, filter and obtain decocting liquid, medicinal residues discard;
S4: be condensed into extractum after being merged by the decocting liquid in S2 step and S3 step, then extractum vacuum drying obtained dry cream, is prepared into dried cream powder end by broken for dried cream powder rear mistake 60 ~ 80 mesh sieve;
S5: the volatile oil clathrate compound of S1 step is mixed with the dried cream powder end of S4 step, adds pharmaceutically acceptable adjuvant and be prepared into pharmaceutically conventional preparation.
Pharmaceutically acceptable adjuvant of the present invention comprises starch, magnesium stearate, dextrin and microcrystalline Cellulose.
Compound preparation of the present invention is tablet, capsule, granule, pill, powder or oral liquid.
Chinese medicine composition of the present invention can be prepared into dosage form described on any one pharmaceutics according to the conventional method of pharmaceutical field; Chinese medicine composition can by oral, to suck or the mode such as intestinal external administration is applied to patient.Dosage form on described pharmaceutics comprises: the tablet used during oral administration, capsule, pill, powder, granule, syrup, oral liquid etc.; The freeze-dried powder used when intestinal external administration and injection etc.
For enabling above-mentioned dosage form realize, the acceptable adjuvant of pharmacy need be added when preparing these dosage forms, such as: filler, disintegrating agent, lubricant, suspending agent, binding agent, sweeting agent, correctives, antiseptic, substrate etc.Filler comprises: starch, pregelatinized Starch, lactose, mannitol, chitin, microcrystalline Cellulose, sucrose etc.; Disintegrating agent comprises: starch, pregelatinized Starch, microcrystalline Cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose etc.; Lubricant comprises: magnesium stearate, sodium lauryl sulphate, Pulvis Talci, silicon dioxide etc.; Suspending agent comprises: polyvinylpyrrolidone, microcrystalline Cellulose, sucrose, agar, hydroxypropyl emthylcellulose etc.; Binding agent comprises, starch slurry, polyvinylpyrrolidone, hydroxypropyl emthylcellulose etc.; Sweeting agent comprises: saccharin sodium, Aspartane, sucrose, cyclamate, enoxolone etc.; Correctives comprises: sweeting agent and various essence; Antiseptic comprises: parabens, benzoic acid, sodium benzoate, sorbic acid and its esters, benzalkonium bromide, acetic acid chloroethene are fixed, Folium eucalypti globueli (Eucalyptus globulus Labill.) wet goods; Substrate comprises: PEG6000, PEG4000, insect wax etc.
Radix Curcumae in Chinese medicine composition of the present invention, Rhizoma Chuanxiong, Talcum, roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Herba Artemisiae Scopariae, Cortex Magnoliae Officinalis, Herba Pogostemonis, Radix Sophorae Flavescentis, Radix Arnebiae (Radix Lithospermi) are 2010 editions " Chinese Pharmacopoeias " first Chinese medicine of recording or its processed product.Radix Curcumae is the tuber of dicotyledon medicine zingiberaceous plant Rhizoma Curcumae Longae, Radix Curcumae or Rhizoma Curcumae, pungent, bitter, cool.GUIXIN, lung, Liver Channel, has promoting QI circulation for relieving depression, the effect of removing heat from blood removing blood stasis with potent drugs; Rhizoma Chuanxiong is the rhizome of samphire Rhizoma Chuanxiong, and acrid in the mouth is warm in nature, returns liver, gallbladder, pericardium channel, has blood-activating and qi-promoting, the effect of wind-expelling pain-stopping; Talcum is silicates mineral talc race Talcum, and primary aqueous magnesium silicate is sweet, light, cold, returns bladder, lung, stomach warp, has inducing diuresis for treating stranguria syndrome, clearing away summer-heat, the effect of damp eliminating sore; Roud cardamon seed is the dry mature fruit of zingiberaceous plant Fructus Amomi Rotundus, pungent, warm, returns lung, spleen, stomach warp, has regulating the flow of QI to ease the stomach, dry cold-damp, deinebriating effect; Semen Armeniacae Amarum is the dry mature seed of rosaceous plant Prunus armeniaca L.var.ansu Maxim., Siberia Fructus Pruni, prunus mandshuricaKoehne, bitter in the mouth, tepor; Slightly poisonous, return lung, large intestine channel, there is sending down the abnormal ascending QI relieving cough and asthma, the effect of loosening bowel to relieve constipation; Semen Coicis is the kernel of grass Semen Coicis, and sweet in the mouth, light, cold nature, return spleen, stomach, lung, large intestine channel, has the effect of invigorating spleen to remove dampness, clearing away heat and discharging pus; Herba Artemisiae Scopariae is the seedling of feverfew Herba Artemisiae Scopariae, bitter in the mouth, pungent, is slightly cold, returns spleen, stomach, liver, gallbladder meridian, have the effect of heat-clearing and dampness-resolving; Cortex Magnoliae Officinalis is Magnoliaceae, the dry dried bark of magnolia, root bark and branch skin, bitter, pungent, warm in nature, returns spleen, stomach, large intestine channel, has circulation of qi promoting removing food stagnancy, dampness except effect that is full, lowering the adverse QI to relieve asthma; Herba Pogostemonis is labiate, the ratan of the aerial parts of perennial herb upright plant Herba Pogostemonis, and acrid in the mouth, tepor, return spleen, stomach, lung meridian, has eliminating turbid pathogen with aromatics, the preventing or arresting vomiting that whets the appetite, delivers the effect of expelling summer-heat; Radix Sophorae Flavescentis is the root of perennial fallen leaves semishrub plant Radix Sophorae Flavescentis, bitter in the mouth, cold in nature, returns liver, kidney, large intestine, small intestine meridian, heart channel, urinary bladder channel, has the effect of heat clearing and damp drying, parasite killing diuresis; Radix Arnebiae (Radix Lithospermi) is the root of comfrey Radix Arnebiae (Radix Lithospermi), the false Radix Arnebiae (Radix Lithospermi) in Xinjiang-Tibet or Onosma paniculatum, cold in nature, sweet in the mouth, salty, and GUIXIN, Liver Channel, have the effect of removing heat from blood and promoting blood circulation, removing toxic substances rash.
The invention has the beneficial effects as follows: prove that compound preparation of the present invention has good therapeutical effect to oral lichen planus by experiment, novel formula of the present invention, composition is simple, each taste principal agent price all inexpensively, drug cost is more cheap, preparation method of the present invention is simple to operate, is applicable to suitability for industrialized production.In addition, in experimentation, unexpected discovery compound preparation of the present invention can significantly improve the immunologic function of human body, to promote the rehabilitation of body further.
Detailed description of the invention
Below in conjunction with specific embodiment, technical scheme of the present invention is described in further detail, but protection scope of the present invention is not limited to the following stated.
Embodiment 1:
Take raw material Radix Curcumae 10g, Rhizoma Chuanxiong 10g, Talcum 10g, roud cardamon seed 8g, Semen Armeniacae Amarum 8g, Semen Coicis 8g, Herba Artemisiae Scopariae 6g, Cortex Magnoliae Officinalis 6g, Herba Pogostemonis 6g, Radix Sophorae Flavescentis 3g, Radix Arnebiae (Radix Lithospermi) 3g, add supplementary product starch 70g and granulate, magnesium stearate 5g, dextrin 30g, microcrystalline Cellulose 30g, evenly obtained granule, tabletting, obtains tablet.
Embodiment 2:
Take raw material Radix Curcumae 100g, Rhizoma Chuanxiong 100g, Talcum 100g, roud cardamon seed 80g, Semen Armeniacae Amarum 80g, Semen Coicis 80g, Herba Artemisiae Scopariae 60g, Cortex Magnoliae Officinalis 60g, Herba Pogostemonis 60g, Radix Sophorae Flavescentis 30g, Radix Arnebiae (Radix Lithospermi) 30g, add supplementary product starch 800g and granulate, magnesium stearate 80g, DEXTRIN 0g, microcrystalline Cellulose 400g, evenly obtained granule, tabletting, obtains tablet.
Embodiment 3:
Take raw material Radix Curcumae 20g, Rhizoma Chuanxiong 20g, Talcum 20g, roud cardamon seed 15g, Semen Armeniacae Amarum 15g, Semen Coicis 15g, Herba Artemisiae Scopariae 10g, Cortex Magnoliae Officinalis 10g, Herba Pogostemonis 10g, Radix Sophorae Flavescentis 8g, Radix Arnebiae (Radix Lithospermi) 8g, add supplementary product starch 150g and granulate, magnesium stearate 15g, dextrin 60g, microcrystalline Cellulose 80g, evenly obtained granule, tabletting, obtains tablet.
Embodiment 4:
Take raw material Radix Curcumae 80g, Rhizoma Chuanxiong 80g, Talcum 80g, roud cardamon seed 60g, Semen Armeniacae Amarum 60g, Semen Coicis 60g, Herba Artemisiae Scopariae 40g, Cortex Magnoliae Officinalis 40g, Herba Pogostemonis 40g, Radix Sophorae Flavescentis 20g, Radix Arnebiae (Radix Lithospermi) 20g, add supplementary product starch 580g and granulate, magnesium stearate 60g, dextrin 300g, microcrystalline Cellulose 200g, evenly obtained granule, tabletting, obtains tablet.
Embodiment 5:
Take raw material Radix Curcumae 40g, Rhizoma Chuanxiong 40g, Talcum 40g, roud cardamon seed 30g, Semen Armeniacae Amarum 30g, Semen Coicis 30g, Herba Artemisiae Scopariae 20g, Cortex Magnoliae Officinalis 20g, Herba Pogostemonis 20g, Radix Sophorae Flavescentis 10g, Radix Arnebiae (Radix Lithospermi) 10g, add supplementary product starch 300g and granulate, magnesium stearate 30g, dextrin 150g, microcrystalline Cellulose 150g, evenly obtained granule, tabletting, obtains tablet.
Embodiment 6:
Take raw material Radix Curcumae 60g, Rhizoma Chuanxiong 60g, Talcum 60g, roud cardamon seed 50g, Semen Armeniacae Amarum 50g, Semen Coicis 50g, Herba Artemisiae Scopariae 30g, Cortex Magnoliae Officinalis 30g, Herba Pogostemonis 30g, Radix Sophorae Flavescentis 15g, Radix Arnebiae (Radix Lithospermi) 15g, add supplementary product starch 480g and granulate, magnesium stearate 50g, dextrin 200g, microcrystalline Cellulose 200g, evenly obtained granule, tabletting, obtains tablet.
Embodiment 7:
Take raw material Radix Curcumae 30g, Rhizoma Chuanxiong 20g, Talcum 20g, roud cardamon seed 12g, Semen Armeniacae Amarum 12g, Semen Coicis 12g, Herba Artemisiae Scopariae 8g, Cortex Magnoliae Officinalis 8g, Herba Pogostemonis 8g, Radix Sophorae Flavescentis 5g, Radix Arnebiae (Radix Lithospermi) 5g add supplementary product starch 140g and granulate, magnesium stearate 10g, dextrin 70g, microcrystalline Cellulose 70g, evenly obtained granule, tabletting, obtains tablet.
Embodiment 8:
Take raw material Radix Curcumae 10g, Rhizoma Chuanxiong 10g, Talcum 10g, roud cardamon seed 8g, Semen Armeniacae Amarum 8g, Semen Coicis 8g, Herba Artemisiae Scopariae 6g, Cortex Magnoliae Officinalis 6g, Herba Pogostemonis 6g, Radix Sophorae Flavescentis 3g, Radix Arnebiae (Radix Lithospermi) 3g, add supplementary product starch 70g and granulate, magnesium stearate 5g, dextrin 30g, microcrystalline Cellulose 30g, evenly obtained granule, incapsulate, obtain capsule.
Embodiment 9:
Take raw material Radix Curcumae 100g, Rhizoma Chuanxiong 100g, Talcum 100g, roud cardamon seed 80g, Semen Armeniacae Amarum 80g, Semen Coicis 80g, Herba Artemisiae Scopariae 60g, Cortex Magnoliae Officinalis 60g, Herba Pogostemonis 60g, Radix Sophorae Flavescentis 30g, Radix Arnebiae (Radix Lithospermi) 30g, adds supplementary product starch 800g and granulates, magnesium stearate 80g, DEXTRIN 0g, microcrystalline Cellulose 400g, conveniently technique is prepared into powder.
Embodiment 10:
Take raw material Radix Curcumae 20g, Rhizoma Chuanxiong 20g, Talcum 20g, roud cardamon seed 15g, Semen Armeniacae Amarum 15g, Semen Coicis 15g, Herba Artemisiae Scopariae 10g, Cortex Magnoliae Officinalis 10g, Herba Pogostemonis 10g, Radix Sophorae Flavescentis 8g, Radix Arnebiae (Radix Lithospermi) 8g adds supplementary product starch 150g and granulates, magnesium stearate 15g, dextrin 60g, microcrystalline Cellulose 80g, conveniently technique is prepared into granule.
Embodiment 11:
Take raw material Radix Curcumae 80g, Rhizoma Chuanxiong 80g, Talcum 80g, roud cardamon seed 60g, Semen Armeniacae Amarum 60g, Semen Coicis 60g, Herba Artemisiae Scopariae 40g, Cortex Magnoliae Officinalis 40g, Herba Pogostemonis 40g, Radix Sophorae Flavescentis 20g, Radix Arnebiae (Radix Lithospermi) 20g, adds supplementary product starch 580g and granulates, magnesium stearate 60g, dextrin 300g, microcrystalline Cellulose 200g, conveniently technique is prepared into powder.
Embodiment 12:
Take raw material Radix Curcumae 40g, Rhizoma Chuanxiong 40g, Talcum 40g, roud cardamon seed 30g, Semen Armeniacae Amarum 30g, Semen Coicis 30g, Herba Artemisiae Scopariae 20g, Cortex Magnoliae Officinalis 20g, Herba Pogostemonis 20g, Radix Sophorae Flavescentis 10g, Radix Arnebiae (Radix Lithospermi) 10g, adds supplementary product starch 300g and granulates, magnesium stearate 30g, dextrin 150g, microcrystalline Cellulose 150g, conveniently technique is prepared into pill.
Embodiment 13:
Take raw material Radix Curcumae 60g, Rhizoma Chuanxiong 60g, Talcum 60g, roud cardamon seed 50g, Semen Armeniacae Amarum 50g, Semen Coicis 50g, Herba Artemisiae Scopariae 30g, Cortex Magnoliae Officinalis 30g, Herba Pogostemonis 30g, Radix Sophorae Flavescentis 15g, Radix Arnebiae (Radix Lithospermi) 15g, conveniently technique is prepared into decoction.
Embodiment 14:
Take raw material Radix Curcumae 30g, Rhizoma Chuanxiong 20g, Talcum 20g, roud cardamon seed 12g, Semen Armeniacae Amarum 12g, Semen Coicis 12g, Herba Artemisiae Scopariae 8g, Cortex Magnoliae Officinalis 8g, Herba Pogostemonis 8g, Radix Sophorae Flavescentis 5g, Radix Arnebiae (Radix Lithospermi) 5g, conveniently technique is prepared into oral liquid.
Embodiment 15:
Take raw material Radix Curcumae 10g, Rhizoma Chuanxiong 10g, Talcum 10g, roud cardamon seed 8g, Semen Armeniacae Amarum 8g, Semen Coicis 8g, Herba Artemisiae Scopariae 6g, Cortex Magnoliae Officinalis 6g, Herba Pogostemonis 6g, Radix Sophorae Flavescentis 3g, Radix Arnebiae (Radix Lithospermi) 3g, its concrete preparation method comprises the following steps: S1: take roud cardamon seed by weight, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi), use extraction by steam distillation roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi) volatile oil, collect volatile oil and carry out enclose with 2 ~ 4 times amount β – cyclodextrin and after porphyrize, cross 60 ~ 80 mesh sieves being prepared into roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi) volatile oil clathrate compound, medicinal residues are for subsequent use, S2: take after Talcum mixes with the medicinal residues of S1 step by weight, add the soak by water 1 ~ 1.5 hour of medical material 3 ~ 5 times amount, filter and obtain decocting liquid, medicinal residues discard, S3: take Radix Curcumae, Rhizoma Chuanxiong, Herba Artemisiae Scopariae, Cortex Magnoliae Officinalis, Herba Pogostemonis, Radix Sophorae Flavescentis by weight, adds the water soaking 0.5 ~ 1 hour of medical material 4 ~ 6 times amount, decocts 0.5 ~ 1 hour subsequently after mixing, filter and obtain decocting liquid, medicinal residues discard, S4: be condensed into extractum after being merged by the decocting liquid in S2 step and S3 step, then extractum vacuum drying obtained dry cream, is prepared into dried cream powder end by broken for dried cream powder rear mistake 60 ~ 80 mesh sieve, S5: mixed with the dried cream powder end of S4 step by the volatile oil clathrate compound of S1 step, conveniently technique is prepared into tablet.
Embodiment 16:
Take raw material Radix Curcumae 100g, Rhizoma Chuanxiong 100g, Talcum 100g, roud cardamon seed 80g, Semen Armeniacae Amarum 80g, Semen Coicis 80g, Herba Artemisiae Scopariae 60g, Cortex Magnoliae Officinalis 60g, Herba Pogostemonis 60g, Radix Sophorae Flavescentis 30g, Radix Arnebiae (Radix Lithospermi) 30g, its concrete preparation method comprises the following steps: S1: take roud cardamon seed by weight, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi), use extraction by steam distillation roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi) volatile oil, collect volatile oil and carry out enclose with 2 ~ 4 times amount β – cyclodextrin and after porphyrize, cross 60 ~ 80 mesh sieves being prepared into roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi) volatile oil clathrate compound, medicinal residues are for subsequent use, S2: take after Talcum mixes with the medicinal residues of S1 step by weight, add the soak by water 1 ~ 1.5 hour of medical material 3 ~ 5 times amount, filter and obtain decocting liquid, medicinal residues discard, S3: take Radix Curcumae, Rhizoma Chuanxiong, Herba Artemisiae Scopariae, Cortex Magnoliae Officinalis, Herba Pogostemonis, Radix Sophorae Flavescentis by weight, adds the water soaking 0.5 ~ 1 hour of medical material 4 ~ 6 times amount, decocts 0.5 ~ 1 hour subsequently after mixing, filter and obtain decocting liquid, medicinal residues discard, S4: be condensed into extractum after being merged by the decocting liquid in S2 step and S3 step, then extractum vacuum drying obtained dry cream, is prepared into dried cream powder end by broken for dried cream powder rear mistake 60 ~ 80 mesh sieve, S5: mixed with the dried cream powder end of S4 step by the volatile oil clathrate compound of S1 step, conveniently technique is prepared into capsule.
Embodiment 17:
Take raw material Radix Curcumae 20g, Rhizoma Chuanxiong 20g, Talcum 20g, roud cardamon seed 15g, Semen Armeniacae Amarum 15g, Semen Coicis 15g, Herba Artemisiae Scopariae 10g, Cortex Magnoliae Officinalis 10g, Herba Pogostemonis 10g, Radix Sophorae Flavescentis 8g, Radix Arnebiae (Radix Lithospermi) 8g, its concrete preparation method comprises the following steps: S1: take roud cardamon seed by weight, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi), use extraction by steam distillation roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi) volatile oil, collect volatile oil and carry out enclose with 2 ~ 4 times amount β – cyclodextrin and after porphyrize, cross 60 ~ 80 mesh sieves being prepared into roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi) volatile oil clathrate compound, medicinal residues are for subsequent use, S2: take after Talcum mixes with the medicinal residues of S1 step by weight, add the soak by water 1 ~ 1.5 hour of medical material 3 ~ 5 times amount, filter and obtain decocting liquid, medicinal residues discard, S3: take Radix Curcumae, Rhizoma Chuanxiong, Herba Artemisiae Scopariae, Cortex Magnoliae Officinalis, Herba Pogostemonis, Radix Sophorae Flavescentis by weight, adds the water soaking 0.5 ~ 1 hour of medical material 4 ~ 6 times amount, decocts 0.5 ~ 1 hour subsequently after mixing, filter and obtain decocting liquid, medicinal residues discard, S4: be condensed into extractum after being merged by the decocting liquid in S2 step and S3 step, then extractum vacuum drying obtained dry cream, is prepared into dried cream powder end by broken for dried cream powder rear mistake 60 ~ 80 mesh sieve, S5: mixed with the dried cream powder end of S4 step by the volatile oil clathrate compound of S1 step, conveniently technique is prepared into pill.
Embodiment 18:
Take raw material Radix Curcumae 80g, Rhizoma Chuanxiong 80g, Talcum 80g, roud cardamon seed 60g, Semen Armeniacae Amarum 60g, Semen Coicis 60g, Herba Artemisiae Scopariae 40g, Cortex Magnoliae Officinalis 40g, Herba Pogostemonis 40g, Radix Sophorae Flavescentis 20g, Radix Arnebiae (Radix Lithospermi) 20g, its concrete preparation method comprises the following steps: S1: take roud cardamon seed by weight, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi), use extraction by steam distillation roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi) volatile oil, collect volatile oil and carry out enclose with 2 ~ 4 times amount β – cyclodextrin and after porphyrize, cross 60 ~ 80 mesh sieves being prepared into roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi) volatile oil clathrate compound, medicinal residues are for subsequent use, S2: take after Talcum mixes with the medicinal residues of S1 step by weight, add the soak by water 1 ~ 1.5 hour of medical material 3 ~ 5 times amount, filter and obtain decocting liquid, medicinal residues discard, S3: take Radix Curcumae, Rhizoma Chuanxiong, Herba Artemisiae Scopariae, Cortex Magnoliae Officinalis, Herba Pogostemonis, Radix Sophorae Flavescentis by weight, adds the water soaking 0.5 ~ 1 hour of medical material 4 ~ 6 times amount, decocts 0.5 ~ 1 hour subsequently after mixing, filter and obtain decocting liquid, medicinal residues discard, S4: be condensed into extractum after being merged by the decocting liquid in S2 step and S3 step, then extractum vacuum drying obtained dry cream, is prepared into dried cream powder end by broken for dried cream powder rear mistake 60 ~ 80 mesh sieve, S5: mixed with the dried cream powder end of S4 step by the volatile oil clathrate compound of S1 step, conveniently technique is prepared into granule.
Embodiment 19:
Take raw material Radix Curcumae 40g, Rhizoma Chuanxiong 40g, Talcum 40g, roud cardamon seed 30g, Semen Armeniacae Amarum 30g, Semen Coicis 30g, Herba Artemisiae Scopariae 20g, Cortex Magnoliae Officinalis 20g, Herba Pogostemonis 20g, Radix Sophorae Flavescentis 10g, Radix Arnebiae (Radix Lithospermi) 10g, its concrete preparation method comprises the following steps: S1: take roud cardamon seed by weight, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi), use extraction by steam distillation roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi) volatile oil, collect volatile oil and carry out enclose with 2 ~ 4 times amount β – cyclodextrin and after porphyrize, cross 60 ~ 80 mesh sieves being prepared into roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi) volatile oil clathrate compound, medicinal residues are for subsequent use, S2: take after Talcum mixes with the medicinal residues of S1 step by weight, add the soak by water 1 ~ 1.5 hour of medical material 3 ~ 5 times amount, filter and obtain decocting liquid, medicinal residues discard, S3: take Radix Curcumae, Rhizoma Chuanxiong, Herba Artemisiae Scopariae, Cortex Magnoliae Officinalis, Herba Pogostemonis, Radix Sophorae Flavescentis by weight, adds the water soaking 0.5 ~ 1 hour of medical material 4 ~ 6 times amount, decocts 0.5 ~ 1 hour subsequently after mixing, filter and obtain decocting liquid, medicinal residues discard, S4: be condensed into extractum after being merged by the decocting liquid in S2 step and S3 step, then extractum vacuum drying obtained dry cream, is prepared into dried cream powder end by broken for dried cream powder rear mistake 60 ~ 80 mesh sieve, S5: mixed with the dried cream powder end of S4 step by the volatile oil clathrate compound of S1 step, conveniently technique is prepared into effervescent tablet.
Embodiment 20:
Take raw material Radix Curcumae 60g, Rhizoma Chuanxiong 60g, Talcum 60g, roud cardamon seed 50g, Semen Armeniacae Amarum 50g, Semen Coicis 50g, Herba Artemisiae Scopariae 30g, Cortex Magnoliae Officinalis 30g, Herba Pogostemonis 30g, Radix Sophorae Flavescentis 15g, Radix Arnebiae (Radix Lithospermi) 15g, its concrete preparation method comprises the following steps: S1: take roud cardamon seed by weight, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi), use extraction by steam distillation roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi) volatile oil, collect volatile oil and carry out enclose with 2 ~ 4 times amount β – cyclodextrin and after porphyrize, cross 60 ~ 80 mesh sieves being prepared into roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi) volatile oil clathrate compound, medicinal residues are for subsequent use, S2: take after Talcum mixes with the medicinal residues of S1 step by weight, add the soak by water 1 ~ 1.5 hour of medical material 3 ~ 5 times amount, filter and obtain decocting liquid, medicinal residues discard, S3: take Radix Curcumae, Rhizoma Chuanxiong, Herba Artemisiae Scopariae, Cortex Magnoliae Officinalis, Herba Pogostemonis, Radix Sophorae Flavescentis by weight, adds the water soaking 0.5 ~ 1 hour of medical material 4 ~ 6 times amount, decocts 0.5 ~ 1 hour subsequently after mixing, filter and obtain decocting liquid, medicinal residues discard, S4: be condensed into extractum after being merged by the decocting liquid in S2 step and S3 step, then extractum vacuum drying obtained dry cream, is prepared into dried cream powder end by broken for dried cream powder rear mistake 60 ~ 80 mesh sieve, S5: mixed with the dried cream powder end of S4 step by the volatile oil clathrate compound of S1 step, conveniently technique is prepared into injectable powder.
Embodiment 21:
Take raw material Radix Curcumae 30g, Rhizoma Chuanxiong 20g, Talcum 20g, roud cardamon seed 12g, Semen Armeniacae Amarum 12g, Semen Coicis 12g, Herba Artemisiae Scopariae 8g, Cortex Magnoliae Officinalis 8g, Herba Pogostemonis 8g, Radix Sophorae Flavescentis 5g, Radix Arnebiae (Radix Lithospermi) 5g, its concrete preparation method comprises the following steps: S1: take roud cardamon seed by weight, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi), use extraction by steam distillation roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi) volatile oil, collect volatile oil and carry out enclose with 2 ~ 4 times amount β – cyclodextrin and after porphyrize, cross 60 ~ 80 mesh sieves being prepared into roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi) volatile oil clathrate compound, medicinal residues are for subsequent use, S2: take after Talcum mixes with the medicinal residues of S1 step by weight, add the soak by water 1 ~ 1.5 hour of medical material 3 ~ 5 times amount, filter and obtain decocting liquid, medicinal residues discard, S3: take Radix Curcumae, Rhizoma Chuanxiong, Herba Artemisiae Scopariae, Cortex Magnoliae Officinalis, Herba Pogostemonis, Radix Sophorae Flavescentis by weight, adds the water soaking 0.5 ~ 1 hour of medical material 4 ~ 6 times amount, decocts 0.5 ~ 1 hour subsequently after mixing, filter and obtain decocting liquid, medicinal residues discard, S4: be condensed into extractum after being merged by the decocting liquid in S2 step and S3 step, then extractum vacuum drying obtained dry cream, is prepared into dried cream powder end by broken for dried cream powder rear mistake 60 ~ 80 mesh sieve, S5: mixed with the dried cream powder end of S4 step by the volatile oil clathrate compound of S1 step, conveniently technique is prepared into pill.
Beneficial effect of the present invention is verified below by concrete clinical research:
1 physical data
All cases are selected from the patient meeting oral lichen planus diagnostic criteria of my institute's Stomatology Clinic treatment.Two groups are divided into, treatment group 36 example, wherein man 20 example, female 16 example, 35 ~ 70 years old age, 47.52 ± 6.47 years old mean age by random parallel control method; Matched group 36 example, wherein man 19 example, female 17 example, 35 ~ 70 years old age, 49.12 ± 8.73 years old mean age.Lesion is positioned at the regions such as tongue, buccal, gingiva, lip palate, based on buccal and tongue.The aspect no significant difference such as two groups of Genders, age, courses of disease, have comparability.
2 diagnostic criterias
Western medicine diagnose standard: draft with reference to 2008 the 3rd edition " oral mucosal diseases " and the first edition in 2010 " oral mucosal disease treatment by Chinese herbs essence solution ".(1) symptom: oral mucosa is pearlescent white striped, smooth surface, interlacedly to reticulate, dendroid, ring-type, streak or be fused to the variforms such as plaque-like.Also erythema, hyperemia, erosion, atrophy, blister, pigmentation etc. can occur simultaneously, various disease conditions can overlap each other and change.Mucosa is soft, and elasticity is constant.Multiplely be born in the positions such as cheek, tongue, gum, palate, often symmetrical.(2) sick inspection: during biopsy, see liquifaction degeneration of basal cells under mirror, a large amount of lymphocytic infiltration below basement membrane, in banded.Epithelium and the common colloid corpuscles of lamina propria.Epithelial peg is dashed forward indentation, and acanthosis or atrophy, the obvious hypertrophy of granulosa, epithelium crosses keratinization or parakeratosis.
Inclusive criteria: (1) meets the patient of doctor trained in Western medicine oral lichen planus diagnostic criteria; (2) 35 ~ 70 years old age; (3) person within course of disease 3d; (4) informed consent, volunteers tested.Obtain Informed Consent Form process and meet GCP regulation.
Exclusion standard: (1) is diagnosed as the patient of recurrent oral ulceration, oral leukoplakia, oral cancer; (2) or allergic constitution person irritated to the known composition of investigational agent; (3) serious disease, the psychotics such as severe cardiac, liver, kidney, hemopoietic system and immune system is associated with; (4) severe infections, diabetic ketoacidosis, hyperpotassemia patient is associated with; (5) allergies or the allergic constitution persons such as Chinese medicine, food, pollen is had; (6) gestation, gestation or women breast-feeding their children are prepared; (7) other clinical trial person was participated in nearly 3 months.
Case comes off standard: fill in Informed Consent Form all and screen the qualified patient entering test, exiting clinical trial.
Common cause: adverse events; Lack curative effect; Back of the body testing program (comprising compliance difference); (comprising patient to exit voluntarily) lost to follow-up; Patient recalls Informed Consent Form; Coming off caused by other reason.
The Statistical Principles of the case that comes off: (1) untoward reaction occurs and comes off, should enter untoward reaction statistics; (2) because invalid and self falling person should list curative effect statistics in; (3) less than 1 course for the treatment of and cured person, the case that comes off is not listed in; (4) effective in therapeutic process, but the whole course for the treatment of can not be completed, and patient lost to follow-up, do not list curative effect statistics in.To the case come off, intentional analysis should be done.
Case rejects standard: strict during (1) screening case, the patient not meeting inclusive criteria is included in test; (2) experimenter merges other Chinese and Western Chinese medicine taken this programme and prohibit the use, so that correctly cannot judge efficacy and saferry; (3) clinical data is incomplete, so that correctly cannot judge efficacy and saferry; (4) the improper unblinding in the midway of a variety of causes.
3 Therapeutic Method
Treatment group: take raw material Radix Curcumae 30kg, Rhizoma Chuanxiong 20kg, Talcum 20kg, roud cardamon seed 12kg, Semen Armeniacae Amarum 12kg, Semen Coicis 12kg, Herba Artemisiae Scopariae 8kg, Cortex Magnoliae Officinalis 8kg, Herba Pogostemonis 8kg, Radix Sophorae Flavescentis 5kg, Radix Arnebiae (Radix Lithospermi) 5kg, its concrete preparation method comprises the following steps: S1: take roud cardamon seed by weight, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi), use extraction by steam distillation roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi) volatile oil, collect volatile oil and carry out enclose with 2 ~ 4 times amount β – cyclodextrin and after porphyrize, cross 60 ~ 80 mesh sieves being prepared into roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi) volatile oil clathrate compound, medicinal residues are for subsequent use, S2: take after Talcum mixes with the medicinal residues of S1 step by weight, add the soak by water 1 ~ 1.5 hour of medical material 3 ~ 5 times amount, filter and obtain decocting liquid, medicinal residues discard, S3: take Radix Curcumae, Rhizoma Chuanxiong, Herba Artemisiae Scopariae, Cortex Magnoliae Officinalis, Herba Pogostemonis, Radix Sophorae Flavescentis by weight, adds the water soaking 0.5 ~ 1 hour of medical material 4 ~ 6 times amount, decocts 0.5 ~ 1 hour subsequently after mixing, filter and obtain decocting liquid, medicinal residues discard, S4: be condensed into extractum after being merged by the decocting liquid in S2 step and S3 step, then extractum vacuum drying obtained dry cream, is prepared into dried cream powder end by broken for dried cream powder rear mistake 60 ~ 80 mesh sieve, S5: the volatile oil clathrate compound of S1 step is mixed with the dried cream powder end of S4 step, adds pharmaceutically acceptable adjuvant, calculate the capsule being prepared into 0.2g/ grain according to crude drug.Instructions of taking: take 3 every day, each serving with 3,3 months is 1 course for the treatment of, observes 1 course for the treatment of.
Matched group: give ZHIBAI DIHUANG WAN (the accurate word Z43020148 of traditional Chinese medicines), specification: every bottled 120g, is produced by Jiuzhitang Co., Ltd..Instructions of taking: take 3 every day, each serving using 9 balls, 3 months being 1 course for the treatment of, observing 1 course for the treatment of.
Treatments period two groups of cases all remove ill fitting prosthesis and sharp cusp is crossed in obturator, local, and clean one's teeth, diet is light, avoids maror and cigarette, wine etc., keep sufficient sleep, and give psychotherapy.
4 observation of curative effect
Oral mucosa disease damage alleviates rate or disappearance rate; Badly lapse to the incidence rate ratio of oral cancer (occur).At the end for the treatment of, follow up a case by regular visits at the end of each to evaluate 1 time.Tcm syndrome curative effect: per March records 1 time; Investigation on Quality of Life: carry out investigation of life quality according to SF-36 scale; Relapse rate after drug withdrawal: the ratio occurring symptom and patients with abnormal after drug withdrawal; Therapeutic evaluation comprises short term effect and late result, carries out health economics metrics evaluation to all treatment cases simultaneously.
The standard of curative effect evaluation: recovery from illness: erosion is healed completely, lineae ablicantes or grey stricture of vagina, and hyperemia is disappeared, subjective symptoms disappears; Effective: the healing of rotten to the corn face, without congested, lineae ablicantes or grey stricture of vagina disappear more than 2/3, and symptom obviously alleviates; Take a turn for the better: oral cavity lineae ablicantes or grey stricture of vagina disappear less than 2/3, symptom has part to alleviate; Invalid: unchanged before and after treatment.With recovery from illness and effective calculating total effective rate.
5 safety observations indexs
Comprise blood, urine, stool routine examination, renal function and Electrocardioscopy, before and after treatment, each inspection once, analyzes adverse reaction rate, untoward reaction type and process.
6 statistical methods
Adopt SPSS17.0 software to process, measurement data adopts average
represent, with t inspection, the more useful X 2 test of enumeration data, P < 0.05, has statistical significance.
7 results
7.1 liang of group comparitive study
Treatment group clinical efficacy is better than matched group, and difference has statistical significance (P < 0.05), the results are shown in Table 1.
A table 1 liang group patient total effective rate compares
7.2 untoward reaction and safety indexes
All there is not serious untoward reaction in two groups of patients, before the test, obvious abnormal change does not all appear in general vital sign, electrocardiogram, hepatic and renal function, three large routines.
In addition, show that compound preparation of the present invention can significantly improve index and spleen index and the thymus index of mice by pharmaceutical test, show that compound preparation of the present invention contributes to improving the immunity of body.
In view of the curative effect that herbal mixture obtains for oral lichen planus, present inventor to have ground oral lichen planus miRNAs expression characteristic from the angle of genetics and has conducted in-depth research, and research contents is as follows:
1. materials and methods
1.1 main agents and material
Erythrocyte cracked liquid (C3702, the green skies, Jiangsu Haimen City biotechnology research institute), mirVanaRNAIsolationKit (Ambion company of the U.S.); MiRNAs chip SANGER11.0 version (Affymetrix company of the U.S.) etc.
Heraeus refrigerated centrifuger (Megafuge1.0R, Germany); Eppendorf sample loading gun (1403853, Germany); SANYO ultra cold storage freezer (MDF-382E, Japan) etc.
1.2 clinical case sample collections
1.2.1 clinical case is collected
OLP patient 20 example made a definite diagnosis by clinical pathology inspection, by Syndrome Differentiation of Traditional Chinese Medicine [Xiong great Jing. practical traditional Chinese ear nasopharynx aditus laryngis odontology [M]. Shanghai science tech publishing house, 2001, the first edition: 442-443.], screening type of hyperactivity of fire caused by deficiency of YIN oral lichen planus case 3 example, wherein man 2 example, women 1 example.The routine healthy person of matched group 3, wherein male 2 example, women 1 example.
All get rid of infectivity, cardiovascular, autoimmune, anaphylaxis, tumor, psychotic disorder etc. for each group.
1.2.2 sample collection
Morning is conventional venous blood collection 2 milliliters on an empty stomach, and add EDTA anticoagulant, 4 DEG C of preservations are stand-by; Superclean bench is drawn 6ml erythrocyte cracked liquid respectively to 6 15ml centrifuge tubes, No. 1-6, centrifuge tube numbering.After the anticoagulated whole blood being returned to room temperature is shaken up, draw 2ml and be added to respectively in 6 centrifuge tubes, put upside down 6-8 time, and tube wall mixing is flicked in inversion.Room temperature is placed 5 minutes and is flicked and helps splitting erythrocyte for several times, and shake up, centrifugal 5 minutes of 3000rpm, abandons supernatant, leaves the residual supernatant of leukocyte group and about 10 μ l at the bottom of pipe.6 centrifuge tubes all add erythrocyte cracked liquid re-suspended cell group repeated centrifugation 1 time, exhaustion supernatant, add mirVanaRNAIsolationKit1ml, blow even and move into 12 cryopreservation tubes, corresponding centrifuge tube numbering 1-1,1-2,2-1,2-2,3-1,3-2,4-1,4-2,5-1,5-2,6-1,6-2 respectively ,-80 DEG C of preservations.
1.3miRNAs microarray analysis
The miRNAs chip SANGER11.0 version that chip adopts Affymetrix company of the U.S. to produce, every sheet is containing 1769 probes, and wherein mankind miRNA700 is individual.
1.3.1 chip manufacturing and scanning
Extract TotleRNA, adopt gel electrophoresis and ultraviolet spectrophotometer quality testing, probe mark and hybridization, develop a film after dry rear scanning.
1.3.2 statistical method:
Adopt SAM software, P value is less than 0.05, and to be considered as expression variant.
2. result
The quality judging of 2.1 sample RNA
The microRNA of TotleRNA quality testing and separation and purification all meets the requirement of miRNAs chip.Probe mark and hybridization, quality control of procedure of developing a film are qualified, and scan-data can be analyzed.
The miRNAs of 2.2 differential expressions
Search out the miRNA that 5 OLP patients and normal person have differential expression.The results are shown in Table 2.
The miRNAs list of table 2 differential expression
Study by experiment, searched out the miRNA that 5 OLP patients and normal person have differential expression.MiRNAs is that a class finds recently, the micromolecule played an important role in gene expression regulation network.In higher eucaryote, the miRNAs of wide expression is through the noncoding small RNA molecular of a class after Dicer processing.Due to the existence of complementary series, miRNAs can be combined with special mRNA3 ' untranslated region, causes degraded or the Translational repression of mRNA, thus plays and play down regulation or gene silencing to gene expression.Although miR-96 gene only accounts for a very little part in the genome of the mankind, it is the key regulator that body development and Cell Homeostasis maintain.Each miRNA can have multiple target gene, and multiple miRNA is the same target gene of controllable also, and this feature embodies economy and the elaboration of miRNA regulated and control network.By the further investigation of genetics, for the new drug development for the treatment of OLP patient provides new theoretical foundation.
Claims (4)
1. treat a compound preparation for oral lichen planus, it is characterized in that: the ratio of weight and number of described each raw material is: Radix Curcumae 30 parts, Rhizoma Chuanxiong 20 parts, 20 parts, Talcum, roud cardamon seed 12 parts, Semen Armeniacae Amarum 12 parts, Semen Coicis 12 parts, Herba Artemisiae Scopariae 8 parts, Cortex Magnoliae Officinalis 8 parts, Herba Pogostemonis 8 parts, Radix Sophorae Flavescentis 5 parts, Radix Arnebiae (Radix Lithospermi) 5 parts.
2. prepare a kind of method for the treatment of the compound preparation of oral lichen planus in claim 1 described in any one, it is characterized in that: it comprises the following steps:
S1: take roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi) by weight, with extraction by steam distillation roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi) volatile oil, collect volatile oil and carry out enclose with 2 ~ 4 times amount β – cyclodextrin and cross 60 ~ 80 mesh sieves after porphyrize being prepared into roud cardamon seed, Semen Armeniacae Amarum, Semen Coicis, Radix Arnebiae (Radix Lithospermi) volatile oil clathrate compound, medicinal residues are for subsequent use;
S2: take after Talcum mixes with the medicinal residues of S1 step by weight, add the soak by water 1 ~ 1.5 hour of medical material 3 ~ 5 times amount, filter and obtain decocting liquid, medicinal residues discard;
S3: take Radix Curcumae, Rhizoma Chuanxiong, Herba Artemisiae Scopariae, Cortex Magnoliae Officinalis, Herba Pogostemonis, Radix Sophorae Flavescentis by weight, adds the water soaking 0.5 ~ 1 hour of medical material 4 ~ 6 times amount, decocts 0.5 ~ 1 hour subsequently after mixing, filter and obtain decocting liquid, medicinal residues discard;
S4: be condensed into extractum after being merged by the decocting liquid in S2 step and S3 step, then extractum vacuum drying obtained dry cream, is prepared into dried cream powder end by broken for dried cream powder rear mistake 60 ~ 80 mesh sieve;
S5: the volatile oil clathrate compound of S1 step is mixed with the dried cream powder end of S4 step, adds pharmaceutically acceptable adjuvant and be prepared into pharmaceutically conventional preparation.
3. a kind of preparation method for the treatment of the compound preparation of oral lichen planus according to claim 2, is characterized in that: described pharmaceutically acceptable adjuvant comprises starch, magnesium stearate, dextrin and microcrystalline Cellulose.
4. a kind of preparation method for the treatment of the compound preparation of oral lichen planus according to claim 2, is characterized in that: described preparation is tablet, capsule, granule, pill, powder or oral liquid.
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| CN104225471A (en) | 2014-12-24 |
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