CN104258260A - Dsertliving cistanche alcohol extract, as well as preparation method and use thereof - Google Patents

Dsertliving cistanche alcohol extract, as well as preparation method and use thereof Download PDF

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Publication number
CN104258260A
CN104258260A CN201410548981.3A CN201410548981A CN104258260A CN 104258260 A CN104258260 A CN 104258260A CN 201410548981 A CN201410548981 A CN 201410548981A CN 104258260 A CN104258260 A CN 104258260A
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parts
herba cistanches
alcohol extract
radix
powder
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CN104258260B (en
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孙喜翠
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Inner Mongolia Zhongxing Hua Guan bioengineering Limited by Share Ltd
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BEIJING JINGLONG ZHUOSHANG INVESTMENT Co Ltd
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/64—Orobanchaceae (Broom-rape family)
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
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    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/29—Berberidaceae (Barberry family), e.g. barberry, cohosh or mayapple
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
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    • A61K36/185—Magnoliopsida (dicotyledons)
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    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/75—Rutaceae (Rue family)
    • A61K36/756—Phellodendron, e.g. corktree
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    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
    • A61K36/815—Lycium (desert-thorn)
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    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8969—Polygonatum (Solomon's seal)
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9064—Amomum, e.g. round cardamom
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    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/10—Preparation or pretreatment of starting material
    • A61K2236/13—Preparation or pretreatment of starting material involving cleaning, e.g. washing or peeling
    • A—HUMAN NECESSITIES
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    • A61K2236/10—Preparation or pretreatment of starting material
    • A61K2236/17—Preparation or pretreatment of starting material involving drying, e.g. sun-drying or wilting
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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
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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Abstract

The invention provides an extracting method for extracting desertliving cistanche alcohol extracts in desertliving cistanche peel, a desertliving cistanche alcohol extract obtained according to the method, and use of the desertliving cistanche alcohol extract. The method comprises the following steps: using the desertliving cistanche peel, baking and crushing the desertliving cistanche peel, and performing ultrasonic extraction, ultrafiltration and purification, so as to obtain the desertliving cistanche alcohol extract of which the molecular weight is smaller than 5000 Dalton; performing concerted application on the desertliving cistanche alcohol extract, radish seeds, rhizoma coptidis, Chinese rhubarb, phellodendron, radix salviae miltiorrhizae, rhizoma polygonati, glossy privet fruits and the like, so as to obtain the medical composition disclosed by the invention; researching the medical composition in the respects of treating and preventing radioactive pneumonia for postradiotherapy, improving the organism immunity, and the like. The extracting method disclosed by the invention increases the utilization of desertliving cistanche which belongs to the rare medicinal materials in imminent danger, so that the desertliving cistanche has a higher economic value, and the extracting method provides a medical composition which has the advantages of high efficiency, low toxicity and low cost, and is easy to generalize for vast patients with tumors.

Description

A kind of Herba Cistanches alcohol extract, preparation method and its usage
Technical field
The invention belongs to medical art, be specifically related to a kind of method extracting Herba Cistanches alcohol extract from Herba Cistanches skin, and the Herba Cistanches alcohol extract that obtains of method and the purposes of this Herba Cistanches alcohol extract thus.
Background technology
Herba Cistanches (Cistanche deserticola Y.C.Ma) is the fleshy stem of Orobanchaceae (Orobanchaeceae) Cistanche deserticola (Cistanche) Vegetable meat Herba Cistanches dry zone scale leaf, pitch name essence Radix Crotalariae szemoensis, vertical Rong, dried meat floss Rong, Herba Stellariae Saxatilis, rue greatly, there is the good reputation of " desert Radix Ginseng ", begin to be recorded in Shennong's Herbal, be classified as top grade, one of conventional Chinese medicine, the effect such as there is kidney invigorating and YANG supporting, benefiting essence and marrow, blood enriching and dryness moistening, happy color are prolonged life.About 18, this platymiscium whole world kind, 1 mutation of China's about 4 kinds, is respectively Herba Cistanches, Saline Cistanche Herb, Cistanche Tubulosa, spends salt Herba Cistanches and Herba Cistanches sinensis in vain, and except Herba Cistanches sinensis, other 4 kinds of main products are in each provinces and regions of NORTHWEST CHINA.
Early 1980s, Japanese scholars began one's study the chemical composition of Herba Cistanches.To the later stage eighties 20th century, domestic scholars begins one's study the chemical composition of Herba Cistanches of China's output.Along with the develop rapidly of extraction and isolation and detection technique, be separated number of chemical compositions such as obtaining phenethyl alcohol glycosides, iridoids, volatile ingredient, lignanoids, polysaccharide, alkaloid.
Modern pharmacology research also proves that Herba Cistanches is except having kidney invigorating and YANG supporting, functions of loosening bowel relieving constipation, also has the effects such as anticancer, defying age, Improving memory power, and does not find untoward reaction.Herba Cistanches is widely used in each quasi drugs and health product in recent years.
The traditional preliminary working method of Herba Cistanches has dry in the sun method, salting method, stores sth. in a cellar method etc., and these methods are time-consuming, and by the impact of natural conditions, and quality is unstable, have a strong impact on utilization rate and the curative effect of medical material; Further, traditional preliminary working method oneself can not meet the needs of a large amount of medical material preliminary working in the place of production far away.Therefore, how improving the utilization rate of Precious, Rare, Endangered medical material Herba Cistanches, make it produce higher economic worth, is witch's key issue to be solved.
This patent adopts fresh meat Herba Cistanches to be raw material, peeling process is carried out to its fresh medical material, drying, pulverization process are carried out to the Herba Cistanches skin of gained, get the material powder ethanol extraction sieved, select the ultrafilter membrane of molecular cut off 5000Da again, carry out remove impurity to Herba Cistanches alcohol extract, removing molecular weight is greater than the impurity in the Herba Cistanches alcohol extract of 5000Da, collect filtrate, obtain Herba Cistanches alcohol extract carry out in radiotherapy as with the use of the experimental study of medicine.
Radiotherapy is exactly radiotherapy, refers to eliminate focus with ray, and radiotherapy, as an important means for the treatment of malignant tumor, can produce better effects for many cancers.But radiotherapy can produce many toxicities such as the decline of radiodermatitis, radiation pneumonia, radiation esophagitis and appetite, Nausea and vomiting, stomachache, diarrhoea or constipation, wherein there is symptom more than after radiotherapy 2 ~ 3 weeks in radiation pneumonia, often irritant, dry cough, companion are out of breath, cardiopalmus and chest pain, do not generate heat or low grade fever, even have the situations such as high heat, having a strong impact on the orthobiosis of patient.Utilize Chinese medicine and chemotherapy to carry out partner treatment, not only can effectively eliminate these toxicities, but also the radiosensitivity of cancerous cell can be increased, help lonizing radiation thoroughly to kill cancerous cell.
Chinese patent CN103550506A disclose a kind of in radiotherapy with the use of Chinese medicine composition, comprise Radix Angelicae Sinensis 8-20 part, Rhizoma Chuanxiong 5-15 part, Radix Paeoniae Alba 5-15 part, Rhizoma Pinelliae 3-10 part, Radix Codonopsis 10-25 part, Rhizoma Polygonati 5-15 part, Radix Achyranthis Bidentatae 10-20 part, Fructus Corni 3-10 part, Semen Persicae 10-20 part, Radix Notoginseng 5-15 part, Lentinus Edodes 8-20 part, Radix Rehmanniae Preparata 5-12 part, Radix Puerariae 10-20 part, Pericarpium Citri Reticulatae 3-10 part, Endothelium corneum 5-15 part, Herba Taraxaci 3-10 part, Fructus Ligustri Lucidi 3-10 part, Herba Epimedii 5-12 part, Fructus Lycii 10-15 part, Cutis Bufonis 10-20 part, Rhizoma Anemarrhenae 3-10 part, Herba Hedyotidis Diffusae 5-15 part, Fructus Arctii 5-15 part, Radix Astragali 5-25 part, Radix Glycyrrhizae 10-20 part.The coordinative role of each Chinese medicine of this Chinese medicine composition is not strong, and uncertain therapeutic efficacy is cut.
Therefore research and develop a kind of high-efficiency low-toxicity, cheap, be easy to promote can be used in radiotherapy with the use of pharmaceutical composition seem and be even more important.
Summary of the invention
In order to solve the defect existed in prior art, the object of the present invention is to provide Herba Cistanches alcohol extract, preparation method and its usage.
The present invention's first object there are provided a kind of method preparing Herba Cistanches alcohol extract from Herba Cistanches skin, comprises following steps:
(1) peeling process is carried out to fresh meat Herba Cistanches, drying is carried out at the Herba Cistanches skin obtained 40-60 DEG C, dried Herba Cistanches skin is pulverized, powder crosses 80 mesh sieves, powder weight 6-10 65-75% ethanol is doubly added toward powder, ultrasound wave (25KHz) extracts 20-40min, filter, filtering residue carries out second extraction, add described powder weight 5-7 65-75% ethanol doubly toward filtering residue, ultrasound wave (25KHz) extracts 20-40min, filters, merge twice filtrate, filtrate rotary evaporation obtains Herba Cistanches alcohol extract concentrated solution;
(2) ultrafilter membrane of molecular cut off 5000Da is selected, be 7.0-9.0 at pH value, temperature is 40-50 DEG C, pressure is under 0.7-0.9MPa, ultrafiltration is carried out to the Herba Cistanches alcohol extract concentrated solution that step (1) obtains, collect filtrate, concentrate at 60 DEG C and obtain the extractum that relative density is 1.20, be Herba Cistanches alcohol extract.
Further, a kind of method preparing Herba Cistanches alcohol extract from Herba Cistanches skin, comprises following concrete steps:
(1) peeling process is carried out to fresh meat Herba Cistanches, drying is carried out at the Herba Cistanches skin obtained 40 DEG C, dried Herba Cistanches skin is pulverized, powder crosses 80 mesh sieves, 75% ethanol of powder weight 8 times is added toward powder, ultrasound wave (25KHz) extracts 30min, filter, filtering residue carries out second extraction, add 65% ethanol of described powder weight 6 times toward filtering residue, ultrasound wave (25KHz) extracts 30min, filters, merge twice filtrate, filtrate rotary evaporation obtains Herba Cistanches alcohol extract concentrated solution.
(2) ultrafilter membrane of molecular cut off 5000Da is selected, be 8.0 at pH value, temperature is 45 DEG C, pressure is under 0.8MPa, ultrafiltration is carried out to the Herba Cistanches alcohol extract concentrated solution that step (1) obtains, collect filtrate, concentrate at 60 DEG C and obtain the extractum that relative density is 1.20, be Herba Cistanches alcohol extract.
Second object of the present invention is to provide a kind of Herba Cistanches alcohol extract prepared by said method.
3rd object of the present invention is to provide the purposes of above-mentioned Herba Cistanches alcohol extract after preparation treatment and preventive radiotherapy in radiation pneumonia pharmaceutical composition.
Described pharmaceutical composition is the compositions be made up of the raw material of following weight portion: Herba Cistanches alcohol extract 6-16 part, Semen Raphani 6-12 part, Rhizoma Coptidis 3-9 part, Radix Et Rhizoma Rhei 10-17 part, Cortex Phellodendri 3-9 part, Radix Salviae Miltiorrhizae 10-15 part, Rhizoma Polygonati 3-10 part, Fructus Ligustri Lucidi 3-10 part, Radix Polygoni Multiflori 6-11 part, Fructus Amomi 6-11 part, Herba Epimedii 5-12 part, Fructus Lycii 10-15 part, Radix Angelicae Dahuricae 6-12 part, Galla Chinensis 12-18 part, Periostracum Cicadae 9-14 part, Piper longum 6-12 part, Semen Cuscutae 5-10 part, Radix Angelicae Sinensis 10-20 part and Radix Glycyrrhizae 10-20 part.
Further, described pharmaceutical composition is the compositions be made up of the raw material of following weight portion: Herba Cistanches alcohol extract 16 parts, Semen Raphani 12 parts, Rhizoma Coptidis 3 parts, Radix Et Rhizoma Rhei 10 parts, Cortex Phellodendri 9 parts, Radix Salviae Miltiorrhizae 15 parts, Rhizoma Polygonati 10 parts, Fructus Ligustri Lucidi 10 parts, Radix Polygoni Multiflori 11 parts, Fructus Amomi 6 parts, Herba Epimedii 12 parts, Fructus Lycii 15 parts, the Radix Angelicae Dahuricae 6 parts, Galla Chinensis 18 parts, Periostracum Cicadae 9 parts, Piper longum 12 parts, Semen Cuscutae 10 parts, Radix Angelicae Sinensis 20 parts and 20 parts, Radix Glycyrrhizae.
Further, described pharmaceutical composition is powder, water preparation, tablet or capsule.
The preparation method of described pharmaceutical composition comprises following step: the above-mentioned medical material getting recipe quantity is broken into fine powder, except Herba Cistanches alcohol extract, the alcoholic solution that volumetric concentration is 80-90% is doubly added according to the 6-8 of coarse powder gross weight, reflux, extract, three times, return time is 2-4h, filters, adds Herba Cistanches water extract in the filtrate of gained, concentrate at 60 DEG C and obtain the extractum that relative density is 1.20, namely obtain drug extract of the present invention; Common drug dosage form clinically can be prepared by this area common dosage forms preparation technology.
The present invention's Chinese crude drug used has following pharmacologically active and function cures mainly:
Semen Raphani, having another name called Semen Raphani, trailing plants white chessman, Semen Raphani etc., is the mature seed of crucifer Radix Raphani.Enter spleen, stomach, lung meridian, can help digestion de-swelling, and effect is remarkable, has the title of " rush wall fall wall ".Can be used for Therapeutic diet stagnation, abdominal distention, constipation, stagnant dysentery, expectorant stops up and breath with cough.
Rhizoma Coptidis, cures mainly heat clearing and damp drying, eliminating fire and detoxication.For damp and hot feeling of fullness, vomiting acid regurgitation, dysentery, jaundice, unconsciousness due to high fever, hyperactivity of heart-fire, dysphoria and insomnia, heat in blood tells nosebleed, conjunctival congestion, and toothache, quenches one's thirst, carbuncle furuncle; External treatment eczema, eczema, auditory meatus is suppurated.It is burning hot that Rhizoma Coptidis (processed with wine) is apt to the clear part of the body cavity above the diaphragm housing the heart and lungs.For conjunctival congestion, aphtha.
Radix Et Rhizoma Rhei, nature and flavor: bitter, cold.Gui Jing: stomach warp; Large intestine channel; Liver Channel; Spleen channel.Cure mainly: excess-heat constipation; The accumulation of heat feeling of stuffiness in chest; Damp-heat dysentery; Jaundice; Gonorrhea; Edema abdominal distention; Dysuria; Conjunctival congestion; Laryngopharynx swelling and pain; Aphtha of the mouth and tongue; Gastropyretic vomiting; Spit blood; Spitting of blood; Epistaxis; Have blood in stool; Hematuria; Blood-retention; Amenorrhea; The stagnant stomachache of the stasis of blood in puerperal; Lump in the abdomen; Traumatic injury; Pyretic toxicity carbuncle and ulcer; Erysipelas; Scald.
Cortex Phellodendri is the dry bark of rutaceae wampee or Cortex Phellodendri.Can be used as medicine, nature and flavor bitter cold, cures mainly hematodiarrhoea, has loose bowels, and quenches one's thirst, jaundice ， flaccidity of feet with lamenness, nocturnal emission, stranguria with turbid discharge, and hemorrhoid, have blood in stool, also under leucorrhea, and hectic fever due to YIN-deficiency consumptive fever, conjunctival congestion and swelling pain, aphtha of the mouth and tongue, sore swollen toxin.
Radix Salviae Miltiorrhizae, there is promoting blood circulation to remove blood stasis, detumescence hemostasis, anti-inflammatory analgetic, menstruction regulating and pain relieving, coronary artery dilator, improve myocardial ischemia situation, reduce blood pressure, calm the nerves with all worries set aside, blood sugar lowering and the effect such as antibacterial, to menoxenia, amenorrhea dysmenorrhea, lump in the abdomen, breast ventral spine pain, pyretic arthralgia pain, skin infection swells and ache, dysphoria and insomnia; Hepatosplenomegaly, the diseases such as angina pectoris have certain curative effect.In addition, modern medicine experiment proves, Radix Salviae Miltiorrhizae also has anti-platelet aggregation, reduces the function of blood viscosity and the inside and outside blood coagulation system of adjustment, is the natural Chinese medicine that a kind of safety treats again cardiovascular disease reliably.
Rhizoma Polygonati, cures mainly deficiency of YIN chronic cough; Xeropulmonary cough; Insufficiency of the spleen weak; Lack of appetite xerostomia; Quench one's thirst; Deficiency of the kidney soreness of the waist and knees; Impotence and seminal emission; Tinnitus order is dark; Early whitening of beard and hair; Body void is won thin; Wind favus disease.
Fructus Ligustri Lucidi, blood fat reducing and arteriosclerosis, blood sugar lowering, anti-liver injury, antiinflammatory, anticancer, mutation, endocrine regulation, improves immunity of organisms.
Radix Polygoni Multiflori, enrich and benefit essence and blood; Raw use: removing toxic substances, preventing the attack (or recurrence) of malaria, loosening bowel to relieve constipation.Fibrin contained by Radix Polygoni Multiflori has lytic activity, can reduce the formation of atherosclerotic's thrombosis or microthrombus, can directly reduce or avoid the generation of the heart, cerebrovascular disease, improves, corrects and prevent and treat the clinical diseases such as cerebrovas-cularaccident.According to modern study, Radix Polygoni Multiflori decoct has the effect of falling after rising to blood glucose.Main component lecithin contained by it has promotion hemocyte new life and growth effect.Anthraquinones (as emodin etc.) contained by it has laxative action, and this has therapeutic effect to senile constipation.
Fructus Amomi, acrid in the mouth is warm in nature, returns spleen, stomach, kidney channel, can removing dampness whet the appetite, warming spleen and stopping diarrha, regulates the flow of vital energy antiabortive.Especially specially good effect is had to superficial gastritis, duodenal ulcer, flatulence stomachache.Often edible at ordinary times then have nourishing stomach and spleen, and warm lung supports the health-care effect of kidney.
Herba Epimedii, acrid in the mouth; Sweet; Warm in nature.Cure mainly impotence and seminal emission; Cold caused by deficiency is sterile; Frequent micturition incontinence; Dyspnea and cough due to deficiency of the kidney; Soreness of the waist and knees; Rheumatic arthralgia; Hemiplegia; Extremity are meciless.There is the effect such as defying age, antiinflammatory, also effective in cure to cardiovascular and cerebrovascular disease.
Fructus Lycii, the traditional Chinese medical science commonly use it treating hepatic and renal YIN deficiency, soreness of the waist and knees, dizziness, forgetful, dizzy, the many tear of blurred vision, quench one's thirst, the disease such as seminal emission.Modern pharmacology research confirms Fructus Lycii scalable body's immunity, can effectively grow and cell mutation, have the effect of the aspect such as slow down aging, anti-fatty liver, adjusting blood lipid and blood glucose, promotion hemopoietic function by Tumor suppression, and is applied to clinical.
The Radix Angelicae Dahuricae, warm in nature, acrid in the mouth.Cure mainly wind-damp dispelling, evacuation of pus of invigorating blood circulation, granulation promoting pain relieving.For headache, toothache, nasal sinusitis, hemorrhoidal hamorrhage anal fistula, leucorrhea with red and white discharge, ulcer sores, skin pruritus.
Galla Chinensis, sour in the mouth is puckery, cold in nature.Return lung, large intestine, kidney channel.Astringe the lung; Hidroschesis; Astringing intestine to stop diarrhea; Controlling nocturnal emission with astringent drugs; Hemostasis; Removing toxic substances.
Cure mainly: chronic cough of deficiency lung; Spontaneous sweating; Chronic dysentery chronic diarrhea; Proctoptosis; Seminal emission; Nebulousurine; Various hemorrhage; Carbuncle furuncle.Also there is the effects such as antibacterial, removing toxic substances.
Periostracum Cicadae, sweet, cold.Return lung, Liver Channel.Function cures mainly: loose wind heat extraction, sore-throat relieving, rash, nebula removing, spasmolytic.For anemopyretic cold, pharyngalgia, hoarseness, measles without adequate eruption, rubella pruritus, cataract, convulsion with spasms, tetanus.Have immunosuppressant and anti-allergic effects, shield to erythrocytic
Piper longum, hot in nature, acrid in the mouth.Return spleen, stomach warp.Warming spleen and stomach for dispelling cold, therapeutic method to keep the adverse QI flowing downwards pain relieving, appetizing of being amusing.
Semen Cuscutae, the kidney invigorating and essence nourishing, nourishing the liver to improve visual acuity.The waist knee joint muscles and bones being applicable to deficiency of the liver and kindey is ached, the diseases such as legs and feet weakness, impotence and seminal emission, crazy talk, frequent micturition, dripping urination, dizziness and blurred vision, blurring of vision, Hiccough and deaf and women's leukorrhagia, habitual abortion.
Radix Angelicae Sinensis, cures mainly all cards of blood deficiency; Menoxenia; Amenorrhea; Dysmenorrhea; Lump in the abdomen knot is poly-; Metrorrhagia; Asthenia cold abdominalgia; Flaccidity syndrome and arthralgia syndrome; Numbness of the skin; Dryness of the intestine dyschezia; Heavy after bloody dysentery; Ulcer sores; Injury from falling down.There is anti-hypoxia, conditioner body immunity function, anticancer, improve looks, enrich blood invigorate blood circulation, the effect such as antibacterial, arteriosclerosis.
Radix Glycyrrhizae, feeble QI, taste is sweet and special.Function cures mainly heat-clearing and toxic substances removing, expelling phlegm for arresting cough, gastral cavity abdomen etc.
The present invention is made up of above-mentioned Chinese crude drug compatibility, in conjunction with the Herba Cistanches alcohol extract that the present invention prepares, shows according to the embodiment of the present invention 5 result of the test:
(1) 1 group of patient radiation's property pneumonia incidence rate is treated lower than treatment 2 groups, treat 1 group of patient radiation's property pneumonia incidence rate and be starkly lower than matched group (P < 0.01), difference has statistical significance, result points out medicine of the present invention obviously can reduce the incidence rate of radiation pneumonia after chest radiotherapy, has the effect of prevention radiation pneumonia.
(2) after radiotherapy, treat 1 group after the treatment physical function progressively improve, treat latter 6 months physical function states comparatively before improve, before being even better than radiotherapy, its effect is also better than treatment 2 groups; And matched group patient following up a case by regular visits to 6 the middle of the month physical function situation Progressive symmetric erythrokeratodermia decline, it is obvious that 1 group and matched group two groups of result differences are treated in each monitoring point, illustrates that medicine of the present invention can significantly improve patient body function, improve patients ' life quality.
(3) treat 1 group of cough and symptom symptom after radiotherapy of breathing hard progressively is alleviated, after 6 months, patient's cough and symptom of breathing hard all comparatively alleviate before radiotherapy greatly, and its therapeutic effect is better than treatment 2 groups.Matched group is between follow-up period, and every tcm symptom Progressive symmetric erythrokeratodermia increases the weight of, without improving trend, and after exacerbation of symptoms and radiotherapy the time be proportionate, treat 1 group and be starkly lower than matched group in each monitoring point tcm symptom order of severity, difference has statistical significance.
(4) treat 2 groups and be used alone Herba Cistanches alcohol extract of the present invention, its effect uses the pharmaceutical composition containing Herba Cistanches alcohol extract of the present invention not as good as treatment 1 group, prove that each component synergism of Herba Cistanches alcohol extract of the present invention is strong, therapeutic effect is excellent.
In a word, the present invention compared with prior art, has following outstanding technical advantage:
(1) the present invention adopts fresh meat Herba Cistanches to be raw material, peeling process is carried out to its fresh medical material, drying, pulverization process are carried out to the Herba Cistanches skin of gained, adds ethanol ultrasonic extraction, filter, concentrated, ultrafiltration purification, obtains Herba Cistanches alcohol extract, and extraction process of the present invention is simple, generating period is short, process stabilizing.
(2) by effect experiment, the present invention also proves that pharmaceutical composition of the present invention significantly can suppress incidence of radioactive pneumonia, obviously slow down the cough that radiotherapy occurs, the symptom such as to breathe hard, remarkable quality of life of improving patient, show that medicine coordinative role of the present invention is strong, can be used as in radiotherapy with the use of medicine, its determined curative effect, effectively slows down the misery of patient, and efficacy stability continues, toxic and side effects is low.
Detailed description of the invention
Further describe the present invention below by way of specific embodiment, but the present invention is not limited only to following examples.Within the scope of the invention or not departing from content of the present invention, spirit and scope, change nominally, replacement are only carried out to Herba Cistanches alcohol extract of the present invention, preparation method and purposes, will become apparent to those skilled in the art that they are all deemed to be included within the scope of the invention.
the preparation of Part I, Herba Cistanches alcohol extract
embodiment 1,a kind of method preparing Herba Cistanches alcohol extract from Herba Cistanches skin:
(1) peeling process is carried out to fresh meat Herba Cistanches, drying is carried out at the Herba Cistanches skin obtained 40 DEG C, dried Herba Cistanches skin is pulverized, powder crosses 80 mesh sieves, 75% ethanol of powder weight 8 times is added toward powder, ultrasound wave (25KHz) extracts 30min, filter, filtering residue carries out second extraction, add 65% ethanol of described powder weight 6 times toward filtering residue, ultrasound wave (25KHz) extracts 30min, filters, merge twice filtrate, filtrate rotary evaporation obtains Herba Cistanches alcohol extract concentrated solution.
(2) ultrafilter membrane of molecular cut off 5000Da is selected, be 8.0 at pH value, temperature is 45 DEG C, pressure is under 0.8MPa, ultrafiltration is carried out to the Herba Cistanches alcohol extract concentrated solution that step (1) obtains, collect filtrate, concentrate at 60 DEG C and obtain the extractum that relative density is 1.20, be Herba Cistanches alcohol extract.
part II, the present invention contain the pharmaceutical preparation of Herba Cistanches alcohol extract
embodiment 2,pharmaceutical composition of the present invention and preparation technology:
The weight portion of pharmaceutical composition: Herba Cistanches alcohol extract 6 parts, Semen Raphani 6 parts, Rhizoma Coptidis 9 parts, Radix Et Rhizoma Rhei 17 parts, Cortex Phellodendri 9 parts, Radix Salviae Miltiorrhizae 10 parts, Rhizoma Polygonati 3 parts, Fructus Ligustri Lucidi 3 parts, Radix Polygoni Multiflori 6 parts, Fructus Amomi 6 parts, Herba Epimedii 5 parts, Fructus Lycii 15 parts, the Radix Angelicae Dahuricae 12 parts, Galla Chinensis 12 parts, Periostracum Cicadae 14 parts, Piper longum 6 parts, Semen Cuscutae 5 parts, Radix Angelicae Sinensis 20 parts and 10 parts, Radix Glycyrrhizae.
The above-mentioned medical material getting recipe quantity is broken into fine powder, except Herba Cistanches alcohol extract, the alcoholic solution that volumetric concentration is 80% is added according to 6 times of coarse powder gross weight, reflux, extract, three times, return time is 2h, filters, adds Herba Cistanches water extract in the filtrate of gained, concentrate at 60 DEG C and obtain the extractum that relative density is 1.20, namely obtain drug extract of the present invention; Common drug dosage form clinically can be prepared, as tablet or capsule by this area common dosage forms preparation technology.
embodiment 3,pharmaceutical composition of the present invention and preparation technology:
The weight portion of pharmaceutical composition: Herba Cistanches alcohol extract 10 parts, Semen Raphani 10 parts, Rhizoma Coptidis 5 parts, Radix Et Rhizoma Rhei 12 parts, Cortex Phellodendri 7 parts, Radix Salviae Miltiorrhizae 12 parts, Rhizoma Polygonati 6 parts, Fructus Ligustri Lucidi 7 parts, Radix Polygoni Multiflori 8 parts, Fructus Amomi 10 parts, Herba Epimedii 7 parts, Fructus Lycii 11 parts, the Radix Angelicae Dahuricae 10 parts, Galla Chinensis 15 parts, Periostracum Cicadae 12 parts, Piper longum 8 parts, Semen Cuscutae 7 parts, Radix Angelicae Sinensis 15 parts and 15 parts, Radix Glycyrrhizae.
The above-mentioned medical material getting recipe quantity is broken into fine powder, except Herba Cistanches alcohol extract, the alcoholic solution that volumetric concentration is 90% is added according to 7 times of coarse powder gross weight, reflux, extract, three times, return time is 3h, filters, adds Herba Cistanches water extract in the filtrate of gained, concentrate at 60 DEG C and obtain the extractum that relative density is 1.20, namely obtain drug extract of the present invention; Common drug dosage form clinically can be prepared, as tablet or capsule by this area common dosage forms preparation technology.
embodiment 4,pharmaceutical composition of the present invention and preparation technology:
The weight portion of pharmaceutical composition: Herba Cistanches alcohol extract 16 parts, Semen Raphani 12 parts, Rhizoma Coptidis 3 parts, Radix Et Rhizoma Rhei 10 parts, Cortex Phellodendri 9 parts, Radix Salviae Miltiorrhizae 15 parts, Rhizoma Polygonati 10 parts, Fructus Ligustri Lucidi 10 parts, Radix Polygoni Multiflori 11 parts, Fructus Amomi 6 parts, Herba Epimedii 12 parts, Fructus Lycii 15 parts, the Radix Angelicae Dahuricae 6 parts, Galla Chinensis 18 parts, Periostracum Cicadae 9 parts, Piper longum 12 parts, Semen Cuscutae 10 parts, Radix Angelicae Sinensis 20 parts and 20 parts, Radix Glycyrrhizae.
The above-mentioned medical material getting recipe quantity is broken into fine powder, except Herba Cistanches alcohol extract, the alcoholic solution that volumetric concentration is 85% is added according to 8 times of coarse powder gross weight, reflux, extract, three times, return time is 4h, filters, adds Herba Cistanches water extract in the filtrate of gained, concentrate at 60 DEG C and obtain the extractum that relative density is 1.20, namely obtain drug extract of the present invention; Common drug dosage form clinically can be prepared, as tablet or capsule by this area common dosage forms preparation technology.
the pharmacodynamic study of Part III, Herba Cistanches alcohol extract of the present invention
embodiment 5, pharmaceutical composition of the present invention alleviate radiotherapy side effect clinical research
1 clinical data
1.1 case source and physical data
Selected 150 routine breast tumors all carry out the patient of comfortable Guangzhou Tumor Hospital treatment, choose the case that meets inclusive criteria and get rid for the treatment of with chemotherapy person and fasting simultaneously or the opposition person that takes Chinese medicine, be divided into treatment 1 group of 50 example at random, treat 2 group of 50 example, matched group 50 example.Wherein:
Treat 1 group 50 example, man 28 example, female 22 example, age 56-72 year.Histological type: pulmonary carcinoma 24 example, the esophageal carcinoma 26 example.Average (59.33 ± 6.99) Gy of radiological dose.Treat 2 group 50 example, man 27 example, female 23 example, age 56-72 year.Histological type: pulmonary carcinoma 25 example, the esophageal carcinoma 25 example.Average (59.32 ± 6.98) Gy of radiological dose.Matched group 50 example, man 26 example, female 24 example, age 54-70 year.Histological type: pulmonary carcinoma 24 example, the esophageal carcinoma 26 example.Average (58.69 ± 7.49) Gy of radiological dose.Three groups of Genders, sick kinds, age, exposure dose statistical analysis, three groups of patient clinical datas distributions are similar to, and have comparability.
1.2 inclusion criteria
Inclusive criteria: (1) is clinical clarifies a diagnosis as breast tumor, and determines the patient carrying out radiotherapy; (2) physical function condition grading (KPs) more than 60 points; (3) >6 month life cycle is expected.
Exclusion standard: (1) is treatment with chemotherapy medicine person simultaneously; (2) fasting or the opposition person that takes Chinese medicine.
Rejecting standard: (1) interrupts radiotherapy or cut out Chinese medicine person due to the reason irrelevant with test of cure; (2) owing to there is other diseases in the course for the treatment of, result bias person may be caused.
2 methods
2.1 Therapeutic Method
Treat 1 group, treat 2 groups and all give radiotherapy (radioactive source high energy x line: 23EX high energy two-photon accelerator, by VARIAN company of the U.S. produce) treatment protopathy with matched group.Radical radiation therapy and Palliative radiotherapy is divided into according to conditions of patients.Radical radiation therapy: for T1-3N0M.Case, target area wraps into clinical foci, without the need to preventive radiation lymphatic drainage district; For T1-4NI-3M.Case, irradiation field comprises the internal organs of primary lesion and hilus pulumonis or mediastinum metastatic lymph node and tumor invading.After radical radiation therapy dose,tumor reaches TD40Gy/20 time/4w, adjustment irradiation field and treatment plan, change oblique open country into and avoid spinal cord or radiotherapy planning system design multifield radiation., there is the case of far metastasis for Locally Advanced tumor or oneself in Palliative radiotherapy: only alleviate recent symptom.Chest irradiation open country only wraps into the focus producing symptom.Expection 6-12 life cycle month person, TD30Gy/10 time/2w, or TD45Gy/15 time/3w.
Need to give oxygen uptake according to the state of an illness in experimentation, eliminate the phlegm, bronchodilator etc., concurrent infection and need preventive use antibiotic person to give antibiotic medicine, do Sputum bacterial culture and drug sensitive test if desired to adjust antibiotic, and itemized record patient other medicines treatment information, comprise medicine name, method and dosage.
Treat 1 group to add with medicament composition capsule agent of the present invention (embodiment 4) at radiotherapy, taking dose is 40mg/kg simultaneously.
Treat 2 groups to add with Herba Cistanches alcohol extract capsule of the present invention at radiotherapy, taking dose is 20mg/kg simultaneously.
Medical material is provided by Chinese medicine pharmacy of Guangzhou Tumor Hospital, and it is fried to apply Korea S product DHJ mono-Dl type boiling machine by Chinese medicine pharmacy, and vacuum packaging, 4 DEG C of refrigerators storages, the storage life is no more than 7 days.Provided to patient by researcher.Instructions of taking: 1 times/day, 6 doses/week, serveing on 4 weeks was 1 course for the treatment of, took 2 courses for the treatment of altogether, within every 4 weeks, carried out therapeutic evaluation 1 time.
2.2 observing times put and observation index
The follow-up observation phase is 6 months, respectively before the treatment, carry out when treatment starts latter 1st month, 2 months, 3 months, 6 months, observe patient radiation's property lung damage overall state, patient body functional status, cardinal symptom etc., patient checks at any time if any change of illness state, and carries out record in time to review time and result.
2.2.1 incidence of radioactive pneumonia
Radiation pneumonia diagnostic criteria: " Non ST-segment elevation AMI diagnostic criteria " (GBZll0-2002) in the Occupational sanitary standard that the diagnostic criteria of radiation pneumonia is issued according to Ministry of Public Health:
(1) pulmonary's radioactive dose is more than 8Gy (containing 8Gy);
(2) cough, uncomfortable in chest, the clinical symptoms such as chest pain, dyspnea and low grade fever is had;
(3) sign: the lighter can Non Apparent Abnormality, severe one respiratory murmur reduces, and occurs dry, moist rales.
(4) X-ray examination finds that netted, the irregular fuzzy shape shade in edge appears in exposure pulmonary, or CT scan occurs that ground-glass-like changes and patch shape high density shadow.
2.2.2 evaluation charter
Physical function state evaluation is with the scoring of KPS muscle power situation for index, and after treatment terminates, comparatively KPS scoring increases >=20 and is divided into effective before treatment, increases and 10 is divided into improvement, without increase or reduce >=10 be divided into invalid; Tcm symptom observes scale with reference to Xu Dihua " traditional Chinese medical science Quantitative Diagnosis " the method Curve guide impeller that provides, and cardinal symptom scoring comprises cough, breathes hard, weak classification is scored.
3 results
3.1 incidence of radioactive pneumonia
After breast radiation treatment, treat 1 group of 7 routine patient and radiation pneumonia occurs, incidence of radioactive pneumonia is 14.00%, treat 2 group of 11 routine patient and radiation pneumonia occurs, incidence of radioactive pneumonia is 22.00%, there is radiation pneumonia in the routine patient of matched group 29, incidence of radioactive pneumonia is 53.80%, treat 1 group of patient radiation's property pneumonia incidence rate lower than treatment 2 groups, treat 1 group of patient radiation's property pneumonia incidence rate and be starkly lower than matched group (P < 0.01), difference has statistical significance, result points out pharmaceutical composition of the present invention obviously can reduce the incidence rate of radiation pneumonia after chest radiotherapy, there is the effect of prevention and therapy radiation pneumonia.
Table 1 medicine of the present invention is on the impact of incidence of radioactive pneumonia in radiotherapy
Compare with matched group, #P < 0.05, ##P < 0.01
3.2 3 groups of patients ' life qualities improve situation
Treatment first three groups patient Ka Shi scoring no difference of science of statistics (P > 0.05), there is comparability, after radiotherapy, treat 1 group after the treatment physical function progressively improve, treat the comparatively front improvement of physical function state in latter 6 months, before being even better than radiotherapy, its effect is also better than treatment 2 groups; And matched group patient following up a case by regular visits to 6 the middle of the month physical function situation Progressive symmetric erythrokeratodermia decline, it is obvious that 1 group and matched group two groups of result differences are treated in each monitoring point, illustrates that pharmaceutical composition of the present invention can significantly improve patient body function, improve patients ' life quality.
Table 2 pharmaceutical composition of the present invention improves the impact of situation to radiotherapy Patients Before And After quality of life
Group Before treatment January after treatment February after treatment March after treatment June after treatment
Treat 1 group 81.62±6.50 82.12±6.86 82.84±7.26 83.16±6.88 86.36±9.46
Treat 2 groups 82.38±7.50 82.12±7.30 83.58±5.92 84.16±6.28 84.56±9.48
Matched group 81.95±6.86 75.62±6.54# 73.26±7.22## 71.56±4.28## 70.70±7.56##
Compare with matched group, #P < 0.05, ##P < 0.01
3.3 traditional Chinese medical science cardinal symptom scorings
The tcm symptom no significant difference (P > 0.05) such as before treatment, three groups of patients cough, breathe hard, has comparability.Treat 1 group of cough and symptom symptom after radiotherapy of breathing hard progressively is alleviated, after 6 months, patient's cough and symptom of breathing hard all comparatively alleviate before radiotherapy greatly, and its therapeutic effect is better than treatment 2 groups.Matched group is between follow-up period, and every tcm symptom Progressive symmetric erythrokeratodermia increases the weight of, without improving trend, and after exacerbation of symptoms and radiotherapy the time be proportionate, treat 1 group and be starkly lower than matched group in each monitoring point tcm symptom order of severity, difference has statistical significance.
Table 3 pharmaceutical composition of the present invention is to the improvement of tcm symptom in radiotherapy
Compare with matched group, #P < 0.05, ##P < 0.01.

Claims (8)

1. from Herba Cistanches skin, prepare a method for Herba Cistanches alcohol extract, it is characterized in that, comprise following steps:
(1) carry out peeling process to fresh meat Herba Cistanches, carry out drying at the Herba Cistanches skin obtained 40-60 DEG C, dried Herba Cistanches skin is pulverized, powder crosses 80 mesh sieves, add powder weight 6-10 65-75% ethanol doubly toward powder, ultrasonic extraction 20-40min, filter, filtering residue carries out second extraction, add described powder weight 5-7 65-75% ethanol doubly toward filtering residue, ultrasonic extraction 20-40min, filter, merge twice filtrate, filtrate rotary evaporation obtains Herba Cistanches alcohol extract concentrated solution;
(2) ultrafilter membrane of molecular cut off 5000Da is selected, be 7.0-9.0 at pH value, temperature is 40-50 DEG C, pressure is under 0.7-0.9MPa, ultrafiltration is carried out to the Herba Cistanches alcohol extract concentrated solution that step (1) obtains, collect filtrate, concentrate at 60 DEG C and obtain the extractum that relative density is 1.20, be Herba Cistanches alcohol extract.
2. a kind of method preparing Herba Cistanches alcohol extract from Herba Cistanches skin as claimed in claim 1, is characterized in that, comprise following steps:
(1) carry out peeling process to fresh meat Herba Cistanches, carry out drying at the Herba Cistanches skin obtained 40 DEG C, dried Herba Cistanches skin is pulverized, powder crosses 80 mesh sieves, add 75% ethanol of powder weight 8 times toward powder, ultrasonic extraction 30min, filter, filtering residue carries out second extraction, add 65% ethanol of described powder weight 6 times toward filtering residue, ultrasonic extraction 30min, filter, merge twice filtrate, filtrate rotary evaporation obtains Herba Cistanches alcohol extract concentrated solution;
(2) ultrafilter membrane of molecular cut off 5000Da is selected, be 8.0 at pH value, temperature is 45 DEG C, pressure is under 0.8MPa, ultrafiltration is carried out to the Herba Cistanches alcohol extract concentrated solution that step (1) obtains, collect filtrate, concentrate at 60 DEG C and obtain the extractum that relative density is 1.20, be Herba Cistanches alcohol extract.
3. the Herba Cistanches alcohol extract prepared by the method described in claim 1 or 2.
4. the purposes of Herba Cistanches alcohol extract as claimed in claim 3 after preparation treatment and preventive radiotherapy in radiation pneumonia pharmaceutical composition.
5. purposes as claimed in claim 4, it is characterized in that, described pharmaceutical composition is the compositions be made up of the raw material of following weight portion: Herba Cistanches alcohol extract 6-16 part, Semen Raphani 6-12 part, Rhizoma Coptidis 3-9 part, Radix Et Rhizoma Rhei 10-17 part, Cortex Phellodendri 3-9 part, Radix Salviae Miltiorrhizae 10-15 part, Rhizoma Polygonati 3-10 part, Fructus Ligustri Lucidi 3-10 part, Radix Polygoni Multiflori 6-11 part, Fructus Amomi 6-11 part, Herba Epimedii 5-12 part, Fructus Lycii 10-15 part, Radix Angelicae Dahuricae 6-12 part, Galla Chinensis 12-18 part, Periostracum Cicadae 9-14 part, Piper longum 6-12 part, Semen Cuscutae 5-10 part, Radix Angelicae Sinensis 10-20 part and Radix Glycyrrhizae 10-20 part.
6. purposes as claimed in claim 5, it is characterized in that, described pharmaceutical composition is the compositions be made up of the raw material of following weight portion: Herba Cistanches alcohol extract 16 parts, Semen Raphani 12 parts, Rhizoma Coptidis 3 parts, Radix Et Rhizoma Rhei 10 parts, Cortex Phellodendri 9 parts, Radix Salviae Miltiorrhizae 15 parts, Rhizoma Polygonati 10 parts, Fructus Ligustri Lucidi 10 parts, Radix Polygoni Multiflori 11 parts, Fructus Amomi 6 parts, Herba Epimedii 12 parts, Fructus Lycii 15 parts, the Radix Angelicae Dahuricae 6 parts, Galla Chinensis 18 parts, Periostracum Cicadae 9 parts, Piper longum 12 parts, Semen Cuscutae 10 parts, Radix Angelicae Sinensis 20 parts and 20 parts, Radix Glycyrrhizae.
7. the purposes as described in any one of claim 5 or 6, is characterized in that, described pharmaceutical composition is powder, water preparation, tablet or capsule.
8. purposes as claimed in claim 7, it is characterized in that, the preparation method of described pharmaceutical composition comprises following step: the above-mentioned medical material getting recipe quantity is broken into fine powder, except Herba Cistanches alcohol extract, doubly adds according to the 6-8 of coarse powder gross weight the alcoholic solution that volumetric concentration is 80-90%, reflux, extract, three times, return time is 2-4h, filters, adds Herba Cistanches water extract in the filtrate of gained, concentrate at 60 DEG C and obtain the extractum that relative density is 1.20, namely obtain drug extract of the present invention; Common drug dosage form clinically can be prepared by this area common dosage forms preparation technology.
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CN109513008A (en) * 2019-01-16 2019-03-26 温州医科大学 A kind of pharmaceutical composition and preparation method thereof for treating idiopathic interstitial pneumonia

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