CN104415162A - Traditional Chinese medicine composition for treating leukopenia after chemoradiotherapy and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating leukopenia after chemoradiotherapy and preparation method thereof Download PDFInfo
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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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
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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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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- 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
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
Abstract
The invention discloses a traditional Chinese medicine composition for treating leukopenia after chemoradiotherapy and a preparation method thereof, which belong to the traditional Chinese medicine field. The traditional Chinese medicine composition comprises the following bulk drugs by weight part: 10-20 parts of Radix Codonopsis, 10-20 parts of Poria cocos, 15-45 parts of rhodiola root, 10-20 parts of wolfberry, 10-20 parts of ligustrum lucidum, 5-15 parts of herba epimedii, 5-15 parts of semen cuscutae and 5-15 parts of dried orange peel. The traditional Chinese medicine composition has the characteristics of invigorating spleen and benefiting qi, enriching essence and supplementing marrow, moderate drug nature, and no warmness and hotness; can effectively treat pathology factors such as dysfunctional internal organs and deficiency of essential qi, can improve symptoms of asthenia, soreness of loins and knees and loose stool, can protect bone marrow haematopoietic function, rises white blood cell and increases chemicotherapy completion rate.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition for the treatment of leukopenia after chemoradiotherapy, particularly relate to a kind of Chinese medicine composition for the treatment of leukopenia after concurrent chemoradiotherapy of malignant tumor, the invention still further relates to the preparation method of this Chinese medicine composition, belong to the field of Chinese medicines.
Background technology
Tumor is one of major disease of harm humans health.Data display according to WHO2003 announces: the whole world total malignant tumor patient 1,000 ten thousand, wherein male 5,300,000 in 2000, women 4,700,000; Because mortality of malignant tumors person is up to 6,200,000, account for 12% of total death toll, in developed country, this numeral can reach 25%.In developing country, due to the quickening of urbanization process, the change of life style and dietary habit, the generation of closely-related tumor also will be transformed into the type of developed country gradually with it.If this trend can not improve, anticipate the year two thousand twenty, the annual de novo malignancy case in the whole world will reach 1,500 ten thousand.Therapy of combining Chinese and Western medicine malignant tumor is from China's reality, melt Chinese and western medical science separately advantage be integrated, cancer preventing and treating road with Chinese characteristics, advocates the Comprehensive Treatment of tumor at present, and Chinese medicine conditioning is through tumor patient just its advantage more aobvious of operation chemicotherapy.This advantage curative effect is caused by the pathology link of Trimmed sums torsion malignant tumor.
Chemicotherapy belongs to Chinese medicine and " sends an expedition against " category, and its common toxicity is mainly manifested in two aspects: be bone marrow depression on the one hand, comprise leukopenia, anemia, thrombocytopenia; Be gastrointestinal reaction on the other hand, comprise the symptoms such as appetite decline, nausea and vomiting, abdominal distention diarrhoea.Nearly all chemotherapeutics has bone marrow depression in various degree, because leukocyte proliferation is fast, the life-span is short, so bone marrow depression influenced maximum be leukocyte.Leukopenia, usually affects completing smoothly of chemotherapy, even causes severe infections and dead.Preventing and treating bone marrow depression that chemotherapy causes is the link that treatment tumor patient is badly in need of Trimmed sums and is reversed.General leukocyte increasing Western medicine is as poor in the curative effect such as leucogen, batilol.Granulocyte colony-stimulating factor is used for the leukopenia instant effect caused by chemotherapy, make to obtain solve significantly because leukopenia is difficult to continue chemotherapy this difficult problem, but expensive, and there is rebound phenomenon and the side reaction such as heating, osteodynia in some patients.Many scholars think, granulocyte colony-stimulating factor uses together with chemotherapeutic, can reduce the curative effect of chemotherapy, and have the possibility stimulating some tumor growth.
The leukopenia main manifestations of caused by radiotherapy and chemotherapy is had a dizzy spell, the insomnia of spiritlessness and weakness, soreness of the waist and knees, palpitation and short breath, fidgets due to deficiency, and sweating while acting etc., belong to the traditional Chinese medical science " asthenia " category.Jing-Yue Complete Works is said: " people of all spleen kidney deficiencies and debilitating disorder; have the disease gathered ", illustrates the generation of tumor more, has the deficient situation of internal organs to exist more, especially based on spleen kidney deficiency, the deficient and functional disorder of internal organs or natural endowment deficiency produce blastomogenic intrinsic factor.Tcm theory is thought, the spleen being the foundation of acquired constitution, source of generating QI and blood.Among the five internal organs, spleen and stomach function is particularly important, four dirtyly plays nourishing effect to other, and taste are strong then four dirty all strong, and body function activity remains normal, and taste are decayed, and four dirtyly also decline, and all kinds of diseases and ailments are by giving birth to.Insufficiency of the spleen have pivotal role in tumor invasion process, insufficiency of the spleen then no resource of generating and transforming QI and blood, and deficiency of qi and blood then causes body resistance against diseases to decline; Insufficiency of the spleen in addition, water wets dysfunction of the spleen in transportation and transformation, the turbid interior life of expectorant, hinders QI-blood circulation, causes qi depression to blood stasis, and with the passing of time phlegm and blood stasis, is sent out as carcinoma.The kidney being the origin of congenital constitution, and residence nephroyin and nephroyang is this yuan of life.The raw marrow of kidney controlling essence storage, marrow occupies in bone, and then bone marrow biochemistry is active for kidney essense abundance, and hemopoietic is vigorous.Kidney qi weakness is also the key factor of tumor development.Asthenia mostly is asthenia of both the spleen and kidney, and tonifying speen and tonifying kidney is the key for the treatment of, and clinical treatment should pay attention to tonifying both YIN and YANG especially.Healthy energy is abundant, and the vigor of each internal organs organ is just vigorous, and bone marrow hematogenesis ability also strengthens.
Summary of the invention
Object of the present invention is for providing a kind of Chinese medicine composition for the treatment of leukopenia after chemoradiotherapy and preparation method thereof, the present invention with Radix Codonopsis, Poria, Radix Rhodiolae invigorating the spleen and benefiting QI, with Fructus Lycii, the moon of Fructus Ligustri Lucidi nourishing the liver and kidney, with Herba Epimedii, Semen Cuscutae warming and recuperating the kidney-YANG, the raw marrow of Psoralen, with Pericarpium Citri Reticulatae regulating qi-flowing for harmonizing stomach, full presciption medicine is gentle, not warm not dry.Treatment leukopenia after chemoradiotherapy is respond well.
In order to achieve the above object, the present invention adopts following technical scheme:
The Chinese medicine composition for the treatment of leukopenia after chemoradiotherapy, is characterized in that, comprise the crude drug of following parts by weight: Radix Codonopsis 10-20 part, Poria 10-20 part, Radix Rhodiolae 15-45 part, Fructus Lycii 10-20 part, Fructus Ligustri Lucidi 10-20 part, Herba Epimedii 5-15 part, Semen Cuscutae 5-15 part, Pericarpium Citri Reticulatae 5-15 part.
The weight portion of preferred each crude drug is: Radix Codonopsis 15 parts, 15 parts, Poria, Radix Rhodiolae 30 parts, Fructus Lycii 15 parts, Fructus Ligustri Lucidi 15 parts, Herba Epimedii 10 parts, Semen Cuscutae 10 parts, Pericarpium Citri Reticulatae 10 parts.
Radix Codonopsis nature and flavor are sweet flat, return lung spleen two warp, and " book on Chinese herbal medicine justice " is recorded: spleen reinforcing nourishing the stomach, the lung moistening and production of body fluid promoting, and gas in tendon fortune, this is very mutually not far away with Radix Ginseng.Its outstanding valuable person, then spleen invigorating fortune and not dry, grow stomach-Yin and not wetting, lung moistening and do not violate cold and cool, nourishes blood and partially do not grow greasy, inspiring clear sun, gas in vibration, and without just dry fraud.
Poria is sweet light flat, invigorating spleen to remove dampness, and mind tranquilizing and the heart calming is damp eliminating panacea, and for having loose bowels caused by insufficiency of the spleen dysfunction of the spleen in transportation and transformation, leukorrhagia, application Poria has the effect of giving consideration to both the incidental and fundamental, often uses with Radix Codonopsis mutual reinforcement between, and resonate taste vigour, tonification the foundation of acquired constitution.
Radix Rhodiolae is sweet, bitter, flat, benefiting QI for activating blood circulation, to promote blood circulation, for diseases such as blood stasis due to qi deficiency, obstruction of qi in the chest and cardialgia, apoplectic hemiplegia and asthenia Mental fatigue; see the Tibetan medicine and pharmacology works Four-Volume Medical Code the earliest; have the laudatory title of " snowy region Radix Ginseng ", Compendium of Material Medica is recorded: herbal classic is top grade, eliminating evil; bad odor; mend various symptoms and signs of deficiency, be that in known tonic, institute is rare, mainly apply the immunologic function that Radix Rhodiolae improves body at present; protection and promotion recovery capability, strengthen immunologic cellular activity.Radix Rhodiolae and chemotherapy drugs in combination are applied, the toxicity of chemotherapy can be reduced, improve chemotherapy effect, also can increase the tolerance of patient to operation, radiotherapy or chemotherapy etc., promote the recovery of Post operation body's immunity.Modern study proves that rhodioside by indirect or direct effect, can stimulate the propagation of bone marrow depression anemia mice hemopoietic progenitor cell, promote the recovery of hemopoietic function.
Fructus Lycii nature and flavor are sweet flat, function tonification Liver and kidney, replenishing vital essence to improve eyesight, are the product of flat the kidney invigorating essence liver blood, and " book on Chinese herbal medicine converges and says " carries: " Fructus Lycii can make gas fill, and blood can be mended, Yang Kesheng, and the moon can be grown, and fire can fall, and rheumatism can be gone, and here has perfect magical effect." modern study proves, Fructus Lycii has regulating action to immunity, defying age, antitumor, the liver protecting, promotes hemopoietic function, also has remarkable function of increasing leukocyte to normal healthy people.
Fructus Ligustri Lucidi sweetness and bitterness is cool, the moon of energy liver and kidney tonifying, and begin to be loaded in the Eastern Han Dynasty, Shennong's Herbal is classified as top grade." Bencao Jingshu " carries: " Fructus Ligustri Lucidi, abnormal smells from the patient is all cloudy, and just entering kidney except what vulcanize essence and wanting product, kidney must be mended, then the five internal organs are from peace, and spirit is self-sustaining, and all kinds of diseases and ailments are gone and body is fertile is good for.”
Herba Epimedii and Herba Epimedii, property acrid-sweet flavor temperature, has kidney invigorating and YANG supporting, bone and muscle strengthening, the effect of expelling wind and removing dampness." herbal classic " first year " physical strength profiting, strong will ", Li Shizhen (1518-1593 A.D.) claims it to have the effect of " beneficial vital essence, hard muscles and bones mend waist knee joint, heart tonifying power " in Compendium of Material Medica.Modern pharmacology experimentation shows, Herba Epimedii can promote hemopoietic function, immunologic function and bone metabolism, has the effect such as defying age, antitumor.
Semen Cuscutae nature and flavor Gan Xinping, the kidney invigorating and essence nourishing, nourishing the liver to improve visual acuity.This product is pungent to moisturize, sweet with tonify deficiency, is the product of flat nourishing YIN sun, function kidney-replenishing, kidney tonifying essence, spleen invigorating.According to " Japan hanako materia medica ": mend five kinds of strain and seven kinds of impairment, control and let out essence, hematuria, profit cardiopulmonary.
The arduous temperature of Pericarpium Citri Reticulatae nature and flavor, return spleen lung meridian, regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm, the pungent row temperature of this product is led to, have regulating QI to relieve pain spleen invigorating and in merit, pungent perfume (or spice) and go, is apt to regulating functional activities of vital QI, orderly and clearly middle Jiao, and makes lifting in order, to treat vomiting singultus.Carry in " book on Chinese herbal medicine converges and says ": acrid in the mouth is kind loose, therefore can open gas; The bitter using pungent drugs for dispersion and bitter drugs for purgation of stomach, therefore can manage it expectorant; Its temperature put down, be good at sensible, thus can preventing or arresting vomiting, cough-relieving, invigorating the spleen and regulating the stomach person is also.
Full side's monarch, methodically, had both closed ancient method, had had new meaning again.Above medicine melts nourishing YIN YANG invigorating in one, embodies interdependence between yin and yang, the meaning of cloudy yang invigorating length.Radix Codonopsis, Poria invigorating the spleen and benefiting QI, both can improve spontaneous perspiration, weak symptom, and can promote appetite again, improve blood tonification effect; The moon of Fructus Lycii, Fructus Ligustri Lucidi nourishing the liver and kidney, nourishes blood; Herba Epimedii, Semen Cuscutae warming and recuperating the kidney-YANG, temperature and not dry, Pericarpium Citri Reticulatae regulating qi-flowing for strengthening spleen stomach function regulating, had both helped medicine capable, the antimagnetic greasy stomach that hinders, and effectively can alleviate again the untoward reaction of the digestive system of caused by radiotherapy and chemotherapy.This side's negative and positive of qi and blood, liver spleen kidney is all mended, and except remarkable function of increasing leukocyte, to clinical symptoms such as alleviation spiritlessness and weakness, soreness of the waist and knees, palpitation and insomnia, spontaneous sweatings, all has good curative effect, and without side reaction.
Present invention also offers the preparation method of above-mentioned Chinese medicine composition, each crude drug is taken by described weight portion, each crude drug is pulverized, sieve, add various adjuvants required when preparing different dosage form, such as disintegrating agent, lubricant, adhesive etc., be prepared into the suitable clinical preparation of any one with the method for Chinese medicinal of routine, can be such as capsule, pill, powder, granule, tablet, oral liquid or drop pill etc., be preferably granule.
Preferably, a kind of method preparing Chinese medicine composition of the present invention, comprises the following steps:
(1) each crude drug is taken by described weight portion;
(2) Herba Epimedii, Radix Rhodiolae, Pericarpium Citri Reticulatae are distilled respectively, extract volatile oil, by volatile oil bag by rear pulverizing, for subsequent use;
(3) be 30-95% ethanol extraction by Radix Codonopsis, Fructus Lycii, Fructus Ligustri Lucidi volume fraction, by ethanol extract spraying dry, for subsequent use;
(4) will extract Herba Epimedii, Radix Rhodiolae, Pericarpium Citri Reticulatae medicinal residues and Radix Codonopsis after volatile oil, Fructus Lycii, Fructus Ligustri Lucidi, Poria, Semen Cuscutae one reinstates water extraction, by aqueous extract spraying dry, for subsequent use;
(5) by the product mix homogeneously that step (2), (3) and (4) obtain, add pharmaceutical preparation auxiliary materials and mixing and make intermediate formulations, then make finished dosage form through preparations shaping technique.
Preferably, the ethanol described in above-mentioned steps (3) select volume fraction be 95% ethanol, ethanol add weight be the 3-5 of described medicine gross weight doubly, extracts 2-4 time, at every turn extraction 1.5-2.5 hour.
Preferably, above-mentioned steps (4) is middle uses water extraction secondary, and the weight that adds water for the first time is 3-5 times of described medicine gross weight, decocts 2-4 hour, and the weight that adds water for the second time is 1.5-3 times of described medicine gross weight, decoction 0.5-1.5 hour.
In addition, the purposes of Chinese medicine composition in preparation treatment leukopenia after chemoradiotherapy medicine prepared by the present invention is also comprised.
Chinese medicine composition of the present invention has protection bone marrow, leukocyte during raising malignant tumor patient chemicotherapy, strengthens patient's immunity of organisms, improves gastrointestinal function, thus reaches and alleviate chemicotherapy untoward reaction, improves the object of chemicotherapy completion rate.And Chinese medicine composition Clinical practice safety of the present invention, without any untoward reaction after patient uses, and effectively can improve the whole body function of patient, after medicine of the present invention of stopping using, also can not produce any untoward reaction.
Detailed description of the invention
Further describe the present invention below in conjunction with specific embodiment, advantage and disadvantage of the present invention will be more clear along with description.But embodiment is only exemplary, does not form any restriction to scope of the present invention.It will be understood by those skilled in the art that and can modify to the details of technical solution of the present invention and form or replace down without departing from the spirit and scope of the present invention, but these amendments and replacement all fall within the scope of protection of the present invention.
The preparation of embodiment 1 hard capsule
(1) each raw material decoction pieces is taken by following weight: Radix Codonopsis 1500g, Poria 1500g, Radix Rhodiolae 3000g, Fructus Lycii 1500g, Fructus Ligustri Lucidi 1500g, Herba Epimedii 1000g, Semen Cuscutae 1000g, Pericarpium Citri Reticulatae 1000g.
(2) by Radix Rhodiolae, Herba Epimedii, Pericarpium Citri Reticulatae distillation, extract volatile oil, after getting the beta-schardinger dextrin-of Radix Rhodiolae, Herba Epimedii, Pericarpium Citri Reticulatae volatile oil 10 times amount, the volume fraction adding beta-schardinger dextrin-3 times amount is again after the ethanol mixing of 40%, within 15 minutes, enclose is carried out with colloid mill homogenizing, homogenizing fluid cold preservation after enclose filtered after 24 hours, the clathrate after filtration is pulverized after drying at 40 DEG C of temperature, for subsequent use;
(3) be 95% ethanol extraction by Radix Codonopsis, Fructus Ligustri Lucidi, Fructus Lycii volume fraction, ethanol adds 4 times that weight is described medicine gross weight, extract 3 times, each extraction 2 hours, merge extractive liquid, filter, filtrate is concentrated into 55 DEG C Celsius of relative density 1.30-1.35() clear paste, spraying dry prepares fine powder, for subsequent use;
(4) Herba Epimedii, Radix Rhodiolae, Pericarpium Citri Reticulatae medicinal residues and Radix Codonopsis after volatile oil will be extracted, Fructus Lycii, Fructus Ligustri Lucidi, Poria, Semen Cuscutae one reinstates water extraction secondary, and the weight that adds water for the first time is 4 times of described medicine gross weight, decocts 3 hours, the weight that adds water for the second time is 2 times of described medicine gross weight, decocts 1 hour; Twice decoction liquor merged, filter, it is 55 DEG C Celsius of 1.30-1.35(that filtrate is concentrated into relative density) clear paste, spraying dry prepares fine powder, for subsequent use;
(5) by the product mix homogeneously that step (2), (3) and (4) obtain, add dextrin, Flos Chrysanthemi total glycosides is appropriate, mixing, adds appropriate amount of ethanol and makes granule, cold drying, for subsequent use;
(6) dried particles of preparation in (5) is carried out granulate, be prepared into single-size, for subsequent use;
(7) by the single-size of preparation in (6), be filled in hard capsule case with capsule automatic filling machine, for subsequent use;
(8) hard capsule in (7) is carried out polishing or sealing, to obtain final product.
The preparation of embodiment 2 powder
Each crude drug is taken: Radix Codonopsis 1500g, Poria 1500g, Radix Rhodiolae 3000g, Fructus Lycii 1500g, Fructus Ligustri Lucidi 1500g, Herba Epimedii 1000g, Semen Cuscutae 1000g, Pericarpium Citri Reticulatae 1000g by following weight; After above-mentioned each crude drug is pulverized, cross 800 mesh sieves, to obtain final product.
The preparation of embodiment 3 granule
(1) each raw material is taken by following weight: Radix Codonopsis 1500g, Poria 1500g, Radix Rhodiolae 3000g, Fructus Lycii 1500g, Fructus Ligustri Lucidi 1500g, Herba Epimedii 1000g, Semen Cuscutae 1000g, Pericarpium Citri Reticulatae 1000g;
(2) by Radix Rhodiolae and Herba Epimedii, Pericarpium Citri Reticulatae extracts volatile oil, by volatile oil bag by rear pulverizing, for subsequent use;
(3) by Radix Codonopsis, Fructus Ligustri Lucidi, Fructus Lycii, Semen Cuscutae volume fraction are 95% ethanol extraction, and ethanol adds 4 times that weight is described medicine gross weight, extract 3 times, each extraction 2 hours, merge extractive liquid, filter, filtrate is concentrated into 55 DEG C Celsius of relative density 1.30-1.35() clear paste, spraying dry prepares fine powder, for subsequent use;
(4) Herba Epimedii, Radix Rhodiolae, Pericarpium Citri Reticulatae medicinal residues and Radix Codonopsis after volatile oil will be extracted, Fructus Lycii, Fructus Ligustri Lucidi, Poria, Semen Cuscutae one reinstates water extraction secondary, and the weight that adds water for the first time is 3 times of described medicine gross weight, decocts 3 hours, the weight that adds water for the second time is 2 times of described medicine gross weight, decocts 1 hour; Twice decoction liquor merged, filter, it is 55 DEG C Celsius of 1.30-1.35(that filtrate is concentrated into relative density) clear paste, spraying dry prepares fine powder, for subsequent use;
(5) by the product mix homogeneously that step (2), (3) and (4) obtain, add dextrin, Flos Chrysanthemi total glycosides is appropriate, mixing, add appropriate amount of ethanol and make granule, after cold drying, granulate, subpackage, to obtain final product.
Test example 1: malignant tumor chemotherapy causes leukopenia patient observation of curative effect
1, data and method
1.1 case sources
In January, 2009 ~ 2012 year December Changzhou tumour hospital, outpatient service and Tumor Patients Hospitalized amount to 100 examples.Patient is divided into treatment by Chinese herbs group 50 example at random, matched group 50 example.In treatment by Chinese herbs group, man 22 example, female 28 example; Age 31-75 year, the median age 56 years old, wherein pulmonary carcinoma 8 example, 20 cases of breast cancer, the esophageal carcinoma 3 example, gastric cancer 10 example, colorectal cancer 6 example, cervical cancer 3 example.In matched group, man 24 example, female 26 example; Age 32-75 year, the median age 55 years old; Wherein pulmonary carcinoma 9 example, mammary cancer 16 example, the esophageal carcinoma 4 example, gastric cancer 10 example, colorectal cancer 6 example, cervical cancer 5 example.Two groups of Genders, the age, histological type and by stages, chemotherapy proleukocyte counting and neutrophilic granulocyte number no difference of science of statistics, there is comparability.Above case is all through proved by pathology.Lab testing leukocyte is all lower than 4 × 10
9individual/L, meets leukopenia standard.
1.2 Therapeutic Method
Treatment group: certainly intend prescription: Radix Codonopsis 15g, Poria 15g, Radix Rhodiolae 30g, Fructus Lycii 15g, Fructus Ligustri Lucidi 15g, Herba Epimedii 10g, Semen Cuscutae 10g, Pericarpium Citri Reticulatae 10g day potion, decocting twice, altogether extracting juice 400ml, take sooner or later at twice.Matched group: select and rise BAIYAO: at every turn give batilol 20mg, leucogen 20mg, adenine phosphate 20mg, every day 3 times.The course for the treatment of: two groups equal 10 days be 1 course for the treatment of, the course for the treatment of terminates routine of having a blood test, statistics curative effect.All cases leukocyte 3.0-4.0 × 10
9individual/L does not stop chemotherapy, and leukocyte is lower than 3.0 × 10
9individual/L stops chemotherapy.Period in a medicine strengthens nutrition, feed high protein, high fat diet, prevention infection.
1.3 criterions of therapeutical effect:
With reference to drug for increasing white cells criterion of therapeutical effect in " clinical drug research guideline " that Ministry of Public Health is worked out.Effective: after treatment, total white blood cells rises to 4.0 × 10
9individual/more than L, and can curative effect be maintained until after drug withdrawal 1 week in the course for the treatment of, clinical symptoms significantly alleviates or disappears; Effective: leukocyte <4.0 × 10 after treatment
9individual/L, but the comparatively front rising 0.5 × 10 for the treatment of
9-1.0 × 10
9individual/L, and can curative effect be maintained until after drug withdrawal 1 week in the course for the treatment of, clinical symptoms takes a turn for the better; Invalid: total white blood cells rising <0.5 × 10 after treatment
9individual/L, clinical symptoms is without improvement.
2, therapeutic outcome
Treatment group 50 example, effective 35 examples, effective 11 examples, invalid 4 examples, total effective rate is 92%; Matched group 50 example, effective 18 examples, effective 17 examples, invalid 15 examples, total effective rate is 70%; Two groups of curative effects have significant difference (P<0.05) through statistical procedures.The symptom such as dizzy, weak for patient's subjective symptoms, spontaneous perspiration, appetite are poor, sleep is poor, treatment group is improved obviously.
3, conclusion
Chinese medicine composition prepared by the present invention has protection bone marrow, raises leukocyte during Chemotherapy in Malignant Carcinoma Patients, strengthens patient's immunity of organisms, improves gastrointestinal function, thus reaches and alleviate chemotherapy adverse effect, improves the object of chemotherapy completion rate.
Claims (9)
1. treat the Chinese medicine composition of leukopenia after chemoradiotherapy, it is characterized in that, comprise the crude drug of following parts by weight: Radix Codonopsis 10-20 part, Poria 10-20 part, Radix Rhodiolae 15-45 part, Fructus Lycii 10-20 part, Fructus Ligustri Lucidi 10-20 part, Herba Epimedii 5-15 part, Semen Cuscutae 5-15 part, Pericarpium Citri Reticulatae 5-15 part.
2. Chinese medicine composition according to claim 1, is characterized in that, the weight portion of each crude drug is: Radix Codonopsis 15 parts, 15 parts, Poria, Radix Rhodiolae 30 parts, Fructus Lycii 15 parts, Fructus Ligustri Lucidi 15 parts, Herba Epimedii 10 parts, Semen Cuscutae 10 parts, Pericarpium Citri Reticulatae 10 parts.
3. Chinese medicine composition according to claim 1 and 2, is characterized in that, is prepared into preparation suitable clinically according to Chinese medicine preparation.
4. according to Chinese medicine composition according to claim 3, it is characterized in that, described preparation comprises capsule, pill, powder, granule, tablet, oral liquid or drop pill.
5. prepare the method for the Chinese medicine composition described in claim 1 or 2 for one kind, its step comprises: take each crude drug by described weight portion, each crude drug is pulverized, sieve, add the adjuvant needed for preparations shaping or excipient, be prepared into capsule, pill, powder, granule, tablet, oral liquid or drop pill.
6. prepare a method for the Chinese medicine composition described in claim 1 or 2, its step comprises:
(1) each crude drug is taken by described weight portion;
(2) Herba Epimedii, Radix Rhodiolae, Pericarpium Citri Reticulatae are distilled respectively, extract volatile oil, by volatile oil bag by rear pulverizing, for subsequent use;
(3) be 30-95% ethanol extraction by Radix Codonopsis, Fructus Lycii, Fructus Ligustri Lucidi volume fraction, by ethanol extract spraying dry, for subsequent use;
(4) will extract Herba Epimedii, Radix Rhodiolae, Pericarpium Citri Reticulatae medicinal residues and Radix Codonopsis after volatile oil, Fructus Lycii, Fructus Ligustri Lucidi, Poria, Semen Cuscutae one reinstates water extraction, by aqueous extract spraying dry, for subsequent use;
(5) by the product mix homogeneously that step (2), (3) and (4) obtain, add pharmaceutical preparation auxiliary materials and mixing and make intermediate formulations, then make finished dosage form through preparations shaping technique.
7. preparation method according to claim 6, is characterized in that, the ethanol described in described step (3) select volume fraction be 95% ethanol, ethanol add weight be the 3-5 of described medicine gross weight doubly, extracts 2-4 time, at every turn extraction 1.5-2.5 hour.
8. preparation method according to claim 6, is characterized in that, uses water extraction secondary in described step (4), the weight that adds water for the first time is 3-5 times of described medicine gross weight, decoct 2-4 hour, the weight that adds water for the second time is 1.5-3 times of described medicine gross weight, decocts 0.5-1.5 hour.
9. the purposes of the Chinese medicine composition described in claim 1 or 2 after preparation treatment concurrent chemoradiotherapy of malignant tumor in leukopenia disease drug.
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