CN104623015A - New application of garden burnet root and India madder root composition - Google Patents
New application of garden burnet root and India madder root composition Download PDFInfo
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Abstract
The invention provides an application of a garden burnet root and India madder root combined medicine to preparation of medicines for treating or preventing myelosuppression. After garden burnet root and India madder root are used in a combined manner, the synergistic effects are exerted, the pharmacological activities of the garden burnet root and India madder root combined medicine are obviously improved, and a new choice is provided for clinical medication.
Description
Technical field
The invention provides the novelty teabag of Radix Sanguisorbae and Radix Rubiae.
Background technology
Put/amic therapy method be modern medicine to one of Main Means for the treatment of malignant tumor, Differentiation of Bone Marrow Cells degree is low, and proliferation activity is high, be its sensitive cells, therefore X-ray therapy is while killing tumor cell, also makes myeloid tissue sustain damage.Chemotherapeutics can coup injury DNA stop it to copy, obvious bone marrow depression can be there is after using, cause monosystem or complete set cytopenia, patient Chang Yin infects, hemorrhage, anemia complication etc. and affect therapeutic process, reduce life quality, severe patient even causes death.
Radix Sanguisorbae is the dry root of rosaceous plant Radix Sanguisorbae Sanguisorba officinalis L. or Radix Sanguisorbae Sanguisorbad officinalis L.var.longifolia (Bert.) the Yuet Li that comes into leaves, begin to be loaded in Shennong's Herbal, be listed in middle product." its cold nature, bitter in the mouth, acid, puckery, return liver, large intestine channel ".There is cooling blood for hemostasis, effect of removing toxic substances sore.Clinical data shows, Radix Sanguisorbae raw medicinal herbs is remarkable to the therapeutic effect of the leukopenia that tumor patient causes because of chemicotherapy, dose little (5mg onset), and Coming-of-Age Day takes maximal dose and becomes to be only 60mg raw medicinal herbs.
Radix Rubiae is the dry root and rhizome of Maguireothamnus speciosus Radix Rubiae Rubia cordifolia L., and property bitter cold, returns Liver Channel, have removing heat from blood, hemostasis, blood stasis dispelling, the effect such as to stimulate the menstrual flow.For spitting blood, epistaxis, metrorrhagia, traumatic hemorrhage, amenorrhea stasis blocking, arthralgia, the symptoms such as tumbling and swelling.Modern study shows the leukopenia that Radix Rubiae causes a variety of causes, such as due to tumor radiotherapy chemotherapy, by x-ray and other radioactive substance radiation, benzolism, take some antipyretic analgesic, the leukopenia that the reasons such as some infectious disease cause and the leukopenia that some unknown cause causes all have good therapeutical effect, and its principle active component is Rubidate.
Summary of the invention
The object of the present invention is to provide the novelty teabag of Radix Sanguisorbae and Radix Rubiae.Another object of the present invention is to a kind for the treatment of is provided or prevents myelosuppressive pharmaceutical composition.
The invention provides Radix Sanguisorbae treat in preparation and Radix Rubiae drug combination or prevent the purposes in myelosuppressive medicine.
Wherein, the weight proportion of Radix Sanguisorbae and Radix Rubiae is 1 ~ 15 part: 0.001 ~ 0.063 part.
Further preferably, the weight proportion of Radix Sanguisorbae and Radix Rubiae is 5 ~ 7 parts: 0.025 ~ 0.035 part.
Still more preferably, the weight proportion of Radix Sanguisorbae and Radix Rubiae is 6 parts: 0.029 part.
Present invention also offers a kind for the treatment of or prevent myelosuppressive pharmaceutical composition, it is the preparation be prepared from by the raw material of following weight proportion:
The weight ratio of Radix Sanguisorbae and Radix Rubiae is 1 ~ 15 part: 0.001 ~ 0.063 part.
Further preferably, the weight ratio of Radix Sanguisorbae and Radix Rubiae is 5 ~ 7 parts: 0.025 ~ 0.035 part.
Still more preferably, the weight ratio of Radix Sanguisorbae and Radix Rubiae is 6 parts: 0.029 part.
Wherein, described preparation is oral formulations.
Present invention also offers the preparation method of described pharmaceutical composition, it comprises following operating procedure:
(1) raw material is taken by weight ratio;
(2) with the water of the medicated powder of raw material or raw material or ethanol extraction for active component, add pharmaceutically conventional adjuvant or be complementaryly prepared into preparation.
Wherein, described active component is Madder extract and Radix Sanguisorbae medicated powder; In Madder extract, the content of Rubidate is 2.1 ~ 3.2%.
Wherein, described active component is Madder extract and Radix Sangusorbae extract; In Madder extract, the content of Rubidate is 2.1 ~ 3.2%; In Radix Sangusorbae extract, Radix Sanguisorbae content of tannin is 50% ~ 90%.
Present invention also offers described pharmaceutical composition treat in preparation or prevent the purposes in myelosuppressive medicine.
Present invention also offers described pharmaceutical composition and prepare the purposes had in the medicine of leukocyte increasing.
Based on the modern study of Radix Sanguisorbae and Radix Rubiae, this experiment is under modern medicine theory and clinical application experience instruct, based on clinical experience, take effect experiment as hands section, draft the myelosuppressive basic side's medicine of the treatment by Chinese herbs be made up of Radix Sanguisorbae and Radix Rubiae flavour of a drug, protect according to Radix Rubiae and Radix Sanguisorbae the quantity that marrow rises blood again and carry out orthogonal design as factor level, take quantity of leucocyte as MAIN OUTCOME MEASURES, observe the Chinese medicine compound of different ratio dosage to the myelosuppressive impact of cyclophosphamide inducing mouse, filter out optimum prescription and optimum proportioning relation, for myelosuppressive treatment by Chinese herbs lays the foundation.
The present invention, by after Radix Sanguisorbae and Radix Rubiae conbined usage, has played synergistic function, and its drug activity significantly improves, for clinical application provides new selection.
Detailed description of the invention
Embodiment 1 tablet
[method for making] gets recipe quantity Radix Rubiae, after adding 8 ~ 10 times amount soak with ethanol 30min, and heating extraction 3 ~ 4h, filter, merge extractive liquid, is evaporated to the fluid extract that relative density is 1.2 ~ 1.4; Add mixing after Radix Sanguisorbae being broken into fine powder, make half extractum, add adjuvant after 60 DEG C of temperature dryings, cross 80 mesh sieves, mix homogeneously, adds 95% ethanol soft material, and 16 order nets are granulated; Granulate after 60 DEG C of temperature dryings, then adds magnesium stearate 50g, and mixing, is pressed into 1000, coating and get final product.
Embodiment 2 capsule
[method for making] gets recipe quantity Radix Rubiae, after adding 8 ~ 10 times amount soak with ethanol 30min, and heating extraction 3 ~ 4h, filter, merge extractive liquid, is evaporated to the fluid extract that relative density is 1.2 ~ 1.4; Add mixing after Radix Sanguisorbae being broken into fine powder, make half extractum, add adjuvant after 60 DEG C of temperature dryings, cross 80 mesh sieves, mix homogeneously, adds 95% ethanol soft material, and 16 order nets are granulated; Granulate after 60 DEG C of temperature dryings, encapsulated, make 1000 altogether.
Embodiment 3 drop pill
[method for making] gets recipe quantity Radix Rubiae, and after adding 8 ~ 10 times amount soak with ethanol 30min, heating extraction 3 ~ 4h, filters, merge extractive liquid, concentrating under reduced pressure, purification by macroporous resin, and eluate concentrating under reduced pressure is dry; Radix Sanguisorbae is broken into fine powder, with the alcohol reflux of 6 ~ 10 times of volumes, with ether defatting after concentrating under reduced pressure, purification by macroporous resin, the dry purification of eluate concentrating under reduced pressure; Get recipe quantity PEG-4000 and PEG-6000, heating in water bath melting, add after Madder extract and Radix Sangusorbae extract co-grinding, mixing, dripping becomes 1000 balls.
Embodiment 4 soft capsule
[method for making] gets recipe quantity Radix Rubiae, and after adding 8 ~ 10 times amount soak with ethanol 30min, heating extraction 3 ~ 4h, filters, merge extractive liquid, concentrating under reduced pressure, purification by macroporous resin, and eluate concentrating under reduced pressure is dry; Radix Sanguisorbae is broken into fine powder, with the alcohol reflux of 6 ~ 10 times of volumes, with ether defatting after concentrating under reduced pressure, then carries out macroporous resin separation, collect eluent, be evaporated to appropriate, dry, then with by Madder extract co-grinding, add soybean oil mixing, make 1000 soft capsules.
Beneficial effect of the present invention is illustrated below by way of test example.
Test example 1
1 experiment material
1.1 medical material
(1) Radix Sanguisorbae pharmaceutical decocting piece.
(2) Radix Rubiae pharmaceutical decocting piece.
1.2 positive drug: Rubidatum Tablets.
1.3 laboratory animals: SPF level KM mice.
1.4 chemical reagent
(1) cyclophosphamide.(2) normal saline.(3) dehydrated alcohol.(4) DMEM culture medium.(5) hyclone.(6) dual anti-(penicillin+streptomycin).
1.5 experimental apparatus
(1) full-automatic blood cell analysis machine.(2) ultraviolet spectrophotometer.(3) global function microplate reader.(4) constant-temperature table.(5) refiner.(6) refrigerated centrifuge.(7) flow cytometer.
2 experimental techniques
2.1 medicine groups pair
For carrying out the screening of optimal drug compatibility and optimum dose proportion relation fully and effectively to primary election prescription, and reduce test number (TN), this experiment adopts geometric ratio base-line method to carry out Formulation as far as possible.What reference Radix Sanguisorbae and Radix Rubiae treated the clinical dosage of leukopenia is distribution rate baseline (Radix Sanguisorbae: 5 ~ 60mg, Radix Rubiae 3 ~ 15g), Radix Rubiae dosage successively decreases with 10 ~ 30% therebetween, Radix Sanguisorbae dosage increases progressively with 10 ~ 30%, or Radix Sanguisorbae dosage successively decreases with 10 ~ 30%, Radix Rubiae dosage increases progressively to both sides expansion with 10 ~ 30%, and finally expand limit to, both sides limit is respectively simple Radix Rubiae and simple Radix Sanguisorbae.With Radix Rubiae and the grouping of Radix Sanguisorbae two kinds of medicines several proportioning, according to research purpose with two medicine main effects and secondary efficacy for evaluation index, analyzed by integrated information, carry out the optimal screening of each proportioning.Two medicine ratio are in table 1.
Table 1 Radix Rubiae and Radix Sanguisorbae geometric ratio baseline proportion design table
The preparation method of 2.2 medicines and chemical characterization thereof
2.2.1 the preparation of Madder extract and chemical characterization thereof
The Radix Rubiae of 1 ~ 10 dosage group is taken respectively by consumption in table 1, the alcoholic solution of certain volume is added by equal medical material solvent proportioning, heating extraction 2 ~ 3h, collect extracting solution, purification refine, methanol constant volume, then adopt high performance liquid chromatography to measure the content of Rubidate in 1 ~ 10 group of Radix Rubiae, the content that result records Rubidate in Radix Rubiae is 2.8 ~ 3.5%;
The Radix Rubiae of 1 ~ 10 dosage group is taken respectively by consumption in table 1, the pure water of certain volume is added by equal medical material solvent proportioning, heating extraction 2 ~ 3h, collect extracting solution, add ethanol purification to refine, collecting precipitation, dissolve with methanol standardize solution, then adopt high performance liquid chromatography to measure the content of Rubidate in 1 ~ 10 group of Radix Rubiae, the content that result records Rubidate in Radix Rubiae is 2.1 ~ 3.2%;
2.2.2 the preparation of Radix Sangusorbae extract and chemical characterization thereof
Get Radix Sanguisorbae medical material in table 1, after magnify 20 amount, be ground into coarse powder, extract with the acetone of 8 ~ 12 times of volumes, adopt extracted with diethyl ether defat after concentrating under reduced pressure extracting solution, be then extracted with ethyl acetate for several times, combined ethyl acetate, decompression cryoconcentration is to appropriate, and drying under reduced pressure, to obtain final product.Then the content of method to Radix Sanguisorbae tannin specified according to 2010 editions " Chinese Pharmacopoeias " measures, and in result extract, content of tannin is 50%.
Get Radix Sanguisorbae medical material in table 1, be ground into coarse powder after magnify 20 amount, with the alcohol reflux of 6 ~ 10 times of volumes, with ether defatting after concentrating under reduced pressure, be then extracted with ethyl acetate for several times, combined ethyl acetate, decompression cryoconcentration is to appropriate, and drying under reduced pressure, to obtain final product.Then the content of method to Radix Sanguisorbae tannin specified according to 2010 editions " Chinese Pharmacopoeias " measures, and in result extract, content of tannin is 70%.
Get Radix Sanguisorbae medical material in table 1, after magnify 20 amount, be ground into coarse powder, with the alcohol reflux of 6 ~ 10 times of volumes, with ether defatting after concentrating under reduced pressure, then carry out macroporous resin separation, collect eluent, be evaporated to appropriate, spraying dry and get final product.Then the content of method to Radix Sanguisorbae tannin specified according to 2010 editions " Chinese Pharmacopoeias " measures, and in result extract, content of tannin is 90%.
2.3 experimental pharmacology experiment screenings
2.3.1 the preparation of test medicine
Take the Radix Rubiae of 1 ~ 10 dosage group by consumption in table 1 respectively, add the alcoholic solution of certain volume by equal medical material solvent proportioning, heating extraction 2 ~ 3h, collect extracting solution, be evaporated to proper volume and get final product.Radix Sanguisorbae directly beats powder by 1 ~ 10 group of consumption shown in table 1, then by proportioning, powder and Madder extract is mixed to get 1 ~ 10 kind of drug ratios.
2.3.2 experiment grouping and administration
All Animal adaptabilities are divided at random by body weight after feeding 1 week: normal group, model group, Rubidatum Tablets; Extract 1 ~ 10 group, often organizes 12.Each experimental group starts according to dosage from experimental day, administering mode gives relative medicine, normal group and model group mouse stomach equal-volume pure water, continuous 10 days.
2.3.3 animal model preparation and collection of specimens
Test the 4th day, except blank group, all the other respectively organize mice by 100mgkg
-1dosage intraperitoneal injection of cyclophosphamide normal saline solution, continuous 4 days, naive mice lumbar injection equal-volume normal saline.Test the 10th day, each experimental mice eye socket gets blood, collects to be measured with the 0.5mlEP pipe that EDTA anticoagulant is housed; Disconnected neck puts to death mice, gets left and right sides femur on superclean bench, Ex-all muscle and connective tissue.
2.3.4 Testing index and method
1. peripheral hemogram detects: adopt full-automatic blood counting instrument to count each experimental mice peripheral blood leucocyte (WBC), erythrocyte (RBC), platelet (PLTC).
2. bone marrow DNA content measures: peel off mice left rear limb femur, cut and cut off at femur two ends, expose medullary cavity with ophthalmologic operation.With the CaCl of 10ml0.005mol/L
2rinse bone marrow in centrifuge tube, the centrifugal 15min of 30min, 2500r/min placed by 4 DEG C of refrigerators.Abandon supernatant, add 0.2mo1/L HClO
4solution 5ml, after vibration mixing, 90 DEG C of heating 15min.Be cooled to room temperature cooled and filtered with flowing water, filtrate measures the absorbance A value of 268nm through ultraviolet spectrophotometer.
3. right side of mice femur bone marrow cell gone out by Bone Marrow Hematopoietic Stem counting (HSPC, with hematopoietic stem cell phenotype molecule CD34 for label) the PBS buffer containing bovine serum albumin concentration being 0.2%, takes out 10
6individual cell centrifugation, abandons supernatant, adds 30 μ L Normal Mouse Serum with closed unspecific binding sites, then adds the rat anti-mouse CD34 antibody of 10 μ L FITC labellings, and control tube adds the corresponding control antibodies of 10 μ L, 4 DEG C of lucifuge reaction 30min.Add 2mL erythrocyte cracked liquid, effect 5min, washes cell 2 times, adds the PI dye liquor that final concentration is 3 μ g/mL, adopts flow cytomery medullary cell CD34
+antigen presentation.
4. marrow protection Morphology observation: get part bone marrow, 10% neutral formalin is fixed, plastic embedding, femur stage casing slices across, and Giemsa dyes, and observes marrow hematopoietic capacity percentage change under high power light microscopic.
2.4 statistical method
Adopt SPSS17.0 software to carry out statistical analysis, data are with mean ± standard deviation
represent, adopt one factor analysis of variance between group, carry out LSD inspection between the neat person's group of variance, heterogeneity of variance person carries out Tamhane ' sT2 and checks.
2.5 experimental result
2.5.1 2 be the results are shown in Table on the impact of bone marrow depression mouse peripheral blood cell quantity.
Table 2 each experimental mice peripheral white blood cell amount
Note: compare with model group, * P<0.05, * * P<0.01; Compare with Radix Sanguisorbae group,
△p<0.05,
△ △p<0.01; Compare with Radix Rubiae group,
▲p<0.05,
▲ ▲p<0.01.
As shown in Table 2, compare with normal group, model group mouse peripheral blood WBC has extremely significantly reduction (P<0.01); Compare with model group, extract 1 ~ 11 group of mouse peripheral blood WBC all has remarkable rising (P<0.05), and wherein, extract 5 groups has extremely significantly rising (P<0.01); Compare with normal group, model group mouse peripheral blood RBC has extremely significantly reduction (P<0.01); Compare with model group, extract 1 ~ 11 group of mouse peripheral blood RBC all has remarkable rising (P<0.05), and wherein, extract 5 groups has extremely significantly rising (P<0.01); Compare with normal group, model group mouse peripheral blood PLTC has remarkable reduction (P<0.05); Compare with model group, extract 1 ~ 11 group of mouse peripheral blood PLTC all has remarkable rising (P<0.05).Compare with Radix Sanguisorbae, Radix Rubiae group, extract 5 groups of mouse peripheral bloods WBC, RBC and PLTC all have remarkable rising (P<0.05).
2.5.2 3 be the results are shown in Table on the impact of bone marrow depression mouse DNA content.
Table 3 each experimental mice bone marrow DNA content
Note: compare with model group, * P<0.05, * * P<0.01; Compare with Radix Sanguisorbae group,
△p<0.05,
△ △p<0.01; Compare with Radix Rubiae group,
▲p<0.05,
▲ ▲p<0.01.
As shown in Table 3, compare with normal group, model group mouse bone marrow cells DNA content has extremely significantly reduction (P<0.01); Compare with model group, extract 1 ~ 11 group of mouse bone marrow cells DNA content all has remarkable rising (P<0.05), and wherein, extract 5 groups has extremely significantly rising (P<0.01).Compare with Radix Sanguisorbae, Radix Rubiae group, extract 5 groups of mouse bone marrow cells DNA contents all have remarkable rising (P<0.05).
2.5.3 4 be the results are shown in Table on the impact of bone marrow depression mouse hematopoietic stem cell quantity.
Table 4 each experimental mice hematopoietic stem cell quantity
Note: compare with model group, * P<0.05, * * P<0.01; Compare with Radix Sanguisorbae group,
△p<0.05,
△ △p<0.01; Compare with Radix Rubiae group,
▲p<0.05,
▲ ▲p<0.01.
As shown in Table 4, compare with normal group, model group mouse hematopoietic stem cell quantity has extremely significantly reduction (P<0.01); Compare with model group, extract 1 ~ 11 group of mouse hematopoietic stem cell quantity all has remarkable rising (P<0.05), and wherein, extract 5 groups has extremely significantly rising (P<0.01).Compare with Radix Sanguisorbae, Radix Rubiae group, extract 5 groups of mouse bone marrow cells HSPC all have remarkable rising (P<0.05).
2.5.4 5 be the results are shown in Table on the impact of bone marrow depression mouse hemopoietic volume of tissue.
Table 5 each experimental mice hemopoietic tissue capacity
Note: compare with model group, * P<0.05, * * P<0.01; Compare with Radix Sanguisorbae group,
△p<0.05,
△ △p<0.01; Compare with Radix Rubiae group,
▲p<0.05,
▲ ▲p<0.01.
As shown in Table 5, compare with normal group, model group mouse hemopoietic volume of tissue has extremely significantly reduction (P<0.01); Compare with model group, extract 1 ~ 11 group of mouse hemopoietic volume of tissue all has remarkable rising (P<0.05), and wherein, extract 5 groups has extremely significantly rising (P<0.01).Compare with Radix Sanguisorbae, Radix Rubiae group, extract 5 groups of mouse hemopoietic volume of tissue all have remarkable rising (P<0.05).
3 experiment conclusion
(1) Radix Rubiae and Radix Sanguisorbae 10 kinds of ratio compatibilities suppress all have good therapeutical effect to caused by cyclophosphamide mouse bone marrow cells, and the therapeutic effect of various ratio compatibility is all better than Radix Rubiae and Radix Sanguisorbae is alone.
(2) Radix Rubiae compatibility Radix Sanguisorbae treats myelosuppressive optimal proportion is 6g:29mg.
Claims (10)
1. Radix Sanguisorbae treats and/or prevents the purposes in myelosuppressive medicine in preparation and Radix Rubiae drug combination.
2. purposes according to claim 1, is characterized in that: the weight proportion of Radix Sanguisorbae and Radix Rubiae is 1 ~ 15 part: 0.001 ~ 0.063 part; Preferably, the weight proportion of Radix Sanguisorbae and Radix Rubiae is 5 ~ 7 parts: 0.025 ~ 0.035 part.
3. purposes according to claim 2, is characterized in that: the weight proportion of Radix Sanguisorbae and Radix Rubiae is 6 parts: 0.029 part.
4. treat or prevent a myelosuppressive pharmaceutical composition, it is characterized in that: it is the preparation be prepared from by the raw material of following weight proportion:
The weight ratio of Radix Sanguisorbae and Radix Rubiae is 1 ~ 15 part: 0.001 ~ 0.063 part.
5. pharmaceutical composition according to claim 4, is characterized in that: the weight ratio of Radix Sanguisorbae and Radix Rubiae is 5 ~ 7 parts: 0.025 ~ 0.035 part; Preferably, the weight ratio of Radix Sanguisorbae and Radix Rubiae is 6 parts: 0.029 part.
6. the pharmaceutical composition according to claim 4 or 5, is characterized in that: it be with the water of the medicated powder of Radix Sanguisorbae, Radix Rubiae or raw material or ethanol extraction for active component, add pharmaceutically conventional adjuvant or be complementaryly prepared into preparation.
7. pharmaceutical composition according to claim 6, is characterized in that: described active component is Madder extract and Radix Sanguisorbae medicated powder; In Madder extract, the content of Rubidate is 2.1 ~ 3.2%; Or described active component is Madder extract and Radix Sangusorbae extract; In Madder extract, the content of Rubidate is 2.1 ~ 3.2%; In Radix Sangusorbae extract, Radix Sanguisorbae content of tannin is 50% ~ 90%.
8. pharmaceutical composition according to claim 6, is characterized in that: described preparation is oral formulations.
9. the preparation method of pharmaceutical composition described in claim 4 ~ 8 any one, is characterized in that: it comprises following operating procedure:
(1) raw material is taken by weight ratio;
(2) with the water of the medicated powder of raw material or raw material or ethanol extraction for active component, add pharmaceutically conventional adjuvant or be complementaryly prepared into preparation.
10. pharmaceutical composition described in claim 4 ~ 8 any one is treated in preparation or is prevented the purposes in the medicine of bone marrow depression or leukocyte increasing.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116870069A (en) * | 2023-06-27 | 2023-10-13 | 郑涛 | Compound preparation and preparation method and application thereof |
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| WO2012034519A1 (en) * | 2010-09-14 | 2012-03-22 | 成都科尔医药技术有限公司 | Tannin extract of sanguisorba officinalis l. and preparation method and use thereof |
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2014
- 2014-11-07 CN CN201410628584.7A patent/CN104623015A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2012034519A1 (en) * | 2010-09-14 | 2012-03-22 | 成都科尔医药技术有限公司 | Tannin extract of sanguisorba officinalis l. and preparation method and use thereof |
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| 宫卫星: "《中医内科常用中药》", 31 October 2010, 中国中医药出版社 * |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN116870069A (en) * | 2023-06-27 | 2023-10-13 | 郑涛 | Compound preparation and preparation method and application thereof |
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