CN1850149A - Compounded preparation of Radix As tragali seu Hedy ari extract and mushroom polysaccharide and preparing method - Google Patents
Compounded preparation of Radix As tragali seu Hedy ari extract and mushroom polysaccharide and preparing method Download PDFInfo
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- CN1850149A CN1850149A CN 200610024289 CN200610024289A CN1850149A CN 1850149 A CN1850149 A CN 1850149A CN 200610024289 CN200610024289 CN 200610024289 CN 200610024289 A CN200610024289 A CN 200610024289A CN 1850149 A CN1850149 A CN 1850149A
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Abstract
The present invention relates to a compound preparation formed from astragalus extract and lentinan and its preparation method. Its preparation method includes the following steps: dissolving lentinan in sodium hydroxide solution at room temperature, adding mannitol injection in dissolved solution, uniformly stirring them, adding astragalus extract, using acid to regulate pH value, aseptic filtering so as to obtain compound astragalus and lentinan freeze-dried powder injection, water injection, transfusion agent and capsule preparation. It can be used for preventing and curing the diseases of tumor, viral myocarditis, viral hepatitis, immunologic hypofunction, chronic nephritis and chronic renal failure and chronic bronchitis, etc.
Description
Technical field
The present invention relates to compound preparation of a kind of Radix Astragali extract and lentinan composition and preparation method thereof, this compound preparation has immunological enhancement, prevention and treatment in tumor, the valetudinarian sets upright, and have therapeutical effect at aspects such as viral myocarditis, viral hepatitis, immunologic hypofunction, chronic nephritis and renal failure, chronic bronchitiss, belong to the medicine preparation technical field.
Background technology
Along with the variation of human habitat, living standard and life style and the progress of medical science, significant variation has taken place in the human diseases spectrum, general infectious disease is controlled gradually, and malignant tumor then becomes one of principal disease of common day by day and serious threat human life and quality of life.World Health Organization's statistics shows, the annual morbidity of world's cancer 1,000 ten thousand people, and dead 7,000,000 people are the mankind the 2nd killers that are only second to the cardiovascular diseases.
Seeking effective cancer therapy drug and method, thoroughly capture cancer, is the world medical circle important research project.Chemotherapy, radiotherapy, operative treatment are the main means for the treatment of tumor now, but toxic and side effects is bigger.Can find can killing tumor cell, medicine that toxic and side effects is smaller again and Therapeutic Method, and seeming in tumor treatment is even more important.
The Radix Astragali is the dry root of leguminous plant Radix Astagali Astragalus membranaceus (Fisch.) Bge.vat.Mongholicus (Bge.) Hsiao or Radix Astragali Astragalus membranaceus (Fisch.) Bge..Astragalus is a kind of draft medicinal plants of perennial, deep-rootedness, call continuous stilbene, the continuous Radix Astragali, mainly be distributed in northern area in China, generally be grown in Changbai Mountain, the Xiaoxinanlin Mountains, Wanda Mountain normal pulse Losses in Eastern Mountain Area of Liao Ning and the Daxing'an Mountainrange of the Eastern Mountain Area in northeast, the part plains region also can be seen, and provinces and regions such as Hebei, Shanxi, Shandong, the Inner Mongol, Shaanxi, Gansu, Ningxia, Qinghai, Xinjiang all have in addition, and also there are distribution in Korea, Mongolia, the Soviet Union.
The polysaccharide composition that extracts in the Radix Astragali can stimulate the T lymphocyte in-vitro multiplication of animal, thereby strengthens its specific immune function; Astragalus polysaccharides also can make the phagocytic percentage of Turnover of Mouse Peritoneal Macrophages and phagocytic index obviously raise, and shows that it can strengthen non-specific immunity in the animal body; Astragalus polysaccharides also has stronger inhibitory action to multiple virus, can be referring to the Henan agricultural sciences, and 2005 the 4th phases, 78-90 page or leaf.The astragaloside that extracts in the Radix Astragali, have benefiting QI and nourishing blood, strengthening vital QI to eliminate pathogenic factors, nourish heart promote blood circulation, the effect of invigorating spleen to remove dampness, Chang Zuowei contains the index components that the Chinese medicine preparation of the Radix Astragali detects.
The polysaccharide of the lentinan system homogeneous component that the extraction separation purification obtains from Agaricaceae fungus Lentinus Edodes [Lentinus edodes (Berk) Sing] sporophore of artificial culture.Lentinan (Lentinan) is a kind of medicament for immunity enhancement of immunity regulating type intravenously administrable, and it is low to have dosage, good effect, advantage such as toxic and side effects is little.Be mainly used in inoperable cancer patient clinically, energy significant prolongation patient's time-to-live, and the recurrence of cancer afterwards that prevents to perform the operation.Japan at first obtained lentinan from mushroom fruiting body in 1966, and be applied to clinical the seventies in 20th century.China in 1988 from Japanese import, obtain good curative effect.But import price is very expensive.China in 1994 succeeds in developing with the freeze dried lentinan holoside powder injecta of the same dosage form of Japanese lentinan also goes into operation.
Lentinan is a kind of effective tumour medicine.General and chemotherapy drugs in combination uses.For the gastric cancer of recurrence and colon cancer patient's clinical 4 years of III phase tracing observation, 1,2,3 and 4 annual survival rates use chemotherapeutics to improve (Tsuburs E.Rationale of Biological Response modifiersin cancer treatment.Amsterdan:Excerpta Medica.1985:151) respectively more separately.Lentinan and interleukin-2 are united use can increase anti-tumor activity greatly.The toxic and side effects of lentinan compares with common chemotherapeutics, since slight, so can ignore.In actual applications, lentinan mainly shows as immunological enhancement because of it, thus in clinical practice by and the other medicines compatibility, help to strengthen the effects such as antitumor, antiviral, antiinflammatory of other medicines.
Summary of the invention
The purpose of this invention is to provide a kind of Radix Astragali extract of the pharmaceutical dosage form that is suitable for clinical practice and the compound preparation that lentinan is formed, have simultaneously at aspects such as setting upright of the prevention of tumor and treatment, viral myocarditis, viral hepatitis, immunologic hypofunction, chronic nephritis and renal failure, chronic bronchitis, valetudinarian and can play possesses synergistic, easy to use.
For realizing above purpose, technical scheme of the present invention provides the compound preparation of a kind of Radix Astragali extract and lentinan composition, it is characterized in that: the weight ratio of Radix Astragali extract and lentinan is 1: 0.1-5, the pharmaceutical dosage form that is suitable for clinical practice comprises: tablet, capsule, injectable powder, lyophilized injectable powder, aqueous injection, infusion solution.
The compound preparation that a kind of Radix Astragali extract and lentinan are formed is characterized in that, the immunological enhancement of lentinan and antiviral and antiphlogistic Radix Astragali extract are united use, and its preparation method is:
(1): take by weighing lentinan 0.1-5 part by weight, put into the sodium hydrate aqueous solution room temperature dissolving of container with 0.3-1mol/L;
(2): in step (1) lysate, add 100-300 times of weight 10-30% of lentinan formula mannitol injection liquid, stir evenly;
(3): in step (2) lysate, add 1 part of Radix Astragali extract, transfer pH to 6-10 with acid solution then, filter, require to make compound astragalus membranaceus-lentinan freeze-dried powder according to the operation of Chinese medicine lyophilized injectable powder;
(4): or add 1 part of Radix Astragali extract in step (1) lysate, stirring and dissolving is transferred pH to 6-10 with acid solution, filters, and requires to make compound astragalus membranaceus-lentinan aqueous injection according to the operation of Chinese medicine aqueous injection;
(5): or in step (1) lysate, add 1 part of Radix Astragali extract, the dissolving back adds the equivalent hydrochloric acid solution, the sodium hydroxide solution of reuse same concentrations or hydrochloric acid solution are transferred pH to 6-10, filter, and require to make compound astragalus membranaceus-lentinan infusion solution according to the operation of Chinese medicine infusion solution;
(6): or adding 1 part of Radix Astragali extract in step (1) lysate, add the starch of 10-100 times of weight of Radix Astragali extract, is binding agent with the ethanol water of water or 60-90%, makes compound astragalus membranaceus-lentinan capsule by the operation requirement of capsule.
Described Radix Astragali extract is to extract the water soluble ingredient that obtains behind the purification from Chinese medicine astragalus according to a conventional method, and wherein the content of astragalus polysaccharides is at 30%-100% (W/W); Described Radix Astragali extract or from Chinese medicine astragalus, extract the liposoluble constituent that obtains behind the purification according to a conventional method, wherein the content of astragaloside is at 10%-100% (W/W); The mixture that obtains after water soluble ingredient that described Radix Astragali extract or will extract respectively according to a conventional method from Chinese medicine astragalus obtains behind the purification and liposoluble constituent mix again, its weight ratio is 1: 0.1-5; The acid solution of adjusting pH to 6-10 described in step (3), (4) is hydrochloric acid solution or aqueous citric acid solution.
The compound preparation of being made up of Radix Astragali extract and lentinan of the present invention is in the application of aspects such as setting upright of the prevention of tumor and treatment, viral myocarditis, viral hepatitis, immunologic hypofunction, chronic nephritis and renal failure, chronic bronchitis, valetudinarian.
Lentinan of the present invention is meant from mushroom fruiting body [Lentinus edodes (Berk) Sing] extraction, purified, meets the lentinan for injection of national drug quality standard WS-320 (X-263)-94.
The present invention is directed to prior art, the compound preparation that provides can be brought into play the more powerful immunological enhancement of working in coordination with after making the effective extract of enhance immunity effect in the Radix Astragali and lentinan combination; Simultaneously by with the compatibility of lentinan, can also better bring into play effect such as effective extract antiviral and antiinflammatory in the Radix Astragali.
In the process of the compound preparation of studying Radix Astragali extract and lentinan composition, find, when the content of astragalus polysaccharides in the water solubility extract of the Radix Astragali is lower than 30%, the underproof phenomenon of clarity can appear in compound preparation that this Radix Astragali extract and lentinan are formed such as aqueous injection in depositing process, thus one of feature of the present invention be from the Radix Astragali, extract the content of astragalus polysaccharides in the water soluble ingredient that obtains behind the purification according to a conventional method should be at 30%-100% (W/W).
In the process of the compound preparation of studying Radix Astragali extract and lentinan composition, find equally, when the content of astragaloside in the liposoluble extract of the Radix Astragali is lower than 10%, the underproof phenomenon of clarity can appear in compound preparation that this Radix Astragali extract and lentinan are formed such as aqueous injection in depositing process, thus one of feature of the present invention be from the Radix Astragali, extract the content of astragaloside in the liposoluble constituent that obtains behind the purification according to a conventional method should be at 10%-100% (W/W).
Advantage of the present invention is to be suitable for clinical practice, have simultaneously at aspects such as setting upright of the prevention of tumor and treatment, viral myocarditis, viral hepatitis, immunologic hypofunction, chronic nephritis and renal failure, chronic bronchitis, valetudinarian and can play possesses synergistic, easy to use.
The specific embodiment
The invention will be further described below in conjunction with embodiment.
Embodiment 1:
Get lentinan for injection 2 grams, put into the sodium hydrate aqueous solution 700ml room temperature dissolving of container with 0.6mol/L, the dissolving back adds common 20% formula mannitol injection liquid 400ml, stir evenly, add Radix Astragali extract 4 grams that contain astragalus polysaccharides 50%, it is 7-9 that pH is transferred with dilute acid soln in the dissolving back, filter, be evaporated to 1000ml, aseptic filtration, sterilization is surveyed content, packing, the 1ml/ bottle, cool drying seals, and gets compound astragalus membranaceus-lentinan freeze-dried powder.
Embodiment 2:
Get lentinan for injection 1 gram, put into the sodium hydrate aqueous solution 700ml room temperature dissolving of container, after the dissolving fully, add Radix Astragali extract 0.5 gram that contains astragaloside 20% with 0.2mol/L, it is 7-9 that pH is transferred with dilute acid soln in the dissolving back, filter, add the injection water to 1200ml, aseptic filtration, sterilization, divide and irritate in appropriate containers, seal, promptly get the compound lentinan liquid drugs injection.
Embodiment 3:
Get lentinan for injection 0.1 gram, put into the sodium hydrate aqueous solution 923ml room temperature dissolving of container with 1mol/L, after the dissolving fully, add Radix Astragali extract 0.2 gram that contains astragaloside 30% and Radix Astragali extract 0.3 gram that contains astragalus polysaccharides 70%, the dissolving back adds 1mol/L hydrochloric acid solution 923ml, the sodium hydroxide solution of reuse same concentrations or hydrochloric acid solution are transferred pH to 7-9, filter, add the injection water to 6000ml, aseptic filtration, sterilization divides and irritates in appropriate containers, promptly gets compound astragalus membranaceus-lentinan transfusion.
Embodiment 4:
Get lentinan 10 grams, put into container with adding Radix Astragali extract 60 grams that contain astragaloside 10% and Radix Astragali extract 30 grams that contain astragalus polysaccharides 30%, add starch 3000 grams, behind the mix homogeneously, the ethanol water with 75% is a binding agent, makes soft material.Put into granulation machine, make granule.Dry back granulate, the encapsulated compound astragalus membranaceus-lentinan capsule that promptly gets.
The present invention has carried out the drug effect that serial pharmacological evaluation is verified the compound preparation that Radix Astragali extract and lentinan are formed.
1. tumor suppression test: with the compound recipe aqueous injection that contains astragaloside 0.15mg/ml and contain lentinan 1mg/ml is experimental drug.4～5 age in week Kunming mouse, body weight is at 20 ± 5g, the male and female dual-purpose, random packet, every group of average 10-12 only, each group is all raised under the same conditions, freely drinks water.Negative control group is established in experiment: do not process after the corresponding tumor strain of mouse inoculation; Positive controls: after the corresponding tumor strain of mouse inoculation second day intraperitoneal (ip) give commercially available Radix Astragali injection, 1ml/ only, once a day, two weeks of logotype; Experimental group: after the corresponding tumor strain of mouse inoculation second day intraperitoneal (ip) contain astragaloside 1mg/ml and contain the compound recipe liquid drugs injection of lentinan 1mg/ml, 1ml/ only, once a day, two weeks of logotype.With S
180, H
22The strain of ascitic type tumor is gone down to posterity through kunming mice ip, and after extracting from the abdominal cavity with syringe, normal saline is diluted to the cell suspension of debita spissitudo, and cell concentration is 5 * 10
6/ 0.2ml, ip in mice is injected, and judges its tumor-inhibiting action according to ascites growth and decline degree then.End product shows that this compound recipe aqueous injection has significant inhibitory effect to mice-transplanted tumor, the life span of energy significant prolongation tumor-bearing mice, and the life span of experimental group tumor-bearing mice obviously is longer than positive controls.
Compound astragalus membranaceus lentinan aqueous injection and Radix Astragali injection influence contrast table to the life span of tumor-bearing mice
| Mean survival time (n=10) | |
| Radix Astragali injection | 12.5 my god |
| Compound astragalus membranaceus lentinan aqueous injection | 22.5 my god |
2. lymphocyte proliferation assay: with the compound astragalus membranaceus lentinan aqueous injection that contains astragaloside 0.15mg/ml, astragalus polysaccharides 1.5mg/ml and lentinan 1.5mg/ml is experimental drug, is contrast with commercially available Radix Astragali injection.The aseptic dirty peripheral blood of Cor Gigeriae Galli, the anticoagulant heparin adopted.Percoll cell layering liquid isolated lymphocytes.The lymphocyte for preparing joins 96 porocyte culture plates, and 50 μ L/ holes add medicinal liquid to be measured (liquid drugs injection) 50 μ L then, and respectively as T, bone-marrow-derived lymphocyte mitogen, concentration is respectively 45,22.5 μ g/ml with concanavalin A, bacteria lipopolysaccharide.Each handles 3 multiple holes, puts 40 ℃, 5% CO
2After cultivating 60h under the condition, Brdu-ELISA test kit (Bioehringer Mannheim company) labelling, colour developing are measured OD with 318～MC microplate reader
450nmValue.Data are added up with SPSS software.The result is as follows:
| Medicine | OD 450nmValue (X ± SD) | |
| The T lymphocyte | Bone-marrow-derived lymphocyte | |
| Compound astragalus membranaceus lentinan aqueous injection | 0.672±0.145 | 1.212±0.147 |
| Commercially available Radix Astragali injection | 0.527±0.114 | 0.915±0.098 |
| Blank | 0.395±0.034 | 0.762±0.133 |
The result shows that this compound recipe aqueous injection all has obvious facilitation to the inductive chicken T of concanavalin A lymphopoiesis and to the inductive chicken B lymphocyte propagation of bacteria lipopolysaccharide.
Claims (7)
1. the compound preparation formed of Radix Astragali extract and lentinan, it is characterized in that: the weight ratio of Radix Astragali extract and lentinan is 1: 0.1-5, the pharmaceutical dosage form that is suitable for clinical practice comprises: tablet, capsule, injectable powder, lyophilized injectable powder, aqueous injection, infusion solution.
2. the compound preparation formed of Radix Astragali extract and lentinan is characterized in that, the immunological enhancement of lentinan and antiviral and antiphlogistic Radix Astragali extract are united use, and its preparation method is:
(1): take by weighing lentinan 0.1-5 part by weight, put into the sodium hydrate aqueous solution room temperature dissolving of container with 0.3-1mol/L;
(2): in step (1) lysate, add the 10-30% formula mannitol injection liquid of 100-300 times of weight of lentinan, stir evenly;
(3): in step (2) lysate, add 1 part of Radix Astragali extract, transfer pH to 6-10 with acid solution then, filter, require to make compound astragalus membranaceus-lentinan freeze-dried powder according to the operation of Chinese medicine lyophilized injectable powder;
(4): or add 1 part of Radix Astragali extract in step (1) lysate, stirring and dissolving is transferred pH to 6-10 with acid solution, filters, and requires to make compound astragalus membranaceus-lentinan aqueous injection according to the operation of Chinese medicine aqueous injection;
(5): or in step (1) lysate, add 1 part of Radix Astragali extract, the dissolving back adds the equivalent hydrochloric acid solution, the sodium hydroxide solution of reuse same concentrations or hydrochloric acid solution are transferred pH to 6-10, filter, and require to make compound astragalus membranaceus-lentinan infusion solution according to the operation of Chinese medicine infusion solution;
(6): or adding 1 part of Radix Astragali extract in step (1) lysate, add the starch of 10-100 times of weight of Radix Astragali extract, is binding agent with the ethanol water of water or 60-90%, makes compound astragalus membranaceus-lentinan capsule by the operation requirement of capsule.
3. compound preparation and preparation method that a kind of Radix Astragali extract according to claim 1 and 2 and lentinan are formed, it is characterized in that, described Radix Astragali extract is to extract the water soluble ingredient that obtains behind the purification from Chinese medicine astragalus according to a conventional method, and wherein the content of astragalus polysaccharides is at 30%-100% (W/W).
4. compound preparation and preparation method that a kind of Radix Astragali extract according to claim 1 and 2 and lentinan are formed, it is characterized in that, described Radix Astragali extract or extract the liposoluble constituent that obtains behind the purification from Chinese medicine astragalus according to a conventional method, wherein the content of astragaloside is at 10%-100% (W/W).
5. compound preparation and preparation method that a kind of Radix Astragali extract according to claim 1 and 2 and lentinan are formed, it is characterized in that, the mixture that obtains after water soluble ingredient that described Radix Astragali extract or will extract respectively according to a conventional method from Chinese medicine astragalus obtains behind the purification and liposoluble constituent mix again, its weight ratio is 1: 0.1-5.
6. the preparation method of compound lentinan agent according to claim 2 is characterized in that, the acid solution of the adjusting pH to 6-10 described in step (3), (4) is hydrochloric acid solution or aqueous citric acid solution.
7. the compound preparation that a kind of Radix Astragali extract according to claim 1 and 2 and lentinan are formed, it is characterized in that the compound preparation that described Radix Astragali extract and lentinan are formed can be used for the treatment of aspects such as setting upright of the prevention of tumor and treatment, viral myocarditis, viral hepatitis, immunologic hypofunction, chronic nephritis and renal failure, chronic bronchitis, valetudinarian and uses.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101019911B (en) * | 2007-03-09 | 2010-08-18 | 上海慈瑞医药科技有限公司 | Chinese medicine composition possessing antifatigue and immunoregulation functions |
| CN104288172A (en) * | 2014-10-10 | 2015-01-21 | 天津瑞贝特科技发展有限公司 | Composition for preventing and treating inclusion body hepatitis of poultry and preparation method thereof |
| CN105726865A (en) * | 2016-02-25 | 2016-07-06 | 毛德英 | Lentinan oral liquid and preparation method and application thereof |
-
2006
- 2006-03-02 CN CN 200610024289 patent/CN1850149A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101019911B (en) * | 2007-03-09 | 2010-08-18 | 上海慈瑞医药科技有限公司 | Chinese medicine composition possessing antifatigue and immunoregulation functions |
| CN104288172A (en) * | 2014-10-10 | 2015-01-21 | 天津瑞贝特科技发展有限公司 | Composition for preventing and treating inclusion body hepatitis of poultry and preparation method thereof |
| CN105726865A (en) * | 2016-02-25 | 2016-07-06 | 毛德英 | Lentinan oral liquid and preparation method and application thereof |
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