CN101766604A - Preparation method and pharmaceutical uses of curcumin and pidotimod composition - Google Patents

Preparation method and pharmaceutical uses of curcumin and pidotimod composition Download PDF

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Publication number
CN101766604A
CN101766604A CN200810247444A CN200810247444A CN101766604A CN 101766604 A CN101766604 A CN 101766604A CN 200810247444 A CN200810247444 A CN 200810247444A CN 200810247444 A CN200810247444 A CN 200810247444A CN 101766604 A CN101766604 A CN 101766604A
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Prior art keywords
pidotimod
curcumin
composition
preparation
infection
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CN200810247444A
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Chinese (zh)
Inventor
王翰斌
郑明月
李彬彬
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HUBO-GUANGHUA MEDICINE SCIENCE-TECHNOLOGY DEVELOPMENT Co Ltd BEIJING
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HUBO-GUANGHUA MEDICINE SCIENCE-TECHNOLOGY DEVELOPMENT Co Ltd BEIJING
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Priority to CN200810247444A priority Critical patent/CN101766604A/en
Publication of CN101766604A publication Critical patent/CN101766604A/en
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Abstract

The invention discloses a preparation method and pharmaceutical uses of a curcumin and pidotimod composition. The curcumin and pidotimod composition is used for treating: (1) recurrent upper and lower respiratory tract infections (pharyngitis, tracheitis, bronchitis and tonsillitis); (2) ENT recurrent infections (rhinitis, sinusitis and otitis); (3) urinary system infection; (4) gynecological infection; (5) clinical patients with low cellular immune function after chemotherapy; and (6) specific and non-specific immune deficiency diseases such as cancer and the like. The curcumin and pidotimod composition can be used for reducing the number of acute attack, shortening the course of medication and reducing the degree of attack, and also can be used for the adjuvant treatment of antibiotics during acute infection. The pidotimod and curcumin composition together with various pharmaceutically acceptable excipients are comprised, and various pharmaceutically acceptable dosage forms can be prepared, including but not limited to tablets, capsules, injection agents and the like.

Description

The preparation of curcumin and pidotimod composition and pharmaceutical use
Technical field
The invention belongs to the medicine new technical field, relate to the preparation and the pharmaceutical use of curcumin and pidotimod composition, be used for the treatment of 1. the last lower respiratory infection (pharyngitis, tracheitis, bronchitis, tonsillitis) of outbreak repeatedly; 2. department of otorhinolaryngology repeated infection (rhinitis, sinusitis, otitis); 3. urinary system infection; 4. gynecological infection; 5. the low clinical patients of cellular immune function after the chemotherapy; 6. specificity and nonspecific immunity defective disorders such as cancers etc.In order to reduce the number of times of acute attack, shorten the course of disease, alleviate the degree of outbreak; Antibiotic auxiliary treatment when also can be used as actute infection.The preparation method and the pharmaceutical usage thereof of specifically a kind of curcumin and pidotimod composition.
Background technology
The immune system of human body is being defended the health of human body just as a well-trained crack troops.Immune system is people's usually said " immunity ", " resistance " to the defence capability of pathogen.
People's defence capability comprises nonspecific immunity and specific immunity.Nonspecific immunity is to be born with the man day, so be called the inherency immunity again, comprise the skin, mucosa of body barrier effect to pathogen, phagocyte in the blood, neutrophilic granulocyte be to the phagocytosis of pathogen, and complement, lyase bacterium, properdin, interferon etc. are to the killing action of pathogen.Specific immunity is meant human body to the resistance targetedly that certain pathogen had, and this immunity varies with each individual, and generally can obtain by prophylactic immunization, ill or inapparent infection.Specific immunity mainly forms after the people is born, so be acquired immunity again.
Sound immunity is to guarantee that body avoids the key factor of pathogen invasion and attack, and in fact, for some reason or other, often causes people's hypoimmunity.
Pharmacodynamic study shows that pidotimod is an immunopotentiating agent, can promote nonspecific immune reaction, can promote specific immune response again.Pidotimod can promote the activate the phagocytic capacity of macrophage and neutrophilic granulocyte, improves its chemotaxis; Activate natural killer cell; The former lymphopoiesis that causes of mitosis promoting, the helper T lymphocyte (CD that reduces when making immunologic hypofunction 4 +) and suppressor T lymphocyte (CD 8 +) ratio raise to recover normal; By stimulating interleukin-2 and gamma interferon to promote cell immune response.
Although all showing pidotimod, animal experiment and clinical trial do not have directly antibiotic and antiviral activity, by bringing into play the curative effect that significant treatment antibacterial (Diplococcus pneumoniae, escherichia coli, bacillus pyocyaneus, Bacillus proteus etc.) and virus (influenza virus, herpes simplex virus, murine encephalomyocarditis virus and Mengo virus etc.) infect to the promotion of the immunologic function of human body.
Pidotimod is by cellular immunization, humoral immunization approach performance antibacterium, antiviral, the antifungic action of enhancing body.Clinical practice has all obtained good effect in repeatedly respiratory tract infection of control child, old people's chronic bronchitis, urinary system infection, malignant tumor and the chemotherapy of outbreak repeatedly, the auxiliary treatment after the radiotherapy.The multicenter open clinical trial shows that curative effect is reliable, and the human tolerance is good, and toxic and side effects is little.
Rhizoma Curcumae Longae be clinical commonly used in, one of illiteracy, Tibetan medicine.In " Newly Revised Canon of Materia Medica ", " Bencao Tujing ", Compendium of Material Medica, " book on Chinese herbal medicine is looked for the truth ", " brilliant pearl book on Chinese herbal medicine " etc., all record.Has the removing blood stasis circulation of qi promoting, the effect of inducing menstruation to relieve menalgia.Be used for the costa sternales twinge, amenorrhea, mass in the abdomen, rheumatism shoulder arm pain, tumbling and swelling., curcumin is yellow food plant pigment, is extracted by the Chinese crude drug Rhizoma Curcumae Longae, main component is that curcumin is about 70%, demethoxycurcumin is about 15%, remove dimethoxy curcumin about 10%.Curcumin is the main active of Rhizoma Curcumae Longae performance pharmacological action, because it is wide that it has pharmacological action, as antiinflammatory, antioxidation, antimutagenic, anticoagulant, blood fat reducing, atherosclerosis, anti HIV-1 virus, antibiotic and antitumor action etc.,, toxicity is low and have wide medicinal application prospect, is widely used as pigment, food additive and flavoring agent.
The anti-inflammatory activity research of curcumin has report more, says curcumin to be applied to clinically as non-sterols anti-inflammatory agent, and good result is arranged.The antipyretic effect of curcumin is not strong, and stomach is not had significantly to stimulate, and cardiovascular and central nervous system are not had to be influenced other curcumin homologue certain anti-inflammatory activity is also arranged, but effect is all not as curcumin.
The focus of the domestic and international research of antitumor research having become of curcumin, curcumin has value to the treatment chronic myelocytic leukemia.The curcumin inducing apoptosis of tumour cell may be an importance of curcumin antitumaous effect mechanism.External report is pointed out curcumin, and Rhizoma Curcumae Longae and water extract thereof prevent and therapeutical effect having of cancer.Curcumin in the food is the mammary neoplasms of anti-virus and inductive mice of chemical carcinogens and rat in advance.Curcumin has the obvious suppression effect to the generation and the body of gland propagation of rat colon cancer, and tangible dose-response relationship arranged, and in the animal model of the inductive breast carcinoma of DMBA, curcumin only produces slight effect, only can prolong tumorigenic incubation period when higher dosage.Curcumin can improve the rat heart muscle oxygen-resistant ability, and the ischemia injury of rat heart muscle is had the certain protection effect.The patient of hyperlipemia takes the alcohol extract of the Rhizoma Curcumae Longae that contains 50% total curcumin, hypercholesterolemia reducing, triglyceride significantly, and the effect of its triglyceride reducing is greater than the effect of cholesterol reducing.The alcohol extract of Rhizoma Curcumae Longae does not all have obvious influence to blood glucose, creatinine, carbamide, serum alkaline phosphatase and serum gamma-glutamyl transferase activity and to serum globulin.The alcohol extract that Rhizoma Curcumae Longae is described to the equal free of toxic effects of hepatic and renal function, and when may the certain protection effect be arranged to liver, to the equal free of toxic effects of hepatic and renal function, and may have the certain protection effect to liver in blood fat reducing.Prompting curcumol extract is to fall the ester medicine based on triglyceride reducing safely and effectively simply.
The present invention is prepared into compositions with pidotimod and curcumin, has stronger synergism.Increase simultaneously mutual stability again.Be mainly used in treatment cancer and various infection, the patient with severe symptoms.
The compositions of pidotimod of the present invention and curcumin adds pharmaceutically acceptable various adjuvant, can be prepared into pharmaceutically acceptable various dosage form, includes but not limited to tablet, capsule, injection etc.Safety is good, good stability.
Summary of the invention
Pidotimod of the present invention is that pidotimod and curcumin are mixed according to a certain percentage with the common method for making of the compositions of curcumin, and it is an amount of to add dodecyl sodium sulfate simultaneously, and arginine or lysine or the methylamine of crawling are an amount of.Add mix homogeneously such as an amount of adjuvant such as microcrystalline Cellulose, dextrin, starch, magnesium stearate again, load capsule or be pressed into slice, thin piece.
The present invention also provides said composition in pharmaceutically purposes, is used for the treatment of 1. the last lower respiratory infection (pharyngitis, tracheitis, bronchitis, tonsillitis) of outbreak repeatedly; 2. department of otorhinolaryngology repeated infection (rhinitis, sinusitis, otitis); 3. urinary system infection; 4. gynecological infection; 5. the low clinical patients of cellular immune function after the chemotherapy; 6. specificity and nonspecific immunity defective disorders such as cancers etc.In order to reduce the number of times of acute attack, shorten the course of disease, alleviate the degree of outbreak; Antibiotic auxiliary treatment when also can be used as actute infection.
The specific embodiment
Following examples are to be used for illustrating the present invention, but do not limit the present invention in any way.
Embodiment 1: capsule
Pidotimod 400g
Curcumin 400g
Lysine 100g
Microcrystalline Cellulose 50g
Dodecyl sodium sulfate 4g
Low-substituted hydroxypropyl cellulose 50g
Make 2000
Method for making: the pidotimod, curcumin, lysine, microcrystalline Cellulose, dodecyl sodium sulfate, the low-substituted hydroxypropyl cellulose that take by weighing recipe quantity are crossed 60 mesh sieve mix homogeneously, and the fill capsule gets final product.
Embodiment 2: tablet
Prescription: pidotimod 400g
Curcumin 400g
Lysine 100g
Microcrystalline Cellulose 50g
Dodecyl sodium sulfate 5g
Low-substituted hydroxypropyl cellulose 50g
Make 2000
Method for making: the pidotimod, curcumin, lysine, microcrystalline Cellulose, dodecyl sodium sulfate, the low-substituted hydroxypropyl cellulose that take by weighing recipe quantity are crossed 60 mesh sieve mix homogeneously, compressing dry granulation, and the bag film-coat gets final product.
Embodiment 3: dispersible tablet
Prescription: pidotimod 400g
Curcumin 500g
Microcrystalline Cellulose 100g
Arginine 50g
Polyvinylpolypyrrolidone 80g
Mannitol 100g
Aspartame 5g
5% 30 POVIDONE K 30 BP/USP 30 (40% ethanol) solution is an amount of
Dodecyl sodium sulfate 5.5g
Make 1000
Method for making: pidotimod, curcumin, microcrystalline Cellulose, arginine, polyvinylpolypyrrolidone, the mannitol of getting recipe quantity are crossed 80 mesh sieve mix homogeneously, it is an amount of to add 5% 30 POVIDONE K 30 BP/USP 30 (40% ethanol) solution, stir the system soft material, crossing 20 mesh sieves granulates, drying is 1 hour in 60 ℃ of baking ovens, add dodecyl sodium sulfate, with 20 mesh sieve granulate.Tabletting, the bag film-coat, packing, promptly.

Claims (8)

1. the preparation of curcumin and pidotimod composition and pharmaceutical use is characterized in that said composition includes by curcumin and pidotimod.Wherein pidotimod has following structural formula (I), and chemical name is (R)-3-[(S)-(5-oxygen-2-pyrrolidinyl) carbonyl]-Thiazolidine-4-carboxylic acid.
Figure F200810247444XC0000011
Formula (I)
Molecular formula: C 9H 12N 2O 4S
Molecular weight: 244.26.
2. the preparation and the pharmaceutical use of curcumin according to claim 1 and pidotimod composition is characterized in that curcumin has following structural formula (II), and chemical name is 1, two (the 4-hydroxy 3-methoxybenzene bases)-1 of 7-, 6-heptadiene-3,5-diketone.
Figure F200810247444XC0000012
Formula (II)
Molecular formula: C 21H 20O 6
Molecular weight: 368.3854.
3. the preparation and the pharmaceutical use of curcumin according to claim 1 and pidotimod composition, the proportion that it is characterized in that curcumin and pidotimod is 1: 100~100: 1.
4. the preparation and the pharmaceutical use of curcumin according to claim 3 and pidotimod composition, the proportion that it is characterized in that curcumin and pidotimod is 1: 50~50: 1.
5. the preparation and the pharmaceutical use of curcumin according to claim 1 and pidotimod composition, it is characterized in that adopting said composition to add pharmaceutically acceptable various adjuvant, pharmaceutically acceptable various dosage form be can be prepared into, tablet, capsule, injection etc. included but not limited to.
6. the preparation and the pharmaceutical use of curcumin according to claim 1 and pidotimod composition is characterized in that said composition is used for the treatment of the various patients of cancer and hypoimmunity thereof.The two composite reagent has certain synergism.
7. the preparation and the pharmaceutical use of curcumin according to claim 5 and pidotimod composition, the preparation that it is characterized in that said composition includes but not limited to following steps: pidotimod and curcumin are mixed according to a certain percentage, it is an amount of to add dodecyl sodium sulfate simultaneously, and arginine or lysine or the methylamine of crawling are an amount of.Add mix homogeneously such as an amount of adjuvant such as microcrystalline Cellulose, dextrin, starch, magnesium stearate again, load capsule or be pressed into slice, thin piece.
8. 1. the preparation and the pharmaceutical use of curcumin according to claim 1 and pidotimod composition is characterized in that being used for the treatment of the last lower respiratory infection (pharyngitis, tracheitis, bronchitis, tonsillitis) of outbreak repeatedly; 2. department of otorhinolaryngology repeated infection (rhinitis, sinusitis, otitis); 3. urinary system infection; 4. gynecological infection; 5. the low clinical patients of cellular immune function after the chemotherapy; 6. specificity and nonspecific immunity defective disorders such as cancers etc.In order to reduce the number of times of acute attack, shorten the course of disease, alleviate the degree of outbreak; Antibiotic auxiliary treatment when also can be used as actute infection.
CN200810247444A 2008-12-31 2008-12-31 Preparation method and pharmaceutical uses of curcumin and pidotimod composition Pending CN101766604A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103830393A (en) * 2014-03-27 2014-06-04 袁萍 Stable curcumin health-care composition

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103830393A (en) * 2014-03-27 2014-06-04 袁萍 Stable curcumin health-care composition

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Application publication date: 20100707