CN110755601A - Kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution defect and preparation method and application thereof - Google Patents
Kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution defect and preparation method and application thereof Download PDFInfo
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- 101710186708 Agglutinin Proteins 0.000 title claims abstract 19
- 101710146024 Horcolin Proteins 0.000 title claims abstract 19
- 101710189395 Lectin Proteins 0.000 title claims abstract 19
- 101710179758 Mannose-specific lectin Proteins 0.000 title claims abstract 19
- 101710150763 Mannose-specific lectin 1 Proteins 0.000 title claims abstract 19
- 101710150745 Mannose-specific lectin 2 Proteins 0.000 title claims abstract 19
- 244000046052 Phaseolus vulgaris Species 0.000 title claims abstract 19
- 239000000910 agglutinin Substances 0.000 title claims abstract 19
- 239000003814 drug Substances 0.000 title claims abstract 18
- 239000000203 mixture Substances 0.000 title claims abstract 16
- 208000030507 AIDS Diseases 0.000 title claims abstract 14
- 241000196324 Embryophyta Species 0.000 title claims abstract 8
- 230000007547 defect Effects 0.000 title claims abstract 5
- 238000002360 preparation method Methods 0.000 title abstract 2
- 235000006533 astragalus Nutrition 0.000 claims abstract 4
- 210000000582 semen Anatomy 0.000 claims abstract 3
- 241000045403 Astragalus propinquus Species 0.000 claims abstract 2
- 230000036039 immunity Effects 0.000 claims abstract 2
- 230000007812 deficiency Effects 0.000 claims 9
- 229940079593 drug Drugs 0.000 claims 6
- 238000000034 method Methods 0.000 claims 4
- 239000002994 raw material Substances 0.000 claims 4
- 238000001035 drying Methods 0.000 claims 3
- 239000000843 powder Substances 0.000 claims 3
- 241001061264 Astragalus Species 0.000 claims 2
- 244000077995 Coix lacryma jobi Species 0.000 claims 2
- 235000002722 Dioscorea batatas Nutrition 0.000 claims 2
- 235000006536 Dioscorea esculenta Nutrition 0.000 claims 2
- 240000001811 Dioscorea oppositifolia Species 0.000 claims 2
- 235000003416 Dioscorea oppositifolia Nutrition 0.000 claims 2
- 239000002775 capsule Substances 0.000 claims 2
- 239000000706 filtrate Substances 0.000 claims 2
- 238000009472 formulation Methods 0.000 claims 2
- 239000008187 granular material Substances 0.000 claims 2
- 239000007788 liquid Substances 0.000 claims 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims 2
- 210000004233 talus Anatomy 0.000 claims 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 1
- 239000009636 Huang Qi Substances 0.000 claims 1
- 229920002774 Maltodextrin Polymers 0.000 claims 1
- 239000005913 Maltodextrin Substances 0.000 claims 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- 229920002472 Starch Polymers 0.000 claims 1
- 238000007865 diluting Methods 0.000 claims 1
- 238000001914 filtration Methods 0.000 claims 1
- 235000003599 food sweetener Nutrition 0.000 claims 1
- 238000004108 freeze drying Methods 0.000 claims 1
- 235000019359 magnesium stearate Nutrition 0.000 claims 1
- 229940057948 magnesium stearate Drugs 0.000 claims 1
- 229940035034 maltodextrin Drugs 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 1
- 239000008108 microcrystalline cellulose Substances 0.000 claims 1
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 1
- 238000002156 mixing Methods 0.000 claims 1
- 238000011127 radiochemotherapy Methods 0.000 claims 1
- 238000007873 sieving Methods 0.000 claims 1
- 238000002791 soaking Methods 0.000 claims 1
- 239000008107 starch Substances 0.000 claims 1
- 235000019698 starch Nutrition 0.000 claims 1
- 229940032147 starch Drugs 0.000 claims 1
- 239000003765 sweetening agent Substances 0.000 claims 1
- 239000003826 tablet Substances 0.000 claims 1
- 238000001291 vacuum drying Methods 0.000 claims 1
- 238000005303 weighing Methods 0.000 claims 1
- 230000000694 effects Effects 0.000 abstract 4
- 206010028980 Neoplasm Diseases 0.000 abstract 1
- 210000001744 T-lymphocyte Anatomy 0.000 abstract 1
- 238000002512 chemotherapy Methods 0.000 abstract 1
- 201000010099 disease Diseases 0.000 abstract 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract 1
- 235000013305 food Nutrition 0.000 abstract 1
- 238000001959 radiotherapy Methods 0.000 abstract 1
- 238000011084 recovery Methods 0.000 abstract 1
- 231100000331 toxic Toxicity 0.000 abstract 1
- 230000002588 toxic effect Effects 0.000 abstract 1
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- A61K38/00—Medicinal preparations containing peptides
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/481—Astragalus (milkvetch)
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- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8969—Polygonatum (Solomon's seal)
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- A61P31/18—Antivirals for RNA viruses for HIV
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- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
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Abstract
The invention provides a kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution defect, a preparation method and an application thereof, wherein the plant medicine composition comprises, by weight, 1-5 parts of kidney bean agglutinin, 25-30 parts of astragalus membranaceus, 25-30 parts of rhizoma polygonati and 25-30 parts of semen coicis. The invention can obviously improve CD4 in a short time+The effect of the T cells can enhance the corresponding curative effect of the medicine and shorten the treatment time of the patient. The components are from a list of homology of medicine and food, the effect is obvious, and no toxic or side effect exists. The medicine of the invention can play a good role in the treatment of HIV/AIDS immune reconstitution defect, and can be used for immunityOther diseases caused by hypofunction, such as the recovery of immunity of tumor patients after radiotherapy and chemotherapy.
Description
Technical Field
The invention belongs to the technical field of botanical drug treatment of AIDS (acquired immune deficiency syndrome), and particularly relates to a kidney bean agglutinin botanical drug composition for treating HIV/AIDS immune reconstitution defect, and a preparation method and application thereof.
Background
Currently, the HIV/AIDS infected population is treated with HARRT or ART.HAART is the current most major clinical means for treating HIV chronic infection and AIDS, can permanently inhibit virus replication, improve the immune function of patients to a certain extent, partially realize immune reconstruction, and obviously improve the disease progression and prognosis of HIV/AIDS patients. However, HAART-mediated immune reconstitution has its limitations, and clinical observations have shown that about 15-30% of patients treated with antiviral therapy still exhibit immune reconstitution failure, resulting in significant increases in the incidence and mortality of opportunistic infections, tumors, cardiovascular disease, liver disease, and the like in patients. Studies have shown CD4 before antiviral treatment+A low T lymphocyte count is significantly positively correlated with the incidence of AIDS-related complications, and is also more likely to be associated with non-AIDS-related events, including the occurrence of cardiovascular disease, liver disease, kidney disease, and neoplastic disease. The relevant literature shows that by 2018 there are only 6 clinical trials worldwide on the cohort of patients with immune dysfunction after HIV infection. The clinical test result of the drug malanovine in the IV stage shows that the CD4+The recovery capacity of T cells is not obviously improved, the tripterygium wilfordii extract can reduce the immune activation level of a patient to a certain extent and simultaneously enhance the recovery capacity of CD4+ T cells, but CD4+Absolute T cell count<200 pieces/. mu.l.
In China, a large number of patients with immune reconstitution defects are treated by combining traditional Chinese medicines, and good results are obtained. However, the adopted formula is complex, the dosage is large, the administration time is usually 1 year or more, and the CD4 is not taken after the administration+T cannot be maintained stable for a long time.
Chinese patent application No. CN97119177.8 discloses a Chinese herbal medicine for treating AIDS, which mainly comprises trichosanthes root, balsam pear, dandelion, pulsatilla, liquorice, semigrette, astragalus root, marbao, honeysuckle, dyers woad leaf, scutellaria root, wild ginseng, antelope horn, epaulet lotus, water flea, tongshan cloud grass, Qixinjianwei (small size) and duoyun (large size), and the Chinese herbal medicine for treating AIDS is prepared by animal chewing and rumination, can inhibit the reproduction of AIDS virus, improve the antibody ability of human body, and increase the adrenal cortex, gonad and cellular immunity. However, the curative effect is not ideal, and the preparation method is not suitable for industrial production.
The Chinese invention patent with the application number of CN200410030849.X discloses a Chinese medicinal preparation for treating AIDS and a processing method thereof. The prescription is prepared from the raw materials of Chinese herbal medicines of old psidium guajaponicas, honeysuckle, trichosanthes bark, radix bupleuri, cattail, pomegranate bark, astragalus, liquorice, kapok, suberect spatholobus stem, safflower, glutinous rice root, myrobalam, spreading hedyotis herb, water caltrop, ginkgo leaf, purslane, picrorhiza rhizome, black nightshade and scorpion, and has the effect of improving CD4+Effect of T, in the treatment of HIV/AIDS, CD4 in patients+The baseline T level was 100-400 and did not indicate whether the patient met the range of immune reconstitution defects.
Aiming at the condition that no definite and effective method for immune reconstitution defects exists at home and abroad, research and exploration are necessary to find a more effective treatment method.
Disclosure of Invention
Aiming at the defects in the prior art, the invention aims to provide a kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution defect, a preparation method and application thereof. By adopting the method, the CD4 can be obviously improved in a short time+The function of T cells can be used for treating HIV/AIDS patients with immune reconstitution deficiency, and can also be used for recovering immunity of other diseases caused by low immunity, such as tumor patients after radiotherapy and chemotherapy treatment.
In order to achieve the above purpose, the solution adopted by the invention is as follows:
a kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution defect comprises, by weight, 1-5 parts of kidney bean agglutinin, 25-30 parts of radix astragali, 25-30 parts of rhizoma Polygonati, and 25-30 parts of semen Coicis.
Further, the botanical drug composition comprises, by weight, 1 part of kidney bean agglutinin, 27 parts of astragalus membranaceus, 25 parts of rhizoma polygonati and 27 parts of semen coicis.
The kidney bean agglutinin is glycoprotein, has the functions of blood coagulation activity and promotion of T lymphocyte transformation, has important functions in various signal processes such as signal transduction, immunoreaction and the like due to the specific binding capacity to monosaccharide or polysaccharide complex, can play an effective role in prevention and treatment of HIV, has little chance of obtaining resistance by changing a glycosyl structure because the glycosylation of glycoprotein of HIV shell is completed by a host, can act on different points of HIV shell by innovatively using the kidney bean agglutinin, needs a large amount of variation in virus breaking away from the binding, can inhibit fusion/entry and transmission of HIV virus and has the function of a reverse transcriptase inhibitor, and can promote humoral immunity and stimulate splenocytes to generate interferon (IFN-gamma), tumor necrosis factor (TNF- α) and interleukin (IL-2).
The astragalus is a traditional Chinese medicine for tonifying qi and nourishing blood in the traditional Chinese medicines, is used for treating low immune function and reducing the number of T cells of AIDS patients, and can obviously improve the symptoms of the patients and improve the immune function.
Rhizoma Polygonati is sweet and neutral in taste, has effects of invigorating qi, nourishing yin, invigorating spleen and invigorating kidney, contains polysaccharide, amino acids, mucus, starch, etc., has effects of reducing blood lipid and lowering blood pressure, and can also enhance heart and lung function of the elderly and delay aging.
The coix seeds are traditional Chinese medicines for tonifying spleen and removing dampness, the traditional Chinese medicine considers that spleen qi deficiency is the most common pathogenesis in the pathogenesis process of AIDS, and long-term clinical application shows that the coix seeds also have the effects of enhancing the immune function and improving the life quality of patients.
The kidney bean agglutinin preparation is obtained by combining the traditional Chinese medicine theory on the basis of modern research on kidney bean agglutinin through a large number of preparation process experiments and years of practice. Based on the characteristics of clear multi-target action and action mechanism and high safety of kidney bean agglutinin, the kidney bean agglutinin extracted from kidney beans is combined with medicinal and edible components (astragalus, sealwort and coix seed) to form a novel botanical drug composition with less and fine combined components.
A kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution defect comprises, by weight, 1-5 parts of kidney bean agglutinin, 20-30 parts of radix astragali, 20-30 parts of Chinese yam and 20-30 parts of semen coicis.
Furthermore, the botanical drug composition comprises 2 parts of kidney bean agglutinin, 20 parts of astragalus membranaceus, 20 parts of Chinese yam and 20 parts of coix seeds in parts by weight.
Rhizoma Dioscoreae has effects of invigorating spleen, benefiting stomach, promoting digestion, replenishing kidney essence, benefiting lung, and relieving cough.
The invention further discovers that Chinese yam is added on the basis of the ingredients of kidney bean agglutinin, astragalus and coix seed, has good curative effect on spleen-qi deficiency of the most common disease machine in the process of treating AIDS, enhances the immune function and further improves the treatment effect on the AIDS.
The plant medicine composition disclosed by the invention is prepared by applying the modern biological science of kidney bean agglutinin and the related research results of HIV, assisting the practice of treating related diseases by traditional Chinese medicines, taking the principles of preparation and prescription guiding, such as clear mechanism, concise formula, convenience for comparison, safety and effectiveness, and being beneficial to research and mechanism analysis in practice and quality control of large-scale production.
Further, the botanical drug composition and pharmaceutically acceptable auxiliary materials are processed into a preparation.
Further, the adjuvants include one or more of starch, maltodextrin, microcrystalline cellulose, magnesium stearate and sweetener.
Furthermore, the preparation can be any one of tablets, granules, capsules and oral liquid.
A method for preparing a kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution deficiency comprises the following steps:
(1) weighing the components of the claim 1, respectively crushing and sieving astragalus mongholicus, polygonatum sibiricum and coix seeds with a 100-mesh sieve for later use, performing freeze-drying treatment on the kidney bean agglutinin by adopting a vacuum concentration or freeze-vacuum drying method, then mixing the raw materials, adding 50-70% of alcohol which is 5-10 times of the weight of the raw materials for soaking, percolating, and collecting percolate;
wherein, the extraction of the kidney bean agglutinin: white kidney beans or red kidney beans are used as raw materials, kidney bean agglutinin is extracted and purified by adopting the technology disclosed by Chinese patent with application number of 200910094233.1, and the content of the obtained agglutinin protein is measured by adopting a general double venation contraction method.
Activity assay of kidney bean agglutinin: the method is carried out by adopting the technology disclosed by Chinese patent with the application number of 201110184061.4. Then, the kidney bean agglutinin activity is detected by adopting a multiple dilution method, and when the kidney bean agglutinin activity is greater than or equal to 1/32mg/ml, the kidney bean agglutinin activity can be used for preparing related preparations.
(2) Standing the percolate, filtering, collecting filtrate, concentrating the filtrate under reduced pressure, and drying to obtain concentrated solution;
(3) diluting the concentrated solution to obtain oral liquid; drying the concentrated solution into powder, and granulating by a wet method into granules; the dry powder is granulated and encapsulated into capsules, or the dry powder is granulated and tabletted into tablets.
Further, the drying temperature in the step (2) is 50-60 ℃.
An application of kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution defect in preparing medicine for treating HIV/AIDS immune reconstitution defect or recovering immunity after radiotherapy and chemotherapy is disclosed.
The invention has the beneficial effects that:
1. the kidney bean agglutinin and other plant medicine composition (Yun Sheng or Kangzhou No. 1) which is prepared by combining a plurality of raw materials from a medicine-food homologous list in the medicine can effectively improve CD4+The number of T cells and the level of increase was greater.
2. Compared with the existing treatment method, the medicine provided by the invention is small in dosage and can remarkably improve CD4 in a shorter time+The effect of the T cells can enhance the corresponding curative effect of the medicine, shorten the treatment time of the patient and relieve the physical and psychological health of the patient.
3. The medicine formula disclosed by the invention is safe in components, all the components are from a list of homology of medicine and food, the effect is obvious, and no toxic or side effect is caused.
4. The medicine of the invention plays a good role in the treatment of HIV/AIDS immune reconstitution defect, and can be used for the recovery of immunity of other diseases caused by low immunity, such as tumor patients after radiotherapy and chemotherapy treatment.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available commercially.
The kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution deficiency and the preparation method and the application thereof are concretely explained below.
In the following examples, the drug 100g consists of the following components:
example 1
A kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution defect comprises, by weight, 1g of kidney bean agglutinin, 30g of radix astragali, 30g of rhizoma polygonati, 30g of semen coicis, 8.5g of kidney bean starch and 0.5g of sweetener.
Further, the dosage form of the preparation is a tablet.
A method for preparing a kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution deficiency comprises the following steps:
(1) weighing the components of the claim 1, respectively crushing astragalus mongholicus, polygonatum sibiricum and coix seeds, sieving the crushed materials with a 100-mesh sieve for later use, performing freeze-drying treatment on the kidney bean agglutinin by adopting a vacuum concentration or freeze-vacuum drying method, then mixing the raw materials, adding 70 percent edible alcohol which is 5 times of the weight of the raw materials, soaking the raw materials, percolating the mixture, and collecting percolate;
(2) standing the percolate, filtering, collecting filtrate, concentrating the filtrate under reduced pressure, and drying at 50 deg.C to obtain concentrated solution;
(3) drying the concentrated solution to obtain powder, granulating the powder, and tabletting. The diameter of the tablet is 10mm, and the weight of each tablet is 0.5 g.
Example 2
A kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution defect comprises, by weight, 5g of kidney bean agglutinin, 25g of radix astragali, 25g of rhizoma polygonati, 25g of semen coicis, 10g of kidney bean starch, 7g of maltodextrin, 2.5g of magnesium stearate and 0.5g of sweetener.
Further, the preparation is in the form of granules.
A method for preparing a kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution deficiency comprises the following steps:
(1) weighing the components of the claim 1, respectively crushing astragalus mongholicus, polygonatum sibiricum and coix seeds, sieving the crushed materials with a 100-mesh sieve for later use, performing freeze-drying treatment on the kidney bean agglutinin by adopting a vacuum concentration or freeze-vacuum drying method, then mixing the raw materials, adding 10 times of 50% edible alcohol by weight, soaking, percolating, and collecting percolate;
(2) standing the percolate, filtering, collecting filtrate, concentrating the filtrate under reduced pressure, and drying at 60 deg.C to obtain concentrated solution;
(3) drying the concentrated solution to obtain powder, and granulating by wet method to obtain granule.
Example 3
A kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution deficiency comprises, by weight, 2g of kidney bean agglutinin, 26g of radix astragali, 26g of rhizoma polygonati, 26g of semen coicis, 9.5g of kidney bean starch, 8g of maltodextrin, 2g of magnesium stearate and 0.5g of sweetener.
Further, the dosage form of the preparation is a tablet.
A method for preparing a kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution deficiency comprises the following steps:
(1) weighing astragalus mongholicus, polygonatum sibiricum and coix seeds according to the components in the claim 1, respectively crushing the astragalus mongholicus, the polygonatum sibiricum and the coix seeds, sieving the powder with a 100-mesh sieve for later use, performing freeze-drying treatment on the kidney bean agglutinin by adopting a vacuum concentration or freeze-vacuum drying method, then mixing the raw materials, adding 60 percent edible alcohol in 6 times of the weight of the raw materials for soaking, percolating, and collecting percolate;
(2) standing the percolate, filtering, collecting filtrate, concentrating the filtrate under reduced pressure, and drying at 55 deg.C to obtain concentrated solution;
(3) drying the concentrated solution to obtain powder, granulating the powder, and tabletting. The diameter of the tablet is 10mm, and the weight of each tablet is 0.5 g.
Example 4
A kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution defect comprises, by weight, 1g of kidney bean agglutinin, 30g of radix astragali, 30g of Chinese yam, 30g of semen coicis, 4.5g of kidney bean starch, 4g of maltodextrin and 0.5g of sweetener.
Further, the dosage form of the preparation is a tablet.
A method for preparing a kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution deficiency comprises the following steps:
(1) weighing the components of the claim 1, respectively crushing astragalus mongholicus, polygonatum sibiricum and coix seeds, sieving the crushed materials with a 100-mesh sieve for later use, performing freeze-drying treatment on the kidney bean agglutinin by adopting a vacuum concentration or freeze-vacuum drying method, then mixing the raw materials, adding 70 percent edible alcohol which is 5 times of the weight of the raw materials, soaking the raw materials, percolating the mixture, and collecting percolate;
(2) standing the percolate, filtering, collecting filtrate, concentrating the filtrate under reduced pressure, and drying at 50 deg.C to obtain concentrated solution;
(3) drying the concentrated solution to obtain powder, granulating the powder, and tabletting. The diameter of the tablet is 10mm, and the weight of each tablet is 0.5 g.
Example 5
A kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution deficiency comprises, by weight, 5g of kidney bean agglutinin, 20g of radix astragali, 20g of Chinese yam, 20g of semen coicis, 13.5g of kidney bean starch, 10g of maltodextrin, 1g of magnesium stearate and 0.5g of sweetener.
Further, the dosage form of the preparation is a tablet.
A method for preparing a kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution deficiency comprises the following steps:
(1) weighing the components of the claim 1, respectively crushing astragalus mongholicus, polygonatum sibiricum and coix seeds, sieving the crushed materials with a 100-mesh sieve for later use, performing freeze-drying treatment on the kidney bean agglutinin by adopting a vacuum concentration or freeze-vacuum drying method, then mixing the raw materials, adding 10 times of 50% edible alcohol by weight, soaking, percolating, and collecting percolate;
(2) standing the percolate, filtering, collecting filtrate, concentrating the filtrate under reduced pressure, and drying at 60 deg.C to obtain concentrated solution;
(3) drying the concentrated solution to obtain powder, granulating the powder, and tabletting. The diameter of the tablet is 10mm, and the weight of each tablet is 0.5 g.
Example 6
A kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution deficiency comprises, by weight, 2g of kidney bean agglutinin, 20g of radix astragali, 20g of Chinese yam, 20g of semen coicis, 20g of corn starch, 15.5g of maltodextrin, 2g of magnesium stearate and 0.5g of sweetener.
Further, the dosage form of the preparation is a tablet.
A method for preparing a kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution deficiency comprises the following steps:
(1) weighing astragalus mongholicus, polygonatum sibiricum and coix seeds according to the components in the claim 1, respectively crushing the astragalus mongholicus, the polygonatum sibiricum and the coix seeds, sieving the powder with a 100-mesh sieve for later use, performing freeze-drying treatment on the kidney bean agglutinin by adopting a vacuum concentration or freeze-vacuum drying method, then mixing the raw materials, adding 60 percent edible alcohol in 6 times of the weight of the raw materials for soaking, percolating, and collecting percolate;
(2) standing the percolate, filtering, collecting filtrate, concentrating the filtrate under reduced pressure, and drying at 55 deg.C to obtain concentrated solution;
(3) drying the concentrated solution to obtain powder, granulating the powder, and tabletting. The diameter of the tablet is 10mm, and the weight of each tablet is 0.5 g.
Example 7
A kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution defect comprises, by weight, 1g of kidney bean agglutinin, 30g of radix astragali, 30g of Chinese yam, 30g of semen coicis, 1g of microcrystalline cellulose, 5.5g of maltodextrin, 2g of magnesium stearate and 0.5g of sweetener.
Further, the dosage form of the preparation is a tablet.
A method for preparing a kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution deficiency comprises the following steps:
(1) weighing astragalus mongholicus, polygonatum sibiricum and coix seeds according to the components in the claim 1, respectively crushing the astragalus mongholicus, the polygonatum sibiricum and the coix seeds, sieving the powder with a 100-mesh sieve for later use, performing freeze-drying treatment on the kidney bean agglutinin by adopting a vacuum concentration or freeze-vacuum drying method, then mixing the raw materials, adding 55% edible alcohol which is 7 times of the weight of the raw materials for soaking, percolating, and collecting percolate;
(2) standing the percolate, filtering, collecting filtrate, concentrating the filtrate under reduced pressure, and drying at 54 deg.C to obtain concentrated solution;
(3) drying the concentrated solution to obtain powder, granulating the powder, and tabletting. The diameter of the tablet is 10mm, and the weight of each tablet is 0.5 g.
Example 8
Use of a kidney bean agglutinin botanical pharmaceutical composition for the treatment of HIV/AIDS immune reconstitution deficiency as described in examples 1-7 for the preparation of a medicament for the treatment of HIV/AIDS immune reconstitution deficiency or for restoring immunity after treatment with chemo-radiation.
Experimental example 1
(1) Subject: is an HIV/AIDS infected person in Jianshui county, Mongolia city and old city of Red river in Yunnan province. The inclusion condition is selected according to the following two definitions, (1) HIV infected persons are treated with antiviral therapy for more than one year, in case of viral nucleic acid turning negative (less than 50 cop/. mu.l), if CD4 is present+T lymphocyte count still less than 200/μ l, or CD4+An increase in T lymphocyte count of less than 20% of baseline is called immune reconstitution insufficiency; (2) according to the 2013 AIDS treatment guideline in the United states, AIDS patients are treated with 4-7 years combined antiviral treatment, if CD4+T lymphocyte count of 350 or 500/μ l is not reached, and it can be judged that the immune reconstitution is incomplete.
The trial was performed on a total of 54 persons, of which male members were 32 persons, aged 40-55 years; female 22, age 30-49 years. Wherein, the time of HIV positive diagnosis is firstly 1 month in 2002 and secondly 3 months in 2016. The Carlo-Fisher score is 70-90 points. The basic conditions of the test personnel are shown in Table 1:
TABLE 1 basic conditions of the test personnel
Wherein B represents Blood infection; s represents Sexual transmitted; u represents uncartiain (unclear); HB represents hepatitis B; HC represents hepatitis C.
(2) The test method comprises the following steps: the tablet prepared in example 1 (i.e. "kangzi No. 1" prepared by yunnan kangzi biotechnology limited) is taken 1-2 times a day, and is recommended to be taken before sleep, 2-4 tablets each time, if the tablet is habitually taken in the morning, the tablet can be taken on an empty stomach in the morning, but the tablet needs to be taken at least 2-3 hours apart from other Chinese and western medicines, the taking time is 3 months, the test condition is not known regularly in the test, the problem in the test is solved in time, and a solution is provided. And in the later stage of the test, the participants are visited back by telephone to know and verify the test condition.
(3) The test curative effect standard is as follows: according to the evaluation staging standard and the evaluation index system of the effect of the traditional Chinese medicine for treating HIV/AIDS, CD4+The classification criteria for T changes were:
the method has the following advantages: CD4 before and after treatment+T is increased by 50/mu l;
and (3) stabilizing: CD4 before and after treatment+T is increased or decreased by less than 50/mu l;
and (4) invalidation: there was a 50 drop/μ l after treatment.
(4) And (3) test results:
a、CD4+t detection data: after 3 months of medication, the local registration and institutional settings were used to take venous blood samples and test CD4+T lymphocyte number, index for all concerned especially CD4+And recording the quantity change, performing statistical analysis by using SSP software, and performing data statistics to form the following test result table:
among them, CD4 was collected from 23 subjects in total after 3 months of follow-up+T test data, 15 male subjects, 8 female subjects. Wherein the patients with more than 10 years are 17, and the patients with 6-10 years are 6. Of the 23 subjects, the duration of the disease was 6 years at the shortest and 14 years at the longest.
TABLE 2 CD4 3 months after taking "conzhou No. 1" tablet provided in this example 1+T comparison table
The above results show that after the test subjects take the "congtian No. 1" tablet provided in this example 1 for 3 months, the effective rate of 21 persons, the stable rate of 1 person, and the ineffective rate of 1 person is 91.3%, wherein the effective rate of male is 93.33%, and the ineffective rate is 6.6%; the effective rate of the female reaches 100 percent. In addition, the test object is stopped taking the medicine for 30-90 days, followed and observed, and CD4 is observed after the medicine is stopped+T is maintained at a stable level without any adverse reaction.
In addition, of the 23 subjects, 3 subjects did not take antiviral drugs, 2 men and 1 woman (due to the high side effects of western medicines). One of the male test subjects, age 47, positive definite time 2006.08, and no antiviral drugs and Chinese medicinal herbs, was administered the tablet provided in example 1 alone, and the CD4 of the male test subject+The values before and after T are: 50/202, CD4+T is increased by 152, which indicates that the test result is effective; another male test subject, age 42, positive determination time 2006.07, was not administered an anti-viral drug, but administered a Chinese medicinal composition and the tablet provided in example 1, was CD4+The values before and after T are: 180/310, CD4T increased by 130, indicating that the test results were valid. A female test subject aged 44 years, was determined to have a positive timing of 2006.01, was not administered antiviral drugs and herbal medicines (clearly indicated that administration of antiviral drugs has a great side effect and is discontinued), and was administered only the tablet provided in example 1, CD4+The values before and after T are: 201/286, CD4+T is increased by 85, which indicates that the test result is effective.
It should be noted that: for the treatment of patients with immune reconstitution deficiency, western medicines such as interleukin-2 (IL-2) or traditional Chinese medicines are adopted for treatment at home and abroad on the basis of continuous use of antiviral medicines. In addition, 3 people in the population treated by the kidney bean agglutinin plant medicine composition provided by the invention stop taking antiviral western medicines due to excessive side effects of the western medicines, but the CD4+ T of 3 people is increased. The effects observed by taking the kidney bean agglutinin plant medicine composition provided by the invention can be found in the effect of the agglutinin alone. In addition, although the formula of the medicine contains the components of astragalus, coix seed, rhizoma polygonati and the like, the content of each traditional Chinese medicine is not more than 0.3g at most. In all anti-HIV traditional Chinese medicine formulas, the dosage of the medicines is not less than 1 g. In addition, in terms of dosage, the other traditional Chinese medicine treatment dosage is taken 3-4 times a day, and more than 3g of the traditional Chinese medicine treatment dosage is taken each time, so that the traditional Chinese medicine composition with extremely small amount cannot play an obvious role in the formula.
b. Call return visit: after 3 months of medication trial, 28 persons had telephone visits to obtain the information, 6 persons had not taken for 3 months, of which 3 persons had 1 CD4+T added value>100, 2 persons CD4+The increase value of T is more than or equal to 300 pieces/mul.
Weight condition: among the questions regarding weight change in the call-back of 25 persons, there was a 10-person weight increase, 14 persons had essentially no weight change, and 1-person weight decreased.
Whether the sleep is improved or not, in the problem that 24 people have improved sleep or not in the call return visit, the sleep of 12 people is obviously improved, the sleep of 11 people is basically maintained, and the sleep quality of 1 person is reduced.
Whether or not there is an increase in meal size: in the question of "whether there is an increase in meal volume" of 28 people on the telephone call back, there were 15 people who have an increase in meal volume, 12 people who have no change in meal volume, and 1 person who has a decrease in meal volume.
Other symptoms of improvement: the 24 people visited the question on the "other symptoms improved" on the phone, with 2 people feeding back more vigorous than before, 3 people feeding back more mental than before, and 19 people feeding back essentially unchanged from before.
Whether or not the patient is willing to continue taking the drugs provided in this example: the 24 questions on whether or not to wish to continue taking kang continent number 1 during the call back were 19 people answering yes (79.2%), 3 people answering consider, and 2 people answering no (where 1 indicates: only a slight try without any other change).
According to the test results, the kidney bean agglutinin and other raw materials from a medicinal and edible homologous list in the medicine are combined to form the botanical medicine composition(Kangzhou No. 1) can effectively improve CD4+The number of T cells. Compared with the existing treatment method, the medicine of the invention can obviously improve the CD4 in a shorter time+Compared with the prior treatment time at home and abroad, the treatment time of the T cells is between 6 months and 1 year, while the administration time of the medicine is only 3 months, the treatment time of a patient is shortened while the corresponding curative effect of the medicine is enhanced; the medicine of the invention has small dosage, and Kangzhou-1 is taken for 1 to 2 times every day, and 2 to 4 tablets are taken each time, thus relieving the physical and psychological health of patients; meanwhile, the medicine of the invention promotes CD4+The level of T increase was greater among 23 subjects, CD4+The T increase value is more than 100/mu l, and the T increase value accounts for 87 percent of 20 people; the medicine formula disclosed by the invention is safe in components, all the components are from a list of homology of medicine and food, the effect is obvious, and no toxic or side effect is caused.
Typical cases
Plum, HIV and hepatitis C infected patients take antiviral drugs for twelve years, and the compliance is good, so the physical condition is good. 2016 month 7 stopped antiviral therapy for two years due to its own cause, with a sharp shift in health, CD4+T is reduced from more than or equal to 1000 to 128 and opportunistic infection occurs. After retreatment, CD4+Slow rise of T, emaciation, weakness and alopecia.
After taking the drug 'kangzhou i' provided in the embodiment 6 in 2018 and 7 months, the weight is increased, and the situations of fatigue and alopecia are improved. CD4 three months later+T rose to 366/. mu.l. The yield of the table tennis ball rises to 482 pieces/mu l in 7 months in 2019, the appetite and the sleep quality are greatly improved, the table tennis ball can be used for keeping on exercising, and the table tennis ball can be played for two hours every day and can achieve better performance in small-scale games. The person who works for twelve hours every day in 8 months in 2019 is energetic and basically cannot see that the person is a person who keeps life every day by taking medicines.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (10)
1. A kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution defect is characterized by comprising, by weight, 1-5 parts of kidney bean agglutinin, 25-30 parts of radix astragali, 25-30 parts of rhizoma polygonati and 25-30 parts of semen coicis.
2. The kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution deficiency according to claim 1, which comprises 1 part of kidney bean agglutinin, 27 parts of astragalus, 25 parts of rhizoma polygonati and 27 parts of semen coicis by weight.
3. A kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution defect is characterized by comprising, by weight, 1-5 parts of kidney bean agglutinin, 20-30 parts of astragalus membranaceus, 20-30 parts of Chinese yam and 20-30 parts of coix seeds.
4. The kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution deficiency according to claim 3, which comprises 2 parts of kidney bean agglutinin, 20 parts of astragalus, 20 parts of Chinese yam and 20 parts of coix seed by weight.
5. The kidney bean agglutinin botanical drug composition for treating HIV/AIDS immune reconstitution deficiency according to any of claims 1-4, wherein the botanical drug composition and pharmaceutically acceptable excipients are processed into a formulation.
6. The kidney bean agglutinin botanical drug composition for treating HIV/AIDS immune reconstitution deficiency according to any of claim 5, wherein the excipients comprise one or more of starch, maltodextrin, microcrystalline cellulose, magnesium stearate and sweeteners.
7. The kidney bean agglutinin plant medicine composition for treating HIV/AIDS immune reconstitution deficiency according to claim 6, wherein the formulation is in any one of tablet, granule, capsule and oral liquid.
8. A method for preparing a kidney bean agglutinin botanical drug composition for the treatment of HIV/AIDS immune reconstitution deficiency according to any of claims 1-7, comprising the steps of:
(1) weighing the components except for the kidney bean agglutinin respectively, crushing the components respectively, sieving the crushed components with a 100-mesh sieve for later use, carrying out freeze-drying treatment on the kidney bean agglutinin by adopting a vacuum concentration or freeze-vacuum drying method, mixing the raw materials, adding 50-70% of edible alcohol which is 5-10 times of the weight of the raw materials, soaking the raw materials, percolating the raw materials, and collecting percolate;
(2) standing the percolate, filtering, collecting filtrate, concentrating the filtrate under reduced pressure, and drying to obtain concentrated solution;
(3) diluting the concentrated solution to obtain oral liquid; drying the concentrated solution into powder, and granulating by a wet method into granules; the dry powder is granulated and encapsulated into capsules, or the dry powder is granulated and tabletted into tablets.
9. The method for preparing a kidney bean agglutinin botanical drug composition for the treatment of HIV/AIDS immune reconstitution deficiency according to claim 8, wherein the drying temperature in step (2) is 50-60 ℃.
10. Use of a kidney bean agglutinin botanical drug composition for the treatment of HIV/AIDS immune reconstitution deficiency according to any of claims 1-7 in the manufacture of a medicament for the treatment of HIV/AIDS immune reconstitution deficiency or for restoring immunity after treatment with chemo-radiotherapy.
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