CN114306580A - Method and process for preparing compound paclitaxel anti-leukemia capsule tablet - Google Patents
Method and process for preparing compound paclitaxel anti-leukemia capsule tablet Download PDFInfo
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- CN114306580A CN114306580A CN202110435996.9A CN202110435996A CN114306580A CN 114306580 A CN114306580 A CN 114306580A CN 202110435996 A CN202110435996 A CN 202110435996A CN 114306580 A CN114306580 A CN 114306580A
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Abstract
The invention provides a method for preparing a compound paclitaxel anti-leukemia capsule tablet and a process thereof, the pharmaceutical composition of the compound paclitaxel anti-leukemia capsule tablet aiming at acute lymphocytic leukemia is as follows: astragalus root, pilose asiabell root, licorice root, asparagus root, prepared Siberian solomonseal rhizome, wolfberry fruit, Chinese angelica root, root of herbaceous peony, hairy vein agrimony, eclipta, cogongrass rhizome, alkanna tinctoria, scrophularia root, isatis root, clerodendroa cyrtophyllum leaf, poppy shell, plaster stone, tiger's eye rohdea saponin, papaya alkaloid, antrodia camphorata polysaccharide, superoxide dismutase SOD, gynostemma pentaphylla and compound taxol. The A agent and the B agent contain a plurality of saponins, terpenoids, alkaloids, flavonoids, sterols, polysaccharides and other compounds, are prepared by magnetized water, promote the micronization of drug molecules after ultrasonic oscillation, can be fully absorbed and utilized, have outstanding effects of clearing away heat and toxic materials, cooling blood, nourishing yin and promoting the production of body fluid, stopping bleeding and regulating spleen and stomach under the synergistic action of the drugs, have quick response, and can relieve symptoms 1 hour after being taken.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a method and a process for preparing compound paclitaxel anti-leukemia capsule tablets.
Background
Leukemia is a malignant clonal disease of hematopoietic stem cells. Clonal leukemia cells proliferate and accumulate in bone marrow and other hematopoietic tissues in large quantities due to mechanisms such as uncontrolled proliferation, differentiation disorder, apoptosis blockage, etc., infiltrate other non-hematopoietic tissues and organs, and inhibit normal hematopoietic function. Different degrees of anemia, hemorrhage, fever due to infection, enlargement of liver, spleen and lymph nodes, bone pain and the like can be seen clinically.
In recent years, although there have been many effective methods for treating leukemia and some clinical results, there are many disadvantages, such as: the radiochemical therapy has great toxic and side effects, often causes a plurality of disease symptoms and brings unnecessary pain to patients; although the bone marrow transplantation can save the lives of patients, the bone marrow matching is difficult, the rejection reaction is stronger, and many leukemia patients die of the patients due to the reasons; after many patients take anti-leukemia chemotherapy drugs, the disease condition is partially relieved or controlled, but the recurrence rate is still high.
Disclosure of Invention
In view of the above, the present invention aims to provide a method and a process for preparing a compound paclitaxel anti-leukemia capsule tablet, which can rapidly play a role in clearing away heat and toxic materials, nourishing yin, promoting the production of body fluid, benefiting qi, nourishing blood, enhancing immunity, inhibiting the growth and replication of cancer cells, stimulating and recovering the hematopoietic function of bone marrow.
In order to achieve the purpose, the technical scheme of the invention is realized as follows:
the compound paclitaxel anti-leukemia capsule tablet has the following medicinal compositions aiming at acute lymphocytic leukemia: astragalus root, pilose asiabell root, licorice root, asparagus root, roasted rhizoma polygonati, medlar, angelica, white peony root, hairyvein agrimony, eclipta alba, cogongrass rhizome, lithospermum, figwort root, isatis root, dyers woad leaf, poppy shell, gypsum, tiger's eye rohdea saponin, papaya alkaloid, antrodia camphorata polysaccharide with the function of enhancing immunity, superoxide dismutase SOD, gynostemma pentaphylla and compound paclitaxel; the compound paclitaxel anti-leukemia capsule tablet has the following medicinal compositions aiming at the chronic myelocytic leukemia: indigo naturalis, radix rehmanniae, radix Paeoniae Rubra, cortex moutan, cortex Lycii, radix aucklandiae, Carthami flos, squama Manis, Concha Ostreae, radix Pseudostellariae, rhizoma Dioscoreae, Glycyrrhrizae radix, Polygoni Multiflori radix Preparata, radix Angelicae sinensis, carapax Trionycis, carapax et Plastrum Testudinis, endothelium corneum Gigeriae Galli, Ornithogalum caudatum saponin, fructus Caricae alkaloid, Antrodia camphorata polysaccharide with immunity enhancing effect, superoxide dismutase SOD, herba Gynostemmatis, and compound paclitaxel.
Further, Gynostemma pentaphyllum Makino is perennial herb vine of Gynostemma of Cucurbitaceae, and the whole herb can be used as medicine; the Gynostemma pentaphyllum contains more than 80 kinds of saponins, wherein 5 kinds of saponins are the same substance with the ginseng, so that the Gynostemma pentaphyllum is called as a second Korean ginseng; the effect of the ginseng tea is similar to that of ginseng, and the ginseng tea is superior to ginseng in some aspects and has no worrying adverse reaction as much as ginseng; the gynostemma pentaphylla has the varieties of 3 leaves, 5 leaves, 7 leaves and 9 leaves, and the traditional Chinese medicines in various gynostemma pentaphylla varieties are basically 5 leaves and 7 leaves; the gynostemma pentaphylla not only contains more than 80 kinds of saponins with different physiological activities, but also contains abundant micromolecule polysaccharide, more than 18 kinds of free amino acids, abundant vitamins, more than 23 kinds of macroelements and microelements, particularly boron, magnesium, manganese, zinc, molybdenum, copper, selenium and the like, and abundant bioflavonoids; gynostemma pentaphyllum has effects of tonifying, tranquilizing, clearing away heat and toxic materials, expelling phlegm, relieving cough, protecting liver, promoting gallbladder function, reducing blood lipid, preventing atherosclerosis, thrombosis, aging, tumor, stress, peptic ulcer, blood pressure, ischemic myocardium, myocardial contraction, enhancing immunity, and turning HBsAg to negative; a plurality of years of pharmacological experiments show that the gynostemma pentaphylla contains more than 80 kinds of saponins and organic selenium with different physiological activities, has extremely obvious cancer inhibition activity for leukemia, esophageal cancer, gastrointestinal cancer, liver cancer, malignant melanoma and brain glioma, can relieve and eliminate cancer pain, can increase normal white blood cells and platelets, and is more suitable for patients with leukopenia and thrombocytopenia after radiotherapy and chemotherapy; therefore, the gynostemma pentaphylla is added into the formula for treating acute leukemia, and the formula has an extremely important effect.
Furthermore, the star-of-Bethlehem is a perennial herbal plant of Liliaceae, the rhizome of the star-of-Bethlehem is spherical, and after growing on the ground for 1 year, many small stem beads similar to the star-of-Bethlehem grow around the bulb, and are cut off for cultivation, so the star-of-Bethlehem is called the star-of-Bethlehem; the star-of-Bethlehem contains a large amount of saponins, alkaloids and bioflavonoids, has more than 27 tested chemical components, and is a plant anticancer Chinese herbal medicine with great development potential; the star-of-Bethlehem saponin has high affinity and identification, can be excessively polymerized with cancer cells, attack cancer cell DNA, directly lock cancer cell mitosis, inhibit cancer cell proliferation, and destroy the oxygen supply pathway of cancer cell neogenesis microcapillary blood vessels, so that cancer cells can be atrophied, suicide and apoptotic in a short time without damaging normal cells.
Furthermore, papaya is also called crown-fruit, breast-melon, papaya and papaya, which is also called papaya in China and Yunnan Guizhou area, but is not the same family as chaenomeles speciosa of Rosaceae, i.e. northern pawpaw; papaya is a typical tropical and subtropical fruit, contains 17 kinds of amino acids and microelements, calcium and iron, and mainly contains papain, caricaine and the like; the papaya alkaloid added in the preparation of the formula is a crude extract extracted from fresh papaya in water, and the content of the crude extract is more than 5%; the unique papaya alkali of papaya has the anti-tumor effect, can prevent the synthesis of nitrosamine in human body, and especially has strong anti-cancer activity on acute lymphocytic leukemia; multiple pharmacological experiments show that the action of the caricaine on the acute lymphocytic leukemia is 100 times stronger than that of other plant anti-leukemia drugs, and no side effect is shown due to moderate dosage; therefore, the addition of papaya alkaloids is crucial to the treatment of acute leukemia.
Further, the Antrodia camphorata contains 32-37% of crude fat, and the mycelium powder mainly contains carbohydrate and protein, 53.46% and 23.83% respectively; the antrodia camphorata and mycelium powder contain a series of pharmacological actions of resisting tumor, resisting cell oxidation, resisting cardiovascular diseases, protecting liver and the like, and a plurality of physiological active substances are analyzed, and the currently known main active ingredients are polysaccharides and triterpenoids; mainly contains neutral sugar such as galactose, glucose, mannose and galactosamine; the antrodia camphorata polysaccharide with the content of 30 percent is a mycelium polysaccharide jointly developed by Shenzhen Shanghai Huikang Biotech limited company and Jiangxi Kangdao biological limited company; the physiological activity of the polysaccharide is higher than that of antrodia camphorata sporocarp, and pharmacological experiments for years show that the antrodia camphorata polysaccharide can inhibit the growth of cervical cancer cells (Hela) and gastric cancer cells (AGS), and the inhibition rates are 83%, 84%, 75% and 87% respectively. The antrodia camphorata water-extracted polysaccharide has cytotoxicity to leukemia cells HL-60, but has no toxicity to human endothelial cells, the antrodia camphorata polysaccharide can activate mononuclear cells (MNCs) so as to inhibit the proliferation of human leukemia cells U937, the antrodia camphorata polysaccharide can improve the activity of various immune cells, has the functions of resisting hepatitis B virus, resisting cancer, resisting cell oxidation, resisting inflammation, relaxing blood vessels and resisting virus infection, and especially has unique treatment effect on protecting liver and liver cancer; therefore, the addition of the antrodia camphorata polysaccharide in the formula preparation has very important significance for enhancing the immunity of leukemia patients, resisting cell oxidation, viruses and cancers.
Furthermore, superoxide dismutase SOD is a gram of free radicals in human bodies, cancerated cells must go through two stages of induction and promotion, carcinogens must form free radicals in vivo and attack and oxidize nuclear DNA to cause canceration, and the free radicals participate in the whole process of cancer occurrence and development; the SOD is taken by high risk people (people with chronic diseases not cured for a long time and low immunity) with possibility of generating cancer, the generation process of the cancer can be prevented, the development of the cancer can be controlled, and for patients who carry out radiotherapy and chemotherapy to treat various cancers, because the toxicity of radioactive rays and a plurality of medicines causes a large amount of superoxide anion free radicals to be generated inside and outside cells, the adverse reactions such as bone marrow damage, white blood cells, thrombocytopenia and the like are often caused, so that the radiotherapy and chemotherapy are difficult to maintain; free radicals are intermediate metabolites of various biochemical reactions in the life activity process of various oxides in a human body and are also effective defense systems in the organism, but when the free radicals are excessively generated or are slowly eliminated, the free radicals can attack life macromolecular substances and various tissues and organs to cause various injuries of the organism at the molecular level, the cell level and the tissue level, accelerate the decay process of cells of the organism and induce various diseases including tumors; the superoxide dismutase SOD is a functional enzyme extracted from maize germs by adopting a pure physical method, has the activity of 3000UI international units, and has no chemical residue; harmful superoxide anion free radicals accumulated in a patient can be converted into hydrogen peroxide through enzymatic reaction, and although the hydrogen peroxide is active oxygen harmful to the body, Catalase (CAT) and Peroxidase (POD) with strong activity in the body can immediately decompose the hydrogen peroxide into safe and harmless water; therefore, the effect of adding SOD in the prescription on leukemia and other tumor patients is very important.
Furthermore, the proportion of each component in the pharmaceutical composition for treating the chronic myelocytic leukemia is as follows: 30g of indigo naturalis, 30g of turtle shell, 15g of radix rehmanniae recen, 9g of Chinese angelica, 10g of stir-fried pangolin scales, 10g of endothelium corneum gigeriae galli, 9g of red paeony root, 9g of cortex moutan, 6g of costus root, 6g of safflower, 3g of liquorice, 15g of tortoise plastron, 15g of raw oyster, 15g of radix pseudostellariae, 15g of Chinese yam, 15g of cortex lycii radicis, 30g of gynostemma pentaphylla, 15g of roasted polygonum multiflorum, 0.3g of tiger eye rohdea japonica saponin, 0.3g of papaya alkaloid, 0.3g of antrodia polysaccharide, 10mg of SOD and 0.066g of compound taxol.
Further, the pharmaceutical composition for acute lymphocytic leukemia comprises the following components in proportion: 30g of astragalus membranaceus, 15g of roasted rhizoma polygonati, 15g of wolfberry fruit, 15g of asparagus, 15g of radix scrophulariae, 15g of angelica sinensis, 15g of radix paeoniae alba, 15g of lithospermum, 15g of eclipta alba, 15g of hairyvein agrimonia herb and bud, 15g of scutellaria baicalensis, 15g of coptis chinensis, 15g of cortex phellodendri, 20g of codonopsis pilosula, 15g of gynostemma pentaphylla, 3g of poppy shell, 15g of folium isatidis, 30g of gypsum, 0.3g of star-of-Begonia-sinensis saponin, 0.3g of papaya alkaloid, 0.3g of antrodia polysaccharide, 10mg of SOD and 0.066g of compound taxol.
The preparation method of the compound paclitaxel anti-leukemia capsule tablet comprises the following steps:
step (1): 30g of astragalus membranaceus, 15g of roasted rhizoma polygonati, 15g of wolfberry fruit, 15g of asparagus, 15g of radix scrophulariae, 15g of angelica sinensis, 15g of radix paeoniae alba, 15g of lithospermum, 15g of eclipta alba, 15g of hairyvein agrimony, 15g of scutellaria baicalensis, 15g of coptis chinensis, 15g of cortex phellodendri, 20g of codonopsis pilosula, 15g of gynostemma pentaphylla, 3g of poppy shell, 15g of folium isatidis and 30g of gypsum are completely mixed, are subjected to superfine grinding to 300 meshes, and are placed into a stainless steel container to be used as an agent A for later use;
step (2): 30g of indigo naturalis, 30g of turtle shell, 15g of radix rehmanniae recen, 9g of angelica sinensis, 10g of stir-fried pangolin scales, 10g of endothelium corneum gigeriae galli, 9g of red paeony root, 9g of cortex moutan, 6g of costus root, 6g of safflower, 3g of liquorice, 15g of tortoise plastron, 15g of raw oyster, 15g of radix pseudostellariae, 15g of Chinese yam, 15g of cortex lycii radicis, 30g of gynostemma pentaphylla and 15g of prepared polygonum multiflorum are all mixed, are ground into 300 meshes of ultrafine powder, and are put into a stainless steel container to be used as a preparation B for standby;
and (3): then 3000ml of magnetized water is respectively injected into the container of the agent A and the container of the agent B, the mixture is soaked for 3 hours, and the mixture is stirred for 1 time per hour, so that the magnetized water quickly permeates, the medicine powder particles can quickly absorb water and expand, and the separation of each medicine component is promoted;
and (4): decocting the A and B agents respectively with strong fire for 8 min, then decocting with slow fire for 5 min, filtering with 500 mesh filter screen, collecting decoction, respectively injecting 2000ml of magnetized water into the residue, decocting, filtering, collecting decoction, decocting for 3 times, removing residue, mixing the filtrates, and placing into another stainless steel container;
and (5): placing the agent A and the agent B into hot water which is indirectly heated at 80 ℃, taking out when water is volatilized in a water bath until the original volume is 1/3, respectively adding 0.3g of rhodea japonica saponins, 0.3g of papaya alkaloids, 0.3g of antrodia camphorata polysaccharides, 10g of SOD (superoxide dismutase), and 0.066g of compound paclitaxel into the agent A and the agent B when the temperature is reduced to 40 ℃, stirring until the agents are completely dissolved, placing the agent A and the agent B into a 50HZ ultrasonic oscillator, and ultrasonically oscillating for 10 minutes, wherein the aim is to crush cytoplasm of each medicinal substance in the agent liquid through ultrasonic oscillation so as to achieve quantization of each medicinal substance and promote absorption and utilization of a human body;
and (6): injecting the agent A liquid medicine after ultrasonic oscillation into a material container of a spray dryer for sealing, fixing a high-pressure nozzle with the diameter of 0.5mm, adjusting the set feeding amount to 2000ml/h, the set spraying pressure to 4bar, adjusting the air inlet temperature to 165 ℃, adjusting the air outlet temperature to 80 ℃, and drying for 1.5 s; the air inlet temperature is actually the drying temperature of the material, although the drying temperature is designed to be 165 ℃, the spray drying time is only 1.5s, and the sprayed feed liquid can contact with the high temperature only when being sprayed into an atomized state, so that the feed liquid is heated instantly only and can be completely kept to maintain the physiological activity of the feed liquid after being dried; starting a fan switch, starting an electric heater to release heat, starting a high-pressure spray switch after 5 seconds, regulating the high-pressure spray switch until liquid medicine jet flow is gasified into an atomized state, stopping the machine after all liquid medicine is gradually sprayed and dried, taking out a collecting tank, pouring out medicinal powder, injecting the liquid medicine of the agent B into a material container, performing spray drying according to the set data of the liquid medicine of the agent A in sequential links, and packaging the dosage after all liquid medicine is dried;
and (7): the medicine powder A and the medicine powder B are successively put into a material container of a capsule filling machine, and are made into capsules under the linkage action of the capsule filling machine, wherein the medicine powder A and the medicine powder B are both contained in 0.4g per capsule.
Furthermore, the compound paclitaxel anti-leukemia capsule tablet is used for acute lymphocytic leukemia or chronic myelocytic leukemia, and the dosage of the compound paclitaxel anti-leukemia capsule tablet is 3 times per day for adults, 3 granules each time; the composition is administered orally to children 3 times per day, 1-2 granules each time.
Compared with the prior art, the compound paclitaxel anti-leukemia capsule tablet has the following advantages:
1. the A agent and the B agent contain a plurality of saponins, terpenoids, alkaloids, flavonoids, sterols, polysaccharides and other compounds, are prepared by magnetized water, promote the micronization of drug molecules after ultrasonic oscillation, can be fully absorbed and utilized, have outstanding effects of clearing away heat and toxic materials, cooling blood, nourishing yin and promoting the production of body fluid, stopping bleeding and regulating spleen and stomach under the synergistic effect of the drugs, have quick response, and can relieve symptoms after being taken for 1 hour;
2. the invention can quickly stimulate and activate human body macrophage M heavy, TB lymphocyte, natural killer cell NK, cytotoxic cell CTL, lymphokine activated LAK killer cell, antigen dependent specific killer cell TC, dendritic cell DC and other immune cells, can quickly improve specific immunity, cellular immunity, humoral immunity function and antibody generating capacity of lymphosplenocyte, simultaneously two immune cells of DC and CTL activated by the preparation of the invention are important components of immune hematogenesis anticancer, the former identifies antigen and can activate acquired immune system, the latter activates complement system by exerting own toxic secretory factor killing cancer cell, can quickly promote factor generation, so as to realize the antibody generation of leukemia patient, and can regulate the quantity of red and white blood cells by inhibiting the generation of active oxygen in human neutrophile and monocyte, the immunity enhancement effect is achieved, and all the substances have no cytotoxicity;
3. the A agent and the B agent are applied to the bone marrow hematopoiesis gradual recovery of acute and chronic leukemia, improve the bone marrow suppression after chemoradiotherapy, obviously increase the concentration of peripheral blood hemoglobin and the number of platelets, can promote mononuclear macrophages to generate cytokines such as ILI beta, TNF-a, IL-6 and the like, and greatly promote T lymphocytes to release ITN-y; generally, after the preparation is orally taken for 5 days, the 3H-thymidine, the 3H leucine and the 3H-pyrimidine nucleoside can be respectively permeated into bone marrow cell protein, DNA and RNA, and the permeation amount is increased by 48.2 to 59.6 percent compared with a control group, which shows that the preparation can promote the synthesis of the bone marrow cell protein and nucleic acid, accelerate the division and proliferation of bone marrow cells, recover the hematopoietic function and realize the effectiveness of early rehabilitation and relapse prevention of leukemia patients.
Detailed Description
Unless defined otherwise, technical terms used in the following examples have the same meanings as commonly understood by one of ordinary skill in the art to which the present invention belongs.
The present invention will be described in detail below.
The compound paclitaxel anti-leukemia capsule tablet has the following medicinal compositions aiming at acute lymphocytic leukemia: astragalus root, pilose asiabell root, licorice root, asparagus root, roasted rhizoma polygonati, medlar, angelica, white peony root, hairyvein agrimony, eclipta alba, cogongrass rhizome, lithospermum, figwort root, isatis root, dyers woad leaf, poppy shell, gypsum, tiger's eye rohdea saponin, papaya alkaloid, antrodia camphorata polysaccharide with the function of enhancing immunity, superoxide dismutase SOD, gynostemma pentaphylla and compound paclitaxel; the compound paclitaxel anti-leukemia capsule tablet has the following medicinal compositions aiming at the chronic myelocytic leukemia: indigo naturalis, radix rehmanniae, radix Paeoniae Rubra, cortex moutan, cortex Lycii, radix aucklandiae, Carthami flos, squama Manis, Concha Ostreae, radix Pseudostellariae, rhizoma Dioscoreae, Glycyrrhrizae radix, Polygoni Multiflori radix Preparata, radix Angelicae sinensis, carapax Trionycis, carapax et Plastrum Testudinis, endothelium corneum Gigeriae Galli, Ornithogalum caudatum saponin, fructus Caricae alkaloid, Antrodia camphorata polysaccharide with immunity enhancing effect, superoxide dismutase SOD, herba Gynostemmatis, and compound paclitaxel.
In this example, Gynostemma pentaphyllum Makino is a perennial herb vine of Gynostemma of Cucurbitaceae, and the whole herb can be used as a medicine; the Gynostemma pentaphyllum contains more than 80 kinds of saponins, wherein 5 kinds of saponins are the same substance with the ginseng, so that the Gynostemma pentaphyllum is called as a second Korean ginseng; the effect of the ginseng tea is similar to that of ginseng, and the ginseng tea is superior to ginseng in some aspects and has no worrying adverse reaction as much as ginseng; the gynostemma pentaphylla has the varieties of 3 leaves, 5 leaves, 7 leaves and 9 leaves, and the traditional Chinese medicines in various gynostemma pentaphylla varieties are basically 5 leaves and 7 leaves; the gynostemma pentaphylla not only contains more than 80 kinds of saponins with different physiological activities, but also contains abundant micromolecule polysaccharide, more than 18 kinds of free amino acids, abundant vitamins, more than 23 kinds of macroelements and microelements, particularly boron, magnesium, manganese, zinc, molybdenum, copper, selenium and the like, and abundant bioflavonoids; gynostemma pentaphyllum has effects of tonifying, tranquilizing, clearing away heat and toxic materials, expelling phlegm, relieving cough, protecting liver, promoting gallbladder function, reducing blood lipid, preventing atherosclerosis, thrombosis, aging, tumor, stress, peptic ulcer, blood pressure, ischemic myocardium, myocardial contraction, enhancing immunity, and turning HBsAg to negative; a plurality of years of pharmacological experiments show that the gynostemma pentaphylla contains more than 80 kinds of saponins and organic selenium with different physiological activities, has extremely obvious cancer inhibition activity for leukemia, esophageal cancer, gastrointestinal cancer, liver cancer, malignant melanoma and brain glioma, can relieve and eliminate cancer pain, can increase normal white blood cells and platelets, and is more suitable for patients with leukopenia and thrombocytopenia after radiotherapy and chemotherapy; therefore, the gynostemma pentaphylla is added into the formula for treating acute leukemia, and the formula has an extremely important effect.
In the embodiment, the star-of-Bethlehem is a perennial herbal plant of Liliaceae, the rootstock of the star-of-Bethlehem is spherical, and after growing on the ground for 1 year, many small stem beads similar to the star-of-Bethlehem grow around the corm and are cultivated after being divided, so that the star-of-Bethlehem is called the star-of-Bethlehem; the star-of-Bethlehem contains a large amount of saponins, alkaloids and bioflavonoids, has more than 27 tested chemical components, and is a plant anticancer Chinese herbal medicine with great development potential; the star-of-Bethlehem saponin has high affinity and identification, can be excessively polymerized with cancer cells, attack cancer cell DNA, directly lock cancer cell mitosis, inhibit cancer cell proliferation, and destroy the oxygen supply pathway of cancer cell neogenesis microcapillary blood vessels, so that cancer cells can be atrophied, suicide and apoptotic in a short time without damaging normal cells.
In the embodiment, the papaya is also called crown fruit, breast melon, papaya and papaya, is also called papaya in China and Yunnan Guizhou area, but is different from chaenomeles speciosa of Rosaceae, namely the northern papaya is not a plant of the same family; papaya is a typical tropical and subtropical fruit, contains 17 kinds of amino acids and microelements, calcium and iron, and mainly contains papain, caricaine and the like; the papaya alkaloid added in the preparation of the formula is a crude extract extracted from fresh papaya in water, and the content of the crude extract is more than 5%; the unique papaya alkali of papaya has the anti-tumor effect, can prevent the synthesis of nitrosamine in human body, and especially has strong anti-cancer activity on acute lymphocytic leukemia; multiple pharmacological experiments show that the action of the caricaine on the acute lymphocytic leukemia is 100 times stronger than that of other plant anti-leukemia drugs, and no side effect is shown due to moderate dosage; therefore, the addition of papaya alkaloids is crucial to the treatment of acute leukemia.
In the embodiment, the antrodia camphorata contains 32-37% of crude fat, and the mycelium powder mainly contains carbohydrate and protein which are 53.46% and 23.83% respectively; the antrodia camphorata and mycelium powder contain a series of pharmacological actions of resisting tumor, resisting cell oxidation, resisting cardiovascular diseases, protecting liver and the like, and a plurality of physiological active substances are analyzed, and the currently known main active ingredients are polysaccharides and triterpenoids; mainly contains neutral sugar such as galactose, glucose, mannose and galactosamine; the antrodia camphorata polysaccharide with the content of 30 percent is a mycelium polysaccharide jointly developed by Shenzhen Shanghai Huikang Biotech limited company and Jiangxi Kangdao biological limited company; the physiological activity of the polysaccharide is higher than that of antrodia camphorata sporocarp, and pharmacological experiments for years show that the antrodia camphorata polysaccharide can inhibit the growth of cervical cancer cells (Hela) and gastric cancer cells (AGS), and the inhibition rates are 83%, 84%, 75% and 87% respectively. The antrodia camphorata water-extracted polysaccharide has cytotoxicity to leukemia cells HL-60, but has no toxicity to human endothelial cells, the antrodia camphorata polysaccharide can activate mononuclear cells (MNCs) so as to inhibit the proliferation of human leukemia cells U937, the antrodia camphorata polysaccharide can improve the activity of various immune cells, has the functions of resisting hepatitis B virus, resisting cancer, resisting cell oxidation, resisting inflammation, relaxing blood vessels and resisting virus infection, and especially has unique treatment effect on protecting liver and liver cancer; therefore, the addition of the antrodia camphorata polysaccharide in the formula preparation has very important significance for enhancing the immunity of leukemia patients, resisting cell oxidation, viruses and cancers.
In the embodiment, superoxide dismutase SOD is a gram of free radicals in a human body, cancerated cells must go through two stages of induction and promotion, carcinogens must form free radicals in the body and attack and oxidize nuclear DNA to cause canceration, and the free radicals participate in the whole process of cancer occurrence and development; the SOD is taken by high risk people (people with chronic diseases not cured for a long time and low immunity) with possibility of generating cancer, the generation process of the cancer can be prevented, the development of the cancer can be controlled, and for patients who carry out radiotherapy and chemotherapy to treat various cancers, because the toxicity of radioactive rays and a plurality of medicines causes a large amount of superoxide anion free radicals to be generated inside and outside cells, the adverse reactions such as bone marrow damage, white blood cells, thrombocytopenia and the like are often caused, so that the radiotherapy and chemotherapy are difficult to maintain; free radicals are intermediate metabolites of various biochemical reactions in the life activity process of various oxides in a human body and are also effective defense systems in the organism, but when the free radicals are excessively generated or are slowly eliminated, the free radicals can attack life macromolecular substances and various tissues and organs to cause various injuries of the organism at the molecular level, the cell level and the tissue level, accelerate the decay process of cells of the organism and induce various diseases including tumors; the superoxide dismutase SOD is a functional enzyme extracted from maize germs by adopting a pure physical method, has the activity of 3000UI international units, and has no chemical residue; harmful superoxide anion free radicals accumulated in a patient can be converted into hydrogen peroxide through enzymatic reaction, and although the hydrogen peroxide is active oxygen harmful to the body, Catalase (CAT) and Peroxidase (POD) with strong activity in the body can immediately decompose the hydrogen peroxide into safe and harmless water; therefore, the effect of adding SOD in the prescription on leukemia and other tumor patients is very important.
In this embodiment, the pharmaceutical composition for chronic myelocytic leukemia comprises the following components in proportion: 30g of indigo naturalis, 30g of turtle shell, 15g of radix rehmanniae recen, 9g of Chinese angelica, 10g of stir-fried pangolin scales, 10g of endothelium corneum gigeriae galli, 9g of red paeony root, 9g of cortex moutan, 6g of costus root, 6g of safflower, 3g of liquorice, 15g of tortoise plastron, 15g of raw oyster, 15g of radix pseudostellariae, 15g of Chinese yam, 15g of cortex lycii radicis, 30g of gynostemma pentaphylla, 15g of roasted polygonum multiflorum, 0.3g of tiger eye rohdea japonica saponin, 0.3g of papaya alkaloid, 0.3g of antrodia polysaccharide, 10mg of SOD and 0.066g of compound taxol.
In this embodiment, the pharmaceutical composition for acute lymphocytic leukemia comprises the following components in proportion: 30g of astragalus membranaceus, 15g of roasted rhizoma polygonati, 15g of wolfberry fruit, 15g of asparagus, 15g of radix scrophulariae, 15g of angelica sinensis, 15g of radix paeoniae alba, 15g of lithospermum, 15g of eclipta alba, 15g of hairyvein agrimonia herb and bud, 15g of scutellaria baicalensis, 15g of coptis chinensis, 15g of cortex phellodendri, 20g of codonopsis pilosula, 15g of gynostemma pentaphylla, 3g of poppy shell, 15g of folium isatidis, 30g of gypsum, 0.3g of star-of-Begonia-sinensis saponin, 0.3g of papaya alkaloid, 0.3g of antrodia polysaccharide, 10mg of SOD and 0.066g of compound taxol.
The preparation method of the compound paclitaxel anti-leukemia capsule tablet comprises the following steps:
step (1): 30g of astragalus membranaceus, 15g of roasted rhizoma polygonati, 15g of wolfberry fruit, 15g of asparagus, 15g of radix scrophulariae, 15g of angelica sinensis, 15g of radix paeoniae alba, 15g of lithospermum, 15g of eclipta alba, 15g of hairyvein agrimony, 15g of scutellaria baicalensis, 15g of coptis chinensis, 15g of cortex phellodendri, 20g of codonopsis pilosula, 15g of gynostemma pentaphylla, 3g of poppy shell, 15g of folium isatidis and 30g of gypsum are completely mixed, are subjected to superfine grinding to 300 meshes, and are placed into a stainless steel container to be used as an agent A for later use;
step (2): 30g of indigo naturalis, 30g of turtle shell, 15g of radix rehmanniae recen, 9g of angelica sinensis, 10g of stir-fried pangolin scales, 10g of endothelium corneum gigeriae galli, 9g of red paeony root, 9g of cortex moutan, 6g of costus root, 6g of safflower, 3g of liquorice, 15g of tortoise plastron, 15g of raw oyster, 15g of radix pseudostellariae, 15g of Chinese yam, 15g of cortex lycii radicis, 30g of gynostemma pentaphylla and 15g of prepared polygonum multiflorum are all mixed, are ground into 300 meshes of ultrafine powder, and are put into a stainless steel container to be used as a preparation B for standby;
and (3): then 3000ml of magnetized water is respectively injected into the container of the agent A and the container of the agent B, the mixture is soaked for 3 hours, and the mixture is stirred for 1 time per hour, so that the magnetized water quickly permeates, the medicine powder particles can quickly absorb water and expand, and the separation of each medicine component is promoted;
and (4): decocting the A and B agents respectively with strong fire for 8 min, then decocting with slow fire for 5 min, filtering with 500 mesh filter screen, collecting decoction, respectively injecting 2000ml of magnetized water into the residue, decocting, filtering, collecting decoction, decocting for 3 times, removing residue, mixing the filtrates, and placing into another stainless steel container;
and (5): placing the agent A and the agent B into hot water which is indirectly heated at 80 ℃, taking out when water is volatilized in a water bath until the original volume is 1/3, respectively adding 0.3g of rhodea japonica saponins, 0.3g of papaya alkaloids, 0.3g of antrodia camphorata polysaccharides, 10g of SOD (superoxide dismutase), and 0.066g of compound paclitaxel into the agent A and the agent B when the temperature is reduced to 40 ℃, stirring until the agents are completely dissolved, placing the agent A and the agent B into a 50HZ ultrasonic oscillator, and ultrasonically oscillating for 10 minutes, wherein the aim is to crush cytoplasm of each medicinal substance in the agent liquid through ultrasonic oscillation so as to achieve quantization of each medicinal substance and promote absorption and utilization of a human body;
and (6): injecting the agent A liquid medicine after ultrasonic oscillation into a material container of a spray dryer for sealing, fixing a high-pressure nozzle with the diameter of 0.5mm, adjusting the set feeding amount to 2000ml/h, the set spraying pressure to 4bar, adjusting the air inlet temperature to 165 ℃, adjusting the air outlet temperature to 80 ℃, and drying for 1.5 s; the air inlet temperature is actually the drying temperature of the material, although the drying temperature is designed to be 165 ℃, the spray drying time is only 1.5s, and the sprayed feed liquid can contact with the high temperature only when being sprayed into an atomized state, so that the feed liquid is heated instantly only and can be completely kept to maintain the physiological activity of the feed liquid after being dried; starting a fan switch, starting an electric heater to release heat, starting a high-pressure spray switch after 5 seconds, regulating the high-pressure spray switch until liquid medicine jet flow is gasified into an atomized state, stopping the machine after all liquid medicine is gradually sprayed and dried, taking out a collecting tank, pouring out medicinal powder, injecting the liquid medicine of the agent B into a material container, performing spray drying according to the set data of the liquid medicine of the agent A in sequential links, and packaging the dosage after all liquid medicine is dried;
and (7): the medicine powder A and the medicine powder B are successively put into a material container of a capsule filling machine, and are made into capsules under the linkage action of the capsule filling machine, wherein the medicine powder A and the medicine powder B are both contained in 0.4g per capsule.
In the embodiment, the compound paclitaxel anti-leukemia capsule tablet is used for treating acute lymphocytic leukemia or chronic myelocytic leukemia, and the dosage of the compound paclitaxel anti-leukemia capsule tablet is 3 times per day for adults, 3 granules each time; the composition is administered orally to children 3 times per day, 1-2 granules each time.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.
Claims (5)
1. The preparation method and the process of the compound paclitaxel anti-leukemia capsule tablet are characterized in that: the pharmaceutical composition of the compound paclitaxel anti-leukemia capsule tablet aiming at acute lymphocytic leukemia is as follows: astragalus root, pilose asiabell root, licorice root, asparagus root, roasted rhizoma polygonati, medlar, angelica, white peony root, hairyvein agrimony, eclipta alba, cogongrass rhizome, lithospermum, figwort root, isatis root, dyers woad leaf, poppy shell, gypsum, tiger's eye rohdea saponin, papaya alkaloid, antrodia camphorata polysaccharide with the function of enhancing immunity, superoxide dismutase SOD, gynostemma pentaphylla and compound paclitaxel; the compound paclitaxel anti-leukemia capsule tablet has the following medicinal compositions aiming at the chronic myelocytic leukemia: indigo naturalis, radix rehmanniae, radix Paeoniae Rubra, cortex moutan, cortex Lycii, radix aucklandiae, Carthami flos, squama Manis, Concha Ostreae, radix Pseudostellariae, rhizoma Dioscoreae, Glycyrrhrizae radix, Polygoni Multiflori radix Preparata, radix Angelicae sinensis, carapax Trionycis, carapax et Plastrum Testudinis, endothelium corneum Gigeriae Galli, Ornithogalum caudatum saponin, fructus Caricae alkaloid, Antrodia camphorata polysaccharide with immunity enhancing effect, superoxide dismutase SOD, herba Gynostemmatis, and compound paclitaxel.
2. The method and process for preparing the compound paclitaxel anti-leukemia capsule tablet as claimed in claim 1, wherein: the pharmaceutical composition for treating acute lymphocytic leukemia comprises the following components in proportion: 30g of astragalus membranaceus, 15g of roasted rhizoma polygonati, 15g of wolfberry fruit, 15g of asparagus, 15g of radix scrophulariae, 15g of angelica sinensis, 15g of radix paeoniae alba, 15g of lithospermum, 15g of eclipta alba, 15g of hairyvein agrimonia herb and bud, 15g of scutellaria baicalensis, 15g of coptis chinensis, 15g of cortex phellodendri, 20g of codonopsis pilosula, 15g of gynostemma pentaphylla, 3g of poppy shell, 15g of folium isatidis, 30g of gypsum, 0.3g of star-of-Begonia-sinensis saponin, 0.3g of papaya alkaloid, 0.3g of antrodia polysaccharide, 10mg of SOD and 0.066g of compound taxol.
3. The method and process for preparing the compound paclitaxel anti-leukemia capsule tablet as claimed in claim 1, wherein: the medicine composition for treating chronic myelocytic leukemia comprises the following components in proportion: 30g of indigo naturalis, 30g of turtle shell, 15g of radix rehmanniae recen, 9g of Chinese angelica, 10g of stir-fried pangolin scales, 10g of endothelium corneum gigeriae galli, 9g of red paeony root, 9g of cortex moutan, 6g of costus root, 6g of safflower, 3g of liquorice, 15g of tortoise plastron, 15g of raw oyster, 15g of radix pseudostellariae, 15g of Chinese yam, 15g of cortex lycii radicis, 30g of gynostemma pentaphylla, 15g of roasted polygonum multiflorum, 0.3g of tiger eye rohdea japonica saponin, 0.3g of papaya alkaloid, 0.3g of antrodia polysaccharide, 10mg of SOD and 0.066g of compound taxol.
4. The method and process for preparing the compound paclitaxel anti-leukemia capsule tablet as claimed in claim 1, wherein: the method comprises the following steps:
step (1): 30g of astragalus membranaceus, 15g of roasted rhizoma polygonati, 15g of wolfberry fruit, 15g of asparagus, 15g of radix scrophulariae, 15g of angelica sinensis, 15g of radix paeoniae alba, 15g of lithospermum, 15g of eclipta alba, 15g of hairyvein agrimony, 15g of scutellaria baicalensis, 15g of coptis chinensis, 15g of cortex phellodendri, 20g of codonopsis pilosula, 15g of gynostemma pentaphylla, 3g of poppy shell, 15g of folium isatidis and 30g of gypsum are completely mixed, are subjected to superfine grinding to 300 meshes, and are placed into a stainless steel container to be used as an agent A for later use;
step (2): 30g of indigo naturalis, 30g of turtle shell, 15g of radix rehmanniae recen, 9g of angelica sinensis, 10g of stir-fried pangolin scales, 10g of endothelium corneum gigeriae galli, 9g of red paeony root, 9g of cortex moutan, 6g of costus root, 6g of safflower, 3g of liquorice, 15g of tortoise plastron, 15g of raw oyster, 15g of radix pseudostellariae, 15g of Chinese yam, 15g of cortex lycii radicis, 30g of gynostemma pentaphylla and 15g of prepared polygonum multiflorum are all mixed, are ground into 300 meshes of ultrafine powder, and are put into a stainless steel container to be used as a preparation B for standby;
and (3): then 3000ml of magnetized water is respectively injected into the container of the agent A and the container of the agent B, the mixture is soaked for 3 hours, and the mixture is stirred for 1 time per hour, so that the magnetized water quickly permeates, the medicine powder particles can quickly absorb water and expand, and the separation of each medicine component is promoted;
and (4): decocting the A and B agents respectively with strong fire for 8 min, then decocting with slow fire for 5 min, filtering with 500 mesh filter screen, collecting decoction, respectively injecting 2000ml of magnetized water into the residue, decocting, filtering, collecting decoction, decocting for 3 times, removing residue, mixing the filtrates, and placing into another stainless steel container;
and (5): placing the agent A and the agent B into hot water which is indirectly heated at 80 ℃, taking out when water is volatilized in a water bath until the original volume is 1/3, respectively adding 0.3g of rhodea japonica saponins, 0.3g of papaya alkaloids, 0.3g of antrodia camphorata polysaccharides, 10g of SOD (superoxide dismutase), and 0.066g of compound paclitaxel into the agent A and the agent B when the temperature is reduced to 40 ℃, stirring until the agents are completely dissolved, placing the agent A and the agent B into a 50HZ ultrasonic oscillator, and ultrasonically oscillating for 10 minutes, wherein the aim is to crush cytoplasm of each medicinal substance in the agent liquid through ultrasonic oscillation so as to achieve quantization of each medicinal substance and promote absorption and utilization of a human body;
and (6): injecting the agent A liquid medicine after ultrasonic oscillation into a material container of a spray dryer for sealing, fixing a high-pressure nozzle with the diameter of 0.5mm, adjusting the set feeding amount to 2000ml/h, the set spraying pressure to 4bar, adjusting the air inlet temperature to 165 ℃, adjusting the air outlet temperature to 80 ℃, and drying for 1.5 s; the air inlet temperature is actually the drying temperature of the material, although the drying temperature is designed to be 165 ℃, the spray drying time is only 1.5s, and the sprayed feed liquid can contact with the high temperature only when being sprayed into an atomized state, so that the feed liquid is heated instantly only and can be completely kept to maintain the physiological activity of the feed liquid after being dried; starting a fan switch, starting an electric heater to release heat, starting a high-pressure spray switch after 5 seconds, regulating the high-pressure spray switch until liquid medicine jet flow is gasified into an atomized state, stopping the machine after all liquid medicine is gradually sprayed and dried, taking out a collecting tank, pouring out medicinal powder, injecting the liquid medicine of the agent B into a material container, performing spray drying according to the set data of the liquid medicine of the agent A in sequential links, and packaging the dosage after all liquid medicine is dried;
and (7): the medicine powder A and the medicine powder B are successively put into a material container of a capsule filling machine, and are made into capsules under the linkage action of the capsule filling machine, wherein the medicine powder A and the medicine powder B are both contained in 0.4g per capsule.
5. The method and process for preparing the compound paclitaxel anti-leukemia capsule tablet as claimed in claim 4, wherein: the compound paclitaxel anti-leukemia capsule tablet is used for treating acute lymphocytic leukemia or chronic myelocytic leukemia, and the dosage of the compound paclitaxel anti-leukemia capsule tablet is 3 times per day for adults, 3 granules each time; the composition is administered orally to children 3 times per day, 1-2 granules each time.
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