CN105169105A - Chinese medicinal preparation having functions of preventing tumors, nourishing yin and stomach and enhancing immunity and preparation method thereof - Google Patents

Chinese medicinal preparation having functions of preventing tumors, nourishing yin and stomach and enhancing immunity and preparation method thereof Download PDF

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Publication number
CN105169105A
CN105169105A CN201510670095.2A CN201510670095A CN105169105A CN 105169105 A CN105169105 A CN 105169105A CN 201510670095 A CN201510670095 A CN 201510670095A CN 105169105 A CN105169105 A CN 105169105A
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chinese medicine
concentrated
gained
parts
dry
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贾福怀
陶刚
涂宏建
王俊
熊菲菲
王彩霞
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NINGBO YUFANGTANG BIOTECHNOLOGY CO Ltd
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NINGBO YUFANGTANG BIOTECHNOLOGY CO Ltd
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Abstract

The invention relates to a Chinese medicinal preparation having functions of preventing tumors, nourishing yin and stomach and enhancing immunity. The Chinese medicinal preparation comprises the following components in parts by weight: 14-30 parts of dendrobium candidum, 12-30 parts of American ginseng, 27-42 parts of lucid ganoderma, 10-20 parts of pseudo-ginseng and 5-12 parts of coix seeds. The invention further relates to a preparation method of the Chinese medicinal preparation. Specific to the feature that active components such as fatty acid and lactone in the coix seeds tend to volatilize, a CO2 supercritical extraction technology is adopted in combination with embedding and spray drying methods, so that the active components in the coix seeds are protected from being damaged to the maximum extent. Active components of the dendrobium candidum and the lucid ganoderma are extracted fully with a reduced-pressure concentration process, so that the prepared Chinese medicinal preparation has good functions of preventing tumors, nourishing yin and stomach and enhancing immunity. Pills are directly made under the mutual actions of medicinal materials without adding of any other auxiliary material, so that bioactive components of the medicinal materials are kept fully, the utilization ratios and medicinal effects of the medicinal materials are improved effectively, the dosage can be reduced, and the bioavailability is enhanced greatly.

Description

There is the Chinese medicine preparation and preparation method thereof of antitumor, tonifying-Yin and nourishing-stomach, enhancing immunity function
Technical field
The present invention relates to technical field of traditional Chinese medicine preparation, specifically refer to a kind of Chinese medicine preparation with antitumor, tonifying-Yin and nourishing-stomach, enhancing immunity function, the invention still further relates to the preparation method of above-mentioned Chinese medicine preparation.
Background technology
Immunity typically refers to the resistivity of human body to various disease, and it is exactly liable to illness that hypoimmunity the most directly shows.Frequent ill meeting increases the weight of the consumption of body; so generally have have a delicate constitution, the reduction of malnutrition, listlessness, fatigue and weak, appetite, the performance such as sleep disorder crowd; at every turn sickly all to could to recover for a long time; and usually recurrent exerbation; if things go on like this can cause health and intelligent development bad, easily bring out major disease.When immune system can not play immunosurveillance, just can not identify in time and mutant cell in purged body, cause the generation of cancer.World's cancer report is estimated, within 2012, Cancer in China number of the infected is 306.5 ten thousand, accounts for 1/5th of whole world morbidity; Number of cancer deaths is 220.5 ten thousand, accounts for global number of cancer deaths's 1/4th.Wreck along with aging aggravation, ecological environment, unhealthy life style and food-safety problem show especially, China's tumor incidence continues to rise for many years, become a public health problem and even social problem that must pay much attention to, China need declare a war to tumor.
Herba Dendrobii has the effects such as reinforcing stomach reg fluid, nourishing YIN and clearing away heat, lung moistening kidney tonifying, the strong waist of improving eyesight, antitumor, has in the market in a lot of Chinese medicine preparation and all employ Herba Dendrobii.Such as, publication number is the Chinese invention patent application " Herba Dendrobii compound dripping pill agent and preparation method thereof " (application number: CN200310113916.X) of CN1613485A, 201410029075.2) etc. publication number is Chinese invention patent application " honey refining Herba Dendrobii the ball " (application number: all disclose the Chinese medicine preparation containing Herba Dendrobii of CN103768406A, Herba Dendrobii has played different efficacies in above-mentioned Chinese medicine preparation, but by the restriction of composition components, Herba Dendrobii is not fully developed in effect of anti-tumor aspect, and due in the preparation process of Chinese medicine preparation, the state being shaped to pill etc. to make Chinese medicine preparation and being convenient to take and deposit, usual meeting adds binding agent (as Mel in preparation process, rice is stuck with paste, batter, syrup etc.), disintegrating agent is (as CMC, CMC-Na, HPMC etc.), wetting agent is (as wine, vinegar, water honey, medicine juice etc.) etc. a large amount of adjuvant, this just reduces biological availability and the drug effect of preparation to a great extent, cause the bioactive ingredients content of product Chinese medicine low, not only have a strong impact on and take effect, too much amount also very easily causes the detest psychology of consumer, affect the market sales volume of product.
Summary of the invention
Technical problem to be solved by this invention is the present situation for prior art, provides a kind of Chinese medicine preparation with antitumor, tonifying-Yin and nourishing-stomach, enhancing immunity function.
Another technical problem to be solved by this invention is the present situation for prior art, a kind of preparation method of above-mentioned Chinese medicine preparation is provided, the method can retain the bioactive ingredients of medicine, the utilization rate improving medicine and drug effect to greatest extent, thus reaches good antitumor, tonifying-Yin and nourishing-stomach, enhancing immunity function.
The present invention solves the problems of the technologies described above adopted technical scheme: a kind of Chinese medicine preparation with antitumor, tonifying-Yin and nourishing-stomach, enhancing immunity function, is characterized in that comprising following component by weight:
A preparation method for above-mentioned Chinese medicine preparation, is characterized in that comprising the following steps:
(1) 5 ~ 12 parts of Semen Coiciss are adopted CO 2the Coixol of collection also carries out embedding and dried by supercritical fluid extraction Coixol successively, obtains the Semen Coicis extract of powdery;
(2) respectively 12 ~ 30 parts of Radix Panacis Quinquefolii decoction pieces and 10 ~ 20 parts of Radix Notoginseng powder are broken into 120 ~ 250 object fine powders, 14 ~ 30 parts of Herba Dendrobii are ground into 10 ~ 14 object coarse granules, 27 ~ 42 portions of Ganodermas are cut into the thin slice that thickness is 0.5 ~ 1.5mm, for subsequent use;
(3) step (2) gained Herba Dendrobii coarse granule is placed in 25 ~ 35 times of weight in the water of Herba Dendrobii, lixiviate 2 ~ 5 times at 85 ~ 95 DEG C, each lixiviate 2 ~ 4 hours, merge after the solution of each lixiviate is filtered, be concentrated into 1.02 ~ 1.08 times of former density, obtain concentrated solution I; Step (2) gained Ganoderma tablet being placed in 10 ~ 20 times of weight in the water of Ganoderma tablet decocts 2 ~ 3 times, each 1.5 ~ 2.5 hours, merges, be concentrated into 1.02 ~ 1.08 times of former density, obtain concentrated solution II after being filtered the solution that at every turn decocts; Continue 1.20 ~ 1.30 times that are concentrated into former density after being mixed with concentrated solution II by concentrated solution I, obtain concentrated extract;
(4) step (1) gained Semen Coicis extract powder and step (2) gained Radix Panacis Quinquefolii powder, Radix Notoginseng powder all to be added in step (3) gained concentrated extract and stir and obtain soft material;
(5) step (4) gained soft material is placed in Chinese medicine medicine refining machine, extruding refining 2 ~ 6 times is to the even toughness of soft material, soft material after this refining is placed in Chinese medicinal pills preparing machine bar, pelleting obtains wet ball, finally wet ball is carried out dry sterilization.
As a further improvement on the present invention, CO described in step (1) 2the extraction temperature of supercritical extraction is 38 ~ 46 DEG C, and extracting pressure is 25 ~ 40MPa, CO 2flow is 8 ~ 12kg/h, and extraction time is 160 ~ 200min.
Improve, dried described in step (1) adopts spraying dry, and nozzle temperature during spraying dry is 165 ~ 185 DEG C, and material loading speed is 1.5 ~ 3.5L/h again.
As preferably, the concentrated condition of Herba Dendrobii filtrate described in step (3) is 65 ~ 75 DEG C ,-0.04 ~-0.06MPa.
Preferably, the concentrated condition of Ganoderma filtrate described in step (3) is 70 ~ 80 DEG C ,-0.04 ~-0.06MPa.
Preferably, concentrated solution I described in step (3) is 55 ~ 65 DEG C ,-0.06 ~-0.08MPa with the concentrated condition of the mixed liquor of concentrated solution II.
In order to make the ball type of pill perfect, in step (5) before dry sterilization is carried out to wet ball, first wet ball being placed in buffing machine and being polished to smooth surface.
As preferably, dry sterilization process described in step (5) adopts micro-wave drying sterilising apparatus, and setting dry power is 48 ~ 58kW, and line speed is 0.2 ~ 0.4m/min, drop temperature is 70 ~ 90 DEG C, and dry sterilization is to water content≤7% in pill.
After step (5) completes, dry for gained pill is carried out coating, inspection.
Above-mentioned Radix Panacis Quinquefolii, Radix Notoginseng take superfine communication technique process, and the bioavailability be conducive to retaining bioactive ingredients, increasing medical material, promotes medical material utilization rate and drug effect.
Compared with prior art, the invention has the advantages that:
Herba Dendrobii energy tonifying-Yin and nourishing-stomach in Chinese medicine preparation of the present invention, lung moistening kidney tonifying, promote the phagocytic function of tumor animal macrophage, strengthen the activity of T lymphocytic propagation, differentiation and NK cell, and significantly improve the serum hemolysin value of tumor animal, no matter be to non-specific immunity, specific cellular immunity or all have good raising effect to humoral immune function, simultaneously, number of chemical composition in Herba Dendrobii, as alkaloids, polysaccharide, sesquiterpenoids, phenanthrenequione class and bibenzyl etc. have the pharmacological action of antitumor and adjunct antineoplastic; Ganoderan contained in Ganoderma and Ganoderma triterpenoids composition energy two-ways regulation function of human body balance, improve immunity of human body itself, promote lymphopoiesis, the phagocytic activity of raising macrophage, NK cell, T cell and lethality, Tumor suppression; Radix Panacis Quinquefolii can promote that serum albumin synthesizes, bone marrow protein synthesizes, organ protein synthesizes, and improve immunity of organisms, anticancer grows; The arasaponin contained in Radix Notoginseng, beta-elemene, trace element-selenium isoreactivity substance significantly improve phagocytic rate and the phagocytic index of macrophage, have immunomodulating and stronger anti-tumor activity; And Semen Coicis has the dual function of antitumor, enhancing human body immunity power, in the present invention, Herba Dendrobii and Ganoderma, Semen Coicis, Radix Panacis Quinquefolii, Radix Notoginseng cooperatively interact, on the basis utilizing the hemostasis of Radix Notoginseng dissipating blood stasis, Herba Dendrobii tonifying-Yin and nourishing-stomach, Ganoderma invigorating QI and tranquilization, Radix Panacis Quinquefolii nourishing YIN and moistening the lung, Semen Coicis spleen invigorating analgesic effect, follow the traditional Chinese medicine theory of monarch, lifting, meridian distribution of property and flavor, under the prerequisite playing Chinese medicine preparation tonifying-Yin and nourishing-stomach, enhancing immunity, fully highlight the antitumous effect of Chinese medicine preparation.
Preparation method of the present invention, for fatty acid, the volatile characteristic of lactone isoreactivity composition in Semen Coicis, adopts CO 2supercritical extraction technique combines embedding and spray-dired method, the active component farthest remained in Semen Coicis is not damaged, simultaneously, adopt concentrating under reduced pressure technique to be fully extracted the effective ingredient of Herba Dendrobii, Ganoderma, thus make the Chinese medicine preparation made reach good antitumor, tonifying-Yin and nourishing-stomach, enhancing immunity function; And Chinese medicine preparation of the present invention directly utilizes the mutual left and right of medical material self to make the pill of the rapid disintegrate of energy, and without the need to adding other adjuvant any (as wetting agent, binding agent, disintegrating agent etc.), fully remain the bioactive ingredients of medicine, effectively improve utilization rate and the drug effect of medicine, can amount be reduced, improve biological availability greatly.
Accompanying drawing explanation
Fig. 1 is the preparation method schematic flow sheet of the embodiment of the present invention.
Detailed description of the invention
Below in conjunction with accompanying drawing embodiment, the present invention is described in further detail, but these embodiments do not form limiting the scope of the invention.
Embodiment 1:
As shown in Figure 1, the present embodiment have antitumor, tonifying-Yin and nourishing-stomach, enhancing immunity function Chinese medicine preparation comprise following component by weight:
The preparation method of above-mentioned Chinese medicine preparation comprises the following steps:
(1) Semen Coicis is adopted CO 2the Coixol of collection also carries out embedding and dried by supercritical fluid extraction Coixol successively, obtains the Semen Coicis extract of powdery; Above-mentioned CO 2the extraction temperature of supercritical extraction is 38 DEG C, and extracting pressure is 25MPa, CO 2flow is 8kg/h, and extraction time is 200min; Dried adopts spraying dry, and nozzle temperature during spraying dry is 165 DEG C, and material loading speed is 1.5L/h;
(2) respectively Radix Panacis Quinquefolii decoction pieces and superfine notoginseng powder are broken into 120 object fine powders, Herba Dendrobii are ground into 10 object coarse granules, Ganoderma is cut into the thin slice that thickness is 1mm, for subsequent use;
(3) step (2) gained Herba Dendrobii coarse granule is placed in 25 times of weight in the water of Herba Dendrobii, lixiviate 5 times at 85 DEG C, each lixiviate 2 hours, merge after the solution of each lixiviate is filtered, 65 DEG C, be concentrated into 1.02 times of former density under-0.04MPa, obtain concentrated solution I; Step (2) gained Ganoderma tablet being placed in 10 times of weight in the water of Ganoderma tablet decocts 2 times, each 2.5 hours, merges after being filtered the solution that at every turn decocts, 70 DEG C, be concentrated into 1.02 times of former density under-0.04MPa, obtain concentrated solution II; Concentrated solution I is mixed with concentrated solution II, 55 DEG C, continue 1.20 times that are concentrated into former density under-0.06MPa, obtain concentrated extract;
(4) step (1) gained Semen Coicis extract powder and step (2) gained Radix Panacis Quinquefolii powder, Radix Notoginseng powder all to be added in step (3) gained concentrated extract and stir and obtain soft material;
(5) step (4) gained soft material is placed in Chinese medicine medicine refining machine, extruding refining 2 times is to the even toughness of soft material, soft material after this refining is placed in Chinese medicinal pills preparing machine bar, pelleting obtains wet ball, wet ball is placed in buffing machine and carries out being polished to smooth surface, finally wet ball is carried out dry sterilization, dry sterilization process adopts micro-wave drying sterilising apparatus, setting dry power is 48kW, line speed is 0.2m/min, drop temperature is 70 DEG C, dry sterilization to the water content in pill is 7%, 0.15g/ ball;
(6) dry for gained pill is carried out coating, inspection.
Embodiment 2:
As shown in Figure 1, the present embodiment have antitumor, tonifying-Yin and nourishing-stomach, enhancing immunity function Chinese medicine preparation comprise following component by weight:
The preparation method of above-mentioned Chinese medicine preparation comprises the following steps:
(1) Semen Coicis is adopted CO 2the Coixol of collection also carries out embedding and dried by supercritical fluid extraction Coixol successively, obtains the Semen Coicis extract of powdery; Above-mentioned CO 2the extraction temperature of supercritical extraction is 46 DEG C, and extracting pressure is 40MPa, CO 2flow is 12kg/h, and extraction time is 200min; Dried adopts spraying dry, and nozzle temperature during spraying dry is 185 DEG C, and material loading speed is 3.5L/h;
(2) respectively Radix Panacis Quinquefolii decoction pieces and superfine notoginseng powder are broken into 250 object fine powders, Herba Dendrobii are ground into 14 object coarse granules, Ganoderma is cut into the thin slice that thickness is 0.5mm, for subsequent use;
(3) step (2) gained Herba Dendrobii coarse granule is placed in 35 times of weight in the water of Herba Dendrobii, lixiviate 2 times at 95 DEG C, each lixiviate 4 hours, merge after the solution of each lixiviate is filtered, 75 DEG C, be concentrated into 1.08 times of former density under-0.06MPa, obtain concentrated solution I; Step (2) gained Ganoderma tablet being placed in 20 times of weight in the water of Ganoderma tablet decocts 3 times, each 1.5 hours, merges after being filtered the solution that at every turn decocts, 80 DEG C, be concentrated into 1.08 times of former density under-0.06MPa, obtain concentrated solution II; Concentrated solution I is mixed with concentrated solution II, 65 DEG C, continue 1.30 times that are concentrated into former density under-0.08MPa, obtain concentrated extract;
(4) step (1) gained Semen Coicis extract powder and step (2) gained Radix Panacis Quinquefolii powder, Radix Notoginseng powder all to be added in step (3) gained concentrated extract and stir and obtain soft material;
(5) step (4) gained soft material is placed in Chinese medicine medicine refining machine, extruding refining 6 times is to the even toughness of soft material, soft material after this refining is placed in Chinese medicinal pills preparing machine bar, pelleting obtains wet ball, wet ball is placed in buffing machine and carries out being polished to smooth surface, finally wet ball is carried out dry sterilization, dry sterilization process adopts micro-wave drying sterilising apparatus, setting dry power is 58kW, line speed is 0.4m/min, drop temperature is 90 DEG C, dry sterilization to the water content in pill is 6%, 0.25g/ ball;
(6) dry for gained pill is carried out coating, inspection.
Embodiment 3:
As shown in Figure 1, the present embodiment have antitumor, tonifying-Yin and nourishing-stomach, enhancing immunity function Chinese medicine preparation comprise following component by weight:
The preparation method of above-mentioned Chinese medicine preparation comprises the following steps:
(1) Semen Coicis is adopted CO 2the Coixol of collection also carries out embedding and dried by supercritical fluid extraction Coixol successively, obtains the Semen Coicis extract of powdery; Above-mentioned CO 2the extraction temperature of supercritical extraction is 40 DEG C, and extracting pressure is 30MPa, CO 2flow is 10kg/h, and extraction time is 180min; Dried adopts spraying dry, and nozzle temperature during spraying dry is 170 DEG C, and material loading speed is 2L/h;
(2) respectively Radix Panacis Quinquefolii decoction pieces and superfine notoginseng powder are broken into 150 object fine powders, Herba Dendrobii are ground into 12 object coarse granules, Ganoderma is cut into the thin slice that thickness is 1.5mm, for subsequent use;
(3) step (2) gained Herba Dendrobii coarse granule is placed in 30 times of weight in the water of Herba Dendrobii, lixiviate 3 times at 90 DEG C, each lixiviate 2 hours, merge after the solution of each lixiviate is filtered, 70 DEG C, be concentrated into 1.05 times of former density under-0.05MPa, obtain concentrated solution I; Step (2) gained Ganoderma tablet being placed in 15 times of weight in the water of Ganoderma tablet decocts 2 times, each 2.5 hours, merges after being filtered the solution that at every turn decocts, 75 DEG C, be concentrated into 1.08 times of former density under-0.04MPa, obtain concentrated solution II; Concentrated solution I is mixed with concentrated solution II, 60 DEG C, continue 1.25 times that are concentrated into former density under-0.07MPa, obtain concentrated extract;
(4) step (1) gained Semen Coicis extract powder and step (2) gained Radix Panacis Quinquefolii powder, Radix Notoginseng powder all to be added in step (3) gained concentrated extract and stir and obtain soft material;
(5) step (4) gained soft material is placed in Chinese medicine medicine refining machine, extruding refining 3 times is to the even toughness of soft material, soft material after this refining is placed in Chinese medicinal pills preparing machine bar, pelleting obtains wet ball, wet ball is placed in buffing machine and carries out being polished to smooth surface, finally wet ball is carried out dry sterilization, dry sterilization process adopts micro-wave drying sterilising apparatus, setting dry power is 50kW, line speed is 0.25m/min, drop temperature is 75 DEG C, dry sterilization to the water content in pill is 5%, 0.20g/ ball;
(6) dry for gained pill is carried out coating, inspection.
Embodiment 4:
As shown in Figure 1, the present embodiment have antitumor, tonifying-Yin and nourishing-stomach, enhancing immunity function Chinese medicine preparation comprise following component by weight:
The preparation method of above-mentioned Chinese medicine preparation comprises the following steps:
(1) Semen Coicis is adopted CO 2the Coixol of collection also carries out embedding and dried by supercritical fluid extraction Coixol successively, obtains the Semen Coicis extract of powdery; Above-mentioned CO 2the extraction temperature of supercritical extraction is 45 DEG C, and extracting pressure is 30MPa, CO 2flow is 11kg/h, and extraction time is 190min; Dried adopts spraying dry, and nozzle temperature during spraying dry is 185 DEG C, and material loading speed is 1.5L/h;
(2) respectively Radix Panacis Quinquefolii decoction pieces and superfine notoginseng powder are broken into 200 object fine powders, Herba Dendrobii are ground into 13 object coarse granules, Ganoderma is cut into the thin slice that thickness is 1mm, for subsequent use;
(3) step (2) gained Herba Dendrobii coarse granule is placed in 35 times of weight in the water of Herba Dendrobii, lixiviate 4 times at 95 DEG C, each lixiviate 3 hours, merge after the solution of each lixiviate is filtered, 75 DEG C, be concentrated into 1.06 times of former density under-0.04MPa, obtain concentrated solution I; Step (2) gained Ganoderma tablet being placed in 18 times of weight in the water of Ganoderma tablet decocts 3 times, each 2.0 hours, merges after being filtered the solution that at every turn decocts, 75 DEG C, be concentrated into 1.02 times of former density under-0.05MPa, obtain concentrated solution II; Concentrated solution I is mixed with concentrated solution II, 62 DEG C, continue 1.26 times that are concentrated into former density under-0.07MPa, obtain concentrated extract;
(4) step (1) gained Semen Coicis extract powder and step (2) gained Radix Panacis Quinquefolii powder, Radix Notoginseng powder all to be added in step (3) gained concentrated extract and stir and obtain soft material;
(5) step (4) gained soft material is placed in Chinese medicine medicine refining machine, extruding refining 5 times is to the even toughness of soft material, soft material after this refining is placed in Chinese medicinal pills preparing machine bar, pelleting obtains wet ball, wet ball is placed in buffing machine and carries out being polished to smooth surface, finally wet ball is carried out dry sterilization, dry sterilization process adopts micro-wave drying sterilising apparatus, setting dry power is 52kW, line speed is 0.3m/min, drop temperature is 80 DEG C, dry sterilization to the water content in pill is 3%, 0.15g/ ball;
(6) dry for gained pill is carried out coating, inspection.
Embodiment 5:
As shown in Figure 1, the present embodiment have antitumor, tonifying-Yin and nourishing-stomach, enhancing immunity function Chinese medicine preparation comprise following component by weight:
The preparation method of above-mentioned Chinese medicine preparation comprises the following steps:
(1) Semen Coicis is adopted CO 2the Coixol of collection also carries out embedding and dried by supercritical fluid extraction Coixol successively, obtains the Semen Coicis extract of powdery; Above-mentioned CO 2the extraction temperature of supercritical extraction is 40 DEG C, and extracting pressure is 25MPa, CO 2flow is 9kg/h, and extraction time is 200min; Dried adopts spraying dry, and nozzle temperature during spraying dry is 180 DEG C, and material loading speed is 3.0L/h;
(2) respectively Radix Panacis Quinquefolii decoction pieces and superfine notoginseng powder are broken into 210 object fine powders, Herba Dendrobii are ground into 11 object coarse granules, Ganoderma is cut into the thin slice that thickness is 1mm, for subsequent use;
(3) step (2) gained Herba Dendrobii coarse granule is placed in 26 times of weight in the water of Herba Dendrobii, lixiviate 4 times at 92 DEG C, each lixiviate 2.5 hours, merge after the solution of each lixiviate is filtered, 68 DEG C, be concentrated into 1.02 times of former density under-0.05MPa, obtain concentrated solution I; Step (2) gained Ganoderma tablet being placed in 17 times of weight in the water of Ganoderma tablet decocts 3 times, each 1.8 hours, merges after being filtered the solution that at every turn decocts, 75 DEG C, be concentrated into 1.08 times of former density under-0.05MPa, obtain concentrated solution II; Concentrated solution I is mixed with concentrated solution II, 65 DEG C, continue 1.25 times that are concentrated into former density under-0.08MPa, obtain concentrated extract;
(4) step (1) gained Semen Coicis extract powder and step (2) gained Radix Panacis Quinquefolii powder, Radix Notoginseng powder all to be added in step (3) gained concentrated extract and stir and obtain soft material;
(5) step (4) gained soft material is placed in Chinese medicine medicine refining machine, extruding refining 5 times is to the even toughness of soft material, soft material after this refining is placed in Chinese medicinal pills preparing machine bar, pelleting obtains wet ball, wet ball is placed in buffing machine and carries out being polished to smooth surface, finally wet ball is carried out dry sterilization, dry sterilization process adopts micro-wave drying sterilising apparatus, setting dry power is 56kW, line speed is 0.3m/min, drop temperature is 80 DEG C, dry sterilization to the water content in pill is 6%, 0.22g/ ball;
(6) dry for gained pill is carried out coating, inspection.
Performance evaluation is carried out to Chinese medicine preparation prepared by the various embodiments described above.
One, enhancing immunity functional trial is evaluated
1.1 material test samples are the fine powder after Chinese medicine preparation of the present invention is pulverized, and people's recommended dose of product is 10g/60kg/ day.Three dosage groups and negative control group (distilled water) are established in experiment.Basic, normal, high three dosage are respectively as product fine powder 0.83,1.67 and 5.00g/kg body weight, be equivalent to 5,10 and 30 times of people's recommended dose, three dosage component do not measure product fine powder 8.3,16.7,50.0g adding distil water is to 100mL, be mixed with concentration be 0.083,0.167, the sample of 0.5g/mL, gavage is to sample, and gavage capacity presses 0.1mL/10g weighing machine.Experiment is with cleaning grade ICR mice, female, body weight 20 ± 2g, test temperature 20-24 DEG C, relative humidity 40-70%, and animal adapts to 4 days before test in Animal House environment.Continuous 30-35 days per os gives the given the test agent of various dose, and negative control group gives with isometric distilled water, and all the other process are with dosage group.
1.2 method
1.2.1 antibody-producting cell detects: respectively group gavage is to sample, once a day, and continuous 35 days.Test the 30th day, often prop up Mus lumbar injection 0.2mL2% (V/V) hematocrit sheep red blood cell (SRBC) suspension, carry out immunity.After 5 days, every Mus is aseptic gets spleen, is placed in the little plate filling appropriate aseptic Harks liquid, tears up gently, make single cell suspension with tweezers, and 200 eye mesh screens filter, washing, counting, finally with RPMI1640 complete culture solution adjustment cell concentration be 5*106 individual/mL.After top layer culture medium (1g agarose adds distilled water to 100mL) heating for dissolving, put 45 DEG C of water bath heat preservations, with equivalent pH7.2 ~ 7.4, the Harks liquid mixing of 2 times of concentration, subpackage small test tube, often pipe 0.5mL, 50 μ L10%SRBC (V/V are added again in pipe, with the preparation of SA liquid), 20 μ L splenocyte suspensions (5*106/mL), rapid mixing, be poured on the slide of brush agarose thin layer, do parallel plate, after agar solidification, slide level being buckled is placed on horse, put into CO2 gas incubator incubation 1 ~ 1.5 hour, then the complement of normal saline dilution (1:8) is used to join in slide frame groove, continue incubation and count hemolysis plaque number after 1 ~ 1.5 hour.
1.2.2 Turnover of Mouse Peritoneal Macrophages engulfs chicken red blood cell test: respectively group gavage is to sample, once a day, and continuous 31 days.First 30 minutes of sacrifice of animal, every Mus intraperitoneal injection 20% (V/V) chicken erythrocyte suspension 1mL, reinject after execution 2mL normal saline, gets abdominal cavity drop sheet, 38 DEG C of incubations 30 minutes, fixing, dyeing, microscopy, counts 100 macrophages, calculates phagocytic rate and phagocytic index.
1.2.3 sheep red blood cell (SRBC) (SRBC) inducing mouse DTH: respectively group gavage is to sample, once a day, continuous 35 days.Test the 30th day, often prop up Mus lumbar injection 0.2mL2% (V/V) hematocrit sheep red blood cell (SRBC) suspension, carry out immunity.Latter 4 days of immunity, measures sufficient sole of the foot portion thickness, and then measuring point subcutaneous injection 20% (V/V) SRBC, every Mus 20 μ L, and measured toes portion, left and right thickness in 24 hours after injection, same position measures three times, averages.
1.3 result of the test
1.3.1 the impact of product antagonist cellulation: the results are shown in Table 1.Initial data meets homogeneity of variance and requires (P > 0.05), compare with negative control group, low, middle dosage group mice hemolysis plaque number all increases, and difference all has significance (q checks, P < 0.05).
Table 1 product is on the impact of mouse antibodies cellulation
Q checks: compare with negative control group, #p < 0.05
1.3.2 product engulfs the impact of chicken red blood cell on Turnover of Mouse Peritoneal Macrophages: the results are shown in Table 2.Phagocytic percentage passes through X=Sin -1p 1/2carry out data conversion, the data fit homogeneity of variance after conversion requires (P > 0.05), and the initial data of phagocytic index meets homogeneity of variance and requires (P > 0.05).Compare with negative control group, middle dosage group Peritoneal Cells of Mice engulfs the phagocytic percentage of chicken red blood cell and phagocytic index all raises, and difference all has significance (q checks, P < 0.05).
Table 2 product engulfs the impact of chicken red blood cell to Turnover of Mouse Peritoneal Macrophages
Q checks: compare with negative control group, #p < 0.05
1.3.3 product is on the impact of sheep red blood cell (SRBC) inducing mouse DTH: the results are shown in Table 3.Initial data meets homogeneity of variance and requires (P > 0.05).Compare with negative control group, toes portion, high dose group mice left and right increases with 0 hour thickness measurements for 24 hours, and difference has significance (q checks, P < 0.05).
Table 3 product is on the impact of sheep red blood cell (SRBC) inducing mouse DTH
Q checks: compare with negative control group, #p < 0.05
1.4 conclusion
Compare with negative control group, given the test agent low, middle dosage group mice hemolysis plaque number all increases, and difference all has significance; Compare with negative control group, in given the test agent, dosage group Turnover of Mouse Peritoneal Macrophages engulfs the phagocytic percentage of chicken red blood cell and phagocytic index all raises, and difference all has significance; Compare with negative control group, the mice spleen lymphocytes proliferation ability that given the test agent high dose group ConA induces and the left back sufficient sole of the foot portion 24h of mice and 0h thickness measurements difference all increase, and difference all has significance.Be there is by the known Chinese medicine preparation of the present invention of above three test data conclusions the function of enhancing immunity.
Two, antitumor Clinical Treatment Test
In the process of clinical treatment, patients with gastric cancer 69 example of random selecting middle and advanced stage, colorectal cancer patients 73 example of middle and advanced stage, patients with lung cancer 78 example of middle and advanced stage, through consulting with patient and family numbers of patients and signing informed consent postscript, carries out clinical treatment.Patient is divided into three groups respectively at random by name of disease difference, and first group is that operative treatment adds Supporting Therapy's group, and second group is that conservative drug chemotherapy adds Supporting Therapy's group, and the 3rd group adds Supporting Therapy's group for taking Chinese medicine preparation of the present invention.Test concrete data in table 4.
Table 4 clinical treatment effective percentage statistical table
From table 4, data are known, select first, the total effective rate of three groups of therapeutic schemes is higher, but first, two groups of operations and chemotherapy all can cause painful injury greatly to patient and produce huge medical expense, from expense, patient's body constitution and treatment extent of injury, 3rd group of therapeutic scheme has larger advantage for patient, can not only cost saving, reduce body and mind injury, and all have inhibitory action to kinds of tumors due to Chinese medicine preparation of the present invention, so good suppression and the positive role of relief of symptoms also can be played to the tumor of transfer diffusion, for patient strives for longer life span.
Below for using the part model case of clinical treatment of the present invention:
Zhao, female, 46 years old, peasant, hospital diagnosis was gastric cancer the year before, and lump is 8mm*6mm, and patient selects to take Drug therapy of the present invention, checks after taking 4 courses for the treatment of continuously, and gastroscope display tumor regression 50%, pain weakens a lot, cures after continuing to take 5 courses for the treatment of.
Zhang, man, 61 years old, retired worker, was diagnosed as colon cancer before 2 years, lump is 7mm*6mm, and patient selects to take Drug therapy of the present invention, checks colonoscope after taking 6 courses for the treatment of continuously, and tumor regression 70%, the state of an illness is under control substantially.
Liu, female, 52 years old, certain dyestuff factory worker, was diagnosed as pulmonary carcinoma the year before, and lump is 9mm*7mm, and patient selects to take Drug therapy of the present invention, checked two lung CT after taking 5 courses for the treatment of continuously, display tumor disappearance.
Left certain, man, 67 years old, retired worker, be diagnosed as gastric cancer the year before, lump is 7mm*5mm, and patient selects to take Drug therapy of the present invention, checks after taking 6 courses for the treatment of continuously, gastroscope shows tumor regression 70%, and pain disappears substantially, cures after continuing to take 4 courses for the treatment of.
Three, the research of gastric mucosa function test is protected
3.1 material
Select SD healthy rat, male and female half and half, 160 ~ 180g, 6 week age.Test arranges three dosage groups, a negative control group (normal saline of same dosage).Be its dosage group with 5 of human body recommended amounts times, 10 times, 30 times.Dissecting instrument, slide gauge, ethanol, microscope, micrometer.Chinese medicine preparation of the present invention crosses 200 eye mesh screens after pulverizing.
3.2 method
3.2.1 the foundation of rat atrophic gastritis model gives 0.05% ammonia 1mL/100g gavage 1 time, continuous two weeks with rat timing in every 2 days.
3.2.2 be divided into 4 groups at random after animal grouping and medication 32 rat modelings, often organize 8, male and female half and half.High dose group (1.67g/kg), middle dosage group (0.83g/kg), low dose group (0.17g/kg) is divided into according to the use amount of fine drug powder, matched group (normal saline) is equivalent to 10,5,1,0 times of people's recommended dose, and product people recommended dose is 10g/60kg/ day.High, normal, basic dose drug is with isometric(al) not isoconcentration method preparation, and by every rat 5mL/kg gastric infusion, matched group gives isometric(al) normal saline, and every day, timing gavaged 1 time, successive administration 4 weeks, and routine feeding, puts to death rat after last administration.
3.2.3 detection method is respectively organized rat etherization and is plucked from full stomach, after cold saline rinsing content, puts in 10% neutral formalin liquid fixing.The longitudinal position of a mucosa is respectively selected in body of stomach front and back walls and little turn of bilge, paraffin embedding, 5 μm of cut into serving pieces after 2 days.A, inflammatory cell count: conventional H E dye, with micrometer under high power lens to (125 μm, 5 visuals field 2/ the visual field) chronic inflammation cell and neutrophil count, get average.B, glandular tube length measurment: respectively select the longitudinal position of a mucosa at body of stomach front and rear wall and little turn of bilge, paraffin section, conventional H E dyes, with the micro-micrometer of every lattice 5 μm, measure the glandular tube length at above-mentioned 3 positions, the length in gland superficial epithelial cells thickness and glandular tube gland portion, gets average.C, gastric mucosa PAS stained positive thickness measurement: method is the same, paraffin section, PAS dyes, and measures above-mentioned 3 position each glandular tube PAS stained positive layer thicknesses, gets average.
3.3 result of the test
3.3.1 inflammatory cell density quantification 3 administration groups are all starkly lower than matched group, and compare with matched group, difference is very significant, high, middle dosage group no significant difference, but compare with low dose group, all lower than low dose group, difference is very significant.Administration group compares with matched group: P < 0.01, and high, middle dosage group is compared: P > 0.05, and high, middle dosage group compares with low dose group: P < 0.01, result is as shown in table 5.
Table 5 product is on the impact of rat inflammatory cell quantity
3.3.2 body of stomach gland length and gastric mucosa PAS (+) layer thickness detect 4 group glandular tube total lengths, glandular tube gland minister degree no significant difference (P > 0.05); The gland superficial epithelial cells thickness of high, middle dosage group is obviously greater than matched group and low dose group, difference has significant (P < 0.05), and no significant difference (P > 0.05) between low dose group and matched group; Three administration group body of stomach PAS (+) layer thicknesses and matched group comparing difference are very significant (P < 0.01), and result is as shown in table 6.
Table 6 product is to the comparison of rat body of stomach gland length and mucosa PAS (+) layer thickness
* administration group compares P < 0.01 with matched group
3.4 conclusion
After bringing out rat atrophic gastritis with ammonia, 3 administration group esogastritis cells and neutrophilic granulocyte number are all starkly lower than matched group, show that administration group has good therapeutical effect to gastric mucosa acute inflammation.Each administration group can make gastric body mucosa PAS (+) layer thickness obviously increase; show that Chinese medicine preparation of the present invention has the curative effect promoting mucous secretion protection gastric mucosa; in addition can also have atrophic gastric mucosa gland superficial epithelium and significantly thicken effect; epithelial atrophy can be prevented; there is good protective effect to gastric mucosa, there is effect that stomach is protected in nourishing the stomach really.
The foregoing is only the preferred embodiments of the present invention; not thereby the scope of the claims of the present invention is limited; every utilize claims of the present invention content to do equivalent structure or flow process conversion; or be directly or indirectly used in other relevant technical fields, be all in like manner included in scope of patent protection of the present invention.

Claims (10)

1. there is a Chinese medicine preparation for antitumor, tonifying-Yin and nourishing-stomach, enhancing immunity function, it is characterized in that comprising following component by weight:
2. a preparation method for Chinese medicine preparation described in claim 1, is characterized in that comprising the following steps:
(1) 5 ~ 12 parts of Semen Coiciss are adopted CO 2the Coixol of collection also carries out embedding and dried by supercritical fluid extraction Coixol successively, obtains the Semen Coicis extract of powdery;
(2) respectively 12 ~ 30 parts of Radix Panacis Quinquefolii decoction pieces and 10 ~ 20 parts of Radix Notoginseng powder are broken into 120 ~ 250 object fine powders, 14 ~ 30 parts of Herba Dendrobii are ground into 10 ~ 14 object coarse granules, 27 ~ 42 portions of Ganodermas are thinly sliced, for subsequent use;
(3) step (2) gained Herba Dendrobii coarse granule is placed in 25 ~ 35 times of weight in the water of Herba Dendrobii, lixiviate 2 ~ 5 times at 85 ~ 95 DEG C, each lixiviate 2 ~ 4 hours, merge after the solution of each lixiviate is filtered, be concentrated into 1.02 ~ 1.08 times of former density, obtain concentrated solution I; Step (2) gained Ganoderma tablet being placed in 10 ~ 20 times of weight in the water of Ganoderma tablet decocts 2 ~ 3 times, each 1.5 ~ 2.5 hours, merges, be concentrated into 1.02 ~ 1.08 times of former density, obtain concentrated solution II after being filtered the solution that at every turn decocts; Continue 1.20 ~ 1.30 times that are concentrated into former density after being mixed with concentrated solution II by concentrated solution I, obtain concentrated extract;
(4) step (1) gained Semen Coicis extract powder and step (2) gained Radix Panacis Quinquefolii powder, Radix Notoginseng powder all to be added in step (3) gained concentrated extract and stir and obtain soft material;
(5) step (4) gained soft material is placed in Chinese medicine medicine refining machine, extruding refining 2 ~ 6 times is to the even toughness of soft material, soft material after this refining is placed in Chinese medicinal pills preparing machine bar, pelleting obtains wet ball, finally wet ball is carried out dry sterilization.
3. the preparation method of Chinese medicine preparation according to claim 2, is characterized in that: CO described in step (1) 2the extraction temperature of supercritical extraction is 38 ~ 46 DEG C, and extracting pressure is 25 ~ 40MPa, CO 2flow is 8 ~ 12kg/h, and extraction time is 160 ~ 200min.
4. the preparation method of Chinese medicine preparation according to claim 2, is characterized in that: dried described in step (1) adopts spraying dry, and nozzle temperature during spraying dry is 165 ~ 185 DEG C, and material loading speed is 1.5 ~ 3.5L/h.
5. the preparation method of Chinese medicine preparation according to claim 2, is characterized in that: the concentrated condition of Herba Dendrobii filtrate described in step (3) is 65 ~ 75 DEG C ,-0.04 ~-0.06MPa.
6. the preparation method of Chinese medicine preparation according to claim 2, is characterized in that: the concentrated condition of Ganoderma filtrate described in step (3) is 70 ~ 80 DEG C ,-0.04 ~-0.06MPa.
7. the preparation method of Chinese medicine preparation according to claim 2, is characterized in that: concentrated solution I described in step (3) is 55 ~ 65 DEG C ,-0.06 ~-0.08MPa with the concentrated condition of the mixed liquor of concentrated solution II.
8. the preparation method of Chinese medicine preparation according to claim 2, is characterized in that: in step (5) before carrying out dry sterilization to wet ball, first wet ball is placed in buffing machine and is polished to smooth surface.
9. the preparation method of Chinese medicine preparation according to claim 2, it is characterized in that: the dry sterilization process described in step (5) adopts micro-wave drying sterilising apparatus, setting dry power is 48 ~ 58kW, line speed is 0.2 ~ 0.4m/min, drop temperature is 70 ~ 90 DEG C, and dry sterilization is to water content≤7% in pill.
10. the preparation method of Chinese medicine preparation according to claim 2, is characterized in that: after step (5) completes, and dry for gained pill is carried out coating, inspection.
CN201510670095.2A 2015-10-13 2015-10-13 Chinese medicinal preparation having functions of preventing tumors, nourishing yin and stomach and enhancing immunity and preparation method thereof Pending CN105169105A (en)

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CN107251728A (en) * 2017-05-09 2017-10-17 贵州济生农业科技有限公司 A kind of extracting method of dendrobium candidum
CN108324921A (en) * 2018-05-18 2018-07-27 宁波御坊堂生物科技有限公司 It is a kind of that there is the pharmaceutical composition and preparation method thereof dispelled tumour, protect gastric mucosa function
CN109394809A (en) * 2018-12-21 2019-03-01 吉林省北域西洋参研究有限公司 A kind of Chinese medicine composition and its preparation method and application improving immunity

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