CN108210745A - One kind has immunoregulatory auxiliary hyperglycemic compound capsules and preparation method thereof - Google Patents

One kind has immunoregulatory auxiliary hyperglycemic compound capsules and preparation method thereof Download PDF

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Publication number
CN108210745A
CN108210745A CN201611197279.2A CN201611197279A CN108210745A CN 108210745 A CN108210745 A CN 108210745A CN 201611197279 A CN201611197279 A CN 201611197279A CN 108210745 A CN108210745 A CN 108210745A
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oil
immunoregulatory
soft capsule
content
auxiliary hyperglycemic
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麦丽谊
蒋杰
安金蒙
陈昕
李沙
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DONGGUAN JINAN UNIVERSITY INSTITUTE
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/898Orchidaceae (Orchid family)
    • A61K36/8984Dendrobium
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06Fungi, e.g. yeasts
    • A61K36/07Basidiomycota, e.g. Cryptococcus
    • A61K36/074Ganoderma
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • A61K9/4825Proteins, e.g. gelatin

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
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  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Biotechnology (AREA)
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  • Bioinformatics & Cheminformatics (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

The invention discloses one kind to have immunoregulatory auxiliary hyperglycemic compound capsules and preparation method thereof.The soft capsule is made of content and soft capsule material;The content is 50 70 by mass ratio:30 50 dendrobium candidum oil and ganoderma lucidum spore oil is made;The soft capsule material is using gelatin, dispersant and water as raw material in mass ratio 40 50:20‑30:40 50 are made.The present invention is based on the main effect of lowering blood sugar of dendrobium candidum oil and the immunoloregulation functions of ganoderma lucidum spore oil, and a kind of compound fat capsule is prepared using dropping preparation method, and find it with auxiliary hyperglycemic and immunoregulatory effect.Soft capsule provided by the invention, which has compared raw produce (fresh goods, micro mist, capsule, tablet, oral liquid etc.), has the characteristics that purity is high, active ingredient is abundant, therefore, in the case of equally effective ingredient intake, single dose is small, and it is low to take number.

Description

One kind has immunoregulatory auxiliary hyperglycemic compound capsules and preparation method thereof
Technical field
The present invention relates to a kind of technical fields of nutrient and healthcare products, and in particular to there is one kind immunoregulatory auxiliary to drop blood Sugared compound capsules and preparation method thereof.
Background technology
Diabetes have become a kind of 21 century worldwide epidemic disease, are the third-largest after tumour, vascular lesion The Chronic Non-Communicable Diseases of serious threat human health has the feature of high lethality, high disability rate and high health care costs.According to IDF is counted, and for global diabetic in 2015 there are about 4.15 hundred million people, every 11 people just has 1 people to suffer from diabetes;China's patient of diabetes About 1.1 hundred million people of person, occupies the first in the world.1,300,000 people of China dies of diabetes and its complication within 2015, wherein 40.8% people Age is less than 60 years old, and rejuvenation trend is gradually presented.
More and more research shows that, there are different degrees of dysimmunities by diabetic, thereby increases and it is possible to reciprocal causation.It is high Blood glucose can make cell membrane glycosylation, granulocyte be undermined the attenuating of Phagocytosis power, and cell-mediated immune function is limited;Conversely, The cell factors such as the TNF-α increased extremely during diabetes and the IL-6 of excess generation can directly or indirectly lead to beta Cell of islet again Autoimmunity is damaged and deterioration, aggravates diabetes.
Traditional Chinese medicine is the Chinese medicine component part in treating diabetes field, and many pharmacological researches show some Chinese medicines in recent years And its compound has improvement result to diabetes immunologic function disorder, so as to assisting diabetes treatment.
Dendrobium candidum (Dendrobium officinale) is long-standing as the Chinese medicine being of illnesses and fitness, Taoist school's medicine warp Allusion quotation《Taoist Scriptures》Dendrobium candidum is classified as first of Chinese nine big celestial grass, it is civil to be called " help celestial grass ", by world plant kingdom Referred to as " medicine circle giant panda ".Stem of noble dendrobium Thick many candies are one of main components of dendrobium candidum, have auxiliary hyperglycemic and intervene glycosuria The effect of sick vascular lesion.Li Xiufang (Li Xiu virtue Dendrobidium huoshanness and four kinds of pharmacopeia dendrobium polysaccharide hypoglycemic activity comparative studies HeFei University of Technology, 2012) diabetic mouse model is established using alloxan as derivant, comparative studies Dendrobidium huoshanness, iron The skin stem of noble dendrobium, HERBA DENDROBII, Dendrobium fimbriatum Hook and Dendrobium Chrysotoxum Lindl Thick many candies hypoglycemic activity, the results show that 5 kinds of stem of noble dendrobium Thick many candies are equal It can balancing blood fat level, and HDL-C contents may be increased by reducing TC, TG content in blood to adjust to a certain extent Blood glucose level.In addition, Dendrobium officinale polysaccharide can also inhibit the expression of the vascular endothelial cell BaxmRNA in Gao Tangyou roads, enhancing Bcl-2mRNA expression inhibiting apoptosis of vascular endothelial cell illustrates that Dendrobium officinale polysaccharide can intervene and protect diabetic vascular (Zhang Beibei, Liu Wenhong, Li Junfeng, leaf will blueness Dendrobium officinale polysaccharides are to vascular endothelial cell Bax, Bcl- of high sugar induced for lesion The influence Chinese Pharmacologicals of 2 expression are led to, 2015Jan;31(1):64-70).
Dendrobium candidum oil has a material base of hypoglycemic and reducing blood lipid, and main component is dendrobium polysaccharide and a certain amount of Fatty acid substance, including octadecanoid acid, palmitic acid, linoleic acid and other substances etc..Horse grows into forest, and (horse grows into forest dendrobium candidum leaves Supercritical CO2Extraction, constituent analysis and immune function Primary Study, Agricultural University Of Nanjing, 2014) using supercritical CO2Extraction Separation identifies the contents of Thick many candies up to 41.77% from dendrobium candidum leaf.Chinese Pharmacopoeia is single-row simultaneously by dendrobium candidum within 2010 Using polysaccharide as one of index for determining whether it is true or false is distinguished, (Liao person of outstanding talent etc., dendrobium candidum active ingredient are in progress with efficacy study, and Guangdong is light Work Vocationl Technical College journal, 2015,14 (3):16-19.).
Reishi sporule (Ganodermalucidum spore) is that more than 2000 years famous medicinal is continued to use in China's traditional Chinese medicine The sexual reproductive cell of fungi ganoderma lucidum, it is numerous research shows that, ganoderma lucidum and Reishi sporule have anticancer, enhancing immunity of organisms, drop The effects that blood fat.Ganoderma lucidum spore oil is the inner lipid ingredient extracted in Reishi sporule, predominantly triterpene substance, also nucleosides Class, organic germanium and part aqueous substance (polysaccharide) are the aggregates of Reishi sporule active ingredient.
Modern research shows that ganoderma lucidum spore oil has the effects that enhance T lymphocyte functions.It tends to have gold etc. and (tends to have gold, recklessly Wink, ganoderma lucidum spore oil was to the Primary Study health researchs of hypoimmunity mice immune regulation mechanism, 2012,41 (5):833- 835) research has shown that, ganoderma lucidum spore oil is to hypoimmunity mice immunological regulation by enhancing the secretion of cell factor, expressing come real It is existing.TNF-α, the content of IFN-γ in cyclophosphamide immunodeficiency models mice serum can be significantly improved, IL- in spleen and thymus gland 2nd, the expression quantity of IL-10, IL-12, IL-4, TNF-α and IFN-γ mRNA, the significant difference between model control group.(Jiang such as Jiang Li It is beautiful, Huang Yuanying, research modern food the science and technology .2013, Vol.29, No.3 of Yin Guang tinkling of pieces of jade ganoderma lucidum spore oil immunoregulation effects). With 333,667, the ganoderma lucidum spore oil of 1000mg/ (kgbw) dosage to mouse continuous gavage 30d after, find ganoderma lucidum spore oil energy Promote mouse lymphocyte proliferation transformation and mouse delayed allergy, improve the antibody-producting cell and serum of mouse Hemolysin level, and significantly improve the activity of NK cells.
Ganoderma lucidum spore oil and dendrobium candidum oil, which share Related product as main component and patent application, at present report Road.
Invention content
To solve the disadvantage that the prior art and shortcoming, primary and foremost purpose of the invention is to provide a kind of with immune tune The auxiliary hyperglycemic compound capsules of section.The soft capsule is using dendrobium candidum oil and ganoderma lucidum spore oil as main component, by reasonable Prepared by technique is made, and has the function of auxiliary hyperglycemic and adjusts immune.
Another object of the present invention is to provide the above-mentioned preparation side with immunoregulatory auxiliary hyperglycemic compound capsules Method.
The object of the invention is achieved through the following technical solutions:
One kind has immunoregulatory auxiliary hyperglycemic compound capsules, is made of content and soft capsule material;It is described Content is 50-70 by mass ratio:The dendrobium candidum oil and ganoderma lucidum spore oil of 30-50 is made;The soft capsule material with gelatin, Dispersant and water are raw material 40-50 in mass ratio:20-30:40-50 is made.
Preferably, the dispersant for glycerine, soybean oil, linolenic oil, rapeseed oil, corn oil, one kind in fish oil or It is several.
It is of the present invention that there are immunoregulatory auxiliary hyperglycemic compound capsules to be obtained using dropping preparation method, including as follows Step:
(1) capsule material glue is prepared:Recipe quantity water is put into glue pot, 50-65 DEG C is heated to, adds under agitation Dispersant stirs 5-10min;Then the gelatin of recipe quantity is added under agitation, is opened vacuum pump degassing, is removed liquid side Foam, it is to stir 20-30min at 50-70 DEG C to keep temperature, stops heating after abundant deaeration, stirs and release vacuum, crosses 60- 80 mesh sieve to obtain clear sol solution, are kept the temperature at 50-70 DEG C, spare;
(2) prepared by content compound lard:The dendrobium candidum oil and ganoderma lucidum spore oil of recipe quantity are poured into Agitation Tank, stirred 20-30min is mixed, is prepared into the content compound lard of stable homogeneous, crosses 60-80 mesh sieve, it is spare;
(3) prepared by soft capsule:Using dropping preparation method by content made from capsule material glue made from step (1) and step (2) A kind of dendrobium candidum oil ganoderma lucidum spore oil compound capsules are made, i.e., it is described that there is immunoregulatory auxiliary hyperglycemic compound flexible glue Capsule.
Preferably, the vacuum degree 0.06-0.08MPa of step (1) the vacuum pump degassing.
By soft capsule made from step (3) through removal moisture drying, polish, pick ball, obtain qualified dendrobium candidum oil Ganoderma lucidum spore oil compound capsules.
The above method specification obtained with immunoregulatory auxiliary hyperglycemic compound capsules is 100-600mg/.
The present invention is based on the main effect of lowering blood sugar of dendrobium candidum oil and the immunoloregulation function of ganoderma lucidum spore oil, using drop Preparation method prepares a kind of compound fat capsule, and finds it with auxiliary hyperglycemic and immunoregulatory effect.
Compared with prior art, the present invention has the following advantages and beneficial effects:
(1) it is main using dendrobium candidum oil and ganoderma lucidum spore oil the present invention is based on the integrally-regulated theoretical foundation of traditional Chinese medicine Ingredient prepares health-care preparation that is a kind of while having improvement diabetes and immunoloregulation function.
(2) ganoderma lucidum spore oil and dendrobium candidum oil are respectively Reishi sporule and the concentrate of dendrobium candidum active ingredient, phase Have the characteristics that purity is high, active ingredient is abundant compared with raw produce (fresh goods, micro mist, capsule, tablet, oral liquid etc.), therefore, In the case of equally effective ingredient intake, single dose is small, and it is low to take number.
(3) this product content is grease, therefore suitable for this one dosage type low temperature of selection soft capsule.Soft capsule, which has, to be absorbed Soon, the features such as bioavilability is high;It can be disintegrated in alimentary canal quickly after by oral administration, release content grease, rapidly Tissue surface widely is adhered to, is conducive to the release and absorption of active material.Soft capsule shape is round and smooth flexible, through saliva, It is swallowed conveniently after water wetting, particularly with swallowing act, inflexible old man is particularly suitable.
(4) it is simple for process in the present invention, it is conveniently operated;The capsule material of soft capsule does not add any pigment and preservative, safety Property is good.
Specific embodiment
With reference to embodiment, the present invention is described in further detail, but the implementation of the present invention is not limited to this. The dendrobium candidum oil and ganoderma lucidum spore oil used in following embodiments is bought by market and obtained.
Embodiment 1
(1) prepared by capsule hide glue gelatin:40 mass parts of gelatin, 20 mass parts of glycerine, 40 mass parts of water are weighed, it is spare.By prescription In the water input glue pot of amount, 50-65 DEG C is heated to, glycerine is added in while stirring, stirs 5-10min.Then it stirs on one side The gelatin for adding in recipe quantity on one side is mixed, opens vacuum pump degassing (vacuum degree 0.06-0.08MPa), removes liquid side foam, is kept Temperature is to stir 30min at 50-70 DEG C.Stop heating after abundant deaeration, stir and release vacuum, cross 80 mesh sieve colloidal sol is molten Liquid is kept the temperature at 50-70 DEG C, spare.
(2) preparation of content miscella:The dendrobium candidum oil and ganoderma lucidum spore oil of recipe quantity are poured into Agitation Tank, stirred 20-30min is mixed, is prepared into the content compound lard of stable homogeneous, crosses 80 mesh sieve, it is spare.
(3) prepared by soft capsule:The above object and capsule material glue are made by a kind of dendrobium candidum oil ganoderma lucidum using dropping preparation method Spore oil compound capsules.20-25 DEG C of production environment temperature, relative humidity 30-50%.During dripping, check within every 60 minutes Net content is primary, and control loading amount is no more than range of the version Chinese Pharmacopoeia in 2015 about capsule content uniformity.
(4) it shapes:Manufactured soft capsule is put into drier, makes the moisture on its surface that cools down and disperse, is shaped And preliminarily dried.
(5) ball is washed:Soft capsule after sizing is washed till surface without oil stain with 95% ethyl alcohol (percentage by volume).
(6) ball is picked:Soft capsule manually picks ball, picks big piller, special-shaped ball, thin-walled ball, apparent wire mark ball, flat ball, gas Bubble ball, rubber have ball of impurity etc., qualified soft capsule packaging.
Prepared dendrobium candidum oil ganoderma lucidum spore oil compound capsules quality is 100-600mg/.
Embodiment 2
The dendrobium candidum oil and 50% ganoderma lucidum spore oil for taking 50% (weight percent, similarly hereinafter) are poured into Agitation Tank, are stirred 20-30min is mixed, is prepared into the content compound lard of stable homogeneous, 60 mesh sieve is crossed, is prepared by embodiment 1, every 600mg.
Prepared soft capsule content uniformity is less than 10%, and disintegration time limited meets standards of pharmacopoeia.
Embodiment 3
The dendrobium candidum oil and 40% ganoderma lucidum spore oil for taking 60% (weight percent, similarly hereinafter) are poured into Agitation Tank, are stirred 20-30min is mixed, is prepared into the content compound lard of stable homogeneous, 60 mesh sieve is crossed, is prepared by embodiment 1, every 400mg.
Prepared soft capsule content uniformity is less than 10%, and disintegration time limited meets standards of pharmacopoeia.
Embodiment 4:The animal experiment of soft capsule auxiliary hyperglycemic function of the present invention
Diabetic mouse model (mouse source is established by derivant of alloxan:In Guangdong Province medical experiment animal The heart), (500mg/kg, 1000mg/kg are equivalent to and take the 15 of recommended doses day soft capsule as obtained by gastric infusion embodiment 2 Times, 30 times) or continuous normal saline after 7 days, measure blood glucose level.It the results are shown in Table 1 and table 2.Experiment shows that each dosage can drop Low alloxan induced hyperglycemia mice fasting blood-glucose, has not significant impact normal mouse fasting blood-glucose.
Influence (x ± s, n=of the 1 dendrobium candidum oil ganoderma lucidum spore oil compound capsules of table to normal mouse fasting blood sugar 10)
* represent statistically significant in 0.05 level differences of P < compared with model control group..
Influence of the 2 dendrobium candidum oil ganoderma lucidum spore oil compound capsules of table to alloxan induced hyperglycemia mice fasting blood sugar (x ± s, n=10)
* represent statistically significant in 0.05 level differences of P < compared with model control group.
Embodiment 5:Soft capsule of the present invention adjusts the animal experiment of immune function
Cleaning grade male Balb/c mouse (source:Guangdong Medical Lab Animal Center), mouse is through cyclophosphamide (40mg/kg/d) is subcutaneously injected 21 days and establishes immunologic hypofunction mouse model, as obtained by the gastric infusion embodiment of the present invention 2 Soft capsule (1 day 1 time, 150mg/kg, 300mg/kg, be equivalent to 15 times that take recommended doses day, 30 times) or blending edible oil After (control group) continuous 30 days, 1 is the results are shown in Table, each dosage is showed no it with control group has bad shadow to mouse weight and weightening It rings.In mice organs/weight ratio measurement, each dosage group is compared with blending edible oil mouse, the equal nothing of organ weight ratio value Significant difference (P>0.05), there were significant differences (P < 0.05) for swelling degree of the paw.Compared to the control group, the serum for improving mouse is molten Sanguinin level (P < 0.05), and significantly improve the activity of macrophage function and NK cells.
Influence (x ± s, n=10) of the 3 dendrobium candidum oil ganoderma lucidum spore oil compound capsules of table to immune function of mice
Dosage (mg/kgbw) Control group 150mg/kg 300mg/kg
Number of animals (only) 10 10 10
Spleen/weight ratio (mg/g) 5.16±0.34 5.01±0.26* 5.34±0.32*
Thymus gland/weight ratio (mg/g) 2.34±0.46 2.19±0.21* 2.33±0.34*
Swelling degree of the paw (mm) 0.30±0.09 0.34±0.12* 0.38±0.11*
Spleen/weight ratio (mg/g) 5.16±0.34 5.01±0.26* 5.34±0.32*
Thymus gland/weight ratio (mg/g) 1.78±0.46 1.56±0.41* 1.64±0.34*
Half hemolytic value (HC50) 118.8±10.3 125.3±12.5* 130.1±13.1*
Phagocytic index 6.12±0.32 6.34±0.23* 6.56±0.33*
NK cell activity (%) 0.234±0.121 0.686±0.021* 0.839±0.056*
* represent statistically significant in 0.05 level differences of P < compared with model control group.
Above-described embodiment is the preferable embodiment of the present invention, but embodiments of the present invention are not by above-described embodiment Limitation, other any Spirit Essences without departing from the present invention with made under principle change, modification, replacement, combine, simplification, Equivalent substitute mode is should be, is included within protection scope of the present invention.

Claims (5)

1. one kind has immunoregulatory auxiliary hyperglycemic compound capsules, which is characterized in that the soft capsule is by content and soft Capsule capsule material forms;The content is 50-70 by mass ratio:The dendrobium candidum oil and ganoderma lucidum spore oil of 30-50 is made;It is described Soft capsule material is using gelatin, dispersant and water as raw material 40-50 in mass ratio:20-30:40-50 is made.
It is 2. according to claim 1 a kind of with immunoregulatory auxiliary hyperglycemic compound capsules, which is characterized in that institute Dispersant is stated as one or more of glycerine, soybean oil, linolenic oil, rapeseed oil, corn oil and fish oil.
3. the preparation method with immunoregulatory auxiliary hyperglycemic compound capsules described in claims 1 or 2, feature exist In including the following steps:
(1) capsule material glue is prepared:Recipe quantity water is put into glue pot, is heated to 50-65 DEG C, adds in dispersion under agitation 5-10min is stirred in agent;Then the gelatin of recipe quantity is added under agitation, is opened vacuum pump degassing, is removed liquid papula Foam, it is to stir 20-30min at 50-70 DEG C to keep temperature, stops heating after abundant deaeration, stirs and release vacuum, crosses 60-80 Mesh sieves to obtain clear sol solution, is kept the temperature at 50-70 DEG C, spare;
(2) prepared by content compound lard:The dendrobium candidum oil and ganoderma lucidum spore oil of recipe quantity are poured into Agitation Tank, stirred 20-30min is prepared into the content compound lard of stable homogeneous, crosses 60-80 mesh sieve;
(3) prepared by soft capsule:Content made from capsule material glue made from step (1) and step (2) is mixed using dropping preparation method Grease is made described with immunoregulatory auxiliary hyperglycemic compound capsules.
4. the preparation method according to claim 3 with immunoregulatory auxiliary hyperglycemic compound capsules, feature It is, the vacuum degree 0.06-0.08MPa of step (1) the vacuum pump degassing.
5. the preparation method according to claim 3 with immunoregulatory auxiliary hyperglycemic compound capsules, feature Be, soft capsule made from step (3) through removal moisture drying, polish, pick ball step, obtain qualified there is immunoregulatory auxiliary Hypoglycemic compound capsules, the specification of soft capsule is 100-600mg/.
CN201611197279.2A 2016-12-22 2016-12-22 One kind has immunoregulatory auxiliary hyperglycemic compound capsules and preparation method thereof Pending CN108210745A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110876733A (en) * 2019-12-06 2020-03-13 浙江仙琚医药科技有限公司 Process for manufacturing soft capsule rubber
CN112057560A (en) * 2020-10-15 2020-12-11 广东粤微食用菌技术有限公司 Ganoderma lucidum spore dendrobium nobile composition capable of enhancing immunity and preparation method and application thereof

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Application publication date: 20180629