CN109620837A - Application of the ginseng sapoglycoside Rg 3 in preparation prevention and/or treatment Severe Acute Pancreatitis SAP drug - Google Patents
Application of the ginseng sapoglycoside Rg 3 in preparation prevention and/or treatment Severe Acute Pancreatitis SAP drug Download PDFInfo
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
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Abstract
The present invention provides application of the ginseng sapoglycoside Rg 3 in preparation prevention and/or treatment Severe Acute Pancreatitis SAP drug, belong to pharmaceutical technology field.Combine the severe acute pancreatitis in rats model of induced by LPS by tree toad element, the influence that NF- κ B p65 is expressed in the influence and ginseng sapoglycoside Rg 3 that verifying ginseng sapoglycoside Rg 3 changes Pancreas pathology, it proves that ginseng sapoglycoside Rg 3 can be obviously improved severe acute pancreatitis in rats pathological phenomenon, reduces the positive expression of NF- κ B p65.As it can be seen that ginseng sapoglycoside Rg 3 has significant Pancreatitis effect, also, this effect is embodied in two aspects for the treatment of and prevention.
Description
Technical field
Technical field is prevented and treated the present invention relates to Severe Acute Pancreatitis SAP more particularly to prepared by ginseng sapoglycoside Rg 3
Application in prevention and/or treatment Severe Acute Pancreatitis SAP drug.
Background technique
Severe Acute Pancreatitis SAP (SevereAcute Pancreatitis, SAP) be that a kind of morbidity is hurried, case fatality rate is high and
The complicated and diversified common seriously disease of clinic of pathogenesis, due to pancreatin abnormal activation, leads to pancreas itself in pathogenic process
While acinus damages, activation relevant cell synthesizes and discharges a large amount of inflammatory factors, such as IL-1 β, TNF-α and IL-6.In order to
Alleviate inflammation and systemic toxicity profiles symptom, clinically often uses dexamethasone to carry out state of an illness control in the acute stage of severe pancreatitis
System, but since dexamethasone may cause the complication such as hemorrhage of digestive tract, immunosupress, there is certain limitation in clinical application
Property.
Ginseng (Panax ginseng C.A.Mey) is China's tradition rare traditional Chinese medicine, solid with reinforcing vital energy, answering arteries and veins
Take off, reinforce the spleen to benefit the lung, is promoting production of body fluid and inducing sedation of the mind and other effects.Modern studies have found that the main matter basis of ginseng physiological activity is ginsenoside
(ginsenosides), wherein Rg3 is one kind important in ginsenoside, with Amplatzer duct occluder that is antitumor, reducing chemotherapeutics
Property and renal toxicity, protection central nervous system and a variety of pharmacological activity such as cardiovascular system, antifatigue, hypoglycemic, wound repairing.
The discovery ginseng sapoglycoside Rg 3 of existing research at present can be used for acute lung injury inflammation (Cheng Zhiqiang ginseng sapoglycoside Rg 3 pair
The protective effect of LPS induction mice with acute lung injury and research [D] the Zhengzhou University of mechanism, 2016.) and flu inflammation (Lee
Anti-inflammatory and antipyretic pharmacodynamic study [D] the Jilin University of rigid ginseng sapoglycoside Rg 3,2006.) treatment, but have no it to severe
The related report for the treatment of acute pancreatitis.
Summary of the invention
The purpose of the present invention is to provide ginseng sapoglycoside Rg 3s to treat and prevent in Severe Acute Pancreatitis SAP drug in preparation
Using.
In order to achieve the above-mentioned object of the invention, the present invention the following technical schemes are provided:
The present invention provides application of the ginseng sapoglycoside Rg 3 in preparation prevention and/or treatment Severe Acute Pancreatitis SAP drug.
Preferably, the drug further includes pharmaceutically acceptable carrier or auxiliary material.
Preferably, the dosage form of the drug includes tablet, capsule, pill, injection, freeze drying powder injection and injection
Emulsion.
Preferably, in terms of single oral drug, the quality of ginseng sapoglycoside Rg 3 is 10~1500mg in the drug.
Preferably, in terms of single oral drug, the quality of ginseng sapoglycoside Rg 3 is 25~500mg in the drug.
Preferably, in terms of single injection drug, the quality of ginseng sapoglycoside Rg 3 is 5~1000mg in the drug.
Preferably, in terms of single injection drug, the quality of ginseng sapoglycoside Rg 3 is 10~250mg in the drug.
Beneficial effects of the present invention: the present invention provides ginseng sapoglycoside Rg 3s in preparation prevention and/or treatment severe acute pancreas
Application in adenositis drug.Combine the severe acute pancreatitis in rats model of induced by LPS by tree toad element, verifies ginseng soap
The influence that NF- κ B p65 is expressed in the influence and ginseng sapoglycoside Rg 3 that glycosides Rg3 changes Pancreas pathology, it was demonstrated that ginseng sapoglycoside Rg 3 energy
It is enough obviously improved severe acute pancreatitis in rats pathological phenomenon, reduces the positive expression of NF- κ B p65.As it can be seen that ginseng sapoglycoside Rg 3
With significant Pancreatitis effect, also, this effect is embodied in two aspects for the treatment of and prevention.
Detailed description of the invention
Fig. 1 shows the influences that ginseng sapoglycoside Rg 3 changes Pancreas pathology, and wherein A indicates normal group of blank normally raised,
B indicates the blank control group being administered in advance, and C indicates normal SAP model group, and D indicates the ginseng sapoglycoside Rg 3 modeled after administration in advance
Group, E indicate dexamethasone acetate group, and F indicates ginseng sapoglycoside Rg 3 group；
Fig. 2 indicates the influence that ginseng sapoglycoside Rg 3 expresses NF- κ B p65, and wherein A indicates that the blank normally raised is normal
Group, B indicate the blank control group being administered in advance, and C indicates normal SAP model group, and D indicates the ginsenoside modeled after administration in advance
Rg3 group, E indicate dexamethasone acetate group, and F indicates ginseng sapoglycoside Rg 3 group.
Specific embodiment
The present invention provides application of the ginseng sapoglycoside Rg 3 in preparation prevention and/or treatment Severe Acute Pancreatitis SAP drug.
In the present invention, the drug preferably further includes pharmaceutically acceptable carrier or auxiliary material.
In the present invention, the dosage form of the drug preferably includes tablet, capsule, pill, injection, freeze drying powder injection
And emulsion for injection, more preferably tablet, pill or emulsion for injection.
In the present invention, in terms of single oral drug, in the drug quality of ginseng sapoglycoside Rg 3 be preferably 10~
1500mg, more preferably 25~500mg, most preferably 50~200mg.
In the present invention, in terms of single injection drug, the quality of ginseng sapoglycoside Rg 3 is preferably 5~1000mg in the drug,
More preferably 10~250mg, most preferably 20~150mg.
In specific implementation process of the present invention, when the dosage form of drug is tablet, the tablet preferably includes following quality
Raw material: 10~40g of ginseng sapoglycoside Rg 3,20~30g of Icing Sugar, 30~40g of lactose, 40~60g of sodium carboxymethyl starch, weight hundred
Dividing content is 3% 10~20g of 5~50g of PVPK30 aqueous solution and magnesium stearate；It is furthermore preferred that the tablet preferably includes
The raw material of following quality: 15~25g of ginseng sapoglycoside Rg 3, Icing Sugar 25g, lactose 35g, sodium carboxymethyl starch 50g, weight percent contain
10~20g of 10~35g of PVPK30 aqueous solution and magnesium stearate that amount is 3%.
The present invention is not particularly limited the preparation method of the tablet, is using this field conventional tablet preparation method
Can, in specific implementation process of the present invention, the tablet is preferably prepared using following methods:
1) ginseng sapoglycoside Rg 3, Icing Sugar, lactose and sodium carboxymethyl starch are mixed, sieving obtains fine powder；
2) the PVPK30 aqueous solution that the step 1) fine powder and weight percentage are 3% is mixed,
It pelletizes, dry and whole grain obtains particle；
3) the step 2) particle and magnesium stearate are mixed, carries out tabletting, obtains tablet.
The present invention first mixes ginseng sapoglycoside Rg 3, Icing Sugar, lactose and sodium carboxymethyl starch, and sieving obtains fine powder；Institute
The mesh size for stating sieving is preferably 80~120 mesh, more preferably 100 mesh.
The PVPK30 aqueous solution that fine powder and weight percentage are 3% is mixed, is made after obtaining fine powder by the present invention
Grain, dry and whole grain, obtains particle；The mode of the granulation is preferably sieved and pelletizes；The mesh size of the sieving is preferably
10~30 mesh, more preferably 20 mesh；The temperature of the drying is preferably 50~70 DEG C, and more preferably 60 DEG C；The drying when
Between preferably 2~4h, more preferably 3h；The mode of the whole grain preferably sieving whole grain；The mesh size of the sieving is preferred
For 15~25 mesh, more preferably 18 mesh.
The present invention mixes particle and magnesium stearate after obtaining particle, carries out tabletting, obtains tablet；The tabletting
Mode is preferably scrobicula stamping；It preferably include adjusting slice weight after the tabletting；The slice weight is preferably 120~180mg, more
Preferably 150mg.
In specific implementation process of the present invention, when the dosage form of drug is pill, the pill preferably includes following
The raw material of quality: 10~40g of ginseng sapoglycoside Rg 3, PEG4005~15g, PEG400010~20g, sodium carboxymethyl starch 0.5~
1.5g, 0.003~0.008g of PVP K30；It is furthermore preferred that the pill preferably includes the raw material of following quality: ginseng
Saponin(e Rg315~25g, PEG40010g, PEG400015g, sodium carboxymethyl starch 1g, PVP K30 0.005g.
The present invention is not particularly limited the preparation method of the pill, using this field routine pill preparation method
, in specific implementation process of the present invention, the pill is preferably prepared using following methods:
A) PEG400, PEG4000, sodium carboxymethyl starch and PVP K30 are mixed, melted, melting spice is obtained；
B ginseng sapoglycoside Rg 3) is added to step A) it mixes in the melting spice, obtained mixing spice is added dropwise
Into atoleine, condensed, it is dry, obtain dripping pill.
The present invention first mixes PEG400, PEG4000, sodium carboxymethyl starch and PVP K30, is melted, is obtained
Melt spice；The temperature of the melting is preferably 90~100 DEG C, and more preferably 95 DEG C；The equipment of the melting is preferably dripping pill
Machine.
Ginseng sapoglycoside Rg 3 is added in melting spice and mixes after obtaining melting spice by the present invention, and what is obtained is mixed
It closes spice to be added dropwise in atoleine, be condensed, it is dry, obtain dripping pill；The mixed process is preferably with stirring；Institute
The temperature for stating mixing spice is preferably 80~90 DEG C, and more preferably 85 DEG C；The drop of the dropwise addition is more excellent away from preferably 15~25cm
It is selected as 20cm；The low speed of the dropwise addition is preferably 25~30 drop .min-1, more preferably 28 drop .min-1；The temperature of the condensation
Preferably 8~15 DEG C, more preferably 10 DEG C；The present invention is not particularly limited the time of the condensation, and dripping pill of being subject to solidifies.
In specific implementation process of the present invention, when the dosage form of drug is emulsion for injection, the emulsion for injection is preferred
Raw material including following quality: 120~180g of ginseng sapoglycoside Rg 3,200~300g of soybean oil, 40~60g of phosphide, oleic acid 5~
15g, 5~15g of poloxamer, 80~120g of glycerol and appropriate water for injection；It is furthermore preferred that the emulsion for injection preferably wraps
Include the raw material of following quality: ginseng sapoglycoside Rg 3 150g, soybean oil 250g, phosphide 50g, oleic acid 10g, poloxamer 10g, glycerol
100g and appropriate water for injection.
In specific implementation process of the present invention, used when the dosage of water for injection is according to the concentration and production of filling preceding medical fluid
The specification of cillin bottle calculates.
The present invention is not particularly limited the preparation method of the emulsion for injection, using this field regular injection emulsion
Preparation method, in specific implementation process of the present invention, the emulsion for injection is preferably prepared using following methods:
A) glycerol and partial syringe are mixed with water, obtains water phase；
B) phosphatide, poloxamer and soybean oil are mixed, obtains oily phase；
C) oily phase is added in oleic acid and ginseng sapoglycoside Rg 3, is mixed, mixed material is added into water phase, carries out
High speed shear obtains colostrum；
D) the step c) colostrum is mixed with remaining injection with water, carries out homogeneous, obtains lipid microsphere, filtered, obtain
Emulsion for injection；
The step a) and step b) is limited without time sequencing.
The present invention mixes glycerol and partial syringe with water, obtains water phase；The temperature of the water phase is preferably 50~60 DEG C,
More preferably 55 DEG C.
The present invention mixes phosphatide, poloxamer and soybean oil, obtains oily phase；The mixed process is preferably adjoint to be stirred
It mixes；The mixed temperature is preferably 50~70 DEG C, and more preferably 60 DEG C.
Oily phase is added after obtaining oily phase and water phase, by oleic acid and ginseng sapoglycoside Rg 3 in the present invention, is mixed, after mixing
Material be added into water phase, carry out high speed shear, obtain colostrum；The mixed process is preferably with stirring；It is described mixed
Material after conjunction is added to the process of water phase with shearing.
The present invention is mixed after obtaining colostrum, by colostrum with remaining injection with water, is carried out homogeneous, is obtained lipid microsphere, mistake
Filter, obtains emulsion for injection；The partial size of the lipid microsphere is preferably 160~280nm, more preferably 200~240nm；It is described
The mode of filtering is preferably membrane filtration；The aperture of the filter membrane is preferably 0.22 μm.
Technical solution provided by the invention is described in detail below with reference to embodiment, but they cannot be understood
For limiting the scope of the present invention.
The preparation of 1 ginseng sapoglycoside Rg 3 piece of embodiment
Prescription:
Preparation method: weighing ginseng sapoglycoside Rg 3, Icing Sugar, lactose and the sodium carboxymethyl starch of recipe quantity, is sufficiently mixed uniformly
After sieve with 100 mesh sieve, 3%PVPk30 aqueous solution softwood processed in right amount, the granulation of 20 meshes is added, 60 DEG C of dry 3h, 18 mesh sieves add
Enter the magnesium stearate of recipe quantity, after mixing scrobicula stamping, adjust slice weight 150mg to get.
The preparation of 2 ginseng sapoglycoside Rg 3 dripping pill of embodiment
Prescription:
Preparation method: weighing the PEG400, PEG4000, sodium carboxymethyl starch, PVP K30 of recipe quantity, and pill dripping machine is added
95 DEG C melting, while stirring be added recipe quantity ginseng sapoglycoside Rg 3, mix well, spice temperature be 85 DEG C, spice with drip away from
20cm .min are dripped by 28-1Drop speed instill in atoleine, 10 DEG C of condensations, solidification, after forming dripping pill, take out, it is dry to get.
The preparation of 3 ginseng sapoglycoside Rg 3 emulsion for injection of embodiment
Prescription:
Operation: weighing the glycerol of recipe quantity, add injection appropriate amount of water, make to dissolve, be made into glycerine water solution, protects at 50 DEG C
Temperature, as water phase；The phosphatide, poloxamer and soybean oil of recipe quantity are weighed, is mixed, in 50 DEG C of stirring and dissolvings, as oily phase；It will
Oily phase is added in oleic acid and ginseng sapoglycoside Rg 3, and stirring makes to be uniformly mixed, and side sheared edge is added in water phase, and high speed shear is formed
Even colostrum crosses homogenizer with water for injection constant volume to 5000mL, and it is micro- that the lipid of uniform particle diameter, average grain diameter in 160nm is made
Ball；By 0.22 μm of film filtering of liquid obtained, inflated with nitrogen, filling, 125 DEG C of flowing steams rotation sterilizings 5 minutes to get.
Effect of 4 ginseng sapoglycoside Rg 3 of embodiment to severe acute pancreatitis in rats
1 material
It is numerous to please experimental animal by Jinan roc by 1.1 experimental animal cleaning grade SD rats, half male and half female, weight (200 ± 25) g
Co., Ltd's offer, animal certificate number: SCXK (Shandong) 20140007 are provided.
1.2 drugs and reagent ginseng sapoglycoside Rg 3 emulsion for injection (embodiment 3 prepares)；Dexamethasone acetate tablets
(Zhejiang Province XianJu Pharmacy stock Co., Ltd)；Tree toad element (Shanghai Yuan Ye Biotechnology Co., Ltd)；Lipopolysaccharides (Shanghai Aladdin
Biochemical technology limited liability company)；Nuclear transcription factor-kappa B (NF- κ B) p65 polyclonal antibody (goat antirabbit/rabbit-anti rat, it is military
Han Aimeijie Science and Technology Ltd.)；Neutral gum (Chinese Shanghai Yi Yang Instrument Ltd.).Other reagents are that analysis is pure,
Sinopharm Chemical Reagent Co., Ltd.'s production.
1.3 instrument SpectraMax iD3 multi-function microplate readers (MolecularDevices company, the U.S.)；Blood biochemistry instrument
(Lang Pu PUZS-300)；Full-automatic tissue dewatering instrument and embedding instrument (Tianjin Aiwa Medical Devices Co., Ltd.)；Pathologic section slicer
(German SLEE)；Optical microscopy (Shanghai You Ke instrument and meter Co., Ltd)；Electronic balance (Mei Tele-support benefit instrument (on
Sea) Co., Ltd)；101-3A type electric drying oven with forced convection (Tianjin Stettlen Instrument Ltd.).
2 methods
The preparation of 2.1 sample solutions takes the dexamethasone acetate of ginseng sapoglycoside Rg 3 injection emulsion and grind into powder appropriate,
It is separately added into 5% carboxymethylcellulose sodium solution, ultrasound mixes, and it is respectively 1.0mg.mL that concentration, which is made,-1Ginseng sapoglycoside Rg 3 it is mixed
Suspension and concentration are 0.15mg.mL-1Dexamethasone acetate suspension.Precision weighs tree toad element and appropriate lipopolysaccharides, with nothing
It is 10 μ g.mL that bacterium physiological saline is formulated as concentration respectively-1Tree toad element solution and concentration be 1mg.mL-1Lipopolysaccharides solution.
The modeling of 2.2 animals takes healthy cleaning grade SD rat 60 with grouping, half male and half female, into the preceding Animal adaptability of experiment
It feeds 1 week, is randomly divided into 6 groups by weight, is respectively as follows:
A group (blank control group normally raised)；
B group (blank control group being administered in advance, ginseng sapoglycoside Rg 3 suspension is given in the preparatory stomach-filling of 6h, 3h, 1h before testing,
Each 4mL)；
C group (normal SAP model group)；
(the ginseng sapoglycoside Rg 3 group modeled after pre-administration, ginseng sapoglycoside Rg 3 is given in the preparatory stomach-filling of 6h, 3h, 1h to D group before modeling
Suspension, each 4mL)；
E group (dexamethasone acetate group)；
F group (ginseng sapoglycoside Rg 3 group).
18h fasting, free water before testing.Tree toad element solution 1mL (50 μ are injected intraperitoneally in the every h of C~F group animal
g.kg-1), continuous 6 times, and in intraperitoneal injection of LPS solution 2mL (10mg.kg immediately after the last administration-1).Rouge is injected intraperitoneally
Dexamethasone suspension is given in 1h, 3h, 6h after polysaccharide solution, E group stomach-filling, and ginseng sapoglycoside Rg 3 suspension is given in F group stomach-filling,
Each 4mL.5% carboxymethylcellulose sodium solution of each stomach-filling equal volume of A~D group.
After 2.3 pathological study modelings for 24 hours, cervical dislocation puts to death each group rat, wins pancreas, and by blood
In 10000rpm.min-1It is centrifuged 5min, takes serum.Part pancreatic tissue is taken to fix through 10% formaldehyde, Gradient elution using ethanol and two
After toluene is transparent, routine paraffin wax embedding, 5 μm are sliced, and HE is dyed after the rehydration that dewaxes, and dimethylbenzene is transparent, with neutral gum mounting, light
Learn the pathological change of microscopically observation pancreatic tissue.
2.4 immunohistochemistry detect the pancreatic tissue for taking paraffin embedding, and dimethylbenzene dewaxes after rehydration, with Tris-EDTA/ lemon
Lemon phthalate buffer high temperature and pressure carries out antigen retrieval；3%H is used respectively2O2At the 37 DEG C of incubations of room temperature and 5%BSA (PBS dilution)
Reason is to close endogenous peroxydase；Then successively with primary antibody (being diluted in the ratio of 1:1000 with PBS) and through horseradish peroxide
Change two process resistant of enzyme label, DAB colour developing, haematoxylin is redyed, and Gradient elution using ethanol, dimethylbenzene is transparent, neutral gum mounting, light
Learn the expression of microscopically observation NF- κ B p65.
3 results
Fig. 1 is shown in the influence that 3.1 ginseng sapoglycoside Rg 3s change Pancreas pathology.Compared with A group, B group has no significant change, says
Bright ginseng sapoglycoside Rg 3 does not have overt toxicity to pancreatic tissue；There is apparent congested phenomenon, explanation in the pancreatic tissue of C~F group
Modeling success, and compared with C group, the congested phenomenon of the pancreatic tissue of D~F group has clear improvement, illustrate dexamethasone acetate,
Ginseng sapoglycoside Rg 3 makes moderate progress to severe acute pancreatitis in rats pathological phenomenon, and the result of D, F group illustrates ginseng soap simultaneously
Glycosides Rg3 not only has therapeutic effect, also there is prevention effect.
3.2 ginseng sapoglycoside Rg 3s are shown in Fig. 2 to the NF- κ B p65 influence expressed.It can be seen from the figure that with two blank pair of A, B
It is compared according to group, NF- κ B p65 has an apparent positive expression after rat modeling, and the sun of Rg3 group (D group, F group) NF- κ B p65
Property expression again be significantly lower than C group (SAP model group), illustrate either modeling before or modeling after be administered, ginseng sapoglycoside Rg 3
Reduce the positive expression of NF- κ B p65.
The studies above the result shows that, ginseng sapoglycoside Rg 3 tree toad element joint lipopolysaccharide mediate building SAP model on shows
Significant Pancreatitis effect is gone out, this effect is embodied in two aspects for the treatment of and prevention.
The above is only a preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art
For member, various improvements and modifications may be made without departing from the principle of the present invention, these improvements and modifications are also answered
It is considered as protection scope of the present invention.
Claims (7)
1. application of the ginseng sapoglycoside Rg 3 in preparation prevention and/or treatment Severe Acute Pancreatitis SAP drug.
2. application according to claim 1, which is characterized in that the drug further includes pharmaceutically acceptable carrier or auxiliary
Material.
3. application according to claim 1 or 2, which is characterized in that the dosage form of the drug includes tablet, capsule, drop
Pill, injection, freeze drying powder injection and emulsion for injection.
4. application according to claim 3, which is characterized in that in terms of single oral drug, ginsenoside in the drug
The quality of Rg3 is 10~1500mg.
5. application according to claim 4, which is characterized in that in terms of single oral drug, ginsenoside in the drug
The quality of Rg3 is 25~500mg.
6. application according to claim 3, which is characterized in that in terms of single injection drug, ginsenoside in the drug
The quality of Rg3 is 5~1000mg.
7. application according to claim 6, which is characterized in that in terms of single injection drug, ginsenoside in the drug
The quality of Rg3 is 10~250mg.
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| CN111358780A (en) * | 2020-03-18 | 2020-07-03 | 烟台汉麻生物技术有限公司 | Application of formononetin in preparation of medicine for preventing and treating severe acute pancreatitis, tablet, dripping pill and injection emulsion |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111358780A (en) * | 2020-03-18 | 2020-07-03 | 烟台汉麻生物技术有限公司 | Application of formononetin in preparation of medicine for preventing and treating severe acute pancreatitis, tablet, dripping pill and injection emulsion |
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