CN106539763A - II solid dispersion of a kind of sanguisorbin and preparation method thereof - Google Patents
II solid dispersion of a kind of sanguisorbin and preparation method thereof Download PDFInfo
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- CN106539763A CN106539763A CN201610825308.9A CN201610825308A CN106539763A CN 106539763 A CN106539763 A CN 106539763A CN 201610825308 A CN201610825308 A CN 201610825308A CN 106539763 A CN106539763 A CN 106539763A
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- sanguisorbin
- solid dispersion
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- polyvidone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/739—Sanguisorba (burnet)
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- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Molecular Biology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a kind of II solid dispersion of sanguisorbin, it is prepared from by the supplementary material of following weight proportioning：II 1 parts of sanguisorbin, 4～30 parts of polyvidone.Quality evaluation experiment shows that the present invention is remarkably improved the dissolubility of sanguisorbin II, and solid dispersion dissolution is up to 85% using polyvidone as carrier material.In effect experiment, compare with model group, II solid dispersion of sanguisorbin of the present invention can significantly raise peripheral blood WBC, RBC, PLT, NEUT and HGB quantity, and drug effect is substantially better than II active compound of sanguisorbin, show that sanguisorbin II is prepared into after solid dispersion the present invention bioavailability that can improve principal agent, strengthen its hemocytes increasing quantity, the effect of preventing and treating bone marrow depression.
Description
Technical field
The present invention relates to II solid dispersion of a kind of sanguisorbin and preparation method thereof, belongs to field of medicaments.
Background technology
Bone marrow depression is clinically common disease of hematopoietic system, and it can betide the radiation of each system tumor disease and control
Treat and (or) chemotherapy, ionizing radiation cause radiation injury, viral hepatitis, piconaviruses infection or medicine (chloromycetin,
Benzene, sulfanilamide, anti-insane carbuncle medicine, tranquilizer, antithyroid drug, antidiabetic drug, malaria, sleeping pill) etc. factor.Bone marrow depression can
Cause the damage of bone marrow microenvironment, hematopoietic stem cell, hematopoietic cell growth factor etc., grain, red, megakaryocytic series unification system, two
It is or three is that cell is suppressed.Agranulocytosises can cause severe infections；Erythrocyte is significantly reduced and can cause severe anemia；Blood is little
Plate is decreased obviously and causes severe haemorrhage, even results in death.At present, clinically for bone marrow depression still lacks effectively treatment handss
Section, needs badly and develops the preferable medicine of drug effect.
Sanguisorbin II, chemical name：- 12 alkene -28- carboxylic acid (ziyu- of 3-O- α--19 Alpha-hydroxy ursol of L-arabinose base
Glycoside II), be from the root of Rosaceae Radix Sanguisorbae platymiscium Radix Sanguisorbae or the Radix Sanguisorbae that comes into leaves extract obtain with pharmacologically active
Compound.CN101119740A discloses purposes of the sanguisorbin II in the medicine for raising erythrocyte and hemoglobin is prepared.
However, actually used middle discovery, II drug effect of sanguisorbin is not good enough, is often difficult to obtain preferable hemocytes increasing during exclusive use
Level, the effect for the treatment of bone marrow depression.Therefore, need badly improve sanguisorbin II drug effect, promote the medicine clinically should
With.
The content of the invention
It is an object of the invention to provide II solid dispersion of a kind of sanguisorbin and preparation method thereof.
The invention provides a kind of II solid dispersion of sanguisorbin, it be prepared by the supplementary material of following weight proportioning and
Into：II 1 parts of sanguisorbin, 4～30 parts of polyvidone.
Further, it is prepared from by the supplementary material of following weight proportioning：II 1 parts of sanguisorbin, polyvidone 4～10
Part.
Further, it is prepared from by the supplementary material of following weight proportioning：II 1 parts of sanguisorbin, 8 parts of polyvidone.
Further, described polyvidone is PVP K30.
The invention provides a kind of preparation method of the solid dispersion, comprises the steps：
A, respectively sanguisorbin II, polyvidone is dissolved in organic solvent, obtains II solution of sanguisorbin, polyvidone molten
Liquid, it is standby；
B, II solution of sanguisorbin is added in povidone solution, mix homogeneously；
C, the organic solvent removed in mixture obtained by b step, crush, obtain final product.
Further, the organic solvent described in a steps is dehydrated alcohol.
Further, in II solution of sanguisorbin described in a steps, sanguisorbin II and the mass volume ratio of solvent are 1：
100；In described povidone solution, polyvidone and the mass volume ratio of solvent are (1：4)～(5：1).
Further, mixture is placed in solvent evaporated on 60 DEG C of water-baths by step c.
The invention provides use of the solid dispersion in hemocytes increasing, the medicine of amount of hemoglobin is prepared
On the way.
The invention provides purposes of the solid dispersion in the medicine for preparing treatment and/or prevention bone marrow depression.
The invention provides a kind of II solid dispersion of sanguisorbin.Inventor had found in research process, sanguisorbin
The reason for II hemocytes increasing horizon effects are not good enough is that its dissolubility is low, gastrointestinal absorption rate is little, causes the biology profit of the medicine
Expenditure is relatively low, limits the performance of its drug effect.Sanguisorbin II is prepared into solid dispersion by carrier material of polyvidone by the present invention
Body, is remarkably improved drug solubility, and solid dispersion dissolution is up to 85%.In effect experiment, compare with model group, this
II solid dispersion of invention sanguisorbin can significantly raise peripheral blood WBC, RBC, PLT, NEUT and HGB quantity, and drug effect is obvious
Better than II active compound of sanguisorbin, show that sanguisorbin II is prepared into after solid dispersion the present invention biology that can improve principal agent
Availability, strengthens its hemocytes increasing quantity, the effect of preventing and treating bone marrow depression.
Obviously, the above of the invention, according to the ordinary technical knowledge and customary means of this area, without departing from
Under the premise of the above-mentioned basic fundamental thought of the present invention, the modification of other various ways can also be made, is replaced or is changed.
The specific embodiment of form, remakes further specifically to the above of the present invention by the following examples
It is bright.But this scope for being interpreted as above-mentioned theme of the invention should not be only limitted to Examples below.It is all based on the above of the present invention
The technology realized belongs to the scope of the present invention.
Specific embodiment
Raw material, equipment used in the specific embodiment of the invention is known product, is obtained by buying commercially available prod.
PEG 8000, PEG 6000, PEG 4000, F68, are purchased from Chengdu Ke Long chemical reagents factory；PVP K30 are purchased from
Chemical Reagent Co., Ltd., Sinopharm Group.
The preparation of 1 sanguisorbin of the present invention of embodiment, II solid dispersion
II 1.0g of sanguisorbin is taken, plus the dehydrated alcohol ultrasound of 100ml obtains solution 1 to dissolving.The PVP of 5.0g is taken separately
K30, adds the dehydrated alcohol ultrasound of 20ml to dissolving, obtains solution 2.Solution 2 is placed in constant temperature blender with magnetic force and is heated to melting
Melt, while solution 1 is slowly added in solution 2 with dropper, after solution 1 all adds solution 2, its mixed liquor is allowed in constant temperature
Stir four hours on magnetic stirring apparatuss.Mixed liquor is poured in evaporating dish, is placed on 60 DEG C of water-baths, is evaporated, taken and be evaporated thing and grind
Solid dispersion is obtained carefully.
The preparation of 2 sanguisorbin of the present invention of embodiment, II solid dispersion
II 1.0g of sanguisorbin is taken, plus the dehydrated alcohol ultrasound of 100ml obtains solution 1 to dissolving.The PVP of 8.0g is taken separately
K30, adds the dehydrated alcohol ultrasound of 32ml to dissolving, obtains solution 2.Solution 2 is placed in constant temperature blender with magnetic force and is heated to melting
Melt, while solution 1 is slowly added in solution 2 with dropper, after solution 1 all adds solution 2, its mixed liquor is allowed in constant temperature
Stir four hours on magnetic stirring apparatuss.Mixed liquor is poured in evaporating dish, is placed on 60 DEG C of water-baths, is evaporated, taken and be evaporated thing and grind
Solid dispersion is obtained carefully.
The preparation of 3 sanguisorbin of the present invention of embodiment, II solid dispersion
II 1.0g of sanguisorbin is taken, plus the dehydrated alcohol ultrasound of 100ml obtains solution 1 to dissolving.The PVP of 20.0g is taken separately
K30, adds the dehydrated alcohol ultrasound of 4ml to dissolving, obtains solution 2.Solution 2 is placed in constant temperature blender with magnetic force and is heated to melting
Melt, while solution 1 is slowly added in solution 2 with dropper, after solution 1 all adds solution 2, its mixed liquor is allowed in constant temperature
Stir four hours on magnetic stirring apparatuss.Mixed liquor is poured in evaporating dish, is placed on 60 DEG C of water-baths, is evaporated, taken and be evaporated thing and grind
Solid dispersion is obtained carefully.
Beneficial effects of the present invention are proved below by way of experimental example.
Dissolution determination method：Take 1, each batch of tablet, according to dissolution method (《Chinese Pharmacopoeia》Ⅹ the second methods of C of annex),
With 1 000mL of pH 6.8PBS as dissolution medium, rotating speed is 100rmin-1, temperature (37 ± 0.5) DEG C, in 0,5,15,20,
25min respectively samples 5mL, and with 0.45 μm of filtering with microporous membrane, filtrate is put in 100mL measuring bottles, plus pH 6.8PBS are diluted to scale,
Shake up, according to ultraviolet visible spectrophotometry (《Chinese Pharmacopoeia》IV A of annex) mensuration absorbance at the 345nm wavelength；25min takes
After sample, dissolution fluid is fully transferred in beaker, in 100 DEG C of 2～3min of heated and stirred, lets cool to 37 DEG C, take by preceding method
Sample and dilution, after being processed with 100 DEG C the absorbance that measures of dissolution fluid as denominator, the absorbance measured with each time point as molecule,
Calculate cumulative leaching rate.
Experimental example 1 prepares the quality evaluation of II solid dispersion of sanguisorbin using different carriers material
5 experimental grouies of this Setup Experiments.II 1.0g of sanguisorbin, plus the dehydrated alcohol ultrasound of 100ml are taken respectively to dissolving,
Obtain solution 1.The different macromolecular material PVP K30 of 8.0g, Poloxamer 188 (F68), Polyethylene Glycol (PEG) 8000, poly- are taken separately
Ethylene glycol (PEG) 6000, Polyethylene Glycol (PEG) 4000, adds the dehydrated alcohol ultrasound of 4ml to dissolving, obtains solution 2.By solution 2
It is placed in constant temperature blender with magnetic force and is heated to melting, while solution 1 is slowly added in solution 2 with dropper, when solution 1 all adds
After entering solution 2, its mixed liquor is allowed to stir in constant temperature blender with magnetic force four hours.Mixed liquor is poured in evaporating dish, is placed on
On 60 DEG C of water-baths, it is evaporated, takes and be evaporated that thing is finely ground to obtain solid dispersion.Solid dispersion dissolubility and dissolution are determined,
The results are shown in Table 1.
1 sanguisorbin of table, II solid dispersion dissolubility and dissolution determination result
Experiment early stage is measured to the dissolubility of II active compound of sanguisorbin, only 0.032mg/ml.As shown in Table 1, adopt
When II solid dispersion of sanguisorbin is prepared with polyvidone class carrier material of the present invention, be remarkably improved drug solubility, and it is molten
Out-degree reaches highest；If using other carrier materials, such as poloxamer, Polyethylene Glycol etc., solid dispersion dissolution significantly under
Drop, the lifting of drug solubility is also be not as obvious as PVP K30.
Result above shows, the II solid dispersion quality of sanguisorbin prepared as carrier material with polyvidone is most
It is good.
Impact of the 2 carrier material consumption of experimental example to II solid dispersion quality of sanguisorbin
6 experimental grouies of this Setup Experiments.II 1.0g of sanguisorbin, plus the dehydrated alcohol ultrasound of 100ml are taken respectively to dissolving,
Obtain solution 1.In addition respectively according to mass ratio as shown in table 2 weigh PVP K30 (II mass of fixed sanguisorbin is 1 part,
PVP K30 mass changes with ratio), add the dehydrated alcohol ultrasound of 4ml to dissolving, obtain solution 2.Solution 2 is placed on into constant temperature magnetic
Melting is heated on power agitator, while solution 1 is slowly added in solution 2 with dropper, when solution 1 all add solution 2 it
Afterwards, its mixed liquor is allowed to stir in constant temperature blender with magnetic force four hours.Mixed liquor is poured in evaporating dish, 60 DEG C of water-baths are placed on
On, it is evaporated, takes and be evaporated that thing is finely ground to obtain solid dispersion.Solid dispersion dissolubility and dissolution are determined, 2 are the results are shown in Table.
2 sanguisorbin of table, II solid dispersion dissolubility and dissolution determination result
Experimental result：It is preferably solid that carrier material PVP K30 consumptions can obtain quality when being II 4-30 times of sanguisorbin
Body dispersion：Drug solubility is improved to 0.594mg/mL, and dissolution reaches more than 64%；PVP K30 consumptions are sanguisorbin
When II 4-10 times, the quality of the pharmaceutical preparations has obtained further optimizing, and drug solubility is improved to more than 0.4mg/mL, and dissolution is not less than
70%；Wherein, in sanguisorbin II：PVPK30 mass ratioes are 1：Under conditions of 8, the solid dispersion dissolubility for preparing and
Dissolution highest.
The effect experiment of 3 sanguisorbin of experimental example, II solid dispersion
1st, experiment material, reagent, instrument
1.1st, test medicine：II solid dispersion of sanguisorbin (being prepared according to embodiment 2), sanguisorbin II.
1.2nd, tool drug：Cyclophosphamide.
1.3, laboratory animal KM- mice：18.5～22.5g.
1.4th, experimental apparatus：Full-automatic blood cell analysis machine；BS-600L electronic balances：Specification：600g/0.1g, Shanghai friend's sound
Weighing apparatus company limited.
2nd, statistical method
Statistical analysiss are carried out with 17.0 softwares of SPSS.Data are with mean ± standard deviationRepresent, between group, adopt Dan Yin
Plain variance analyses, carry out LSD inspections between the neat person's group of variance, heterogeneity of variance person carries out Tamhane ' s T2 inspections.
3rd, experimental technique
3.1st, prepared by laboratory animal packet and model
All Animal adaptabilities are randomly divided into by body weight after feeding 1 week：Blank group；Model group；II solid of sanguisorbin point
Prose style free from parallelism group, is configured to 0.5mgkg respectively-1, 5mgkg-1, 10mgkg-1Suspension, prepared before use；Sanguisorbin II
Group, is configured to 10mgkg-1Suspension, prepared before use.Test the 1st day, in addition to blank group, remaining each group mice presses 50mg
kg-1Dosage intraperitoneal injection of cyclophosphamide normal saline solution, for three days on end, naive mice tail vein injection equal-volume physiology salt
Water.
3.2nd, it is administered
Each experimental group from test the 1st day start according to dosage, gavage give relative medicine, blank group and model group mouse stomach
Administration equal-volume normal saline, continuous 7 days.
3.3rd, collection of specimens
Test the 8th day, each experimental mice eye socket takes blood, collect to be measured with the 0.5mlEP pipes equipped with EDTA anticoagulant.
3.4th, Testing index and method
Peripheral hemogram is detected：Using full-automatic blood counting instrument to each experimental mice peripheral blood leucocyte (WBC), neutrality
Granulocyte (NEUT) erythrocyte (RBC), platelet (PLT), hemoglobin (HGB) are counted.
4th, experimental result
3 each experimental mice peripheral hemogram testing result of table
Note：Compare with model group, * P<0.05, * * P<0.01；II group is compared with sanguisorbin, △ P<0.05, △ △ P<
0.01。
As shown in Table 3, compare with model group, sanguisorbin II solid dispersion each group mouse peripheral blood WBC, RBC, PLT
Quantity has significantly raise (P<0.05), there was no significant difference for II group of sanguisorbin；II group is compared with sanguisorbin, sanguisorbin
II solid dispersion each group mouse peripheral blood WBC, RBC, PLT quantity has significantly raise (P<0.05).
4 each experimental mice peripheral hemogram testing result of table
Note：Compare with model group, * P<0.05, * * P<0.01；II group is compared with sanguisorbin, △ P<0.05, △ △ P<
0.01。
As shown in Table 4, compare with model group, II solid dispersion group mouse peripheral blood NEUT and HGB quantity of sanguisorbin
Having<0.05), there was no significant difference for II group of sanguisorbin；II group is compared with sanguisorbin, and sanguisorbin II is solid
Body dispersion group mouse peripheral blood NEUT and HGB quantity has significantly raise (P<0.05).
Above test result indicate that, sanguisorbin II is prepared into after solid dispersion according to invention formulation prescription, can
The effect of medicine hemocytes increasing level is significantly improved, bone marrow depression can be effectively prevented and treated.
Claims (10)
1. a kind of II solid dispersion of sanguisorbin, is characterized in that：It is prepared from by the supplementary material of following weight proportioning：Ground
II 1 parts of elm saponin, 4～30 parts of polyvidone.
2. solid dispersion as claimed in claim 1, is characterized in that：It is by following weight proportioning supplementary material prepare and
Into：II 1 parts of sanguisorbin, 4～10 parts of polyvidone.
3. solid dispersion as claimed in claim 2, is characterized in that：It is by following weight proportioning supplementary material prepare and
Into：II 1 parts of sanguisorbin, 8 parts of polyvidone.
4. the solid dispersion as described in claims 1 to 3 any one, is characterized in that：Described polyvidone is PVP K30.
5. a kind of preparation method of solid dispersion described in Claims 1 to 4 any one, is characterized in that：Comprise the steps：
A, respectively sanguisorbin II, polyvidone is dissolved in organic solvent, obtains II solution of sanguisorbin, povidone solution,
It is standby；
B, II solution of sanguisorbin is added in povidone solution, mix homogeneously；
C, the organic solvent removed in mixture obtained by b step, crush, obtain final product.
6. preparation method as claimed in claim 5, is characterized in that：Organic solvent described in a steps is dehydrated alcohol.
7. the preparation method as described in claim 5 or 6, is characterized in that：Radix Sanguisorbae soap in II solution of sanguisorbin described in a steps
Glycosides II is 1 with the mass volume ratio of solvent：100；In described povidone solution, polyvidone and the mass volume ratio of solvent are (1：
4)～(5：1).
8. preparation method as claimed in claim 5, is characterized in that：Step c mixture is placed on 60 DEG C of water-baths be evaporated it is molten
Agent.
9. solid dispersion described in Claims 1 to 4 any one is in hemocytes increasing, the medicine of amount of hemoglobin is prepared
Purposes.
10. solid dispersion described in Claims 1 to 4 any one is in the medicine for preparing treatment and/or prevention bone marrow depression
Purposes.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2015106014498 | 2015-09-18 | ||
| CN201510601449 | 2015-09-18 |
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| Publication Number | Publication Date |
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| CN106539763A true CN106539763A (en) | 2017-03-29 |
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ID=58367897
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| Application Number | Title | Priority Date | Filing Date |
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| CN201610825308.9A Pending CN106539763A (en) | 2015-09-18 | 2016-09-14 | II solid dispersion of a kind of sanguisorbin and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2018133110A1 (en) * | 2017-01-23 | 2018-07-26 | 四川英路维特医药科技有限公司 | Ziyuglycoside ii solid dispersion and preparation method therefor |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102406731A (en) * | 2010-12-01 | 2012-04-11 | 成都科尔医药技术有限公司 | Combination medicament for preventing or/and treating bone marrow suppression |
-
2016
- 2016-09-14 CN CN201610825308.9A patent/CN106539763A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102406731A (en) * | 2010-12-01 | 2012-04-11 | 成都科尔医药技术有限公司 | Combination medicament for preventing or/and treating bone marrow suppression |
Non-Patent Citations (1)
| Title |
|---|
| 陈琼等主编: "《中药制剂技术》", 30 November 2014, 中国农业大学出版社 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2018133110A1 (en) * | 2017-01-23 | 2018-07-26 | 四川英路维特医药科技有限公司 | Ziyuglycoside ii solid dispersion and preparation method therefor |
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