CN106606475A - Ziyuglycoside I injection and preparation method thereof - Google Patents
Ziyuglycoside I injection and preparation method thereof Download PDFInfo
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- CN106606475A CN106606475A CN201610899872.5A CN201610899872A CN106606475A CN 106606475 A CN106606475 A CN 106606475A CN 201610899872 A CN201610899872 A CN 201610899872A CN 106606475 A CN106606475 A CN 106606475A
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- sanguisorbin
- ziyuglycoside
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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
- A61K9/08—Solutions
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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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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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Abstract
The invention provides a ziyuglycoside I injection. The ziyuglycoside I injection is prepared from the following raw materials in parts by weight: 0.2 part of ziyuglycoside I, 0.001 to 60 parts of solubilizer and 950 to 1050 parts of water. The ziyuglycoside I is prepared into an injection by specific types of auxiliary materials, so that the solubility of active compounds is increased remarkably; the content of the ziyuglycoside I in the injection is up to 0.19 mg/ml, and the clarity and heat source examination conform to the pharmacopoeia criterion. In a pharmacological experiment, the ziyuglycoside I injection can remarkably increase the WBCs (White Blood Cells), RBCs (Red Blood Cells), PLTs (Platelets), NEUTs (Neutrophile Granulocytes) and HGBs (Hemoglobins) in peripheral blood than a model group, and has remarkably superior efficacy than the ziyuglycoside I active compound. After the ziyuglycoside I is prepared into the injection, the bioavailability of a principal agent can be enhanced, and the blood cell increasing and bone marrow suppression preventing functions of the principal agent are enhanced.
Description
Technical field
The present invention relates to a kind of sanguisorbin I injections and preparation method thereof, belong to drug world.
Background technology
Bone marrow suppression is clinically common disease of hematopoietic system, and it can betide the radiation of each system tumor disease and control
Treat and (or) chemotherapy, ionising radiation cause radiation insult, virus hepatitis, piconavirus infection or medicine (chloramphenicol,
Benzene, sulfanilamide (SN), anti-insane carbuncle medicine, sedative, antithyroid drug, antidiabetic, anti-malarial, hypnotic) etc. factor.Bone marrow suppression can
Cause the damage of bone marrow microenvironment, candidate stem cell, hematopoietic cell growth factor etc., grain, red, megakaryocytic series unification system, two
It is or three is that cell is suppressed.Agranulocytosis can cause severe infections；Red blood cell is significantly reduced 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 suppression still lacks effectively treatment hand
Section, needs badly and develops the preferable medicine of drug effect.
Sanguisorbin I, English name ziyu-glycoside I, CAS 35286-58-9 are from rose family garden burnet platymiscium
The compound with pharmacologically active for obtaining is extracted in the root of garden burnet or the garden burnet that comes into leaves.CN101119740A discloses sanguisorbin
I purposes in the medicine for raising red blood cell and hemoglobin is prepared.However, actually used middle discovery, sanguisorbin I drug effect is owed
It is good, often it is difficult to obtain preferable hemocytes increasing level, the effect for the treatment of bone marrow suppression during exclusive use.Therefore, need badly and carry
The drug effect of high sanguisorbin I, promotes medicine application clinically.
The content of the invention
It is an object of the invention to provide a kind of sanguisorbin I injection and preparation method thereof.
The invention provides a kind of sanguisorbin I injections, it is that the supplementary material comprising following weight proportioning is prepared from：
0.2 part of sanguisorbin I, 0.001～60 part of solubilizer, 950～1050 parts of water.
Further, described solubilizer is one kind or two in Tween 80, Emulsifier EL-60 EL, PLURONICS F87
Plant the mixture of the above.
Further, it also includes pH adjusting agent.
Preferably, described pH adjusting agent is NaOH.
Preferably, it is prepared from by the supplementary material of following weight proportioning：0.2 part of sanguisorbin I, Tween 80
0.001～60 part, add water and pH adjusting agent to sanguisorbin I concentration be 0.2mg/mL, pH=5.0～7.0.
The invention provides a kind of preparation method of the injection, comprises the steps：Sanguisorbin I is scattered in into water
In, solubilizer and pH adjusting agent are added, to filter, sterilizing is obtained final product.
Further, 0.22um filtering with microporous membrane is used.
The invention provides purposes of the injection in the medicine for preparing hemocytes increasing, amount of hemoglobin.
The invention provides purposes of the injection in the medicine for preparing treatment and/or prevention bone marrow suppression.
The invention provides a kind of sanguisorbin I injection.Inventor has found that sanguisorbin I is raised in research process
The reason for blood cell levels less effective is its solubility low (solubility is only 0.042mg/ml in water), gastrointestinal absorption rate
It is little, cause the bioavilability of the medicine relatively low, limit the performance of its drug effect.The present invention selects particular kind of auxiliary material (tween
80th, Emulsifier EL-60 EL or PLURONICS F87) sanguisorbin I is prepared into into injection, extremely considerably improve active compound
Solubility, the content of sanguisorbin I reaches 0.19mg/ml in injection, and clarity, heat source check meet pharmacopeia mark
It is accurate.In effect experiment, compare with model group, sanguisorbin I injection of the present invention can significantly raise peripheral blood WBC, RBC, PLT,
NEUT and HGB quantity, and drug effect is substantially better than sanguisorbin I active compound, shows that the present invention is prepared into sanguisorbin I after injection
The bioavilability of main ingredient can be improved, strengthens its hemocytes increasing quantity, the effect of preventing and treating bone marrow suppression.
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.
Below by way of specific embodiment, the present invention is described in further detail, but is not intended to limit the present invention, ability
Various changes and replacement that field technique personnel make according to the present invention, without departing from the spirit of the present invention, all should belong to this
Bright scope of the following claims.
Specific embodiment
Raw material, equipment used in the specific embodiment of the invention is known product, is obtained by buying commercially available prod.
The preparation of the sanguisorbin I injection of the present invention of embodiment 1
Prescription：Sanguisorbin I 0.1g, Tween 80 0.0001g
Preparation method：Take sanguisorbin I to be scattered in 100mL waters for injection, add Tween 80, NaOH, stir molten
Solution, it is 0.2mg/mL, pH=6.0 to add water for injection 400mL and make the concentration of sanguisorbin I in solution, uses 0.22um micropores
Membrane filtration, sterilizing, obtain final product injection of the present invention.The preparation of the sanguisorbin I injection of the present invention of embodiment 2
Prescription：Sanguisorbin I 0.1g, Emulsifier EL-60 EL 0.001g
Preparation method：Take sanguisorbin I to be scattered in 100mL waters for injection, add Emulsifier EL-60 EL, hydroxide
Sodium, stirring and dissolving, it is 0.2mg/mL, pH=5.0 to add water for injection 400mL and make the concentration of sanguisorbin I in solution, is used
0.22um filtering with microporous membrane, sterilizing, obtain final product injection of the present invention.
The preparation of the sanguisorbin I injection of the present invention of embodiment 3
Prescription：Sanguisorbin I 10g, PLURONICS F87 60g
Preparation method：Take sanguisorbin I to be scattered in 2000mL waters for injection, add PLURONICS F87, NaOH,
Stirring and dissolving, it is 0.2mg/mL, pH=7.0 to add water for injection 48000mL and make the concentration of sanguisorbin I in solution, is used
0.22um filtering with microporous membrane, sterilizing, obtain final product injection of the present invention.
Beneficial effects of the present invention are proved below by way of experimental example.
Experimental example 1 prepares the quality evaluation of sanguisorbin I injections using different auxiliary material
Previous experiments find that solubility of the sanguisorbin I active compound in water is extremely low, only 0.042mg/ml, serious to limit
The performance of drug effect.Therefore, inventor the physicochemical property of garden burnet saponin I and the compatibility of solubilizer have been carried out it is widely studied, most
Find that Tween 80, Emulsifier EL-60 EL, three kinds of auxiliary materials of PLURONICS F87 can to the full extent improve the dissolving of active compound eventually
Degree, sanguisorbin I contents can reach 0.19mg/ml in the injection of preparation.
This experiment is respectively with Tween 80, Emulsifier EL-60 EL, PLURONICS F87, propane diols, lauryl sodium sulfate
As a example by preparing sanguisorbin I injections, the superiority of selected auxiliary material of the invention is illustrated.
Preparation method：Take sanguisorbin I 0.2g to be scattered in 100mL waters for injection, be separately added into different auxiliary materials and (tell
Temperature 80, Emulsifier EL-60 EL, PLURONICS F87, propane diols, lauryl sodium sulfate) 5g and NaOH, stir molten
Solution, it is 0.2mg/mL, pH=6.0 to add water for injection 900mL and make the concentration of sanguisorbin I in solution, uses 0.22um micropores
Membrane filtration, sterilizing, obtain final product injection.Detection thermal source, clarity and medicament contg, the results are shown in Table 1.
Pyrogen is pressed《Chinese Pharmacopoeia》(version in 2010) pyrogen test is determined.
Clarity is pressed《Chinese Pharmacopoeia》Lamp test inspection under (version in 2010) visible foreign matters inspection technique item.
Sanguisorbin I contents, are determined, chromatographic condition using HPLC methods：Agilent extend-C18 chromatographic columns (250 ×
4.6mm, 5 μm), flow velocity：1.0mL·min-1；Column temperature：30℃；Sample size：10μL；With acetonitrile-water (30:70) it is mobile phase；
Detection wavelength is 208nm.
The quality evaluation of the sanguisorbin I injections that table 1 is prepared using different auxiliary material
As shown in Table 1, by the present invention in that (Tween 80, Emulsifier EL-60 EL moor Lip river with particular kind of auxiliary material
Husky nurse 188), sanguisorbin I can be prepared into the injection of clarification, heat source check is qualified；And, wherein sanguisorbin I contents
0.19mg/ml is reached, the solubility of active compound is extremely considerably improved.Using other auxiliary materials such as propane diols, dodecyl sulphur
In the case of sour sodium etc., the sanguisorbin I injection clarity tests for preparing are unqualified, and sanguisorbin I contents are relatively low, system
Agent quality occurs in that significantly decline.
Impact of the supplementary product consumption of experimental example 2 to garden burnet saponin I injection quality
Take sanguisorbin I 0.2g to be scattered in 100mL waters for injection, as shown in table 2, be separately added into different amounts of solubilising
Agent Tween 80 and NaOH, stirring and dissolving, adding water for injection 900mL makes the concentration of sanguisorbin I in solution be
0.2mg/mL, pH=6.0, with 0.22um filtering with microporous membrane, sterilizing, obtain final product injection.Detection thermal source, clarity and medicine contain
Amount, the results are shown in Table 2.
The quality evaluation result of the sanguisorbin I injections of table 2
Experimental result：When solubilizer consumption is in the range of 1.0mg～60g, the sanguisorbin I injection thermals source for preparing
Detection is qualified, injection clarification, and medicament contg reaches 0.18mg/mL；If solubilizer addition is outside the above range, injection
Then there is the situation of the Quality Downs such as milkiness, unqualified, the medicament contg reduction of thermal source detection.Consider production cost, poison secondary
The factors such as effect, solubilizer addition 1.0mg is optimal.
The sanguisorbin I injection pharmacodynamic studies of the present invention of experimental example 3
1 experiment material
1.1 test medicines sanguisorbin I injections A groups (preparing according to embodiment 1) of the present invention, B groups are (according to embodiment 2
Prepare), C groups (preparing according to embodiment 3), sanguisorbin I 10%DMSO- physiological saline groups, endoxan.
1.2 animal used as test KM- mouse：18.5～22.5g.
1.3 laboratory apparatus：Full-automatic blood cell analysis machine；BS-600L electronic balances：Specification：600g/0.1g, Shanghai friend's sound
Weighing apparatus Co., Ltd.
1.4 statistical method
Statistical analysis is carried out with the softwares of SPSS 17.0.Data are represented with mean ± standard deviation (x ± s), using Dan Yin between group
Plain variance analysis, carries out LSD inspections between the neat person's group of variance, heterogeneity of variance person carries out Tamhane ' s T2 inspections.
2 experimental techniques
2.1 animals used as test are grouped and prepared by model
All Animal adaptabilities are randomly divided into after feeding 1 week by body weight：Blank group；Model group；Sanguisorbin I injection A,
B, C group, makes 2.5mgkg-1 suspensions, prepared before use；Sanguisorbin I groups：Sanguisorbin I powder, uses 10%DMSO-
Physiological saline solution, is configured to 2.5mgkg-1 suspensions, prepared before use.Test the 1st day, in addition to blank group, remaining each group
Mouse presses 50mgkg-1 dosage intraperitoneal injection of cyclophosphamide normal saline solutions, for three days on end, naive mice tail vein injection
Equal-volume physiological saline.
2.2 administration
Each experimental group from test the 1st day start according to dosage, administering mode give relative medicine, blank group and model group mouse
Tail vein injection equal-volume physiological saline, continuous 7 days.
2.3 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 anti-coagulants.
2.4 Testing index and method
Peripheral hemogram is detected：Using full-automatic blood counting instrument to each experimental mice PBL (WBC), neutrality
Granulocyte (NEUT) red blood cell (RBC), blood platelet (PLT), hemoglobin (HGB) are counted.
3 experimental results
The each experimental mice peripheral blood haemocyte quantity of table 3
Note：Compare with model group, * P<0.05, * * P<0.01；Compare with sanguisorbin I groups, △ P<0.05, △ △ P<
0.01。
As a result show, compare with model group, sanguisorbin I injections A groups of the present invention, sanguisorbin I injection B groups,
Elm saponin I injection C group mouse hematopoietic stem cell quantity has significantly raise (P<0.05), sanguisorbin I groups are poor without conspicuousness
It is different；Compare with sanguisorbin I groups, sanguisorbin I injections A groups of the present invention, sanguisorbin I injection B groups, sanguisorbin I notes
Penetrating agent C group mouse peripheral blood WBC, RBC, PLT quantity has significantly rising (P<0.05).
The each experimental mice peripheral blood haemocyte quantity of table 4
Note：Compare with model group, * P<0.05, * * P<0.01；Compare with sanguisorbin I groups, △ P<0.05, △ △ P<
0.01。
As a result show, compare with model group, sanguisorbin I injections A groups of the present invention, sanguisorbin I injection B groups,
Elm saponin I injection C group mouse peripheral blood NEUT and HGB quantity has significantly raise (P<0.05), sanguisorbin I groups are without significantly
Sex differernce；Compare with sanguisorbin I groups, sanguisorbin I injections A groups of the present invention, sanguisorbin I injection B groups, sanguisorbin
I injection C group group mouse peripheral blood NEUT and HGB quantity has significantly raise (P<0.05).
Claims (9)
1. a kind of sanguisorbin I injections, is characterized in that：It is that the supplementary material comprising following weight proportioning is prepared from：Garden burnet
0.2 part of saponin I, 0.001～60 part of solubilizer, 950～1050 parts of water.
2. injection as claimed in claim 1, is characterized in that：Described solubilizer be Tween 80, Emulsifier EL-60 EL,
One or more mixture in PLURONICS F87.
3. injection as claimed in claim 1 or 2, is characterized in that：It also includes pH adjusting agent.
4. injection as claimed in claim 3, is characterized in that：Described pH adjusting agent is NaOH.
5. the injection as described in Claims 1 to 4 any one, is characterized in that：It is by the supplementary material of following weight proportioning
It is prepared from：0.2 part of sanguisorbin I, 0.001 part of Tween 80, add water and pH adjusting agent to sanguisorbin I concentration is 0.2mg/
ML, pH=5.0～7.0.
6. a kind of preparation method of injection described in Claims 1 to 5 any one, is characterized in that：Comprise the steps：By ground
Elm saponin I is dispersed in water, and adds solubilizer and pH adjusting agent, filters, and sterilizing is obtained final product.
7. preparation method as claimed in claim 6, is characterized in that：Use 0.22um filtering with microporous membrane.
8. use of the injection in the medicine for preparing hemocytes increasing, amount of hemoglobin described in Claims 1 to 5 any one
On the way.
9. injection described in Claims 1 to 5 any one is preparing the purposes of the medicine for treating and/or preventing bone marrow suppression.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510673440 | 2015-10-16 | ||
| CN2015106734408 | 2015-10-16 |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1504478A (en) * | 2002-12-02 | 2004-06-16 | 成都地奥制药集团有限公司 | Burnet general saponin extract , its preparation method and use |
| CN1593436A (en) * | 2003-09-08 | 2005-03-16 | 成都地奥制药集团有限公司 | Application of ursane type triterpenoid saponin in the preparing process of leucocyte and/or platelet increasing medicine |
| JP2014234346A (en) * | 2013-05-30 | 2014-12-15 | 耕平 山下 | Hair treatment agent |
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2016
- 2016-10-14 CN CN201610899872.5A patent/CN106606475A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1504478A (en) * | 2002-12-02 | 2004-06-16 | 成都地奥制药集团有限公司 | Burnet general saponin extract , its preparation method and use |
| CN1593436A (en) * | 2003-09-08 | 2005-03-16 | 成都地奥制药集团有限公司 | Application of ursane type triterpenoid saponin in the preparing process of leucocyte and/or platelet increasing medicine |
| JP2014234346A (en) * | 2013-05-30 | 2014-12-15 | 耕平 山下 | Hair treatment agent |
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Application publication date: 20170503 |