CN1660072A - Quick dissolving solid injection of yew alkyl group, preparation method and application - Google Patents
Quick dissolving solid injection of yew alkyl group, preparation method and application Download PDFInfo
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- CN1660072A CN1660072A CN 200410093877 CN200410093877A CN1660072A CN 1660072 A CN1660072 A CN 1660072A CN 200410093877 CN200410093877 CN 200410093877 CN 200410093877 A CN200410093877 A CN 200410093877A CN 1660072 A CN1660072 A CN 1660072A
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Abstract
An instant solid injection of taxane for improving immunity is prepared through preparing solution A from taxol or polyenyltaxol, polyoxyvinyl castor oil or tween-80 or glycol laurylhydroxy stearate, and alcohol, preparing solution B from propanediol, hyaluronic acid, high-purity water and mannitol or glucose, slurry adding the solution B to solution A while stirring, homogenizing while emulsifying vacuum removal of alcohol, and freeze (or spray) drying.
Description
Technical field
The invention belongs to field of medicaments, specifically, relate to a kind of taxanes hyaluronic acid preparation, preparation method and the application in the preparation immunoregulation medicament.
Background technology
Current immune disease has become one of principal element of serious threat human health.Immune system injury such as acquired immune deficiency syndrome (AIDS), lupus erythematosus disease does not still have the disease of specific treatment medicine especially at present, and its mortality in said patients is high.A kind of especially serious threat human health of tumor, even life-threatening disease, oneself occupies second of sickness rate of various diseases the mortality rate that is caused by malignant tumor after cardiovascular disease.And the immune system of cancer patient is often suppressed by tumor cell, cause the autonomous immunity of patient to reduce, the easy infection various diseases also aggravates disease, therefore, improve relevant immunity infringement disease patient's autoimmune activity, significant to the survival rate that improves the patient.
Paclitaxel and derivant thereof are present clinical use one of the most effective cancer therapy drugs.They be last century the seventies from the bark of Ramulus et folium taxi cuspidatae or its kind or needle, separate natural product or its semi-synthetic product that obtains.Find that subsequently this is the antitumorigenic substance that a class has special role mechanism.
The main mechanism of paclitaxel and derivant thereof is the polymerization (promoting the cell tubulin polymerization to become microtubule) that promotes intracellular canaliculus, and the depolymerization speed of the microtubule that slows down reaches the effect that stops cell mitogen.Microtubule is to be formed by tubulin polymerization.Tubulin is 1 * 10 by the molecular weight that α and two polypeptide subunits of β are formed then
5Daltonian protein.Between the depolymerisation of the polymerization of tubulin and microtubule, there is dynamic equilibrium, paclitaxel and derivant thereof can be accelerated the collecting process of separating that tubulin polymerization becomes the speed of microtubule and delays or stop microtubule, cause forming the microtubule fasolculus of stable non-functional, thereby destroy the mitosis and the cell proliferation of cell, reach the antineoplastic purpose.Because its unique mechanism, it has better therapeutic effect to the drug-fast solid tumor of many generations.
Hyaluronic acid is a class polysaccharide that exists in the animal body, and it has lubricated joint, keeps moisture, alleviates ballistic effect, mainly is present in articular cavity and vitreum and the intercellular substance.Because its viscosity is bigger, medicinal hyaluronic acid is used for arthritis, ophthalmic remedy and sustained-release administration or site-specific delivery of drugs clinically.In the recent period documents and materials show, can suppress or promote the growth of tumor cell at external hyaluronic acid, and hyaluronic acid comes the physiologically active of regulate tumor cell by combining with the specific receptor of tumor cell surface.When hyaluronic acid concentration is low, the effect that it has protection and promotes the cell growth; And concentration is when higher, and it has cell growth inhibiting, reduces the number that cell enters cycle period, it with cell can't be combined after cell combines with extracellular matrix, thereby make apoptosis.In the experiment, when carrying out injecting hyaluronic acid in the tumor body, has the effect that promotes the necrosis of tumor body in vivo.
At present, taxane and hyaluronic acid are made injection of quick dissolving solid, the application in the preparation immunoregulation medicament of the preparation method of taxane and hyaluronic acid solid injection and this solid injection does not still have report.
Summary of the invention
The purpose of this invention is to provide a kind of quick dissolving solid injection of yew alkyl group.
Second purpose of the present invention provides a kind of preparation method of quick dissolving solid injection of yew alkyl group.
The 3rd purpose of the present invention provides the application of a kind of quick dissolving solid injection of yew alkyl group in the preparation immunoregulation medicament.
Technical scheme of the present invention is summarized as follows:
Quick dissolving solid injection of yew alkyl group, make with following method:
(1) each compositions in weight percentage is formed:
Paclitaxel or Docetaxel: 0.2%～0.5%
Ethanol: 0.2%～0.5%
Hyaluronic acid: 2.5%～10.5%
Glucose or mannitol: 10.5%～47%
Propylene glycol 2.8%～26%
Polyoxyethylene castor oil or soil temperature-80 or
Ten dihydroxystearic acid macrogol esters: 47%～52%
(2) described paclitaxel or Docetaxel are dissolved in the described ethanol, add described polyoxyethylene castor oil or soil temperature-80 or ten dihydroxystearic acid macrogol esters then, make solution one; Described propylene glycol is added in the described hyaluronic acid, it is 0.1%-0.25% that the adding ultra-pure water makes the weight percent concentration of hyaluronic acid aqueous solution, make aqueous solution, add described mannitol or glucose again, make solution two, solution two is slowly joined in the solution one in stirring down, the reuse dispersing emulsification machine is with the solution mix homogeneously, after vacuum is removed ethanol, make quick dissolving solid injection of yew alkyl group with freeze-drying or spray drying method.
Preferred each weight percentages of components is:
Paclitaxel or Docetaxel: 0.3%～0.4%
Ethanol: 0.3%～0.4%
Hyaluronic acid: 3%～9%
Glucose or mannitol: 15%～40%
Propylene glycol 3%～25%
Polyoxyethylene castor oil or
Soil temperature-80 or
Ten dihydroxystearic acid macrogol esters: 48%～50%
The preparation method of quick dissolving solid injection of yew alkyl group, be made up of following step: paclitaxel with 0.2%～0.5% or Docetaxel are dissolved in 0.2%～0.5% the ethanol, add 47%～52% polyoxyethylene castor oil or soil temperature-80 or ten dihydroxystearic acid macrogol esters then, make solution one; Propylene glycol with 2.8%～26% adds in 2.5%～10.5% hyaluronic acid, it is 0.1%-0.25% that the adding ultra-pure water makes hyaluronic weight percent concentration, make aqueous solution, add 10.5%～47% mannitol or glucose again, make solution two, solution two is slowly joined in the solution one in stirring down, the reuse dispersing emulsification machine is with the solution mix homogeneously, after vacuum is removed ethanol, make quick dissolving solid injection of yew alkyl group with lyophilization or spray drying method, described percentage ratio is weight percentage.
The application of quick dissolving solid injection of yew alkyl group in the preparation immunoregulation medicament.
Quick dissolving solid injection of yew alkyl group of the present invention, its maximum characteristics are rapid dissolvings, before use, after diluting with normal saline or glucose solution or Ringer's solution, are solubilized in 2-3 minute.Experiment shows, quick dissolving solid injection of yew alkyl group of the present invention can improve the immunity of laboratory animal, can be used for preparing in the immunoregulation medicament.
Description of drawings
Fig. 1 is the plasma protein two-dimensional map of blank group mice;
Fig. 2 is the plasma protein two-dimensional map of injection hyaluronic acid group mice;
Fig. 3 is the plasma protein two-dimensional map of injection paclitaxel ejection preparation group mice;
Fig. 4 is the plasma protein two-dimensional map of injection quick dissolving solid injection of yew alkyl group group mice of the present invention.
The specific embodiment
The present invention is further illustrated below in conjunction with specific embodiment.
Embodiment 1
(1) each component is by weight:
Paclitaxel: 0.2g
Ethanol: 0.2g
Hyaluronic acid: 10.5g
Glucose: 11.1g
Propylene glycol: 26g
Polyoxyethylene castor oil: 52g
(2) paclitaxel is dissolved in the ethanol, adds polyoxyethylene castor oil then, make solution one; Propylene glycol is added in the hyaluronic acid, it is 0.1% that the adding ultra-pure water makes the weight percent concentration of hyaluronic acid aqueous solution, make aqueous solution, add mannitol again, make solution two, solution two is slowly joined in the solution one in stirring down, the reuse dispersing emulsification machine is with the solution mix homogeneously, after vacuum is removed ethanol, make quick dissolving solid injection of yew alkyl group with freeze-drying or spray drying method.(ethanol can by volume add by converting).
Embodiment 2
(1) each component is by weight:
Docetaxel: 0.5g
Ethanol: 0.5g
Hyaluronic acid: 2.5g
Glucose: 23.5g
Propylene glycol: 26g
Polyoxyethylene castor oil: 47g
(2) preparation process of employing embodiment 1 is replaced paclitaxel with Docetaxel, and other steps are with embodiment 1, and the weight percent concentration of hyaluronic acid aqueous solution is 0.25%.
Embodiment 3
(1) each component is by weight:
Paclitaxel: 0.3g
Ethanol: 0.4g
Hyaluronic acid: 9g
Mannitol: 39.5g
Propylene glycol: 2.8g
Soil temperature-80:48g
(2) preparation process of employing embodiment 1 is replaced glucose with mannitol, replaces polyoxyethylene castor oil with soil temperature-80, and other steps are with embodiment 1, and the weight percent concentration of hyaluronic acid aqueous solution is 0.2%.
Embodiment 4
(1) each component is by weight:
Paclitaxel: 0.4g
Ethanol: 0.3g
Hyaluronic acid: 3g
Glucose: 20.3g
Propylene glycol: 26g
Polyoxyethylene castor oil: 50g
(2) preparation process of employing embodiment 1, and the weight percent concentration of hyaluronic acid aqueous solution is 0.21%.
Embodiment 5
(1) each component is by weight:
Docetaxel: 0.2g
Ethanol: 0.3g
Hyaluronic acid: 2.5g
Glucose: 47g
Propylene glycol: 3g
Soil temperature-80:47g
(2) preparation process of employing embodiment 1 is replaced paclitaxel with Docetaxel, replaces polyoxyethylene castor oil with soil temperature-80, and other steps are with embodiment 1, and the weight percent concentration of hyaluronic acid aqueous solution is 0.2%.
Embodiment 6
(1) each component is by weight:
Docetaxel: 0.3g
Ethanol: 0.2g
Hyaluronic acid: 9g
Mannitol: 13.5g
Propylene glycol: 25g
Ten dihydroxystearic acid macrogol ester: 52g
(2) preparation process of employing embodiment 1, replace paclitaxel with Docetaxel, replace glucose, replace polyoxyethylene castor oil with ten dihydroxystearic acid macrogol esters with mannitol, other steps are with embodiment 1, and the weight percent concentration of hyaluronic acid aqueous solution is 0.2%.
Embodiment 7
(1) each component is by weight:
Docetaxel: 0.4g
Ethanol: 0.5g
Hyaluronic acid: 10.5g
Mannitol: 15.6g
Propylene glycol: 26g
Ten dihydroxystearic acid macrogol ester: 47g
(2) preparation process of employing embodiment 1, replace paclitaxel with Docetaxel, replace glucose, replace polyoxyethylene castor oil with ten dihydroxystearic acid macrogol esters with mannitol, other steps are with embodiment 1, and the weight percent concentration of hyaluronic acid aqueous solution is 0.2%.
Embodiment 8
(1) each component is by weight:
Paclitaxel: 0.5g
Ethanol: 0.5g
Hyaluronic acid: 10.5g
Glucose: 10.5g
Propylene glycol: 26g
Soil temperature-80:52g
(2) preparation process of employing embodiment 1 is replaced polyoxyethylene castor oil with soil temperature-80, and other steps are with embodiment 1, and the weight percent concentration of hyaluronic acid aqueous solution is 0.2%.
Embodiment 9
(1) each component is by weight:
Paclitaxel: 0.5g
Ethanol: 0.5g
Hyaluronic acid: 10.5g
Glucose: 15g
Propylene glycol: 25.5g
Polyoxyethylene castor oil: 48g
(2) preparation process of employing embodiment 1, step is with embodiment 1, and the weight percent concentration of hyaluronic acid aqueous solution is 0.15%.
Embodiment 10
(1) each component is by weight:
Docetaxel: 0.5g
Ethanol: 0.5g
Hyaluronic acid: 10.5g
Mannitol: 12.5g
Propylene glycol: 26g
Soil temperature-80:50g
(2) preparation process of employing embodiment 1 is replaced paclitaxel with Docetaxel, replaces mannitol with glucose, replaces polyoxyethylene castor oil with soil temperature-80, and step is with embodiment 1, and the weight percent concentration of hyaluronic acid aqueous solution is 0.15%.
Embodiment 11
(1) each component is by weight:
Docetaxel: 0.3g
Ethanol: 0.3g
Hyaluronic acid: 2.5g
Mannitol: 40g
Propylene glycol: 8.9g
Ten dihydroxystearic acid macrogol ester: 48g
(2) preparation process of employing embodiment 1, replace paclitaxel with Docetaxel, replace glucose, replace polyoxyethylene castor oil with ten dihydroxystearic acid macrogol esters with mannitol, step is with embodiment 1, and the weight percent concentration of hyaluronic acid aqueous solution is 0.15%.
Embodiment 12
(1) each component is by weight:
Docetaxel: 0.5g
Ethanol: 0.4g
Hyaluronic acid: 8.1g
Mannitol: 15g
Propylene glycol: 26g
Ten dihydroxystearic acid macrogol ester: 50g
(2) preparation process of employing embodiment 1, replace paclitaxel with Docetaxel, replace glucose, replace polyoxyethylene castor oil with ten dihydroxystearic acid macrogol esters with mannitol, step is with embodiment 1, and the weight percent concentration of hyaluronic acid aqueous solution is 0.15%.
Embodiment 13
(1) each component is by weight:
Paclitaxel: 0.5g
Ethanol: 0.5g
Hyaluronic acid: 6g
Glucose: 40g
Propylene glycol: 5g
Ten dihydroxystearic acid macrogol ester: 48g
(2) preparation process of employing embodiment 1 is replaced polyoxyethylene castor oil with ten dihydroxystearic acid macrogol esters, and step is with embodiment 1, and the weight percent concentration of hyaluronic acid aqueous solution is 0.15%.
Embodiment 14
(1) each component is by weight:
Docetaxel: 0.5g
Ethanol: 0.5g
Hyaluronic acid: 10.5g
Mannitol: 10.5g
Propylene glycol: 26g
Soil temperature-80:52g
(2) preparation process of employing embodiment 1 is replaced paclitaxel with Docetaxel, replaces glucose with mannitol: use temperature-80 and replace polyoxyethylene castor oil, step is with embodiment 1, and the weight percent concentration of hyaluronic acid aqueous solution is 0.15%.
Embodiment 15
(1) each component is by weight:
Docetaxel: 0.3g
Ethanol: 0.4g
Hyaluronic acid: 2.5g
Mannitol: 47g
Propylene glycol: 2.8g
Polyoxyethylene castor oil: 47g
(2) preparation process of employing embodiment 1 is replaced paclitaxel with Docetaxel, replaces glucose with mannitol, and step is with embodiment 1, and the weight percent concentration of hyaluronic acid aqueous solution is 0.15%.
Embodiment 16
Quick dissolving solid injection of yew alkyl group of the present invention, volume ratio is 1 by weight: 1-2 adds normal saline, and dissolution time is 2.1 minutes to 3.6 minutes.
Embodiment 17
Behind physiological saline solution, intravenous injection is given in the mice body, injects continuously 5 days with quick dissolving solid injection of yew alkyl group medicine of the present invention, (every day 5mg/kg paclitaxel, the 25mg/kg hyaluronic acid is seen embodiment 2) extracted mouse blood in the 9th day, compare with blank mouse blood.Search and data statistic analysis by ImageMaster 2D Database software, obtain collection of illustrative plates, see Fig. 1, Fig. 2, Fig. 3, Fig. 4, from the figure as can be seen, the blank mice plasma protein graphical spectrum (Fig. 1) of administration not, the Mus serum proteins collection of illustrative plates (Fig. 2 after the medication, 3,4).Above-mentioned collection of illustrative plates is contrasted, and the coupling of the most protein speckle in the serum albumin of serum albumin of the mice after the administration and normal mice better as can be seen.Wherein there are 11 protein spotses differential expression to occur.Protein abundance, pI and the molecular weight of these speckles is by ImageMaster computed in software result.From these proteic classification, they all belong to the conjugated protein super family in the globulin.Wherein No. 8 points that occur in the Mus blood plasma with embodiment 2 administrations of quick dissolving solid injection of yew alkyl group of the present invention injection are new speckle (see figure 4)s, all do not occur in blank group (Fig. 1), hyaluronic acid group (Fig. 2) and paclitaxel group (Fig. 3), it is inquired about in the Mus Protein Data Bank, and the result shows that No. 8 protein spotses and vitamin D binding protein (DBP) are complementary.DBP is the activity factor of body immune system, and its inactivation often causes the inhibition of immunity, the generation that gives rise to diseases.
Collection of illustrative plates (see figure 1) with the blank group of normal mice plasma proteins serves as that the analysis result that contrast is carried out shows.With a lot of protein site expression decreased or disappearance in the blood plasma of the Mus of hyaluronic acid treatment, so although hyaluronic acid has the partial symptoms that tumor remission is grown, DeGrain.And the use of paclitaxel occur to be raised the expression of the immune protein of Mus, and is basic similar to normal mice blood plasma, do not show antimetastatic activity although paclitaxel is described, it can the ameliorate tumor cell to the immunosuppressant of body, raising neoplasm growth activity.Quick dissolving solid injection of yew alkyl group medicine of the present invention can make the level of immunocyte raise (see figure 4), particularly impels the level of DBP to occur significantly raising, and activates the immune system of body in view of the above, thereby improves the immunocompetence of system.
Vitamin D binding protein (DBP) is a kind of plasma protein with multiple function, has 458 amino acid residues (51.2kDa), is made up of two long-chains (every 186 residues) and a short chain (86 residues).It comprises and bites neutrophil cell, fiber element method cell, mononuclear cell, B cell, T cell, the little solencyte of Ren sus domestica, Mus pancreatic cell and human smooth muscular cells etc. by Sulfated proteoglycan and various kinds of cell generation effect.
Studies show that, have malignant tumor patient since tumor cell discharge a kind of in saccharifying enzyme (α-N-acetyl galactase) make DBP that deglycosylation take place, make it can not activating macrophage.And the activation of macrophage is the initiation factor of active immunity, therefore, causes the immunosuppressant of cancer patient.Survival and differentiation for tumor cell provides chance like this.Generally speaking, chemotherapy can reduce the activity of α-N-acetyl galactase, and the concentration of DBP is suitably increased, thereby recovers the ability that macrophage is removed tumor cell.And be that the experiment of therapeutic agent shows with DBP-MAF, DBP can make lotus transplantability Ehrlich ascites tumor Mus life its prolong, the antitumaous effect of DBP also has been described.
DBP combines the therapeutic outcome that is used for head, neck neoplasms agent gastrointestinal tract solid tumor and shows with photodynamic therapy, the use of DBP has been removed because of photodynamics and has been handled the immunosuppressant that body is produced, and makes the effective percentage that suppresses tumor growth bring up to 100% of therapeutic alliance by 25% of simple optical therapeutic.
The immune mouse experimental result shows that tumor can suppress the immune system of mice, and the adding of DBP then can be regulated the immune function of mice, accelerates production of antibodies.
Recent research shows that DBP has the tumor growth inhibitory action to the lotus human pancreas cancer Mus with immunity infringement.The demonstration of tumor body pathological analysis, the macrophage number in the tumor surrounding tissue increased, the capillary density of tumor body reduced, and the level of apoptosis of cell increases, and this explanation DBP has the effect of antineoplastic vascular generation and cell differentiation.Human endotheliocytes such as Kanda are that the experimental result of model also illustrates, DBP suppresses cell differentiation, the chemotaxis of cell and the formation of microtubule by the receptor-mediated approach of CD36.These results illustrate that all DBP has potential using value aspect the treatment of immune diseases such as tumor, HIV.
In sum, paclitaxel-hyaluronic administering drug combinations can activate the immune system of mice body, improves the immune vigor of body, thereby can be used for the treatment of immunodeficiency diseasess such as acquired immune deficiency syndrome (AIDS), lupus erythematosus.
Claims (4)
1. quick dissolving solid injection of yew alkyl group is characterized in that making with following method:
(1) each compositions in weight percentage is formed:
Paclitaxel or Docetaxel: 0.2%～0.5%
Ethanol: 0.2%～0.5%
Hyaluronic acid: 2.5%～10.5%
Glucose or mannitol: 10.5%～47%
Propylene glycol 2.8%～26%
Polyoxyethylene castor oil or
Soil temperature-80 or
Ten dihydroxystearic acid macrogol esters: 47%～52%
(2) described paclitaxel or Docetaxel are dissolved in the described ethanol, add described polyoxyethylene castor oil or soil temperature-80 or ten dihydroxystearic acid macrogol esters then, make solution one; Described propylene glycol is added in the described hyaluronic acid, it is 0.1%-0.25% that the adding ultra-pure water makes the weight percent concentration of hyaluronic acid aqueous solution, make aqueous solution, add described mannitol or glucose again, make solution two, solution two is slowly joined in the solution one in stirring down, the reuse dispersing emulsification machine is with the solution mix homogeneously, after vacuum is removed ethanol, make quick dissolving solid injection of yew alkyl group with freeze-drying or spray drying method.
2. quick dissolving solid injection of yew alkyl group according to claim 1 is characterized in that each weight percentages of components is:
Paclitaxel or Docetaxel: 0.3%～0.4%
Ethanol: 0.3%～0.4%
Hyaluronic acid: 3%～9%
Glucose or mannitol: 15%～40%
Propylene glycol 3%～25%
Polyoxyethylene castor oil or soil temperature-80 or
Ten dihydroxystearic acid macrogol esters: 48%～50%
3. the preparation method of quick dissolving solid injection of yew alkyl group, it is characterized in that being made up of following step: paclitaxel with 0.2%～0.5% or Docetaxel are dissolved in 0.2%～0.5% the ethanol, add 47%～52% polyoxyethylene castor oil or soil temperature-80 or ten dihydroxystearic acid macrogol esters then, make solution one; Propylene glycol with 2.8%～26% adds in 2.5%～10.5% hyaluronic acid, it is 0.1%-0.25% that the adding ultra-pure water makes hyaluronic weight percent concentration, make aqueous solution, add 10.5%～47% mannitol or glucose again, make solution two, solution two is slowly joined in the solution one in stirring down, the reuse dispersing emulsification machine is with the solution mix homogeneously, after vacuum is removed ethanol, make quick dissolving solid injection of yew alkyl group with lyophilization or spray drying method, described percentage ratio is weight percentage.
4. the application of quick dissolving solid injection of yew alkyl group in the preparation immunoregulation medicament.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103315978A (en) * | 2013-07-12 | 2013-09-25 | 上海市第八人民医院 | Dry docetaxel elixir, and preparation method and application thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103315978A (en) * | 2013-07-12 | 2013-09-25 | 上海市第八人民医院 | Dry docetaxel elixir, and preparation method and application thereof |
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