CN1126589A - Injecta of delayed hormone microcapsule and its prepn - Google Patents
Injecta of delayed hormone microcapsule and its prepn Download PDFInfo
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- CN1126589A CN1126589A CN 95111394 CN95111394A CN1126589A CN 1126589 A CN1126589 A CN 1126589A CN 95111394 CN95111394 CN 95111394 CN 95111394 A CN95111394 A CN 95111394A CN 1126589 A CN1126589 A CN 1126589A
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- microcapsule
- water
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Abstract
The said injecta mainly consists of microcapsule bacteria-free powder of polylactate, polyhydroxyl-acetic acid, polyglycol, polyammino acid, gelatin or gum arabic containing valeric estradiol, estriol, propinate testosterone, thyroxine powder or other hormone. It is used in remitting senile diseases caused by reduced hormonel level in body during climacteric and post-climacteric, and it may be also used in the cure of diseases of obesity patient.
Description
The present invention is a kind of injecta of delayed hormone microcapsule and preparation method thereof, belongs to biomedical sector.
At present, the aging society structure is just progressively stepped in Zhong Guo many cities.Along with further going deep into of family planning policy, Chinese in the near future aging problem will be more outstanding.The most outstanding variation is that sex hormone level is low after climacteric in the old human body, and therefore causes Senile disease such as climacteric syndrome, osteoporosis.In addition, the serious iodine deficiency in many places of China causes the hypothyroidism patient to increase year by year.Therefore, the Development of New Generation long-acting sustained-release injection then can reach suitable raising old people hormonal readiness, can replenish thyroxine in right amount to the hypothyroidism patient, and can avoid because of long-term a large amount of various side effect of using hormone medicine to cause.
Polylactic acid (PLA) and Polyethylene Glycol macromolecule Biodegradable material packaging medicines such as (PEG) do controlled-releasing microcapsule existing two more than ten years history.This microcapsule injects in the body, and medicine can slowly discharge in the capsule, and the capsule material acts as the product into the human homergy through enzymolysis or non-enzyme, excretes through the normal physiological metabolic pathway lentamente.Lee-larasamee etc. are the capsule material with PLA, have prepared the hydrocortisone microcapsule; Bodmeier etc. are the capsule material with DL-PLA, with spray drying method for preparation the particle diameter of Progesterone and aminophylline less than the microcapsule of 5 μ; Usefulness L-PLA such as Markins and DL-PLA are the capsule material, have made pluronic F-68 microcapsule with the interface sedimentation, but have not seen in the document that having with PLA or PLA-Polyethylene Glycol etc. is estradiol valerate, estriol, androlin, the thyroid powder (T of film material
4), sodium triiodothyronine (T
3) research of microcapsule injection.We once (see Chinese patent application number 95111307.0) be the film material with PLA etc., developed the micro-balloon injection technology of above-mentioned hormone, obtained good effect.But exist aggressive dosage big, the defect that production cost is higher.
The purpose of this research is that with polylactic acid, polyglycolic acid, polylactic acid-polyglycol, polyglycolic acid-Polyethylene Glycol, polylactic acid-polyglycolic acid, polyamino acid, gelatin, arabic gum be material, seek suitable process conditions, the preparation estradiol valerate, estriol, androlin, thyroid powder (T
4), sodium triiodothyronine (T
3) wait the slow-releasing microcapsule injection of hormone.
Technical scheme of the present invention is: injecta of delayed hormone microcapsule process using subpackage type, promptly form by sterilized powder and aseptic liquor.Delayed hormone microcapsule is a sterile injection powder, and 0.9% normal saline that includes emulsifying agent and silicone oil II is the injection liquor.
The clad material of injecta of delayed hormone microcapsule of the present invention be biodegradable biomedical material as: polylactic acid, polyglycolic acid, polylactic acid-polyglycol, polyglycolic acid-Polyethylene Glycol, polylactic acid-polyglycolic acid, polyamino acid, gelatin, arabic gum, its weight average molecular weight range are 3.0 * 10
4～10.0 * 10
4
Quilt coating hormone as injecta of delayed hormone microcapsule of the present invention is a lot, as estradiol valerate, estriol, androlin, thyroid powder (T
4), sodium triiodothyronine (T
3) etc.The weight ratio of hormone and biomedical material is 1: 5～50.
Cladding process as hormone microcapsule injection of the present invention is: O
1/ W
1/ O
2/ W
2Type (to oil-soluble medicine) and W
1/ O/W
2Type (to water soluble drug).
As the inside and outside organic facies of injecta of delayed hormone microcapsule of the present invention is dichloromethane, chloroform, ethyl acetate, acetic acid methanol, Ethyl formate, dioxane, ether, dichloromethane-vegetable oil and the mixed liquid be made up of them.The polymer overmold material percetage by weight in the organic facies outside is 5.0～30.0.
Inside and outside water as injecta of delayed hormone microcapsule of the present invention is PVA, PVP, and the PMANa aqueous solution, its percetage by weight at interior aqueous phase is 1.0～30.0, the aqueous phase percetage by weight is 0.5～10.0 outside.
Emulsifying agent as injecta of delayed hormone microcapsule of the present invention is oil phase: the HLB value is 4.0～6.0 nonionic emulsifier; Water: the HLB value is 14.0～15.5 nonionic emulsifier, and percetage by weight in oil phase is 0.1～12.0 at inside and outside water and inside and outside reaching for it.
As the organic facies of injecta of delayed hormone microcapsule of the present invention and the volume ratio of water, to O
1/ W
1/ O
2/ W
2Type, its inner phase (O
1/ W
1) be organic facies (O
1): water (W
1)=1: 3.0～10.0, intermediate phase (O
1/ W
1/ O
2) be water (O
1/ W
1): organic facies (O
2)=1: 3.0～10.0, emulsion (O
1/ W
1/ O
2/ W
2) middle organic facies (O
1/ W
1/ O
2): water (W
2)=1: 5～100; To W
1/ O/W
2Type, inner phase (W
1/ O) be water: organic facies=1: 3.0～10.0, emulsion (W
1/ O/W
2) middle organic facies (W
1/ O): water (W
2)=1: 5～100.
Sterilization method and condition as injecta of delayed hormone microcapsule of the present invention are: oxirane was sterilized 48 hours down at 30～45 ℃, and residual ethylene oxide content is less than 5ppm.
If residual ethylene oxide content is then harmful to health greater than 5ppm.
Delayed hormone microcapsule sterilized powder of the present invention injects aseptic 0.9% normal saline liquor earlier, and suspendible evenly back injects in the body.Injecting method: intramuscular injection.
The injecta of delayed hormone microcapsule that adopts preparation method of the present invention to make is a kind of biomedical material preparation that contains hormone.Its gonadal hormone preparation is in order to alleviating after climacteric and climacteric because of hormonal readiness reduces the Senile disease that causes in vivo, but also double as diseases associated treatment therewith.The micro-slow release of thyroxine preparation is used for obesity patient's fat-reducing, and double as diseases associated treatment therewith.Because said preparation has the effect of slow release, has not only brought convenience to the patient aspect medication, and also avoided because of long-term a large amount of various side effect of using hormone medicine to cause.
Provide following example and further specify the present invention, do not limit its protection domain.
Embodiment 1: with the emulsifying agent of 450mg androlin, 2.5mgHLB=4.3, be dissolved in the 1.5ml dichloromethane, with syringe under high degree of agitation with it to being equipped with in the reaction bulb of 30%PVP that 5.0ml includes the 8mgHLB=15 emulsifying agent, form O after fully emulsified 2 hours
1/ W
1Emulsion.Extract above-mentioned emulsion with syringe, under vigorous stirring, slowly it is dropped to 50ml and contain in the mixed solution of dichloromethane, ethyl acetate of 3gPLA, 300mgHLB=5.8 emulsifying agent, formed O in fully emulsified 2 hours
1/ W
1/ O
2Emulsion.Then above-mentioned emulsion is slowly dropped to 300ml again and contains among the 0.5%PMANa of 35gHLB=15.0 emulsifying agent, after fully emulsified 1 hour 40 ℃ of following solvent flashings of normal pressure 6 hours.With reactant transfer centrifugalize to the beaker,, in 40 ℃ of vacuum drying ovens, dry with distilled water wash reactant three times.Sterilized 48 hours down at 40 ℃ with oxirane, guarantee residual ethylene oxide content, promptly get sterilized powder less than 5ppm.The powder that becomes injectable to use by the conventional fill in sterile working again.
With the emulsifying agent of 0.1gHLB=14,0.1g silicone oil II joins in the 100ml0.9% normal saline, is every loading amount 1ml fill with specification, and the leak detection back promptly gets the Injectable sterile liquor with 20 pounds of pressure high-temperature sterilizations 40 minutes.
Embodiment 2: 600mg estradiol valerate, 120mgHLB=5.5 emulsifying agent are dissolved in the 1ml dichloromethane, with syringe under high degree of agitation with it to being equipped with in the reaction bulb of 30%PVA aqueous solution that 3ml includes the 6.0mgHLB=14 emulsifying agent, form O after fully emulsified 2 hours
1/ W
1Breast draws.Extract above-mentioned emulsion with syringe, under the vigorous stirring it is contained to 30ml in the dichloromethane solution of 4.0gPLA, 39mgHLB=4.0 emulsifying agent, fully emulsified 1 hour, form O
1/ W
1/ O
2Emulsion.Then above-mentioned emulsion is slowly dropped to 3000ml and contains in the 0.5%PMANa aqueous solution of 360gHLB=15.5 emulsifying agent, after fully emulsified 1 hour 0.05MPa pressure and 30 ℃ of following solvent flashings 5 hours.Reactant is moved to centrifugalize in the beaker, behind distilled water wash reactant three times, in 35 ℃ of vacuum drying ovens, dry, sterilized 48 hours down at 30 ℃, keep residual ethylene oxide content, promptly get Injectable sterile hormone microcapsule powder less than 5ppm with oxirane.Become the injectable powder by the conventional fill in sterile working again.
2gHLB=15.5 emulsifying agent, 2g silicone oil II are joined in the 100ml0.9% normal saline, are every loading amount 1ml fill by specification, and the leak detection back promptly gets the Injectable sterile liquor with 20 pounds of pressure high-temperature sterilizations 40 minutes.
Claims (10)
1. an injecta of delayed hormone microcapsule mainly is made up of the delayed hormone microcapsule sterilized powder.It is characterized in that skin is mainly coated by the degradable biological medical material, to the water-soluble hormones medicine, kernel is mainly mixed with hormonal medicaments by the water-soluble biological medical material and forms; Oil-soluble hormonal medicaments kernel is mainly formed the oil-in-water type structure by water-soluble biological medical material coating hormonal medicaments to be formed.
2. according to the injection of claim 1, it is characterized in that the microcapsule clad material is for mainly containing biomedical materials such as biodegradable polylactic acid, polyglycolic acid, polylactic acid-polyglycol, polyglycolic acid-Polyethylene Glycol, polylactic acid-polyglycolic acid, polyamino acid, gelatin or arabic gum.
3. according to the injection of claim 1, it is characterized in that the hormone that is coated comprises estradiol valerate, estriol, androlin, thyroid powder (T
4) or sodium triiodothyronine (T
3) etc.
4. according to the injection of claim 1, the sterilized powder weight that it is characterized in that being suspended in the 1ml aseptic parenteral solution is 5.0～200.0mg, and the releasing hormone time is 30～100 days in the body.
5. according to claim 1,2,3 or 4 injection, it is characterized in that biodegradable medical material weight average molecular weight range is: 3.0 * 10
4～10.0 * 10
4The percetage by weight that accounts for microcapsule is: 80-98; The percetage by weight that the hormone that is coated accounts for microcapsule is: 2～20.
6. according to the preparation method of the injection of claim 1, it is characterized in that for the oil-soluble hormone, the microcapsule cladding process carries out as follows: (1) forms the kernel of oil-in-water type, and the volume ratio of kernel organic facies and water is: 1: 3.0～10.0; (2) form the intermediate phase that oil wraps interior caryogram, the volume ratio of interior nuclear phase and organic facies is: 1: 3.0～10.0; (3) emulsion of formation water bag intermediate phase, the volume ratio of intermediate phase and water is 1: 5～100; (4) organic solvent in the emulsion is removed through normal pressure (or decompression) heating or dialysis, obtains Powdered microcapsule.
7. according to the preparation method of the injection of claim 1, it is characterized in that for water-soluble hormones the microcapsule cladding process carries out as follows: form the kernel of water-in-oil type earlier, form the emulsion of water bag kernel again, vapor away the organic solvent in the emulsion then, obtain Powdered microcapsule.The volume ratio of kernel water and organic facies is: 1: 3.0～10.0, and the volume ratio of nuclear phase and water is in the emulsion: 1: 5～100.
8. according to the method for claim 6 or 7, it is characterized in that organic facies that microcapsule coating process adopts comprises the mixed liquid that dichloromethane, chloroform, ethyl acetate, methyl acetate, Ethyl formate, dioxane, ether, dichloromethane-vegetable oil and they are formed; The emulsifying agent that organic facies adopts is: HLB value=4.0～6.0 nonionic emulsifier; Consumption is 0.1～12% of an organic facies; The percetage by weight of biodegradable medical material in organic facies is: 5.0～30.0.The water that adopts comprises polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP), sodium polymethacrylate (PMANa) aqueous solution; PVA, PVP, PMANa in the percetage by weight of kernel aqueous phase are: 1.0～30.0, and the percetage by weight of aqueous phase is 0.5～10.0 outside; The emulsifying agent of aqueous phase is: the nonionic emulsifier of HLB=14.0～15.5, consumption are 0.1～12% of aqueous phase.
9. according to the preparation method of the injection of claim 1, it is characterized in that injection hormone microcapsule sterilized powder adopts epoxyethane sterilization, conditions for sterilization is: 30～45 ℃, 48 hours, residual ethylene oxide content was less than 5ppm.
10. according to the application of the injection of claim 1, it is characterized in that microcapsule is suspended in the sterilization liquor back and injects in the body injecting method: intramuscular injection.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 95111394 CN1126589A (en) | 1995-06-09 | 1995-06-09 | Injecta of delayed hormone microcapsule and its prepn |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 95111394 CN1126589A (en) | 1995-06-09 | 1995-06-09 | Injecta of delayed hormone microcapsule and its prepn |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1126589A true CN1126589A (en) | 1996-07-17 |
Family
ID=5078691
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 95111394 Pending CN1126589A (en) | 1995-06-09 | 1995-06-09 | Injecta of delayed hormone microcapsule and its prepn |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1126589A (en) |
Cited By (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1999059551A1 (en) * | 1998-05-15 | 1999-11-25 | Merck Patent Gmbh | Pharmaceutical preparation containing levothyroxine sodium |
| CN1323604C (en) * | 2005-10-26 | 2007-07-04 | 中国农业科学院饲料研究所 | Vine tea flavone micro capsule and its preparing method |
| CN100358511C (en) * | 2005-09-28 | 2008-01-02 | 浙江大学 | Oil-soluble medicine degradable polymer microcapsule injecta and preparing method |
| CN100364517C (en) * | 2005-09-28 | 2008-01-30 | 浙江大学 | Water-soluble medicine degradable polymer microcapsule injecta and preparing method |
| US7785632B2 (en) | 2003-09-15 | 2010-08-31 | Ordway Research Institute, Inc. | Thyroid hormone analogs and methods of use |
| US8071134B2 (en) | 2003-09-15 | 2011-12-06 | Ordway Research Institute, Inc. | Thyroid hormone analogs and methods of use |
| US8668926B1 (en) | 2003-09-15 | 2014-03-11 | Shaker A. Mousa | Nanoparticle and polymer formulations for thyroid hormone analogs, antagonists, and formulations thereof |
| US8802240B2 (en) | 2011-01-06 | 2014-08-12 | Nanopharmaceuticals Llc | Uses of formulations of thyroid hormone analogs and nanoparticulate forms thereof to increase chemosensitivity and radiosensitivity in tumor or cancer cells |
| US9180107B2 (en) | 2009-03-31 | 2015-11-10 | Nanopharmaceuticals Llc | Combination treatment of cancer with cetuximab and tetrac |
| US9198887B2 (en) | 2003-09-15 | 2015-12-01 | Nanopharmaceuticals Llc | Thyroid hormone analogs and methods of use |
| US9220788B2 (en) | 2009-06-17 | 2015-12-29 | Nanopharmaceuticals Llc | Nanoparticle and polymer formulations for thyroid hormone analogs, antagonists, and formulations and uses thereof |
| US9272049B2 (en) | 2005-09-16 | 2016-03-01 | Nanopharmaceuticals Llc | Methods of stimulating fat mobilization using a polymer conjugated polyphenol |
| US9289395B2 (en) | 2006-12-22 | 2016-03-22 | Nanopharmaceuticals Llc | Nanoparticle and polymer formulations for thyroid hormone analogs, antagonists, and formulations and uses thereof |
| US9498536B2 (en) | 2005-09-15 | 2016-11-22 | Nanopharmaceuticals Llc | Method and composition of thyroid hormone analogues and nanoformulations thereof for treating anti-inflammatory disorders |
| US10130686B2 (en) | 2005-09-15 | 2018-11-20 | Nanopharmaceuticals Llc | Method and composition of thyroid hormone analogues and nanoformulations thereof for treating inflammatory disorders |
| US10201616B2 (en) | 2016-06-07 | 2019-02-12 | Nanopharmaceuticals, Llc | Non-cleavable polymer conjugated with αVβ3 integrin thyroid antagonists |
| US10328043B1 (en) | 2018-04-11 | 2019-06-25 | Nanopharmaceuticals, Llc. | Composition and method for dual targeting in treatment of neuroendocrine tumors |
| US10961204B1 (en) | 2020-04-29 | 2021-03-30 | Nanopharmaceuticals Llc | Composition of scalable thyrointegrin antagonists with improved blood brain barrier penetration and retention into brain tumors |
| US11351137B2 (en) | 2018-04-11 | 2022-06-07 | Nanopharmaceuticals Llc | Composition and method for dual targeting in treatment of neuroendocrine tumors |
| US11723888B2 (en) | 2021-12-09 | 2023-08-15 | Nanopharmaceuticals Llc | Polymer conjugated thyrointegrin antagonists |
-
1995
- 1995-06-09 CN CN 95111394 patent/CN1126589A/en active Pending
Cited By (29)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6646007B1 (en) | 1998-05-15 | 2003-11-11 | Merck Patent Gmbh | Process for preparing a pharmaceutical formulation containing levothyroxine sodium |
| WO1999059551A1 (en) * | 1998-05-15 | 1999-11-25 | Merck Patent Gmbh | Pharmaceutical preparation containing levothyroxine sodium |
| US8008349B2 (en) | 1998-05-15 | 2011-08-30 | Merck Patent Gmbh | Stable pharmaceutical preparation comprising levothyroxine sodium, gelatin and fillers and which is free of organic solvent residues |
| US9198887B2 (en) | 2003-09-15 | 2015-12-01 | Nanopharmaceuticals Llc | Thyroid hormone analogs and methods of use |
| US9980933B2 (en) | 2003-09-15 | 2018-05-29 | Nanopharmaceuticals Llc | Thyroid hormone analogs and methods of use |
| US9750709B2 (en) | 2003-09-15 | 2017-09-05 | Nanopharmaceuticals Llc | Nanoparticle and polymer formulations for thyroid hormone analogs, antagonists, and formulations thereof |
| US7785632B2 (en) | 2003-09-15 | 2010-08-31 | Ordway Research Institute, Inc. | Thyroid hormone analogs and methods of use |
| US8071134B2 (en) | 2003-09-15 | 2011-12-06 | Ordway Research Institute, Inc. | Thyroid hormone analogs and methods of use |
| US8518451B2 (en) | 2003-09-15 | 2013-08-27 | Albany College of Pharmacy and Health Services | Thyroid hormone analogs and methods of use |
| US8668926B1 (en) | 2003-09-15 | 2014-03-11 | Shaker A. Mousa | Nanoparticle and polymer formulations for thyroid hormone analogs, antagonists, and formulations thereof |
| US9579300B2 (en) | 2003-09-15 | 2017-02-28 | Nanopharmaceuticals Llc | Nanoparticle and polymer formulations for thyroid hormone analogs, antagonists, and formulations thereof |
| US10130686B2 (en) | 2005-09-15 | 2018-11-20 | Nanopharmaceuticals Llc | Method and composition of thyroid hormone analogues and nanoformulations thereof for treating inflammatory disorders |
| US9498536B2 (en) | 2005-09-15 | 2016-11-22 | Nanopharmaceuticals Llc | Method and composition of thyroid hormone analogues and nanoformulations thereof for treating anti-inflammatory disorders |
| US9272049B2 (en) | 2005-09-16 | 2016-03-01 | Nanopharmaceuticals Llc | Methods of stimulating fat mobilization using a polymer conjugated polyphenol |
| CN100358511C (en) * | 2005-09-28 | 2008-01-02 | 浙江大学 | Oil-soluble medicine degradable polymer microcapsule injecta and preparing method |
| CN100364517C (en) * | 2005-09-28 | 2008-01-30 | 浙江大学 | Water-soluble medicine degradable polymer microcapsule injecta and preparing method |
| CN1323604C (en) * | 2005-10-26 | 2007-07-04 | 中国农业科学院饲料研究所 | Vine tea flavone micro capsule and its preparing method |
| US9289395B2 (en) | 2006-12-22 | 2016-03-22 | Nanopharmaceuticals Llc | Nanoparticle and polymer formulations for thyroid hormone analogs, antagonists, and formulations and uses thereof |
| US9180107B2 (en) | 2009-03-31 | 2015-11-10 | Nanopharmaceuticals Llc | Combination treatment of cancer with cetuximab and tetrac |
| US9220788B2 (en) | 2009-06-17 | 2015-12-29 | Nanopharmaceuticals Llc | Nanoparticle and polymer formulations for thyroid hormone analogs, antagonists, and formulations and uses thereof |
| US9839614B2 (en) | 2009-06-17 | 2017-12-12 | Nanopharmaceuticals, Llc | Nanoparticle and polymer formulations for thyroid hormone analogs, antagonists, and formulations and uses thereof |
| US8802240B2 (en) | 2011-01-06 | 2014-08-12 | Nanopharmaceuticals Llc | Uses of formulations of thyroid hormone analogs and nanoparticulate forms thereof to increase chemosensitivity and radiosensitivity in tumor or cancer cells |
| US10201616B2 (en) | 2016-06-07 | 2019-02-12 | Nanopharmaceuticals, Llc | Non-cleavable polymer conjugated with αVβ3 integrin thyroid antagonists |
| US10328043B1 (en) | 2018-04-11 | 2019-06-25 | Nanopharmaceuticals, Llc. | Composition and method for dual targeting in treatment of neuroendocrine tumors |
| US11077082B2 (en) | 2018-04-11 | 2021-08-03 | Nanopharmaceuticals, Llc | Composition and method for dual targeting in treatment of neuroendocrine tumors |
| US11351137B2 (en) | 2018-04-11 | 2022-06-07 | Nanopharmaceuticals Llc | Composition and method for dual targeting in treatment of neuroendocrine tumors |
| US10961204B1 (en) | 2020-04-29 | 2021-03-30 | Nanopharmaceuticals Llc | Composition of scalable thyrointegrin antagonists with improved blood brain barrier penetration and retention into brain tumors |
| US11186551B2 (en) | 2020-04-29 | 2021-11-30 | Nanopharmaceuticals Llc | Composition of scalable thyrointegrin antagonists with improved retention in tumors |
| US11723888B2 (en) | 2021-12-09 | 2023-08-15 | Nanopharmaceuticals Llc | Polymer conjugated thyrointegrin antagonists |
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