CN107913252A - A kind of growth hormone release inhibiting hormone powder-injection composition and its preparation process - Google Patents
A kind of growth hormone release inhibiting hormone powder-injection composition and its preparation process Download PDFInfo
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- CN107913252A CN107913252A CN201610883754.5A CN201610883754A CN107913252A CN 107913252 A CN107913252 A CN 107913252A CN 201610883754 A CN201610883754 A CN 201610883754A CN 107913252 A CN107913252 A CN 107913252A
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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
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
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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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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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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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
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Abstract
The invention discloses a kind of growth hormone release inhibiting hormone powder-injection composition and its preparation process, which includes：Growth hormone release inhibiting hormone, lyophilized carrier or excipient, freeze-drying injection part overlay film chlorinated butyl rubber bung.Growth hormone release inhibiting hormone is mixed with lyophilized carrier or excipient, and adds appropriate water for injection stirring and dissolving；Activated carbon stirring, filtering are added, acid-base modifier is added and adjusts pH value, inject water to prescribed volume, dispense；Packing half tamponade of product is put into freeze drier and is freeze-dried；Nitrogen charging tamponade outlet.The present invention significantly inhibits pH change of the growth hormone release inhibiting hormone during freeze-dried powder is prepared into and in finished product preservation for a long time, effectively increase the stability of freeze drying powder injection, 25 DEG C of room temperature are realized to preserve for a long time, shorten freeze-drying time, a large amount of energy consumptions have been saved, have significantly reduced production cost, finished product good forming ability, it is neat and artistic without atrophy.
Description
Technical field
The present invention relates to pharmaceutical technology field, is specifically a kind of growth hormone release inhibiting hormone powder-injection composition and its preparation process.
Background technology
Growth hormone release inhibiting hormone (growth hormone release-inhibiting hormone, growth hormone release-inlease-inhibiting
Hormone GHRIH, or somatostatin are by the tetradecapeptide of the macromolecular peptide cracking of 116 amino acid, its molecule
Structure is annular in shape.
Growth hormone release inhibiting hormone is that a kind of existing endogenous adjusts hormone in human body, is mainly had to a variety of physiological actions extensive
The outer secretion of inhibitory action, such as suppression, gastroenteritic power, internal organ are bled.Late nineteen seventies, Xue Lannuo companies of Switzerland are closed using biology
The tetradecapeptide somatostatin that there is identical chemical constitution and bioactivity with spontaneous growth chalone is obtained into method, and is developed into business
Product (trade name：/Stilamin)。
Growth hormone release inhibiting hormone is artificial synthesized tetradecapeptide, and the peptide bond stability in its molecule is poor, in injection growth hormone release inhibiting hormone
State's pharmacopeia version typical shelf condition in 2015 preserves for cold place.Injection growth hormone release inhibiting hormone (the trade name of Xue Lannuo companies of Switzerland：) using ampoule as interior packaging material, ampoule break when in use it is disconnected during, it is easy to produce chips of glass, pollute medicine
Liquid, there are safe mass risk.
The content of the invention
Stability is improved it is an object of the invention to provide one kind, shortens freeze-drying time, production cost, finished product is greatly reduced
Good forming ability, the growth hormone release inhibiting hormone powder-injection composition without atrophy and its preparation process, to solve to propose in above-mentioned background technology
The problem of.
To achieve the above object, the present invention provides following technical solution：
A kind of growth hormone release inhibiting hormone powder-injection composition, including：Growth hormone release inhibiting hormone, lyophilized carrier or excipient, freeze-drying injection
With local overlay film chlorinated butyl rubber bung.
As the further scheme of the present invention：The lyophilized carrier or excipient uses glycine, glycine it is basic
Depending on growth hormone release inhibiting hormone dosage, the amount ranges of glycine are dosage：Every bottle of 3-50mg, the specification of growth hormone release inhibiting hormone is every bottle respectively
Containing 0.25mg, 0.75mg, 2mg and 3mg.
As the further scheme of the present invention：The dosage of glycine is every bottle of 5-20mg.
As the further scheme of the present invention：The dosage of glycine is every bottle of 10mg.
As the further scheme of the present invention：Injection part overlay film brombutyl is freeze-dried using freeze-drying
Injection locally covers polytetrafluoroethylene film chlorinated butyl rubber bung.
Another object of the present invention is to provide a kind of preparation process of growth hormone release inhibiting hormone powder-injection composition, comprises the following steps：
(1) growth hormone release inhibiting hormone is mixed with lyophilized carrier or excipient, and adds appropriate water for injection stirring and dissolving；
(2) activated carbon stirring is added, filtering, adds acid-base modifier and adjusts pH value, inject water to prescribed volume, point
Dress；
(3) packing half tamponade of product is put into freeze drier and is freeze-dried；
(4) nitrogen charging tamponade outlet.
As the further scheme of the present invention：The step of freeze-drying, includes：
1) pre-freeze：Refrigeration is opened, heat conduction oil temperature is reached -45~-40 DEG C, when insulation 2-6 is small；
2) parsing-desiccation：Open vacuum pump to start to distil, slowly raise heat conduction oil temperature to -15~0 DEG C, keep the temperature to water-line
Be wholly absent, continue insulation 2 it is small when；
3) redrying：Continue to raise heat conduction oil temperature to 15~-25 DEG C, when insulation 2-5 is small.
As the further scheme of the present invention：The scope of pH value is 3.5-6.5.
As the further scheme of the present invention：Acid-base modifier is using sodium hydroxide, potassium hydroxide, phosphate, sulfuric acid, vinegar
One kind or any combination in acid and hydrochloric acid.
As the further scheme of the present invention：Acid-base modifier uses acetum.
Compared with prior art, the beneficial effects of the invention are as follows：
The growth hormone release inhibiting hormone powder-injection composition of the present invention, significantly inhibits growth hormone release inhibiting hormone during freeze-dried powder is prepared into
And the pH changes in finished product preservation for a long time, the stability of freeze drying powder injection is effectively increased, 25 DEG C of room temperature is realized and preserves for a long time.
Meanwhile using in neutral boron silica glass tubular injection bottle and the chlorinated butyl rubber bung conduct of freeze-drying injection part overlay film
Packaging material, solve ampoule as interior packaging material break it is disconnected during, easily produce chips of glass, pollute liquid, there are safe mass
Problem.The present invention additionally uses special freeze drying process, and freezing curve is easy to grasp, and accelerates water sublimed, shortens jelly
The dry time, a large amount of energy consumptions are saved, significantly reduced production cost, finished product good forming ability, no atrophy is neat and artistic.
Embodiment
Below in conjunction with the embodiment of the present invention, the technical solution in the embodiment of the present invention is clearly and completely described,
Obviously, described embodiment is only part of the embodiment of the present invention, instead of all the embodiments.Based in the present invention
Embodiment, those of ordinary skill in the art's all other embodiments obtained without making creative work, all
Belong to the scope of protection of the invention.
Embodiment 1
A kind of growth hormone release inhibiting hormone powder-injection composition, prescription：
Growth hormone release inhibiting hormone 0.25g
Glycine 10g
Water for injection adds to 1000ml, is made 1000.
A kind of preparation process of growth hormone release inhibiting hormone powder-injection composition：
(1) growth hormone release inhibiting hormone and glycine for weighing recipe quantity are put in Agitation Tank, add 80% water for injection stirring and dissolving,
PH value is surveyed, pH to 3.5-5.5 is adjusted with the acetum of 1mol/L.
(2) add 0.05% (w/v) activated carbon to stir 30 minutes, filtering, takes off charcoal.
(3) water for injection is added to full dose, is stirred evenly, is taken intermediate to detect.
(4) intermediate after the assay was approved, through 0.22 μm of polyether sulfone filter element filtering, is sub-packed in 2ml neutral boron silica glass control
In injection bottle, freeze-drying injection locally covers half tamponade of polytetrafluoroethylene film chlorinated butyl rubber bung.
(5) sample is put in freeze drier, opens refrigeration, heat conduction oil temperature is reached -45 DEG C~-40 DEG C, insulation 3 is small
When, open vacuum pump and start to distil, 15 DEG C/h rise shelf temperature to -10 DEG C, and -10 DEG C keep to watermark disappearing, and keep the temperature to watermark
Line is wholly absent, continue insulation 2 it is small when, vacuum maintains 10-20Pa.10 DEG C/h rise shelf temperature to 15 DEG C, remain true
Empty 10-20Pa, keep 4 it is small when after stop vacuum control (no longer aeration, vacuum are set to 0Pa), continue to keep dry to true
Shut down when space-variantization is little, inflated with nitrogen, tamponade, roll lid.
Embodiment 2
A kind of growth hormone release inhibiting hormone powder-injection composition, prescription：
Growth hormone release inhibiting hormone 0.75g
Glycine 10g
Water for injection adds to 1000ml, is made 1000.
A kind of preparation process of growth hormone release inhibiting hormone powder-injection composition：
(1) growth hormone release inhibiting hormone and glycine for weighing recipe quantity are put in Agitation Tank, add 80% water for injection stirring and dissolving,
PH value is surveyed, pH to 3.5-5.5 is adjusted with the acetum of 1mol/L.
(2) add 0.05% (w/v) activated carbon to stir 30 minutes, filtering, takes off charcoal.
(3) water for injection is added to full dose, is stirred evenly, is taken intermediate to detect.
(4) intermediate after the assay was approved, through 0.22 μm of polyether sulfone filter element filtering, is sub-packed in 2ml neutral boron silica glass control
In injection bottle, freeze-drying injection locally covers half tamponade of polytetrafluoroethylene film chlorinated butyl rubber bung.
(5) sample is put in freeze drier, opens refrigeration, heat conduction oil temperature is reached -45 DEG C~-40 DEG C, insulation 3 is small
When, open vacuum pump and start to distil, 15 DEG C/h rise shelf temperature to -10 DEG C, and -10 DEG C keep to watermark disappearing, and keep the temperature to watermark
Line is wholly absent, continue insulation 2 it is small when, vacuum maintains 10-20Pa.10 DEG C/h rise shelf temperature to 15 DEG C, remain true
Empty 10-20Pa, keep 4 it is small when after stop vacuum control (no longer aeration, vacuum are set to 0Pa), continue to keep dry to true
Shut down when space-variantization is little, inflated with nitrogen, tamponade, roll lid.
Embodiment 3
A kind of growth hormone release inhibiting hormone powder-injection composition, prescription：
Growth hormone release inhibiting hormone 3.0g
Glycine 10g
Water for injection adds to 1000ml, is made 1000.
A kind of preparation process of growth hormone release inhibiting hormone powder-injection composition：
(1) growth hormone release inhibiting hormone and glycine for weighing recipe quantity are put in Agitation Tank, add 80% water for injection stirring and dissolving,
PH value is surveyed, pH to 3.5-5.5 is adjusted with the acetum of 1mol/L.
(2) add 0.05% (w/v) activated carbon to stir 30 minutes, filtering, takes off charcoal.
(3) water for injection is added to full dose, is stirred evenly, is taken intermediate to detect.
(4) intermediate after the assay was approved, through 0.22 μm of polyether sulfone filter element filtering, is sub-packed in 2ml neutral boron silica glass control
In injection bottle, freeze-drying injection locally covers half tamponade of polytetrafluoroethylene film chlorinated butyl rubber bung.
(5) sample is put in freeze drier, opens refrigeration, heat conduction oil temperature is reached -45 DEG C~-40 DEG C, insulation 3 is small
When, open vacuum pump and start to distil, 15 DEG C/h rise shelf temperature to -10 DEG C, and -10 DEG C keep to watermark disappearing, and keep the temperature to watermark
Line is wholly absent, continue insulation 2 it is small when, vacuum maintains 10-20Pa.10 DEG C/h rise shelf temperature to 15 DEG C, remain true
Empty 10-20Pa, keep 4 it is small when after stop vacuum control (no longer aeration, vacuum are set to 0Pa), continue to keep dry to true
Shut down when space-variantization is little, inflated with nitrogen, tamponade, roll lid.
Comparative example 1-3
The prescription and packaging material of the growth hormone release inhibiting hormone powder-injection of comparative example 1-3 are shown in Table 1, the preparation method embodiment of comparative example 1-3
1。
Table 1
【Note】：Comparative example 1 has listed the prescription and packaging material of growth hormone release inhibiting hormone powder-injection for domestic manufacturer.
The stability study of 4 present composition freeze-drying process of embodiment and finished product
The change of acidity in high spot reviews freezing dry process, while according to《Chinese Pharmacopoeia version in 2015》General rule 9001 is former
Expect that medicine carries out growth hormone release inhibiting hormone powder-injection composition study on the stability with preparation stability guideline.
Placement condition：25 DEG C ± 2 DEG C of long term test, relative humidity 65 ± 5%.
Investigate the change of acidity in embodiment 1-3, comparative example 1-3 freezing dry process, and by the growth hormone release inhibiting hormone powder of preparation
Injection finished product carries out long term test investigation, the results are shown in Table 2.
Table 2
By table 2 as it can be seen that the growth hormone release inhibiting hormone powder-injection composition of the present invention effectively reduces acidity in freezing dry process
Change, at 0 month, embodiment material related with comparative example is almost identical, but in long term test embodiment catabolite amount it is far low
In comparative example.
By the way that compared with the comparative example of single-factor variable, growth hormone release inhibiting hormone powder-injection composition of the invention significantly improves life
The stability of long chalone powder-injection, realizes 25 DEG C of room temperature and preserves for a long time, while improves the security of packaging material.
It is obvious to a person skilled in the art that the invention is not restricted to the details of above-mentioned one exemplary embodiment, Er Qie
In the case of without departing substantially from spirit or essential attributes of the invention, the present invention can be realized in other specific forms.Therefore, no matter
From the point of view of which point, the present embodiments are to be considered as illustrative and not restrictive, and the scope of the present invention is by appended power
Profit requires rather than described above limits, it is intended that all in the implication and scope of the equivalency of claim by falling
Change is included in the present invention.
Moreover, it will be appreciated that although the present specification is described in terms of embodiments, not each embodiment is only wrapped
Containing an independent technical solution, this narrating mode of specification is only that those skilled in the art should for clarity
Using specification as an entirety, the technical solutions in the various embodiments may also be suitably combined, forms those skilled in the art
It is appreciated that other embodiment.
Claims (10)
- A kind of 1. growth hormone release inhibiting hormone powder-injection composition, it is characterised in that including：Growth hormone release inhibiting hormone, lyophilized carrier or excipient, freezing The local overlay film chlorinated butyl rubber bung of dry injection.
- 2. growth hormone release inhibiting hormone powder-injection composition according to claim 1, it is characterised in that the lyophilized carrier or figuration Agent uses glycine, and depending on growth hormone release inhibiting hormone dosage, the amount ranges of glycine are the basic dosage of glycine：Every bottle of 3- 50mg, the specification of growth hormone release inhibiting hormone are respectively every bottle and contain 0.25mg, 0.75mg, 2mg and 3mg.
- 3. growth hormone release inhibiting hormone powder-injection composition according to claim 2, it is characterised in that the dosage of glycine is every bottle of 5- 20mg。
- 4. growth hormone release inhibiting hormone powder-injection composition according to claim 3, it is characterised in that the dosage of glycine is every bottle 10mg。
- 5. growth hormone release inhibiting hormone powder-injection composition according to claim 1, it is characterised in that freeze-drying injection is locally covered Film brombutyl locally covers polytetrafluoroethylene film chlorinated butyl rubber bung using freeze-drying injection.
- A kind of 6. preparation process of growth hormone release inhibiting hormone powder-injection composition as described in claim 1-5 is any, it is characterised in that bag Include following steps：(1) growth hormone release inhibiting hormone is mixed with lyophilized carrier or excipient, and adds appropriate water for injection stirring and dissolving；(2) activated carbon stirring is added, filtering, adds acid-base modifier and adjust pH value, inject water to prescribed volume, dispense；(3) packing half tamponade of product is put into freeze drier and is freeze-dried；(4) nitrogen charging tamponade outlet.
- 7. the preparation process of growth hormone release inhibiting hormone powder-injection composition according to claim 6, it is characterised in that freeze-drying Step includes：1) pre-freeze：Refrigeration is opened, heat conduction oil temperature is reached -45~-40 DEG C, when insulation 2-6 is small；2) parsing-desiccation：Open vacuum pump to start to distil, slowly raise heat conduction oil temperature to -15~0 DEG C, keep the temperature complete to water-line Disappear, continue insulation 2 it is small when；3) redrying：Continue to raise heat conduction oil temperature to 15~-25 DEG C, when insulation 2-5 is small.
- 8. the preparation process of growth hormone release inhibiting hormone powder-injection composition according to claim 6, it is characterised in that the scope of pH value For 3.5-6.5.
- 9. the preparation process of growth hormone release inhibiting hormone powder-injection composition according to claim 6, it is characterised in that acid-base modifier Using one kind or any combination in sodium hydroxide, potassium hydroxide, phosphate, sulfuric acid, acetate and hydrochloride.
- 10. the preparation process of growth hormone release inhibiting hormone powder-injection composition according to claim 9, it is characterised in that acid-base accommodation Agent uses acetum.
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| CN201610883754.5A CN107913252A (en) | 2016-10-10 | 2016-10-10 | A kind of growth hormone release inhibiting hormone powder-injection composition and its preparation process |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108057022A (en) * | 2016-11-09 | 2018-05-22 | 山东美泰医药有限公司 | A kind of growth hormone release inhibiting hormone powder-injection composition and its preparation process |
| CN114146164A (en) * | 2021-12-09 | 2022-03-08 | 海南皇隆制药股份有限公司 | Somatostatin preparation for injection and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011059779A2 (en) * | 2009-10-29 | 2011-05-19 | Lucia Irene Gonzalez | Ligand-targeted multi- stereoisomer peptide polymer conjugates and uses thereof |
| CN103222963A (en) * | 2013-05-24 | 2013-07-31 | 成都天台山制药有限公司 | Somatostatin freeze-dried powder injection |
-
2016
- 2016-10-10 CN CN201610883754.5A patent/CN107913252A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011059779A2 (en) * | 2009-10-29 | 2011-05-19 | Lucia Irene Gonzalez | Ligand-targeted multi- stereoisomer peptide polymer conjugates and uses thereof |
| CN103222963A (en) * | 2013-05-24 | 2013-07-31 | 成都天台山制药有限公司 | Somatostatin freeze-dried powder injection |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108057022A (en) * | 2016-11-09 | 2018-05-22 | 山东美泰医药有限公司 | A kind of growth hormone release inhibiting hormone powder-injection composition and its preparation process |
| CN114146164A (en) * | 2021-12-09 | 2022-03-08 | 海南皇隆制药股份有限公司 | Somatostatin preparation for injection and preparation method thereof |
| CN114146164B (en) * | 2021-12-09 | 2023-05-23 | 海南皇隆制药股份有限公司 | Somatostatin preparation for injection and preparation method thereof |
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Application publication date: 20180417 |