CN110215433A - A kind of cloprostenol injection and preparation method thereof - Google Patents
A kind of cloprostenol injection and preparation method thereof Download PDFInfo
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- CN110215433A CN110215433A CN201910639349.2A CN201910639349A CN110215433A CN 110215433 A CN110215433 A CN 110215433A CN 201910639349 A CN201910639349 A CN 201910639349A CN 110215433 A CN110215433 A CN 110215433A
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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
- A61K31/557—Eicosanoids, e.g. leukotrienes or prostaglandins
- A61K31/5575—Eicosanoids, e.g. leukotrienes or prostaglandins having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
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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
- A61K47/02—Inorganic compounds
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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
- A61K47/08—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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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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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- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
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- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Pregnancy & Childbirth (AREA)
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- Gynecology & Obstetrics (AREA)
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a kind of cloprostenol injection, the component comprising following content: cloprostenol 0.161mg/mL, dehydrated alcohol 10-100mg/mL, pH adjusting agent, surplus are water for injection;The pH adjusting agent is used to adjust the pH value of injection, which is sodium hydroxide solution or/and acetic acid solution, and the dosage of pH adjusting agent, which is subject to, adjusts the pH value of injection to 7.3~8.3.The cloprostenol injection the preparation method comprises the following steps: according to dosage prepare raw material components, cloprostenol is added in dehydrated alcohol and dissolves and stirs evenly, the mixed liquor of the two is added to again and is cooled in 30 DEG C of waters for injection below, it stirs evenly, pH to 7.8 ± 0.5 is adjusted with pH adjusting agent, water for injection constant volume is used again, then 20~40min is stirred with the mixing speed of 300~350rpm, it is filtered using sterilising filter, then filling in ampoule bottle, sealing, sterilizing, obtains cloprostenol injection.The cloprostenol injection supplementary material is single, good stability, high-quality, can effectively improve female livestock breed fertility quality.
Description
Technical field
The invention belongs to veterinary drug technical field, in particular to a kind of cloprostenol injection and preparation method thereof.
Background technique
The oestrus of different dams and delivery time difference under field conditions (factors), which greatly enhances the lifes of large-scale plant that raises
Produce management difficulty, workload and cost.In actual production, the mistake of a group dam heat is controlled and adjusted frequently with drug
Journey is allowed to heat within the predetermined time, to carry out large-scale artificial insemination and embryo transfer, or is induced using drug
The childbirth of the dam same period, avoids night from farrowing.Drug-induced dam estrus synchronization and same period childbirth have become intensive aquaculture industry
One important subject.
In order to avoid the total quality of commodity animals is farrowed and effectively improved to night, it is difficult that this is solved frequently with same period childbirth
Topic.Pregnant dam childbirth is related with the change of progesterone and prostaglandin level in its internal peripheral blood, and a large number of experiments studies table
It is bright, good effect can be obtained with the induction dam same period childbirth of exogenous prostaglandin and the like Cloprostenol,
Dam can not only be made to concentrate childbirth within a certain period of time, be convenient for intensive production management;Meanwhile because avoiding in spontaneous labor
Phenomenon is produced late, concentrates wean convenient for the dam in the same breeding period, carries out all-in and all-out, it is unified to enter next breeding week
Phase effectively improves breeding potential.
Natural prostaglandins are unsuitable in actual production due to the features such as stability of molecule is poor, bioactivity range is wide
Using.In husbandry sector, the salt or artificial synthesized analog of prostaglandin are generally used, they often compare natural hormone
Have many advantages, such as long action time, bioactivity height and Small side effects.Cloprostenol is that a kind of artificial synthesized PGF2a is similar
Object, biological action is similar to prostaglandin, has powerful dissolution corpus luteum effect, and cause corpus luteum to subside rapidly, inhibits it
Secretion makes the generation of progesterone reduce and stop, promoting heat.Cloprostenol also has directly excited make to uterine smooth muscle simultaneously
With uterine smooth muscle and galactophore epithelial cell being caused to shrink, cervix relaxation participates in childbirth and lactation process.Clinic is available
In treatment standby dam long it is out of heat, wean dam it is out of heat, induction the dam same period childbirth etc..
Summary of the invention
In order to solve the above technical problems, the purpose of the present invention is to provide a kind of cloprostenol injection and its preparation sides
Method, the cloprostenol injection supplementary material is single, good stability, high-quality, can effectively improve female livestock breed fertility quality.
To realize above-mentioned technical purpose and the technique effect, the invention is realized by the following technical scheme: a kind of chlorine
Forefront alcohol injection, the component comprising following content: cloprostenol 0.161mg/mL, dehydrated alcohol 10-100mg/mL, pH adjusting
Agent, surplus are water for injection;
The pH adjusting agent is used to adjust the pH value of injection, which is sodium hydroxide solution or/and acetic acid solution,
The dosage of pH adjusting agent, which is subject to, adjusts the pH value of injection to 7.3~8.3.
Preferably, the component of the cloprostenol infusion pump containing following content: cloprostenol 0.161mg/mL, anhydrous second
Alcohol 10mg/mL, pH adjusting agent, surplus are water for injection;The pH adjusting agent is used to adjust the pH value of injection, which is
Sodium hydroxide solution or/and acetic acid solution, the dosage of pH adjusting agent, which is subject to, adjusts the pH value of injection to 7.6~8.0.
The present invention also provides a kind of preparation methods of cloprostenol injection, comprising the following steps:
Prepare raw material components according to dosage, cloprostenol is added in dehydrated alcohol and dissolves and stirs evenly, then by chlorine
The mixed liquor of the pure and mild dehydrated alcohol in forefront, which is added to, to be cooled in 30 DEG C of waters for injection below, is stirred evenly, is used pH adjusting agent
PH to 7.8 ± 0.5 is adjusted, then with 30 DEG C of water for injection constant volumes below are cooled to, then with the mixing speed of 300~350rpm
20~40min is stirred, sterilising filter filtering is then passed through, it is then filling in ampoule bottle, it seals, sterilizing obtains cloprostenol
Injection.
Wherein, the condition of the sterilizing are as follows:It sterilizes under the conditions of temperature
Further, which further includes ampoule bottle treatment process, the process are as follows: ampoule bottle is first utilized injection
Water is cleaned through ultrasonic cleaning machine, thenSterilizing is dried under the conditions of temperature.
Preferably, the filtering accuracy of the sterilising filter is 0.22um.
The beneficial effects of the present invention are: any extra ingredient, bill of material are not added in cloprostenol injection of the invention
One, avoid complicated component from influencing main function;The present invention uses cloprostenol for major ingredient, and dehydrated alcohol is auxiliary material, major ingredient and auxiliary
Expect that compatibility is good, can effectively ensure that the stability of product, major ingredient and auxiliary material play synergistic effect, atrophy of corpus iuteum promoted to degenerate, and promote
Feelings of setting out and ovulation, while uterus and the young baby of animal are protected, improve breeding fertility quality;Preparation method of the invention is simple,
It is easy to operate, it can be achieved that sterile production, stable product quality obtained, and be applicable to industrialized production.
Specific embodiment
The preferred embodiments of the present invention will be described in detail below so that advantages and features of the invention can be easier to by
It will be appreciated by those skilled in the art that so as to make a clearer definition of the protection scope of the present invention.
Embodiment
EmbodimentFor the formulation Example of cloprostenol injection.
Embodiment 1
A kind of cloprostenol injection, the component comprising following content: cloprostenol 0.161mg/mL, dehydrated alcohol
10mg/mL, pH adjusting agent, surplus are water for injection;
The pH adjusting agent is used to adjust the pH value of injection, which is sodium hydroxide solution or/and acetic acid solution,
The dosage of pH adjusting agent, which is subject to, adjusts the pH value of injection to 7.3~8.3.
Embodiment 2
A kind of cloprostenol injection, the component comprising following content: cloprostenol 0.161mg/mL, dehydrated alcohol
50mg/mL, pH adjusting agent, surplus are water for injection;
The pH adjusting agent is used to adjust the pH value of injection, which is sodium hydroxide solution or/and acetic acid solution,
The dosage of pH adjusting agent, which is subject to, adjusts the pH value of injection to 7.3~8.3.
Embodiment 3
A kind of cloprostenol injection, the component comprising following content: cloprostenol 0.161mg/mL, dehydrated alcohol
100mg/mL, pH adjusting agent, surplus are water for injection;
The pH adjusting agent is used to adjust the pH value of injection, which is sodium hydroxide solution or/and acetic acid solution,
The dosage of pH adjusting agent, which is subject to, adjusts the pH value of injection to 7.3~8.3.
By embodimentDissolution comparison, cloprostenol can effectively dissolve in the dehydrated alcohol of corresponding ratio,
Consider the adverse reaction that dehydrated alcohol amount is excessive in injection process, the dosage of dehydrated alcohol is determined as 10mg/mL.
EmbodimentFor the wash bottle embodiment in the preparation method of cloprostenol injection.
Embodiment 4
Ampoule bottle is got, after taking off outsourcing reason bottle, is sent between wash bottle, is cleaned using water for injection through ultrasonic cleaning machine,
Conveyer belt again through walking speed 50Hz enters the tunnel sterilization drying machine dry sterilization that bringing-up section temperature is 310 DEG C.
Embodiment 5
Ampoule bottle is got, after taking off outsourcing reason bottle, is sent between wash bottle, is cleaned using water for injection through ultrasonic cleaning machine,
Conveyer belt again through walking speed 50Hz enters the tunnel sterilization drying machine dry sterilization that bringing-up section temperature is 320 DEG C.
Embodiment 6
Ampoule bottle is got, after taking off outsourcing reason bottle, is sent between wash bottle, is cleaned using water for injection through ultrasonic cleaning machine,
Conveyer belt again through walking speed 50Hz enters the tunnel sterilization drying machine dry sterilization that bringing-up section temperature is 330 DEG C.
The ampoule bottle after sterilizing in embodiment 4-6 utilizes 320 DEG C of tunnel sterilization drying machine dry sterilizations through examining
Ampoule bottle process conditions are best, no microorganism detection.Determine the ampoule bottle treatment process in preparation method are as follows: first by ampoule bottle benefit
It is cleaned with water for injection through ultrasonic cleaning machine, then sterilizing is dried under the conditions of 320 DEG C of temperature.
Embodiment 7
Prepare raw material components by component, the content in embodiment 1, first utilizes water for injection through ultrasonic cleaning ampoule bottle
Machine cleaning, then sterilizing is dried under the conditions of 320 DEG C of temperature.It is equal that cloprostenol is added to dissolution stirring in dehydrated alcohol
It is even, then the mixed liquor of cloprostenol and dehydrated alcohol is added to and is cooled in 30 DEG C of waters for injection below, it stirs evenly, uses
PH adjusting agent adjusts pH to 7.3, then with 30 DEG C of water for injection constant volumes below are cooled to, then using agitating device with 350rpm
Mixing speed stir 30min;Then pass through the filtering of 0.22um sterilising filter, filling in ampoule bottle, sealing.
Embodiment 8
Prepare raw material components by component, the content in embodiment 1, first utilizes water for injection through ultrasonic cleaning ampoule bottle
Machine cleaning, then sterilizing is dried under the conditions of 320 DEG C of temperature.It is equal that cloprostenol is added to dissolution stirring in dehydrated alcohol
It is even, then the mixed liquor of cloprostenol and dehydrated alcohol is added to and is cooled in 30 DEG C of waters for injection below, it stirs evenly, uses
PH adjusting agent adjusts pH to 7.6, then with 30 DEG C of water for injection constant volumes below are cooled to, then using agitating device with 350rpm
Mixing speed stir 30min;Then pass through the filtering of 0.22um sterilising filter, filling in ampoule bottle, sealing.
Embodiment 9
Prepare raw material components by component, the content in embodiment 1, first utilizes water for injection through ultrasonic cleaning ampoule bottle
Machine cleaning, then sterilizing is dried under the conditions of 320 DEG C of temperature.It is equal that cloprostenol is added to dissolution stirring in dehydrated alcohol
It is even, then the mixed liquor of cloprostenol and dehydrated alcohol is added to and is cooled in 30 DEG C of waters for injection below, it stirs evenly, uses
PH adjusting agent adjusts pH to 8.0, then with 30 DEG C of water for injection constant volumes below are cooled to, then using agitating device with 350rpm
Mixing speed stir 30min;Then pass through the filtering of 0.22um sterilising filter, filling in ampoule bottle, sealing.
Implement 10
Prepare raw material components by component, the content in embodiment 1, first utilizes water for injection through ultrasonic cleaning ampoule bottle
Machine cleaning, then sterilizing is dried under the conditions of 320 DEG C of temperature.It is equal that cloprostenol is added to dissolution stirring in dehydrated alcohol
It is even, then the mixed liquor of cloprostenol and dehydrated alcohol is added to and is cooled in 30 DEG C of waters for injection below, it stirs evenly, uses
PH adjusting agent adjusts pH to 8.3, then with 30 DEG C of water for injection constant volumes below are cooled to, then using agitating device with 350rpm
Mixing speed stir 30min;Then pass through the filtering of 0.22um sterilising filter, filling in ampoule bottle, sealing.
To embodimentCloprostenol injection in the ampoule bottle of preparation carries out comparision contents, result such as table 2
It is shown.
1 embodiment of tableThe cloprostenol injection comparision contents result of preparation
Embodiment 11
The ampoule bottle for being filled with cloprostenol injection prepared by Example 8, carries out sterilization treatment, sterilising conditions to it
Are as follows: sterilize 20min under the conditions of 90 DEG C of temperature.
Embodiment 12
The ampoule bottle for being filled with cloprostenol injection prepared by Example 6, carries out sterilization treatment, sterilising conditions to it
Are as follows: sterilize 30min under the conditions of 90 DEG C of temperature.
Embodiment 13
The ampoule bottle for being filled with cloprostenol injection prepared by Example 6, carries out sterilization treatment, sterilising conditions to it
Are as follows: sterilize 40min under the conditions of 90 DEG C of temperature.
Embodiment 14
The ampoule bottle for being filled with cloprostenol injection prepared by Example 6, carries out sterilization treatment, sterilising conditions to it
Are as follows: sterilize 20min under the conditions of 100 DEG C of temperature.
Embodiment 15
The ampoule bottle for being filled with cloprostenol injection prepared by Example 6, carries out sterilization treatment, sterilising conditions to it
Are as follows: sterilize 30min under the conditions of 100 DEG C of temperature.
Embodiment 16
The ampoule bottle for being filled with cloprostenol injection prepared by Example 6, carries out sterilization treatment, sterilising conditions to it
Are as follows: sterilize 40min under the conditions of 100 DEG C of temperature.
Embodiment 17
The ampoule bottle for being filled with cloprostenol injection prepared by Example 6, carries out sterilization treatment, sterilising conditions to it
Are as follows: sterilize 20min under the conditions of 110 DEG C of temperature.
Embodiment 18
The ampoule bottle for being filled with cloprostenol injection prepared by Example 6, carries out sterilization treatment, sterilising conditions to it
Are as follows: sterilize 30min under the conditions of 110 DEG C of temperature.
Embodiment 19
The ampoule bottle for being filled with cloprostenol injection prepared by Example 6, carries out sterilization treatment, sterilising conditions to it
Are as follows: sterilize 40min under the conditions of 110 DEG C of temperature.
To embodimentCloprostenol injection after sterilizing carries out content and sterilization effect compares, the result is shown in
Table 2.
2 embodiment of tableCloprostenol injection liquid hold-up and sterilization effect comparison result after sterilizing
To embodimentCloprostenol injection liquid hold-up and sterilization effect in ampoule bottle after sterilizing are compared
Compared with, it sterilizes under the conditions of 90 DEG C of temperature, sterilization effect is not achieved, sterilize under the conditions of 110 DEG C of temperature, sterilizing
Temperature is high, and cloprostenol injection percentage composition is decreased obviously, and relative substance content rises.
The result of embodiment 15 is most stable, and sterilization effect is good.
The optimization formula of cloprostenol injection can be obtained according to the comparative test of the above various embodiments are as follows:
Cloprostenol: 0.161mg/mL,
Dehydrated alcohol: 10mg/mL,
PH adjusting agent,
Surplus is water for injection,
Wherein, pH adjusting agent is sodium hydroxide solution or/and acetic acid solution, dosage should adjust the pH value of injection to
7.8±0.2。
The cloprostenol injection optimal the preparation method comprises the following steps:
Prepare raw material components by recipe quantity, cloprostenol is added to dissolution in dehydrated alcohol and is stirred evenly, then will be before chlorine
The mixed liquor for arranging pure and mild dehydrated alcohol, which is added to, to be cooled in 30 DEG C of waters for injection below, is stirred evenly, with pH adjusting agent tune
PH to 7.8 ± 0.2, then with 30 DEG C of water for injection constant volumes below are cooled to, then using agitating device with the revolving speed of 350rpm
Stir 30min;The filtering of 0.22um sterilising filter is then passed through, it is filling in clear through ultrasonic cleaning machine using water for injection
It washes, then in the ampoule bottle that sterilizing is dried at a temperature of 320 DEG C, seals, sterilize 30min under the conditions of 100 DEG C of temperature, must go out
Cloprostenol injection after bacterium.
The above description is only an embodiment of the present invention, is not intended to limit the scope of the invention, all to utilize this hair
Equivalent structure or equivalent flow shift made by bright description is applied directly or indirectly in other relevant technology necks
Domain is included within the scope of the present invention.
Claims (6)
1. a kind of cloprostenol injection, which is characterized in that the component comprising following content: cloprostenol 0.161mg/mL, nothing
Water-ethanol 10-100mg/mL, pH adjusting agent, surplus are water for injection;
The PH regulator is used to adjust the pH value of injection, which is sodium hydroxide solution or/and acetic acid solution, pH tune
The dosage of section agent, which is subject to, adjusts the pH value of injection to 7.3~8.3.
2. a kind of cloprostenol injection according to claim 1, which is characterized in that the cloprostenol infusion pump contains
The component of following content: cloprostenol 0.161mg/mL, dehydrated alcohol 10mg/mL, pH adjusting agent, surplus are water for injection;
The pH adjusting agent is used to adjust the pH value of injection, which is sodium hydroxide solution or/and acetic acid solution, pH tune
The dosage of section agent, which is subject to, adjusts the pH value of injection to 7.6~8.0.
3. a kind of preparation method of cloprostenol injection as claimed in claim 1 or 2, which is characterized in that including following step
It is rapid:
Prepare raw material components according to dosage, cloprostenol is added in dehydrated alcohol and dissolves and stirs evenly, then by chlorine forefront
The mixed liquor of pure and mild dehydrated alcohol, which is added to, to be cooled in 30 DEG C of waters for injection below, is stirred evenly, is adjusted with pH adjusting agent
PH to 7.8 ± 0.5, then with 30 DEG C of water for injection constant volumes below are cooled to, then stirred with the mixing speed of 300~350rpm
20~40min then passes through sterilising filter filtering, then filling in ampoule bottle, seals, sterilizing, obtains cloprostenol injection
Liquid.
4. the preparation method of cloprostenol injection according to claim 3, which is characterized in that the condition of the sterilizing
Are as follows:It sterilizes under the conditions of temperature
5. the preparation method of cloprostenol injection according to claim 3, which is characterized in that the preparation method further includes
Ampoule bottle treatment process, the process are as follows: first ampoule bottle is cleaned using water for injection through ultrasonic cleaning machine, thenSterilizing is dried under the conditions of temperature.
6. the preparation method of cloprostenol injection according to claim 3, which is characterized in that the sterilising filter
Filtering accuracy is 0.22um.
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Cited By (2)
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CN112569340A (en) * | 2020-12-31 | 2021-03-30 | 苏州素仕生物科技有限公司 | Sterile buserelin injection and preparation method and application thereof |
CN113694181A (en) * | 2021-08-30 | 2021-11-26 | 苏州素仕生物科技有限公司 | Clrostinil sodium injection and preparation method thereof |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN112569340A (en) * | 2020-12-31 | 2021-03-30 | 苏州素仕生物科技有限公司 | Sterile buserelin injection and preparation method and application thereof |
CN113694181A (en) * | 2021-08-30 | 2021-11-26 | 苏州素仕生物科技有限公司 | Clrostinil sodium injection and preparation method thereof |
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