CN107362133B - Ciprofloxacin lactate injection and production method thereof - Google Patents

Ciprofloxacin lactate injection and production method thereof Download PDF

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CN107362133B
CN107362133B CN201710499517.3A CN201710499517A CN107362133B CN 107362133 B CN107362133 B CN 107362133B CN 201710499517 A CN201710499517 A CN 201710499517A CN 107362133 B CN107362133 B CN 107362133B
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injection
ciprofloxacin lactate
ciprofloxacin
lactate injection
volume ratio
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CN107362133A (en
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徐海鸥
张殿奎
薛磊
方泰云
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Beijing Lishida Pharmaceutical Co ltd
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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
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene
    • 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
    • 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
    • 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
    • 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

Abstract

The invention relates to a ciprofloxacin lactate injection and a production method thereof, wherein the method comprises the following steps: s1: adding 50-70% of the predetermined preparation volume of water for injection; s2: weighing a predetermined amount of ciprofloxacin lactate and adding the ciprofloxacin lactate into a preparation container; s3: adding lactic acid, propylene glycol, sodium chloride, sodium bisulfite and EDTA disodium into a preparation container, and completely dissolving; s4: adding water for injection to a preset preparation volume, and adjusting the pH value; s5: adding active carbon for injection; s6: filtering and encapsulating; s7: sterilizing and inspecting by lamp; wherein the volume ratio of the added propylene glycol to the ciprofloxacin lactate injection is between 250-350 ml/L; the volume ratio of the added sodium bisulfite to the ciprofloxacin lactate injection is between 1 and 5 g/L; the volume ratio of the added EDTA disodium to the ciprofloxacin lactate injection is 0.3-1 g/L. The ciprofloxacin lactate injection produced by the production method of ciprofloxacin lactate provided by the invention has the advantages of reducing operation steps, shortening working hours, reducing production cost and ensuring product quality.

Description

Ciprofloxacin lactate injection and production method thereof
Technical Field
The invention relates to the field of agricultural pharmacy, in particular to ciprofloxacin lactate injection and a production method thereof.
Background
Ciprofloxacin lactate injection is a product in the ministry of agriculture of the people's republic of China No. 1960 and has been produced for many years. However, after the product produced by the existing production process is stored for several months, floccules appear and visible foreign matters are unqualified, so that a user returns the product for many times, great resource waste is caused to a manufacturer, adverse effects are caused to customers, and the reputation of a company is influenced.
Therefore, the existing ciprofloxacin lactate injection production method needs to be improved urgently.
Disclosure of Invention
In order to solve the defects of the prior art, the invention provides a production method of ciprofloxacin lactate injection, which comprises the following steps:
s1: adding injection water with the preset preparation volume of 50-70% into a preparation container, and starting stirring;
s2: weighing a predetermined amount of ciprofloxacin lactate and adding the ciprofloxacin lactate into a preparation container;
s3: adding lactic acid, propylene glycol, sodium chloride, sodium bisulfite and EDTA disodium salt into a preparation container, and completely dissolving;
s4: adding water for injection to a predetermined preparation volume, adjusting the pH value to 3.9-4.1, and stirring for a certain time to obtain a semi-finished product;
s5: after the semi-finished product is inspected to be qualified, adding activated carbon for injection, stirring for a certain time, and standing for a preset time;
s6: filtering and encapsulating;
s7: sterilizing, lamp-inspecting, printing and packaging according to requirements, and warehousing after the full picking is qualified;
in the step S3, the volume ratio of the added propylene glycol to the ciprofloxacin lactate injection is between 250 and 350 ml/L;
in the step S3, the volume ratio of the added sodium bisulfite to the ciprofloxacin lactate injection is between 1 and 3 g/L;
in the step S3, the volume ratio of the added EDTA disodium to the ciprofloxacin lactate injection is 0.3-1 g/L;
in the step S5, the volume ratio of the added needle activated carbon to the ciprofloxacin lactate injection is between 0 and 1 g/L.
Wherein, in the step S3, the volume ratio of the added propylene glycol to the ciprofloxacin lactate injection is 280-320 ml/L.
Wherein, in the step S3, the volume ratio of the added sodium bisulfite to the ciprofloxacin lactate injection is 1.5-2.5 g/L.
Wherein, in the step S3, the volume ratio of the added EDTA disodium to the ciprofloxacin lactate injection is between 0.5 and 0.8 g/L.
Wherein, in the step S5, the volume ratio of the added needle activated carbon to the ciprofloxacin lactate injection is 0.
Wherein in step S4, the pH is adjusted using lactic acid.
Wherein, the step S6 specifically includes the following steps:
s61: filtering by using a plate frame;
s62: filtering by using a sand filter stick;
s63: filtration was performed using a membrane with a pore size of 0.8 um.
The ciprofloxacin lactate injection comprises the following components in proportion: 1-3g/L of sodium bisulfite; 3-7g/L of ciprofloxacin lactate; 0.3-1g/L of EDTA disodium salt; propylene glycol, 250-350 ml/L; the active carbon for the needle is 0-1g/L, and the solvent of the ciprofloxacin lactate injection is water for injection.
Wherein, in the ciprofloxacin lactate injection, the content of the propylene glycol is between 280 and 320 ml/L; the content of EDTA disodium is 0.5-0.8 g/L; the content of sodium bisulfite is between 1.5 and 2.5 g/L.
Wherein, in the ciprofloxacin lactate injection, the content of the active carbon for the needle is 0.
The ciprofloxacin lactate injection produced by the production method of ciprofloxacin lactate provided by the invention reduces sodium bisulfite and EDTA disodium in the prior art, increases the dosage of propylene glycol, removes active carbon for injection in the prior art, is simpler and more convenient to operate, reduces the production cost and ensures the product quality. The produced ciprofloxacin lactate injection is still qualified after being stored for more than two years.
Detailed Description
In order to further understand the technical solution and the advantages of the present invention, the following detailed description will be provided for the technical solution and the advantages thereof.
The invention provides a production method of ciprofloxacin lactate injection, which comprises the following steps:
s1: adding injection water with the preset preparation volume of 50-70% into a preparation container, and starting stirring;
s2: weighing a predetermined amount of ciprofloxacin lactate and adding the ciprofloxacin lactate into a preparation container;
s3: adding lactic acid, propylene glycol, sodium chloride, sodium bisulfite and EDTA disodium salt into a preparation container, and completely dissolving;
s4: adding water for injection to a predetermined preparation volume, adjusting the pH value to 3.9-4.1, and stirring for a certain time to obtain a semi-finished product;
s5: after the semi-finished product is inspected to be qualified, adding activated carbon for injection, stirring for a certain time, and standing for a preset time;
s6: respectively filtering by using a plate frame, a sand filter stick and a membrane with the aperture of 0.8um, and then encapsulating;
s7: and sterilizing, lamp inspection, printing and packaging according to requirements, and warehousing after the products are completely qualified.
In the present invention, in step S7, the sterilization may be performed by flowing steam at 100 degrees celsius once every half hour, and the lamp should be a clear liquid ranging from colorless to yellowish; during filling and sealing, the ampoule bottle is filled with nitrogen.
In the invention, in the step S3, the volume ratio of the added EDTA disodium to the ciprofloxacin lactate injection is 0.3-1 g/L; preferably, between 0.5 and 0.8 g/L; more preferably, 0.5 g; namely, the invention can reduce the content of EDTA disodium, thereby achieving the purposes of reducing flocculent precipitate and stabilizing the finished product.
In the invention, in the step S3, the volume ratio of the added sodium bisulfite to the ciprofloxacin lactate injection is between 1 and 3 g/L; preferably, between 1.5 and 2.5 g/L; more preferably, it is 2 g; that is, the invention can reduce the content of sodium bisulfite, thereby achieving the purposes of reducing flocculent precipitate and stabilizing the finished product.
In the invention, in the step S3, the volume ratio of the added propylene glycol to the ciprofloxacin lactate injection is between 250 and 350 ml/L; preferably, between 280 and 320 ml/L; more preferably, it is set to 300 ml/L; that is, the invention can achieve the purposes of reducing flocculent precipitate and stabilizing the finished product by increasing the content of the propylene glycol.
In the present invention, in the step S3, the volume ratio of the ciprofloxacin lactate to the ciprofloxacin lactate injection is 3-7g/L, preferably 5 g/L.
In the invention, in the step S5, the volume ratio of the added needle activated carbon to the ciprofloxacin lactate injection is between 0 and 1 g/L; preferably, 0 is set; that is, the invention can reduce or even abandon the content of the active carbon for injection, thereby achieving the purposes of reducing flocculent precipitate and stabilizing the finished product.
The invention also provides a ciprofloxacin lactate injection prepared by the production method.
When the production method of ciprofloxacin lactate injection provided by the invention is implemented specifically, the invention provides the following specific processing methods.
Example 1:
s1: adding injection water with the preset preparation volume of 70% into a preparation container, and starting stirring;
s2: weighing a predetermined amount of ciprofloxacin lactate, and adding the ciprofloxacin lactate into a preparation container, wherein the ratio of the ciprofloxacin lactate to the preparation volume is 5 g/L;
s3: adding lactic acid, propylene glycol, sodium chloride, sodium bisulfite and EDTA disodium salt into a preparation container, and completely dissolving; the volume ratio of the added lactic acid to the ciprofloxacin lactate injection is 2g/L, the volume ratio of the added propylene glycol to the ciprofloxacin lactate injection is 200ml/L, the volume ratio of the added sodium chloride to the ciprofloxacin lactate injection is 9g/L, the volume ratio of the added sodium bisulfite to the ciprofloxacin lactate injection is 5g/L, and the volume ratio of the added disodium EDTA to the ciprofloxacin lactate injection is 0.5 g/L;
s4: adding water for injection to a preset preparation volume, adjusting the pH value to be between 3.9 and 4.1 by lactic acid, adding the water for injection to full amount, and stirring for 10 minutes to obtain a semi-finished product;
s5: after the semi-finished product is inspected to be qualified, adding activated carbon for injection, stirring for 5 minutes, and standing for 15 minutes; wherein the ratio of the added active carbon for the needle to the prepared volume is 1 g/L;
s6: respectively filtering by using a plate frame, a sand filter stick and a membrane with the aperture of 0.8 um; then, the mixture is sent to a potting station for potting;
s7: sterilizing, inspecting by lamp, printing characters and packaging according to requirements to obtain ciprofloxacin lactate injection, then completely picking up the ciprofloxacin lactate injection, and handling warehousing procedures after the ciprofloxacin lactate injection is qualified.
Table 1 shows the results of the damage experiment of the ciprofloxacin lactate injection prepared in example 1 of the present invention, and as shown in table 1, the ciprofloxacin lactate injection prepared in example 1 of the present invention has good product stability and can maintain stability for six months at high temperature or under illumination; can maintain stability for 12 months under freezing condition.
Table 1: example 1 results of destructive test of ciprofloxacin lactate injection
Figure BDA0001333337150000061
Example 2:
s1: adding 60% of injection water with a preset preparation volume into a preparation container, and starting stirring;
s2: weighing a predetermined amount of ciprofloxacin lactate, and adding the ciprofloxacin lactate into a preparation container, wherein the volume ratio of the ciprofloxacin lactate to the ciprofloxacin lactate injection is 5 g/L;
s3: adding lactic acid, propylene glycol, sodium chloride, sodium bisulfite and EDTA disodium salt into a preparation container, and completely dissolving; the volume ratio of the added lactic acid to the ciprofloxacin lactate injection is 2g/L, the volume ratio of the added propylene glycol to the ciprofloxacin lactate injection is 200ml/L, the volume ratio of the added sodium chloride to the ciprofloxacin lactate injection is 9g/L, the volume ratio of the added sodium bisulfite to the ciprofloxacin lactate injection is 2g/L, and the volume ratio of the added EDTA disodium to the ciprofloxacin lactate injection is 1 g/L;
s4: adding water for injection to a preset preparation volume, adjusting the pH value to be between 3.9 and 4.1 by lactic acid, adding the water for injection to full amount, and stirring for 10 minutes to obtain a semi-finished product;
s5: after the semi-finished product is inspected to be qualified, adding activated carbon for injection, stirring for 5 minutes, and standing for 15 minutes; wherein the volume ratio of the added needle activated carbon to the ciprofloxacin lactate injection is 1 g/L;
s6: respectively filtering by using a plate frame, a sand filter stick and a membrane with the aperture of 0.8 um; then, the mixture is sent to a potting station for potting;
s7: sterilizing, inspecting by lamp, printing characters and packaging according to requirements to obtain ciprofloxacin lactate injection, then completely picking up the ciprofloxacin lactate injection, and handling warehousing procedures after the ciprofloxacin lactate injection is qualified.
Table 2 shows the results of the damage experiment of the ciprofloxacin lactate injection prepared in example 2 of the present invention, and as shown in table 2, the ciprofloxacin lactate injection prepared in example 2 of the present invention has good product stability and can maintain stability for six months at high temperature or under illumination; can maintain stability for 12 months under freezing condition.
Table 2: example 2 results of destructive experiment of ciprofloxacin lactate injection
Figure BDA0001333337150000071
Example 3:
s1: adding 60% of injection water with a preset preparation volume into a preparation container, and starting stirring;
s2: weighing a predetermined amount of ciprofloxacin lactate, and adding the ciprofloxacin lactate into a preparation container, wherein the volume ratio of the ciprofloxacin lactate to the ciprofloxacin lactate injection is 5 g/L;
s3: adding lactic acid, propylene glycol, sodium chloride, sodium bisulfite and EDTA disodium salt into a preparation container, and completely dissolving; the volume ratio of the added lactic acid to the ciprofloxacin lactate injection is 2g/L, the volume ratio of the added propylene glycol to the ciprofloxacin lactate injection is 300ml/L, the volume ratio of the added sodium chloride to the ciprofloxacin lactate injection is 9g/L, the volume ratio of the added sodium bisulfite to the ciprofloxacin lactate injection is 5g/L, and the volume ratio of the added EDTA disodium to the ciprofloxacin lactate injection is 1 g/L;
s4: adding water for injection to a preset preparation volume, adjusting the pH value to be between 3.9 and 4.1 by lactic acid, adding the water for injection to full amount, and stirring for 10 minutes to obtain a semi-finished product;
s5: after the semi-finished product is inspected to be qualified, adding activated carbon for injection, stirring for 5 minutes, and standing for 15 minutes; wherein the volume ratio of the added needle activated carbon to the ciprofloxacin lactate injection is 1 g/L;
s6: respectively filtering by using a plate frame, a sand filter stick and a membrane with the aperture of 0.8 um; then, the mixture is sent to a potting station for potting;
s7: sterilizing, inspecting by lamp, printing characters and packaging according to requirements to obtain ciprofloxacin lactate injection, then completely picking up the ciprofloxacin lactate injection, and handling warehousing procedures after the ciprofloxacin lactate injection is qualified.
Table 3 shows the results of the damage experiment of the ciprofloxacin lactate injection prepared in example 3 of the present invention, and as shown in table 3, the ciprofloxacin lactate injection prepared in example 3 of the present invention has good product stability and can maintain stability for nine months at high temperature or under light; can maintain stability for 12 months under freezing condition.
Table 3: example 3 results of destructive test of ciprofloxacin lactate injection
Figure BDA0001333337150000081
Figure BDA0001333337150000091
Example 4:
s1: adding injection water with the preset preparation volume of 50% into a preparation container, and starting stirring;
s2: weighing a predetermined amount of ciprofloxacin lactate, and adding the ciprofloxacin lactate into a preparation container, wherein the ratio of the ciprofloxacin lactate to the preparation volume is 5 g/L;
s3: adding lactic acid, propylene glycol, sodium chloride, sodium bisulfite and EDTA disodium salt into a preparation container, and completely dissolving; the volume ratio of the added lactic acid to the ciprofloxacin lactate injection is 2g/L, the volume ratio of the added propylene glycol to the ciprofloxacin lactate injection is 300ml/L, the volume ratio of the added sodium chloride to the ciprofloxacin lactate injection is 9g/L, the volume ratio of the added sodium bisulfite to the ciprofloxacin lactate injection is 2g/L, and the volume ratio of the added disodium EDTA to the ciprofloxacin lactate injection is 0.5 g/L;
s4: adding water for injection to a preset preparation volume, adjusting the pH value to be between 3.9 and 4.1 by lactic acid, adding the water for injection to full amount, and stirring for 10 minutes to obtain a semi-finished product;
s5: after the semi-finished product is inspected to be qualified, adding activated carbon for injection, stirring for 5 minutes, and standing for 15 minutes; wherein the volume ratio of the added needle activated carbon to the ciprofloxacin lactate injection is 1 g/L;
s6: respectively filtering by using a plate frame, a sand filter stick and a membrane with the aperture of 0.8 um; then, the mixture is sent to a potting station for potting;
s7: sterilizing, inspecting by lamp, printing characters and packaging according to requirements to obtain ciprofloxacin lactate injection, then completely picking up the ciprofloxacin lactate injection, and handling warehousing procedures after the ciprofloxacin lactate injection is qualified.
Table 4 shows the results of the damage experiment of the ciprofloxacin lactate injection prepared in example 4 of the present invention, and as shown in table 4, the ciprofloxacin lactate injection prepared in example 4 of the present invention has good product stability, and can maintain stability for 18 months under high temperature, light or freezing conditions.
Table 4: example 4 results of destructive test of ciprofloxacin lactate injection
Figure BDA0001333337150000101
Example 5:
s1: adding injection water with the preset preparation volume of 70% into a preparation container, and starting stirring;
s2: weighing a predetermined amount of ciprofloxacin lactate, and adding the ciprofloxacin lactate into a preparation container, wherein the volume ratio of the ciprofloxacin lactate to the ciprofloxacin lactate injection is 5 g/L;
s3: adding lactic acid, propylene glycol, sodium chloride, sodium bisulfite and EDTA disodium salt into a preparation container, and completely dissolving; the volume ratio of the added lactic acid to the ciprofloxacin lactate injection is 2g/L, the volume ratio of the added propylene glycol to the ciprofloxacin lactate injection is 200ml/L, the volume ratio of the added sodium chloride to the ciprofloxacin lactate injection is 9g/L, the volume ratio of the added sodium bisulfite to the ciprofloxacin lactate injection is 5g/L, and the volume ratio of the added disodium EDTA to the ciprofloxacin lactate injection is 0.5 g/L;
s4: adding water for injection to a preset preparation volume, adjusting the pH value to be 3.9-4.1, adding water for injection to full amount, and stirring for 10 minutes to obtain a semi-finished product;
s5: after the semi-finished product is inspected to be qualified, directly and respectively filtering by using a plate frame, a sand filter stick and a membrane with the aperture of 0.8um (no active carbon for needles is added); then, the mixture is sent to a potting station for potting;
s6: sterilizing, inspecting by lamp, printing characters and packaging according to requirements to obtain ciprofloxacin lactate injection, then completely picking up the ciprofloxacin lactate injection, and handling warehousing procedures after the ciprofloxacin lactate injection is qualified.
Table 5 shows the results of the damage test of the ciprofloxacin lactate injection prepared in example 5 of the present invention, and as shown in table 5, the ciprofloxacin lactate injection prepared in example 5 of the present invention does not generate floc after 18 months under high temperature, light or freezing conditions, and has very excellent stability compared with the existing products.
Table 5: example 5 results of destructive test of ciprofloxacin lactate injection
Figure BDA0001333337150000111
The method reduces the sodium bisulfite and the EDTA disodium in the prior art, increases the dosage of the propylene glycol, removes the active carbon for injection in the prior art, has simpler and more convenient operation, reduces the production cost, ensures the product quality, prolongs the shelf life, and ensures that all indexes of the produced ciprofloxacin lactate injection are still qualified after being stored for more than two years, thereby meeting the quality standard of the ciprofloxacin lactate injection published by the Ministry of agriculture of the people's republic of China No. 1960, prolonging the storage time and ensuring that all indexes are qualified in the validity period of the product. And simultaneously reduces the environmental pollution factor after the needle active carbon is used.
Although the present invention has been described with reference to the preferred embodiments, it should be understood that the scope of the present invention is not limited thereto, and those skilled in the art will appreciate that various changes and modifications can be made without departing from the spirit and scope of the present invention.

Claims (5)

1. The production method of ciprofloxacin lactate injection is characterized by comprising the following steps:
s1: adding injection water with the preset preparation volume of 50-70% into a preparation container, and starting stirring;
s2: weighing a predetermined amount of ciprofloxacin lactate and adding the ciprofloxacin lactate into a preparation container;
s3: adding lactic acid, propylene glycol, sodium chloride, sodium bisulfite and EDTA disodium salt into a preparation container, and completely dissolving;
s4: adding water for injection to a predetermined preparation volume, adjusting the pH value to 3.9-4.1 by using lactic acid, and stirring for a certain time to obtain a semi-finished product;
s5: after the semi-finished product is inspected to be qualified, adding activated carbon for injection, stirring for a certain time, and standing for a preset time;
s6: filtering and encapsulating;
s7: sterilizing, lamp-inspecting, printing and packaging according to requirements, and warehousing after the full picking is qualified;
in the step S3, the volume ratio of the added propylene glycol to the ciprofloxacin lactate injection is 280-320 ml/L; the volume ratio of the added sodium bisulfite to the ciprofloxacin lactate injection is between 1.5 and 2.5 g/L; the volume ratio of the added EDTA disodium to the ciprofloxacin lactate injection is between 0.5 and 0.8 g/L;
in step S5, the volume ratio of the added needle activated carbon to the ciprofloxacin lactate injection is 0-1 g/L.
2. The method for producing ciprofloxacin lactate injection according to claim 1, wherein: in step S5, the ratio of the volume of the added needle-use activated carbon to the volume of the ciprofloxacin lactate injection was 0.
3. The method for producing ciprofloxacin lactate injection according to claim 1, wherein: step S6 specifically includes the following steps:
s61: filtering by using a plate frame;
s62: filtering by using a sand filter stick;
s63: filtration was performed using a membrane with a pore size of 0.8 um.
4. The method for producing ciprofloxacin lactate injection according to claim 1 or 3, characterized in that: the ciprofloxacin lactate injection prepared by the production method comprises the following components in parts by weight: sodium bisulfite, 1.5-2.5 g/L; 3-7g/L of ciprofloxacin lactate; 0.5-0.8g/L of EDTA disodium salt; propylene glycol, 280-320 ml/L; the active carbon for the needle is 0-1g/L, and the solvent of the ciprofloxacin lactate injection is water for injection.
5. The method for producing ciprofloxacin lactate injection according to claim 4, wherein: in the ciprofloxacin lactate injection, the content of active carbon for needles is 0.
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101108163A (en) * 2006-07-18 2008-01-23 洛阳普莱柯生物工程有限公司 Novel technique of preparing lactic acid ciprofloxacin injection
CN102697725A (en) * 2012-06-07 2012-10-03 山东省健牧生物药业有限公司 Veterinary ciprofloxacin lactate injection and preparation method thereof
CN105147598A (en) * 2015-08-27 2015-12-16 浙江大飞龙动物保健品有限公司 Veterinary ciprofloxacin injection and preparation method thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101108163A (en) * 2006-07-18 2008-01-23 洛阳普莱柯生物工程有限公司 Novel technique of preparing lactic acid ciprofloxacin injection
CN102697725A (en) * 2012-06-07 2012-10-03 山东省健牧生物药业有限公司 Veterinary ciprofloxacin lactate injection and preparation method thereof
CN105147598A (en) * 2015-08-27 2015-12-16 浙江大飞龙动物保健品有限公司 Veterinary ciprofloxacin injection and preparation method thereof

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