CN114939106A - Chlorpromazine hydrochloride injection and preparation method thereof - Google Patents

Chlorpromazine hydrochloride injection and preparation method thereof Download PDF

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CN114939106A
CN114939106A CN202210445967.5A CN202210445967A CN114939106A CN 114939106 A CN114939106 A CN 114939106A CN 202210445967 A CN202210445967 A CN 202210445967A CN 114939106 A CN114939106 A CN 114939106A
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chlorpromazine hydrochloride
injection
phosphate buffer
buffer solution
solution
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龚菊梅
刘修树
沈慧
付恩桃
何晓丽
刘龙云
方丽波
白露雨
范高福
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Hefei Technology College
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/54Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/5415Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
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    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P25/00Drugs for disorders of the nervous system
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/20Hypnotics; Sedatives

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Abstract

The invention discloses a chlorpromazine hydrochloride injection and a preparation method thereof, relating to the technical field of pharmaceutical preparations, wherein each chlorpromazine hydrochloride injection contains: adding 25mg of chlorpromazine hydrochloride, 0.1-0.4mg of sodium metabisulfite, 0.1-0.3mg of cysteine and 2mL of phosphate buffer solution with the pH value of 5.0; the preparation method comprises the following steps: taking 60-70 wt% of phosphate buffer solution, dissolving sodium pyrosulfite in the phosphate buffer solution, adding activated carbon for injection, filtering to be clear, vacuumizing, filling nitrogen, finally adding chlorpromazine hydrochloride and cysteine, stirring for dissolving, adding the rest phosphate buffer solution, and mixing uniformly; filtering with 0.45 μm filter membrane, filtering with 0.22 μm filter membrane, and packaging. The chlorpromazine hydrochloride injection prepared by the invention has good stability, and the content of effective components is not obviously reduced in the long-term storage process.

Description

Chlorpromazine hydrochloride injection and preparation method thereof
Technical Field
The invention relates to the technical field of pharmaceutical preparations, in particular to chlorpromazine hydrochloride injection and a preparation method thereof.
Background
Chlorpromazine hydrochloride, chinese name: n, N-dimethyl-2-chloro-10H-phenothiazine-10-propylamine hydrochloride or 2-chloro-10- (3-dimethylaminopropyl) phenothiazine hydrochloride, the molecular formula is as follows: c 17 H 20 Cl 2 N 2 And S. Chlorpromazine hydrochloride is a representative drug in phenothiazine drugs, is a blocker of central dopamine receptors, and has various pharmacological activities. It has tranquilizing effect on central nervous system in small dose, can inhibit hypothalamic thermoregulation center to make body temperature rise and fall with ambient temperature, and can reduce body temperature to below normal body temperature and reduce metabolism by combining with other medicines, so called artificial hibernation. The medicine is mainly used for treating psychosis, enhancing hypnotic, anesthetic, analgesic and anticonvulsant, is effective medicine for treating psychosis, and can be used for treating emesis and intractable singultus, stopping emesis and inducing artificial hibernation.
Chlorpromazine hydrochloride injection is a common preparation formulation. However, chlorpromazine hydrochloride is easily oxidized and easily degraded during high-temperature sterilization, exposure to light and long-term storage, thereby affecting the safety of the product.
Disclosure of Invention
Based on the technical problems in the background art, the invention provides a chlorpromazine hydrochloride injection and a preparation method thereof.
The invention provides a chlorpromazine hydrochloride injection, each chlorpromazine hydrochloride injection contains: chlorpromazine hydrochloride 25mg, sodium metabisulfite 0.1-0.4mg, cysteine 0.1-0.3mg, phosphate buffer pH 5.0 to 2 mL.
Preferably, the phosphate buffer is formulated as follows: firstly, preparing 0.2mol/L sodium dihydrogen phosphate solution, and then adjusting the pH to 5.0 by using 0.1mol/L sodium hydroxide solution to obtain stock solution; diluting 5-10mL of stock solution to 200mL, and adjusting the pH value to 5.0 by using hydrochloric acid; wherein, the water is water for injection.
Preferably, the water for injection is boiled before use.
Preferably, the chlorpromazine hydrochloride injection contains: to 2mL, a phosphate buffer solution of chlorpromazine hydrochloride 25mg, sodium metabisulfite 0.3mg, cysteine 0.2mg and pH 5.0 was added.
The invention also provides a preparation method of the chlorpromazine hydrochloride injection, which comprises the following steps: taking phosphate buffer solution with the total amount of 60-70 wt%, dissolving sodium metabisulfite in the phosphate buffer solution, adding activated carbon for injection, filtering to be clear, vacuumizing, charging nitrogen, adding chlorpromazine hydrochloride and cysteine, stirring for dissolving, adding the rest phosphate buffer solution, and mixing uniformly; filtering with 0.45 μm filter membrane, filtering with 0.22 μm filter membrane, and packaging.
Preferably, the amount of the activated carbon for needles is 0.1 to 0.3 wt%.
Preferably, the temperature of the system is kept between 10 and 30 ℃ when chlorpromazine hydrochloride is added.
Has the advantages that: the chlorpromazine hydrochloride injection with good stability provided by the invention adopts sodium metabisulfite and cysteine as antioxidants, and compared with the single use of sodium metabisulfite, the combined use of cysteine can effectively reduce the degradation rate of effective components, and the combination of the two has good antioxidant effect; in addition, the phosphate buffer solution is used for preparing chlorpromazine hydrochloride, so that the pH value of the system can be adjusted and maintained, and the stability of the injection is improved. In addition, through vacuumizing and then charging nitrogen and controlling the dissolving temperature of chlorpromazine hydrochloride, the free oxygen concentration in water for injection can be effectively eliminated, the degradation rate of the product in the long-term storage process is reduced, and the stability of the product is further improved. The chlorpromazine hydrochloride injection prepared by the invention has good stability, and the content of effective components is not obviously reduced in the long-term storage process.
Detailed Description
The technical solution of the present invention will be described in detail below with reference to specific examples.
Example 1
The chlorpromazine hydrochloride injection provided by the invention is prepared by adding 25mg of chlorpromazine hydrochloride, 0.3mg of sodium metabisulfite and 0.2mg of cysteine into 2mL of phosphate buffer solution with the pH value of 5.0.
The chlorpromazine hydrochloride injection is prepared as follows:
s1, preparing 0.2mol/L sodium dihydrogen phosphate solution and sodium hydroxide solution respectively by using water for injection, and adjusting the pH value of the sodium dihydrogen phosphate solution to 5.0 by using the sodium hydroxide solution; taking the solution with the pH value of 5.0, mixing the solution with water for injection according to the weight ratio of 7: diluting with 200 vol%, adjusting pH to 5.0 with hydrochloric acid, and recording as phosphate buffer; wherein, the water for injection is boiled before use;
s2, taking 60 wt% of the total amount of the phosphate buffer solution, dissolving sodium metabisulfite in the phosphate buffer solution, adding activated carbon for injection, filtering until the activated carbon is clear, wherein the adding amount of the activated carbon is 0.15 wt% of the total weight of the system, vacuumizing, filling nitrogen, finally adding chlorpromazine hydrochloride and cysteine, keeping the temperature of the system at 10 ℃, stirring for dissolving, adding the rest phosphate buffer solution, and uniformly mixing; filtering with 0.45 μm filter membrane, filtering with 0.22 μm filter membrane, and packaging.
Example 2
The invention provides chlorpromazine hydrochloride injection, each chlorpromazine hydrochloride injection contains: to 2mL, a phosphate buffer solution of chlorpromazine hydrochloride 25mg, sodium metabisulfite 0.4mg, cysteine 0.1mg, and pH 5.0 was added.
The chlorpromazine hydrochloride injection is prepared as follows:
s1, preparing 0.2mol/L sodium dihydrogen phosphate solution and sodium hydroxide solution by using water for injection respectively, and adjusting the pH value of the sodium dihydrogen phosphate solution to 5.0 by using the sodium hydroxide solution; taking the solution with the pH value of 5.0, mixing the solution with water for injection according to the ratio of 5: diluting with 200 vol%, adjusting pH to 5.0 with hydrochloric acid, and recording as phosphate buffer; wherein, the water for injection is boiled before use;
s2, taking 65 wt% of the total amount of the phosphate buffer solution, dissolving sodium metabisulfite in the phosphate buffer solution, adding activated carbon for injection, filtering until the activated carbon is clear, wherein the adding amount of the activated carbon is 0.1 wt% of the total weight of the system, vacuumizing, filling nitrogen, finally adding chlorpromazine hydrochloride and cysteine, keeping the temperature of the system at 20 ℃, stirring for dissolving, adding the rest phosphate buffer solution, and uniformly mixing; filtering with 0.45 μm filter membrane, filtering with 0.22 μm filter membrane twice, and packaging.
Example 3
The invention provides chlorpromazine hydrochloride injection, each chlorpromazine hydrochloride injection contains: to 2mL, a phosphate buffer solution of chlorpromazine hydrochloride 25mg, sodium metabisulfite 0.1mg, cysteine 0.3mg and pH 5.0 was added.
The chlorpromazine hydrochloride injection is prepared as follows:
s1, preparing 0.2mol/L sodium dihydrogen phosphate solution and sodium hydroxide solution respectively by using water for injection, and adjusting the pH value of the sodium dihydrogen phosphate solution to 5.0 by using the sodium hydroxide solution; taking the solution with the pH value of 5.0, mixing the solution with water for injection according to the weight ratio of 10: diluting with 200 vol%, adjusting pH to 5.0 with hydrochloric acid, and recording as phosphate buffer; wherein, the water for injection is boiled before use;
s2, taking 70 wt% of the total amount of the phosphate buffer solution, dissolving sodium metabisulfite in the phosphate buffer solution, adding activated carbon for injection, filtering until the activated carbon is clear, wherein the adding amount of the activated carbon is 0.3 wt% of the total weight of the system, vacuumizing, filling nitrogen, finally adding chlorpromazine hydrochloride and cysteine, keeping the temperature of the system at 30 ℃, stirring for dissolving, adding the rest phosphate buffer solution, and uniformly mixing; filtering with 0.45 μm filter membrane, filtering with 0.22 μm filter membrane twice, and packaging.
Comparative example 1
Chlorpromazine hydrochloride injection, wherein the chlorpromazine hydrochloride is 25mg, the sodium metabisulfite is 0.3mg, the cysteine is 0.2mg, and the injection water is added to 2 mL.
The chlorpromazine hydrochloride injection is prepared as follows:
s1, boiling the water for injection;
s2, taking 60 wt% of the total amount of the water for injection, dissolving sodium metabisulfite in the water, adding activated carbon for injection, filtering until the mixture is clear, wherein the adding amount of the activated carbon is 0.15 wt% of the total weight of the system, vacuumizing, filling nitrogen, adding chlorpromazine hydrochloride and cysteine, keeping the temperature of the system at 10 ℃, stirring for dissolution, adding the rest water for injection, and uniformly mixing; filtering with 0.45 μm filter membrane, filtering with 0.22 μm filter membrane, and packaging.
Comparative example 2
An injection of chlorpromazine hydrochloride is prepared from chlorpromazine hydrochloride (25 mg), sodium pyrosulfite (0.5 mg) and phosphate buffer (pH 5.0) through adding it to 2 mL.
The chlorpromazine hydrochloride injection is prepared as follows:
s1, preparing 0.2mol/L sodium dihydrogen phosphate solution and sodium hydroxide solution by using water for injection respectively, and adjusting the pH value of the sodium dihydrogen phosphate solution to 5.0 by using the sodium hydroxide solution; taking the solution with the pH value of 5.0, mixing the solution with water for injection according to the weight ratio of 7: diluting with 200 vol%, adjusting pH to 5.0 with hydrochloric acid, and recording as phosphate buffer; wherein, the water for injection is boiled before use;
s2, taking 60 wt% of the total amount of the phosphate buffer solution, dissolving sodium metabisulfite in the sodium metabisulfite, adding activated carbon for injection, filtering until the mixture is clear, wherein the adding amount of the activated carbon is 0.15 wt% of the total weight of the system, vacuumizing, charging nitrogen, finally adding chlorpromazine hydrochloride, keeping the temperature of the system at 10 ℃, stirring for dissolving, adding the rest phosphate buffer solution, and uniformly mixing; filtering with 0.45 μm filter membrane, filtering with 0.22 μm filter membrane, and packaging.
Comparative example 3
An injection of chlorpromazine hydrochloride, wherein the chlorpromazine hydrochloride is 25mg, cysteine is 0.5mg, and phosphate buffer solution with pH value of 5.0 is added to 2 mL.
The chlorpromazine hydrochloride injection is prepared as follows:
s1, preparing 0.2mol/L sodium dihydrogen phosphate solution and sodium hydroxide solution by using water for injection respectively, and adjusting the pH value of the sodium dihydrogen phosphate solution to 5.0 by using the sodium hydroxide solution; taking the solution with the pH value of 5.0, and mixing the solution with water for injection according to the weight ratio of 7: diluting with 200 vol%, adjusting pH to 5.0 with hydrochloric acid, and recording as phosphate buffer; wherein, the water for injection is boiled before use;
s2, taking 60 wt% of the total amount of the phosphate buffer solution, adding activated carbon for injection, filtering to be clear, wherein the adding amount of the activated carbon is 0.15 wt% of the total weight of the system, vacuumizing, charging nitrogen, finally adding chlorpromazine hydrochloride and cysteine, keeping the system temperature at 10 ℃, stirring to dissolve, adding the rest phosphate buffer solution, and uniformly mixing; filtering with 0.45 μm filter membrane, filtering with 0.22 μm filter membrane, and packaging.
The stability of the chlorpromazine hydrochloride injection prepared in the inventive example and the comparative example was tested.
And (3) stability test: the chlorpromazine hydrochloride injection prepared in the example and the comparative example is respectively placed under the illumination (5000Lx) and the high temperature (60 ℃) for 1 week and is kept away from light at the normal temperature for 6 months, and the sample is taken and the high performance liquid chromatography is adopted to determine the content of the chlorpromazine hydrochloride in the injection.
TABLE 1 content data of chlorpromazine hydrochloride injection
Figure BDA0003616866660000061
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art should be considered to be within the technical scope of the present invention, and the technical solutions and the inventive concepts thereof according to the present invention should be equivalent or changed within the scope of the present invention.

Claims (7)

1. The chlorpromazine hydrochloride injection is characterized by comprising the following components in parts by weight: chlorpromazine hydrochloride 25mg, sodium metabisulfite 0.1-0.4mg, cysteine 0.1-0.3mg, phosphate buffer pH 5.0 to 2 mL.
2. The chlorpromazine hydrochloride injection according to claim 1, wherein the phosphate buffer solution is prepared by: firstly, preparing 0.2mol/L sodium dihydrogen phosphate solution, and then adjusting the pH to 5.0 by using 0.1mol/L sodium hydroxide solution to obtain stock solution; diluting 5-10mL of stock solution to 200mL, and adjusting the pH value to 5.0 by using hydrochloric acid; wherein, the water is water for injection.
3. The chlorpromazine hydrochloride injection according to claim 2, wherein the water for injection is boiled before use.
4. The chlorpromazine hydrochloride injection according to claim 1, wherein each chlorpromazine hydrochloride injection contains: to 2mL, a phosphate buffer solution of chlorpromazine hydrochloride 25mg, sodium metabisulfite 0.3mg, cysteine 0.2mg and pH 5.0 was added.
5. The method for preparing chlorpromazine hydrochloride injection according to any one of claims 1 to 4, characterized by comprising the following steps: taking phosphate buffer solution with the total amount of 60-70 wt%, dissolving sodium metabisulfite in the phosphate buffer solution, adding activated carbon for injection, filtering to be clear, vacuumizing, charging nitrogen, adding chlorpromazine hydrochloride and cysteine, stirring for dissolving, adding the rest phosphate buffer solution, and mixing uniformly; filtering with 0.45 μm filter membrane, filtering with 0.22 μm filter membrane, and packaging.
6. The method for preparing chlorpromazine hydrochloride injection according to claim 5, wherein the addition amount of the needle activated carbon is 0.1 to 0.3 wt%.
7. The method for preparing chlorpromazine hydrochloride injection according to claim 5, wherein the temperature of the system is kept at 10-30 ℃ when chlorpromazine hydrochloride is added.
CN202210445967.5A 2022-04-26 2022-04-26 Chlorpromazine hydrochloride injection and preparation method thereof Pending CN114939106A (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103637980A (en) * 2013-11-26 2014-03-19 天津药业集团新郑股份有限公司 Preparation method for promethazine hydrochloride injection
CN103637981A (en) * 2013-11-26 2014-03-19 天津药业集团新郑股份有限公司 Promethazine hydrochloride injection

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103637980A (en) * 2013-11-26 2014-03-19 天津药业集团新郑股份有限公司 Preparation method for promethazine hydrochloride injection
CN103637981A (en) * 2013-11-26 2014-03-19 天津药业集团新郑股份有限公司 Promethazine hydrochloride injection

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
顾学裘: "《药物制剂注解》", 人民卫生出版社, pages: 99 - 100 *

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