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CN-117582404-B - Cefodizime sodium preparation for injection and preparation method thereof

CN117582404BCN 117582404 BCN117582404 BCN 117582404BCN-117582404-B

Abstract

The invention provides a cefodizime sodium preparation for injection and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. The cefdinir sodium preparation for injection comprises, by weight, 5 parts of cefdinir sodium, 0.2-0.4 part of a traditional Chinese medicine aqueous-alcoholic extract, 0.3-0.8 part of a pH regulator, 0.5-1 part of a suspending agent and 15-20 parts of an injection, wherein the traditional Chinese medicine aqueous-alcoholic extract is prepared by sequentially extracting linzhi spore powder and blackberry lily powder by water and alcohol, the mass ratio of the linzhi spore powder to the blackberry lily powder is 1-3:1, the suspending agent is prepared by mixing tragacanth, acacia gum and hydroxyethyl cellulose according to the mass ratio of 1:1:0.8-2, and when the cefdinir sodium preparation for injection is used, the injection is diluted according to actual conditions. The antibacterial activity and the long-acting property of the cefdinir sodium preparation for injection prepared by the invention are obviously enhanced.

Inventors

  • FAN HAIFENG
  • WANG HONG
  • LI WENXIAN
  • WU WANGPING
  • WEI TIANQI
  • WU WEIQING
  • LU PINGPING

Assignees

  • 上海欣峰制药有限公司

Dates

Publication Date
20260512
Application Date
20231207

Claims (6)

  1. 1. The cefodizime sodium preparation for injection is characterized by comprising, by weight, 5 parts of cefodizime sodium, 0.2-0.4 part of a traditional Chinese medicine aqueous alcohol extract, 0.3-0.8 part of a pH regulator, 0.5-1 part of a suspending agent and 15-20 parts of a 0.9% sodium chloride injection; The traditional Chinese medicine hydroalcoholic extract is obtained by mixing linzhi spore powder and blackberry lily powder according to the mass ratio of 1-3:1, and then sequentially carrying out water extraction and three times of alcohol extraction, and the preparation method comprises the following steps: A1, adding the linzhi spore powder and the blackberry lily powder into a multifunctional extraction tank, respectively adding 12 times of purified water and 10 times of purified water, extracting twice, starting steam heating each time, keeping a micro-boiling state in the whole process, keeping micro-boiling each time, filtering the two extracting solutions, putting the two extracting solutions into a concentrator, starting circulating cooling water of the concentrator, starting a vacuum pump, starting steam, operating the vacuum at 0.06MPa, controlling the steam pressure within 0.1MPa, controlling the temperature at 80+/-5 ℃, concentrating under reduced pressure, and concentrating the extracting solution to a relative density of 1.11-1.14 to obtain a water concentrate; A2, adopting ethanol, continuously carrying out three times of ethanol precipitation and evaporation alcohol recovery treatment on the water concentrate of the A1 by adopting an ethanol precipitation tank and a single-effect concentrator, wherein the ethanol of 85c/o is added in a stirring state for the first time, the ethanol content is 70c/o, the ethanol is subjected to cold precipitation for 48 hours, then the ethanol is recovered to the full within the steam pressure of 0.09MPa, and the concentration is continued until the relative density is 1.09-1.1; secondly, adding 90c/o of ethanol under the stirring state, enabling the ethanol content to be 75c/o, carrying out cold sedimentation for 48 hours, and then recycling the ethanol to the full within the steam pressure of 0.09 MPa; thirdly, adding 95c/o ethanol under stirring to ensure that the ethanol content is 80c/o, carrying out cold sedimentation for 48 hours, and then recycling the ethanol to the full within the steam pressure of 0.09 MPa; A3, concentrating the alcohol extract obtained in the step A2 in a single-effect concentrator until the relative density is 1.05-1.08, thus obtaining the traditional Chinese medicine aqueous alcohol extract; the suspending agent is prepared by mixing tragacanth, acacia and hydroxyethyl cellulose according to the mass ratio of 1:1:0.8-2; The pH regulator is prepared by mixing 1% of sodium dihydrogen phosphate solution and 0.8% of disodium hydrogen phosphate solution in equal volume; When in use, the cefodizime sodium preparation for injection is diluted by the 0.9 percent sodium chloride injection according to the actual situation.
  2. 2. The cefodizime sodium preparation for injection according to claim 1 is characterized by comprising, by weight, 5 parts of cefodizime sodium, 0.3 part of a traditional Chinese medicine alcohol extract, 0.3-0.8 part of a pH stabilizer, 0.7 part of a suspending agent and 15-20 parts of a 0.9% sodium chloride injection.
  3. 3. The cefodizime sodium preparation for injection according to claim 2 is characterized by comprising, by weight, 5 parts of cefodizime sodium, 0.3 part of a traditional Chinese medicine alcohol extract, 0.5 part of a pH stabilizer, 0.7 part of a suspending agent and 15 parts of an injection.
  4. 4. The cefodizime sodium preparation for injection according to claim 1, wherein the mass ratio of the lindera spore powder to the blackberry lily powder is 2:1.
  5. 5. The cefditoren sodium preparation for injection according to claim 1, wherein the suspending agent is prepared by mixing tragacanth, acacia and hydroxyethyl cellulose in a mass ratio of 1:1:1.
  6. 6. A preparation method of cefodizime sodium preparation for injection is characterized in that, the preparation method for preparing the cefodizime sodium preparation for injection as claimed in any one of claims 1 to 5, which comprises the following steps: s1, uniformly mixing a traditional Chinese medicine aqueous-alcoholic extract, a suspending agent and an injection to obtain a mixed solution; S2, adding a pH regulator into the mixed solution obtained in the step S1, uniformly mixing, adding the cefodizime sodium, and uniformly mixing to obtain the cefodizime sodium preparation for injection.

Description

Cefodizime sodium preparation for injection and preparation method thereof Technical Field The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a cefodizime sodium preparation for injection and a preparation method thereof. Background Cefodizime sodium belongs to the third generation cephalosporin antibiotics for injection, developed by Hurst corporation of Germany and Roc corporation of Japan, and marketed in Japan under the trade name "Neucef" in month 5 of 1990. Cefodizime sodium (molinate) for injection by Herst-Russell company in 1994 was registered in China. The cefodizime sodium has antibacterial activity on gram-positive bacteria and gram-negative bacteria, is stable to beta lactamase and is extremely stable to cephalosporinase and penicillin enzyme. Compared with other similar medicines, the cefodizime sodium has high-efficiency broad-spectrum antibacterial activity and immune enhancement effect, and is clinically mainly used for treating pneumonia, bronchitis, sphagitis, tonsillitis, pyelonephritis, urinary tract infection, gonococcal urethritis, cholecystitis, cholangitis, gynecological infection, septicemia, tympanitis and the like caused by sensitive bacteria such as streptococcus, pneumococcus and the like. The cefodizime sodium preparation in the current market is mainly cefodizime sodium preparation for injection, and the antibacterial activity and the long-acting property of the cefodizime sodium preparation directly determine the actual use curative effect of the cefodizime sodium preparation. Thus, how to improve the antibacterial activity and the long-acting performance of the cefodizime sodium preparation for injection is a direction worthy of research in the field. Disclosure of Invention In order to solve the problems in the background technology, the invention provides the cefodizime sodium preparation for injection and the preparation method thereof, so that the antibacterial activity and the long-acting property of the prepared cefodizime sodium preparation for injection are obviously enhanced. In order to achieve the above object, the present invention provides the following technical solutions: The cefodizime sodium preparation for injection comprises, by weight, 5 parts of cefodizime sodium, 0.2-0.4 part of a traditional Chinese medicine aqueous alcohol extract, 0.3-0.8 part of a pH regulator, 0.5-1 part of a suspending agent and 15-20 parts of an injection; the traditional Chinese medicine hydroalcoholic extract is prepared by sequentially extracting ringer-sesame spore powder and blackberry lily powder with water and alcohol, wherein the mass ratio of the ringer-sesame spore powder to the blackberry lily powder is 1-3:1; the suspending agent is prepared by mixing tragacanth, acacia and hydroxyethyl cellulose according to the mass ratio of 1:1:0.8-2; When in use, the injection is used for diluting the cefodizime sodium preparation for injection according to actual conditions. Further, the composition comprises, by weight, 5 parts of cefodizime sodium, 0.3 part of a traditional Chinese medicine alcohol extract, 0.3-0.8 part of a pH stabilizer, 0.7 part of a suspending agent and 15-20 parts of an injection. Further, the injection comprises, by weight, 5 parts of cefodizime sodium, 0.3 part of a traditional Chinese medicine alcohol extract, 0.5 part of a pH stabilizer, 0.7 part of a suspending agent and 15 parts of an injection. Further, the mass ratio of the linzhi spore powder to the blackberry lily powder is 2:1. Further, the preparation method of the traditional Chinese medicine hydroalcoholic extract comprises the following steps: a1, adding the linzhi spore powder and the blackberry lily powder into a multifunctional extraction tank, respectively adding 12 times and 10 times of purified water, extracting twice, starting steam heating each time, keeping a micro-boiling state in the whole process, filtering the two extracting solutions, putting the two extracting solutions into a concentrator, starting circulating cooling water of the concentrator, starting a vacuum pump, starting steam, and concentrating under reduced pressure to obtain a water concentrate; A2, continuously carrying out alcohol precipitation and evaporation alcohol recovery treatment on the water extraction concentrate obtained in the step A1 for multiple times by adopting ethanol to obtain an alcohol extract; a3, concentrating the alcohol extract obtained in the step A2 in a single-effect concentrator until the relative density is 1.05-1.08, thus obtaining the traditional Chinese medicine aqueous alcohol extract. Further, in A1, vacuum operation is carried out at 0.06MPa, steam pressure is within 0.1MPa, temperature is 80+/-5 ℃, and the extracting solution is concentrated to have a relative density of 1.11-1.14, thus obtaining the water concentrate. Further, in A2, three times of alcohol precipitation and evaporation alcohol recovery treatment are continuo