Novel preparation method of phloroglucinol injection
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A technique for phloroglucinol injection and trimethyl phloroglucinol, which is applied in the field of medicine, can solve the problems of precipitation of trimethyl phloroglucinol, changing the pH value of the medicinal solution, prolonging the process time, etc., so as to reduce the leaching rate. risk, the effect of reducing the content
Pending Publication Date: 2022-06-28
燃点(南京)生物医药科技有限公司
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The advantage of this method is that there is no need to add additional cosolvents and antioxidants; the disadvantage is that after the use of hot water to dissolve trimethylphloroglucinol, it is necessary to cool down and then add phloroglucinol to prolong the process time. There is a risk of precipitation of base phloroglucinol; in addition, carbon dioxide is charged to prevent phloroglucinol from being oxidized, and carbon dioxide is an acidic gas, and it is very likely to change the pH value of the liquid during subsequent placement
[0013] In view of the above-mentioned phloroglucinol and trimethylphloroglucinol injection ethanol residues and possible precipitation after cooling, a new preparation method for phloroglucinol injection was sought to prepare phloroglucinol and trimethylphloroglucinol injection Methylphloroglucinol content meets the requirements, less impurity content, higher quality injection
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Embodiment 1
[0034] The present embodiment provides a new preparation process as follows (operation in the dark):
[0035] (1) Take by weighing 80% of the water for injection of the prescription, continue to fill with nitrogen and stir;
[0036] (2) under continuous nitrogen filling, add phloroglucinol, trimethyl phloroglucinol, sodium chloride of recipe quantity successively, continue to stir until completely dissolved, wherein the D90 of trimethyl phloroglucinol is 4~6 μm ;
[0037] (3) Adjust the pH to 4.2±0.4 with concentrated hydrochloric acid, make up to the full amount with water for injection, continue to fill with nitrogen and stir;
[0038] (4) In the process of continuous stirring, the solution was sterilized and filtered using two stainless steel filter elements of 0.22 μm;
[0039] (5) Adjust the filling amount and fill the liquid medicine into the glass bottle;
[0040] (6) 121℃, 15min moist heat sterilization.
[0041] In addition, latex material pipelines are used in th...
Embodiment 2
[0043] The present embodiment provides a new preparation process as follows (operation in the dark):
[0044] (1) Take by weighing 80% of the water for injection of the prescription, continue to fill with nitrogen and stir;
[0045] (2) under continuous nitrogen filling, add phloroglucinol, trimethylphloroglucinol, sodium chloride of recipe quantity successively, continue to stir to dissolve completely, wherein the D90 of trimethylphloroglucinol is 4.5~5.5 μm;
[0046] (3) Adjust the pH to 4.2±0.4 with concentrated hydrochloric acid, make up to the full amount with water for injection, continue to fill with nitrogen and stir;
[0047] (4) In the process of continuous stirring, the solution was sterilized and filtered using two stainless steel filter elements of 0.22 μm;
[0048] (5) Adjust the filling amount and fill the liquid medicine into the glass bottle;
[0049] (6) 121℃, 15min moist heat sterilization.
[0050] In addition, latex material pipelines are used in the p...
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Abstract
The invention relates to the technical field of medicines, and discloses a novel preparation method of a pharmaceutical composition of an injection containing phloroglucinol and trimethyl phloroglucinol, which comprises the following steps: every 4ml of injection contains the following components by weight: 40mg of phloroglucinol dihydrate, 0.04 mg of trimethyl phloroglucinol and 40mg of sodium chloride; the preparation method comprises the following steps: weighing 80% of prescription dosage of water for injection, continuously filling nitrogen and stirring, sequentially adding prescription dosage of phloroglucinol, micronized trimethyl phloroglucinol and sodium chloride, continuously filling nitrogen and stirring until the phloroglucinol, the micronized trimethyl phloroglucinol and the sodium chloride are completely dissolved; adjusting the pH value to 4.2 + / -0.4 by using concentrated hydrochloric acid, and supplementing the water for injection to full dose; and sterilizing and filtering through a microfiltration membrane, filling, and sterilizing at 121 DEG C for 15 minutes. The problems that trimethylphloroglucinol is extremely difficult to dissolve and the content is unqualified due to adsorption are solved, and meanwhile, due to the adoption of the stainless steel microporous filter element and the latex pipeline, the leaching risk of an extract is reduced.
Description
technical field [0001] The invention relates to the technical field of medicine, in particular to a method for preparing a new pharmaceutical composition for injection containing phloroglucinol and trimethylphloroglucinol. Background technique [0002] Phloroglucinol is used for acute spastic pain caused by dysfunction of the digestive system and biliary tract; acute spastic urethral, bladder, and renal colic; gynecological spastic pain. Its mechanism of action is that phloroglucinol can directly act on the smooth muscle of the gastrointestinal tract and genitourinary tract. Compared with other smooth muscle antispasmodics, it is characterized by no anticholinergic effect. It will not produce a series of anticholinergic side effects while relieving smooth muscle spasm, and will not cause symptoms such as hypotension, increased heart rate, and arrhythmia. , had no effect on cardiovascular function. Animal pharmacological tests show that it only acts on spastic smooth musc...
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