CN111388415A - Moxifloxacin hydrochloride sodium chloride injection and preparation method thereof - Google Patents
Moxifloxacin hydrochloride sodium chloride injection and preparation method thereof Download PDFInfo
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Abstract
The invention relates to the technical field of pharmaceutical preparations, and particularly discloses a moxifloxacin hydrochloride sodium chloride injection and a preparation method thereof. The preparation method comprises the following steps: adding moxifloxacin hydrochloride, sodium chloride and a pH regulator into water for injection, stirring and dissolving, filtering through 3 or 4 groups of polyether sulfone filter cores with sequentially reduced pore diameters, filling, and sterilizing to obtain the moxifloxacin hydrochloride and sodium chloride injection. The injection provided by the invention has stable content among batches, low content of related substances, high effectiveness and safety and good stability.
Description
Technical Field
The invention relates to the technical field of pharmaceutical preparations, in particular to moxifloxacin hydrochloride and sodium chloride injection and a preparation method thereof.
Background
Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone antibacterial drug with broad spectrum and antibacterial activity. The traditional Chinese medicine composition is mainly used for treating acute bacterial nasosinusitis, acute attack of chronic bronchitis, community-acquired pneumonia, complicated intra-abdominal infection, skin and skin tissue infection and the like in clinic. The moxifloxacin hydrochloride sodium chloride injection for clinical intravenous infusion is 250ml large-capacity injection; is used for rescuing critical patients, and has the advantages of quick response and obvious curative effect.
The existing moxifloxacin hydrochloride sodium chloride injection is packaged in a semi-open glass bottle, the preparation method comprises two steps of firstly preparing the moxifloxacin hydrochloride by concentration and then preparing the moxifloxacin hydrochloride by dilution, and activated carbon is firstly added during concentration and then filtered to remove the moxifloxacin hydrochloride. However, in the two-step preparation, the concentrated preparation is not easy to dissolve, two preparation tanks are needed, the cleaning treatment and clean control consumption of equipment is high, and the pollution risk is high. The activated carbon has an adsorption effect on moxifloxacin, the quality requirement can be met only by excessive feeding, the production and quality standards of the activated carbon are different, the risk of promoting the degradation of related substances exists, and meanwhile, the activated carbon is very easy to fly to pollute a clean area when the activated carbon is weighed and fed. The recycling and treatment of the used activated carbon also puts pressure on environmental protection.
Disclosure of Invention
Aiming at the technical problems in the existing preparation process of moxifloxacin hydrochloride sodium chloride injection, the invention provides moxifloxacin hydrochloride sodium chloride injection and a preparation method thereof.
In order to achieve the purpose of the invention, the embodiment of the invention adopts the following technical scheme:
a preparation method of moxifloxacin hydrochloride sodium chloride injection comprises the following steps:
adding moxifloxacin hydrochloride, sodium chloride and a pH regulator into water for injection, stirring and dissolving, filtering through 3 or 4 groups of polyether sulfone filter cores with sequentially reduced pore diameters, filling, and sterilizing to obtain the moxifloxacin hydrochloride and sodium chloride injection.
Compared with the prior art, the preparation method of the moxifloxacin hydrochloride sodium chloride injection provided by the invention has the advantages that medicinal activated carbon is not used in the whole preparation process, the moxifloxacin hydrochloride is prevented from being adsorbed by the activated carbon, the stable content of the product in batches is ensured, the product quality is improved, the pollution to a production clean area is reduced, and the environmental protection pressure is reduced. In addition, 3 or 4 groups of polyether sulfone filter elements with sequentially reduced pore diameters are adopted for filtering before filling, and the stability of product quality is further ensured by matching the filter elements with specific quantity and specific materials with a pH regulator, so that the obtained moxifloxacin hydrochloride sodium chloride injection product has stable quality and low content of related substances, and the effectiveness and safety of medication are ensured.
Further, the preparation method of the moxifloxacin hydrochloride sodium chloride injection comprises the following steps:
s1: adding moxifloxacin hydrochloride and sodium chloride into water for injection accounting for 30-70% of the total volume of the injection, stirring and dissolving, and filtering through a polyether sulfone filter core A to obtain a filtrate;
s2: adding the rest of water for injection into the filtrate, adding a pH regulator, sequentially filtering by a polyether sulfone filter core B, a polyether sulfone filter core C and a polyether sulfone filter core D, filling and sterilizing to obtain the moxifloxacin hydrochloride sodium chloride injection.
The polyethersulfone filter element A in the concentrated preparation stage is used together with the polyethersulfone filter element B, the polyethersulfone filter element C and the polyethersulfone filter element D before filling in the diluted preparation stage, so that the stability of the product quality is ensured, the obtained moxifloxacin hydrochloride sodium chloride injection product has stable quality and low content of related substances, and the effectiveness and the safety of medication are ensured.
Further, in the step S1, the polyethersulfone filter element A is washed by water for injection with the total volume of 10% -20% of the total volume of the injection after filtration, and the washing liquid and the filtrate are combined and then enter the step S2, so that the stable content of the product between batches is further ensured.
Further, the preparation method of the moxifloxacin hydrochloride sodium chloride injection comprises the following steps:
adding moxifloxacin hydrochloride, sodium chloride and a pH regulator into water for injection with the total volume of 100% of the injection, stirring and dissolving, sequentially filtering through a polyether sulfone filter core B, a polyether sulfone filter core C and a polyether sulfone filter core D, filling and sterilizing to obtain the moxifloxacin hydrochloride and sodium chloride injection. Compared with the traditional two-step method of first concentrated preparation and then diluted preparation, the moxifloxacin hydrochloride is prepared by adopting the one-step method, the dissolution speed of moxifloxacin hydrochloride is high, the process is simple, the investment is low, the preparation tank is clean, the treatment capacity is low, and the cost is low.
Furthermore, the dosage of the moxifloxacin hydrochloride is 1.55-1.65 g/L calculated by moxifloxacin based on the total volume of the injection.
Further, the dosage of the moxifloxacin hydrochloride is 1.60 g/L calculated by moxifloxacin.
Furthermore, the sodium chloride is used in an amount of 7.5-8.5 g/L based on the total volume of the injection, and is used as an isotonic agent and suitable for direct intravenous drip of a human body.
Further, the amount of sodium chloride used was 8.0 g/L.
Further, the pore diameter of the polyether sulfone filter element A is 1.0 mu m.
Furthermore, the pore diameter of the polyether sulfone filter core B is 0.45 mu m, the pore diameter of the polyether sulfone filter core C is 0.20-0.22 mu m, and the pore diameter of the polyether sulfone filter core D is 0.10 mu m, so that endotoxin and microorganisms are filtered out.
Further, the pH regulator is sodium hydroxide or hydrochloric acid, and the pH value of the injection is regulated to 4.1-4.6, so that the system is in a relatively stable state, the generation of impurities is effectively controlled, the content of related substances is reduced, and the quality and the stability of the product are improved.
Further, the sterilization temperature is 121 ℃ and the time is 12-20 min.
Furthermore, the filling adopts a multi-layer co-extruded film soft bag or a vertical soft bag, the specification is 250m L, the bag is a fully-closed soft package with a self-contraction function, the problem that secondary pollution is easily caused because air needs to be introduced when the glass bottle package is clinically used can be effectively avoided, and the bag is more suitable for being applied in hospitals and high-pollution environments.
The invention also provides a moxifloxacin hydrochloride sodium chloride injection prepared by the preparation method of the moxifloxacin hydrochloride sodium chloride injection.
Compared with the prior art, the moxifloxacin hydrochloride sodium chloride injection provided by the invention takes moxifloxacin hydrochloride as a main drug, sodium chloride as an isotonic agent, the product quality is stable, the content of related substances is low, the effectiveness and the safety are high, the osmotic pressure molar concentration of the injection is 0.85-1.00, the pH value is 4.1-4.6, the total impurities are less than or equal to 0.1%, and the moxifloxacin hydrochloride sodium chloride injection is suitable for direct intravenous drip of a human body.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail with reference to the following embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
The embodiment of the invention provides a preparation method of moxifloxacin hydrochloride sodium chloride injection, which comprises the following steps:
adding moxifloxacin hydrochloride, sodium chloride and a pH regulator into water for injection, controlling the temperature to be 65-75 ℃, stirring for 10-15min, uniformly dissolving, detecting according to an intermediate quality standard, detecting the content, the pH value and visible foreign matters, filtering through 3 or 4 groups of polyether sulfone filter cores with sequentially reduced pore diameters after the detection is qualified, filling, sterilizing, and packaging after the lamp detection is qualified to obtain a moxifloxacin hydrochloride sodium chloride injection product.
In order to better illustrate the moxifloxacin hydrochloride sodium chloride injection and the preparation method thereof provided by the embodiment of the present invention, the following examples are further provided for illustration.
Example 1
A preparation method of moxifloxacin hydrochloride sodium chloride injection comprises the following steps:
the prescription comprises 400mg of moxifloxacin hydrochloride (calculated as moxifloxacin), 2.0g of sodium chloride, 250m L of water for injection, a proper amount of pH regulator (sodium hydroxide or hydrochloric acid), and a loading specification of 0.4g/250m L in 1000 bags.
S1: adding water for injection with the volume of 50% of the total volume of the injection into a thick preparation tank, controlling the temperature to be 65 ℃, sequentially adding moxifloxacin hydrochloride and sodium chloride with the prescription amount, stirring and dissolving, filtering through a polyether sulfone filter core A with the pore diameter of 1.0 mu m, flushing the polyether sulfone filter core A with the water for injection with the volume of 15% of the total volume of the injection, and conveying flushing fluid and filtrate to a thin preparation tank;
s2, adding the rest of water for injection into the diluting preparation tank, adding a pH regulator, detecting the content, the pH value (4.3) and visible foreign matters, filtering after the detection is qualified, sequentially filtering through a polyether sulfone filter core B with the aperture of 0.45 mu m, a polyether sulfone filter core C with the aperture of 0.22 mu m and a polyether sulfone filter core D with the aperture of 0.10 mu m, filling into a multi-layer co-extruded film soft bag (the specification is 250m L), sealing, sterilizing at 121 ℃ for 15min, and packaging after the lamp inspection is qualified to obtain the moxifloxacin hydrochloride sodium chloride injection product.
Example 2
A preparation method of moxifloxacin hydrochloride sodium chloride injection comprises the following steps:
the prescription comprises 413mg of moxifloxacin hydrochloride (calculated as moxifloxacin), 2.1g of sodium chloride, 255m L of water for injection, and a proper amount of pH regulator (sodium hydroxide or hydrochloric acid), wherein the filling amount specification is 0.4g/250m L, and the amount is 1000 bags.
S1: adding injection water accounting for 30% of the total volume of the injection into a thick preparation tank, controlling the temperature to be 75 ℃, sequentially adding moxifloxacin hydrochloride and sodium chloride according to the prescription amount, stirring and dissolving, filtering through a polyether sulfone filter core A with the aperture of 1.0 mu m, flushing the polyether sulfone filter core A with the injection water accounting for 20% of the total volume of the injection, and conveying flushing fluid and filtrate to a thin preparation tank;
s2, adding the rest of water for injection into the diluting preparation tank, adding a pH regulator, detecting the content, the pH value (4.1) and visible foreign matters, filtering after the detection is qualified, sequentially filtering through a polyether sulfone filter core B with the aperture of 0.45 mu m, a polyether sulfone filter core C with the aperture of 0.20 mu m and a polyether sulfone filter core D with the aperture of 0.10 mu m, filling into a multi-layer co-extruded film soft bag (the specification is 250m L), sealing, sterilizing at 121 ℃ for 12min, and packaging after the lamp inspection is qualified to obtain the moxifloxacin hydrochloride sodium chloride injection product.
Example 3
A preparation method of moxifloxacin hydrochloride sodium chloride injection comprises the following steps:
the prescription comprises 400mg of moxifloxacin hydrochloride (calculated as moxifloxacin), 1.8g of sodium chloride, 250m L of water for injection, and a proper amount of pH regulator (sodium hydroxide or hydrochloric acid), wherein the filling amount specification is 0.4g/250m L, and the amount is 1000 bags.
S1: adding 70% of injection water in the total volume of the injection into a thick preparation tank, controlling the temperature to be 70 ℃, sequentially adding moxifloxacin hydrochloride and sodium chloride in a prescription amount, stirring and dissolving, filtering through a polyether sulfone filter core A with the aperture of 1.0 mu m, flushing the polyether sulfone filter core A with 10% of the injection water in the total volume of the injection, and conveying flushing fluid and filtrate to a diluting preparation tank;
s2, adding the rest of water for injection into the diluting preparation tank, adding a pH regulator, detecting the content, the pH value (4.6) and visible foreign matters, filtering after the detection is qualified, sequentially filtering through a polyether sulfone filter core B with the aperture of 0.45 mu m, a polyether sulfone filter core C with the aperture of 0.22 mu m and a polyether sulfone filter core D with the aperture of 0.10 mu m, filling into a multi-layer co-extruded film soft bag (the specification is 250m L), sealing, sterilizing at 121 ℃ for 20min, and packaging after the lamp inspection is qualified to obtain the moxifloxacin hydrochloride sodium chloride injection product.
Example 4
A preparation method of moxifloxacin hydrochloride sodium chloride injection comprises the following steps:
the prescription comprises 400mg of moxifloxacin hydrochloride (calculated as moxifloxacin), 2.0g of sodium chloride, 250m L of water for injection, a proper amount of pH regulator (sodium hydroxide or hydrochloric acid), and a loading specification of 0.4g/250m L in 1000 bags.
Adding water for injection with the total volume of 100 percent of the injection into a preparation tank, sequentially adding moxifloxacin hydrochloride, sodium chloride and a pH regulator in a prescription amount, stirring for 10min, dissolving uniformly, detecting according to an intermediate quality standard, detecting the content, the pH value (4.3) and visible foreign matters, filtering by a polyether sulfone filter element B with the aperture of 0.45 mu m, a polyether sulfone filter element C with the aperture of 0.22 mu m and a polyether sulfone filter element D with the aperture of 0.10 mu m after passing the detection, filling into a multi-layer co-extrusion film soft bag (the specification is 250m L), sealing, sterilizing at 121 ℃ for 15min, and packaging after passing the lamp inspection to obtain a moxifloxacin hydrochloride sodium chloride injection product.
Example 5
A preparation method of moxifloxacin hydrochloride sodium chloride injection comprises the following steps:
the prescription comprises 413mg of moxifloxacin hydrochloride (calculated as moxifloxacin), 2.1g of sodium chloride, 255m L of water for injection, and a proper amount of pH regulator (sodium hydroxide or hydrochloric acid), wherein the filling amount specification is 0.4g/250m L, and the amount is 1000 bags.
Adding water for injection with the total volume of 100 percent of the injection into a preparation tank, sequentially adding moxifloxacin hydrochloride, sodium chloride and a pH regulator in a prescription amount, stirring for 15min, dissolving uniformly, detecting according to an intermediate quality standard, detecting the content, the pH value (4.6) and visible foreign matters, filtering sequentially through a polyether sulfone filter element B with the aperture of 0.45 mu m, a polyether sulfone filter element C with the aperture of 0.22 mu m and a polyether sulfone filter element D with the aperture of 0.10 mu m after passing the detection, filling into a vertical soft bag (the specification is 250m L), sealing, sterilizing at 121 ℃ for 20min, and packaging after passing the lamp inspection to obtain a moxifloxacin hydrochloride sodium chloride injection product.
In order to better illustrate the technical solution of the present invention, further comparison is made below by means of a comparative example and an example of the present invention.
Comparative example 1
By adopting the formula in the embodiment 1, the preparation process of adding the active carbon for injection comprises the following steps:
the prescription comprises 400mg of moxifloxacin hydrochloride (calculated as moxifloxacin), 2.0g of sodium chloride, 250m L of water for injection, a proper amount of pH regulator (sodium hydroxide or hydrochloric acid), and a loading specification of 0.4g/250m L in 1000 bags.
Adding water for injection with the total volume of 100 percent of the injection into a preparation tank, sequentially adding moxifloxacin hydrochloride, sodium chloride and a pH regulator with the formula amount, stirring for 12min, dissolving uniformly, adding activated carbon for injection with the total volume of 0.05 (w/v)% of the injection, continuously stirring for 20min, filtering through a polyether sulfone filter element with the aperture of 1.0 mu m, detecting the content, the pH value (4.5) and visible foreign matters, filtering through the polyether sulfone filter element with the aperture of 0.45 mu m and the polyether sulfone filter element with the aperture of 0.22 mu m after the detection is qualified, filling into a multi-layer coextrusion membrane soft bag (the specification is 250m L), sealing, sterilizing at 121 ℃ for 12min, and packaging after the lamp inspection is qualified to obtain a moxifloxacin hydrochloride sodium chloride injection product.
Comparative example 2
By adopting the formula in the embodiment 1, the polyether sulfone filter element is replaced by the polypropylene filter element in the preparation process, and the rest is the same as the formula in the embodiment 1, so that the moxifloxacin hydrochloride sodium chloride injection is obtained.
Comparative example 3
The formula in the example 4 is adopted, the polyether sulfone filter core B is removed in the preparation process, and the rest is the same as the formula in the example 4, so that the moxifloxacin hydrochloride sodium chloride injection is obtained.
In order to better illustrate the characteristics of the preparation method of the moxifloxacin hydrochloride sodium chloride injection provided by the embodiment of the invention, the stability of the moxifloxacin hydrochloride sodium chloride injection is investigated by referring to a drug stability guiding principle, the moxifloxacin hydrochloride sodium chloride injection products obtained in the embodiments 1 to 5 and the comparative examples 1 to 3 are subjected to influence factor investigation tests, and preliminary influence factor tests of 0 day, 5 days and 10 days are respectively carried out at the temperature of 60 ℃, and the results are shown in table 1.
TABLE 1
From the data, compared with the preparation process of adding the activated carbon for injection in the comparative example 1, the moxifloxacin hydrochloride sodium chloride injection provided by the embodiment of the invention has the advantages that the content of the moxifloxacin hydrochloride sodium chloride injection is stable among batches, the content of related substances is low, the content of the related substances is basically unchanged, the stability is good, the effectiveness and the safety are high, and the preparation method is suitable for direct intravenous drip of a human body. Compared with comparative examples 2 and 3, the polypropylene filter core adopted in the comparative example 2 has a large adsorption amount on moxifloxacin hydrochloride, so that the effective content of a final product is influenced, and the polyether sulfone filter core C and the polyether sulfone filter core D are only adopted in the comparative example 3, so that endotoxin is difficult to effectively remove, and the endotoxin content of the product does not reach the standard. Further, under the condition that activated carbon is not used, the stability of the product quality can be effectively ensured by matching the filter elements with specific quantity and specific material quality and the pH regulator, so that the obtained moxifloxacin hydrochloride sodium chloride injection product has stable quality and low content of related substances, and the effectiveness and the safety of medication are ensured.
In addition, according to the technical guidance principle of the research of chemical pharmaceutical preparations, the low-temperature freeze-thaw test is carried out on the example 1 and the comparative example 1, three freeze-thaw cycles are carried out, each freeze-thaw cycle is carried out for 2 days at the temperature of-10 ℃ to-20 ℃, then the test is carried out for 2 days at the temperature of 40 ℃, and the results of sampling and detection are shown in table 2.
TABLE 2
The data show that the moxifloxacin hydrochloride sodium chloride injection provided by the embodiment of the invention has the advantages that the appearance and the color of the product are not obviously changed, related substances and content are basically unchanged, and the moxifloxacin hydrochloride sodium chloride injection has certain standing stability under the condition of low-temperature cycle test, so that the moxifloxacin hydrochloride sodium chloride injection provided by the embodiment of the invention has better stability and safety in the transportation and use processes.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents or improvements made within the spirit and principle of the present invention should be included in the scope of the present invention.
Claims (10)
1. A preparation method of moxifloxacin hydrochloride sodium chloride injection is characterized by comprising the following steps: the method comprises the following steps:
adding moxifloxacin hydrochloride, sodium chloride and a pH regulator into water for injection, stirring and dissolving, filtering through 3 or 4 groups of polyether sulfone filter cores with sequentially reduced pore diameters, filling, and sterilizing to obtain the moxifloxacin hydrochloride and sodium chloride injection.
2. The method for preparing moxifloxacin hydrochloride sodium chloride injection as claimed in claim 1, characterized in that: the method comprises the following steps:
s1: adding moxifloxacin hydrochloride and sodium chloride into water for injection accounting for 30-70% of the total volume of the injection, stirring and dissolving, and filtering through a polyether sulfone filter core A to obtain a filtrate;
s2: adding the rest of water for injection into the filtrate, adding a pH regulator, sequentially filtering by a polyether sulfone filter core B, a polyether sulfone filter core C and a polyether sulfone filter core D, filling and sterilizing to obtain the moxifloxacin hydrochloride sodium chloride injection.
3. The method for preparing moxifloxacin hydrochloride sodium chloride injection as claimed in claim 1, characterized in that: the method comprises the following steps:
adding moxifloxacin hydrochloride, sodium chloride and a pH regulator into water for injection with the total volume of 100% of the injection, stirring and dissolving, sequentially filtering through a polyether sulfone filter core B, a polyether sulfone filter core C and a polyether sulfone filter core D, filling and sterilizing to obtain the moxifloxacin hydrochloride and sodium chloride injection.
4. The preparation method of the moxifloxacin hydrochloride sodium chloride injection as claimed in any one of claims 1 to 3, characterized in that the dosage of the moxifloxacin hydrochloride is 1.55-1.65 g/L calculated by moxifloxacin.
5. The preparation method of moxifloxacin hydrochloride sodium chloride injection as claimed in any one of claims 1 to 3, characterized in that the amount of sodium chloride is 7.5-8.5 g/L.
6. The method for preparing moxifloxacin hydrochloride sodium chloride injection as claimed in claim 2, characterized in that: the pore diameter of the polyethersulfone filter element A is 1.0 mu m.
7. The method for preparing moxifloxacin hydrochloride sodium chloride injection as claimed in claim 2 or 3, characterized in that: the pore diameter of the polyether sulfone filter element B is 0.45 mu m, the pore diameter of the polyether sulfone filter element C is 0.20-0.22 mu m, and the pore diameter of the polyether sulfone filter element D is 0.10 mu m.
8. The method for preparing moxifloxacin hydrochloride sodium chloride injection as claimed in any of claims 1 to 3, characterized in that: the pH regulator is sodium hydroxide or hydrochloric acid, and the pH value of the injection is regulated to 4.1-4.6.
9. The method for preparing moxifloxacin hydrochloride sodium chloride injection as claimed in any of claims 1 to 3, characterized in that: the filling adopts a multi-layer co-extruded film soft bag or a vertical soft bag.
10. The moxifloxacin hydrochloride sodium chloride injection is characterized in that: prepared by the preparation method of the moxifloxacin hydrochloride sodium chloride injection of any one of claims 1 to 9.
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| CN202010196194.2A CN111388415A (en) | 2020-03-19 | 2020-03-19 | Moxifloxacin hydrochloride sodium chloride injection and preparation method thereof |
| PCT/CN2020/113782 WO2021184699A1 (en) | 2020-03-19 | 2020-09-07 | Moxifloxacin hydrochloride and sodium chloride injection and preparation method therefor |
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| WO2021184699A1 (en) * | 2020-03-19 | 2021-09-23 | 石家庄四药有限公司 | Moxifloxacin hydrochloride and sodium chloride injection and preparation method therefor |
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