CN113116815A - Preparation method of dexmedetomidine hydrochloride injection - Google Patents
Preparation method of dexmedetomidine hydrochloride injection Download PDFInfo
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- CN113116815A CN113116815A CN202110633537.1A CN202110633537A CN113116815A CN 113116815 A CN113116815 A CN 113116815A CN 202110633537 A CN202110633537 A CN 202110633537A CN 113116815 A CN113116815 A CN 113116815A
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- stirring
- dexmedetomidine hydrochloride
- injection
- liquid medicine
- preparation
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- VPNGEIHDPSLNMU-MERQFXBCSA-N dexmedetomidine hydrochloride Chemical compound Cl.C1([C@@H](C)C=2C(=C(C)C=CC=2)C)=CNC=N1 VPNGEIHDPSLNMU-MERQFXBCSA-N 0.000 title claims abstract description 38
- 229960002746 dexmedetomidine hydrochloride Drugs 0.000 title claims abstract description 35
- 238000002347 injection Methods 0.000 title claims abstract description 33
- 239000007924 injection Substances 0.000 title claims abstract description 33
- 238000002360 preparation method Methods 0.000 title claims abstract description 24
- 238000003756 stirring Methods 0.000 claims abstract description 22
- 239000003814 drug Substances 0.000 claims abstract description 19
- 239000007788 liquid Substances 0.000 claims abstract description 19
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 18
- 238000007789 sealing Methods 0.000 claims abstract description 17
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 17
- 239000004743 Polypropylene Substances 0.000 claims abstract description 14
- -1 polypropylene Polymers 0.000 claims abstract description 14
- 229920001155 polypropylene Polymers 0.000 claims abstract description 14
- 238000011049 filling Methods 0.000 claims abstract description 13
- 238000001514 detection method Methods 0.000 claims abstract description 12
- 239000008215 water for injection Substances 0.000 claims abstract description 12
- 239000011780 sodium chloride Substances 0.000 claims abstract description 9
- 238000002156 mixing Methods 0.000 claims abstract description 8
- 238000007664 blowing Methods 0.000 claims abstract description 6
- 239000002245 particle Substances 0.000 claims abstract description 4
- 230000001954 sterilising effect Effects 0.000 claims description 14
- 238000004659 sterilization and disinfection Methods 0.000 claims description 12
- 238000007689 inspection Methods 0.000 claims description 8
- 238000000034 method Methods 0.000 claims description 8
- 238000004806 packaging method and process Methods 0.000 claims description 6
- 239000000203 mixture Substances 0.000 claims description 3
- 238000009472 formulation Methods 0.000 claims 1
- 239000000463 material Substances 0.000 abstract description 7
- 238000004519 manufacturing process Methods 0.000 abstract description 6
- 238000012856 packing Methods 0.000 abstract description 6
- 239000003708 ampul Substances 0.000 description 13
- 239000000047 product Substances 0.000 description 10
- 239000011521 glass Substances 0.000 description 9
- 230000000052 comparative effect Effects 0.000 description 3
- 229960004253 dexmedetomidine Drugs 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- 239000003153 chemical reaction reagent Substances 0.000 description 2
- 238000001816 cooling Methods 0.000 description 2
- CUHVIMMYOGQXCV-NSHDSACASA-N dexmedetomidine Chemical compound C1([C@@H](C)C=2C(=C(C)C=CC=2)C)=CNC=N1 CUHVIMMYOGQXCV-NSHDSACASA-N 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 229940087659 precedex Drugs 0.000 description 2
- 238000005070 sampling Methods 0.000 description 2
- 206010039897 Sedation Diseases 0.000 description 1
- 230000001133 acceleration Effects 0.000 description 1
- 239000000048 adrenergic agonist Substances 0.000 description 1
- 239000005388 borosilicate glass Substances 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000005538 encapsulation Methods 0.000 description 1
- 239000002158 endotoxin Substances 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 238000002695 general anesthesia Methods 0.000 description 1
- 239000013067 intermediate product Substances 0.000 description 1
- 238000005399 mechanical ventilation Methods 0.000 description 1
- 239000005022 packaging material Substances 0.000 description 1
- 230000036280 sedation Effects 0.000 description 1
- 230000001624 sedative effect Effects 0.000 description 1
- 210000003437 trachea Anatomy 0.000 description 1
- 238000002627 tracheal intubation Methods 0.000 description 1
Classifications
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4174—Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/06—Ampoules or carpules
- A61J1/065—Rigid ampoules, e.g. glass ampoules
-
- 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
- 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
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/20—Hypnotics; Sedatives
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- Neurology (AREA)
- Hematology (AREA)
- Anesthesiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biomedical Technology (AREA)
- Inorganic Chemistry (AREA)
- Neurosurgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
The invention discloses a preparation method of dexmedetomidine hydrochloride injection, which comprises the following steps: adding water for injection into a container, adding sodium chloride, stirring to dissolve completely, adding dexmedetomidine hydrochloride, and stirring and mixing; adding injection water to the theoretical preparation amount, stirring, starting a self circulation pipeline of the dispensing system, and circularly stirring and mixing; detecting the pH value and the content of the liquid medicine; and after the detection is qualified, the polypropylene particles are subjected to bottle making in a sterile environment by adopting blowing, filling and sealing integrated equipment, and then the bottle is sealed after the liquid medicine is filled. According to the invention, by adopting the polypropylene blowing, filling and sealing integrated machine, bottle making, filling and sealing are carried out in an aseptic environment, the production link and the exposure time of the interior of the packing material and the liquid medicine are reduced, and the quality controllability is better.
Description
Technical Field
The invention relates to the technical field of pharmacy, in particular to a preparation method of dexmedetomidine hydrochloride injection.
Background
Dexmedetomidine hydrochloride injection is a relatively selective alpha adrenoceptor agonist and has a sedative effect. The main clinical indication is sedation of the surgical patient, trachea, intubation and mechanical ventilation which may be applicable to general anesthesia.
The product is listed in the United states in 3 months in 2000, the product is Precedex, in Japan in 1 month in 2004, the product is Precedex, in 2011, in European Union, the product is Dexdor, in 2009, Hengsu Henry is first approved to be listed, and various enterprises are produced in China. The adopted packaging form is mostly glass ampoules, the cost is low, and the packaging method is suitable for mass production. However, the existing production process is to fill the qualified liquid medicine into a glass ampoule which is washed and dried, and then to sterilize, leak, lamp test and package after sealing. The production process is multiple, the exposure time of the interior of the packing material and the liquid medicine is long, and the potential risk is caused to the two quality attributes of visible foreign matters and bacterial endotoxin; and the liquid medicine is filled into a glass ampoule, and the pH value tends to rise after the liquid medicine is placed and sterilized. And the glass ampoule is not prevented from being collided and extruded in the transferring and transporting processes, so that the glass ampoule is cracked or cracked, and great potential safety hazards are caused to the product quality.
Disclosure of Invention
Therefore, the invention aims to overcome the defect of high risk of compatibility between dexmedetomidine hydrochloride injection and packing materials in the prior art, and provides a preparation method of dexmedetomidine hydrochloride injection.
The invention provides a preparation method of dexmedetomidine hydrochloride injection, which comprises the following steps:
(1) adding water for injection into a container, adding sodium chloride, stirring to dissolve completely, adding dexmedetomidine hydrochloride, and stirring and mixing;
(2) adding injection water to the theoretical preparation amount, stirring, starting a self circulation pipeline of the dispensing system, and circularly stirring and mixing;
(3) detecting the pH value and the content of the liquid medicine;
(4) and after the detection is qualified, the polypropylene particles are subjected to bottle making in a sterile environment by adopting blowing, filling and sealing integrated equipment, and then the bottle is sealed after the liquid medicine is filled.
Preferably, the amount of water for injection in the step (1) is 80% to 90% of the amount of water for injection.
Preferably, the circulating stirring and mixing time in the step (2) is 10min to 30 min.
Preferably, the pH value in the step (3) is 5-6, and the content is 99.0% -99.9%.
Preferably, sterilization, leak detection, light detection and packaging after sealing are also included.
Preferably, the sterilization temperature is 120-130 ℃, and the sterilization time is 10-20 min.
The technical scheme of the invention has the following advantages:
1. according to the preparation method of dexmedetomidine hydrochloride injection, provided by the invention, the polypropylene blowing, filling and sealing integrated machine equipment is adopted, and bottle making, filling and sealing are carried out in a sterile environment, so that the production link, the exposure time of the interior of a packing material and the liquid medicine are reduced, and the quality controllability is better;
2. according to the preparation method of the dexmedetomidine hydrochloride injection, the compatibility of the polypropylene material and the liquid medicine is good, after the dexmedetomidine hydrochloride injection filled in the polypropylene packing material is subjected to accelerated inspection for 6 months, all indexes are stable, and the change of the pH value cannot be caused; meanwhile, compared with the dexmedetomidine hydrochloride injection packaged by a glass ampoule, the dexmedetomidine hydrochloride injection filled by the polypropylene packaging material has the advantages that the number of unqualified products with visible foreign matters for lamp inspection is less, and the qualified rate of lamp inspection is higher.
3. The preparation method of the dexmedetomidine hydrochloride injection provided by the invention has the advantages that the polypropylene packing material has good sealing property, can not be cracked and cracked due to collision and extrusion, and effectively avoids the potential safety hazard.
Detailed Description
The following examples are provided to further understand the present invention, not to limit the scope of the present invention, but to provide the best mode, not to limit the content and the protection scope of the present invention, and any product similar or similar to the present invention, which is obtained by combining the present invention with other prior art features, falls within the protection scope of the present invention.
The examples do not show the specific experimental steps or conditions, and can be performed according to the conventional experimental steps described in the literature in the field. The reagents or instruments used are not indicated by manufacturers, and are all conventional reagent products which can be obtained commercially.
Examples
Prescription: dexmedetomidine hydrochloride injection (10 ten thousand)
| Dexmedetomidine hydrochloride (based on dexmedetomidine) | 20g |
| Sodium chloride | 1800g |
| Water for injection | Adding to 200L |
| Total amount of | 200L |
The preparation method comprises the following steps:
(1) preparation: adding about 90% of the prepared amount of water for injection into a dosing tank, starting a stirrer, reducing the temperature of the water for injection to 50-70 ℃, adding the sodium chloride with the formula amount, and stirring for 5min to completely dissolve the sodium chloride. Adding dexmedetomidine hydrochloride, stirring for 10min to dissolve and mix uniformly;
(2) and (3) volume fixing: adding injection water to a theoretical preparation amount, stirring for 15min, starting a self circulation pipeline of the dispensing system, circularly stirring for 15min, respectively sampling, and cooling and maintaining the temperature of liquid medicine at 30-40 ℃;
(3) the pH value of the intermediate product detection liquid medicine is 5.3, and the content is 99.3%;
(4) encapsulating: after the polypropylene particles are qualified, adopting blowing, filling and sealing integrated equipment to make bottles in an aseptic environment, and sealing after filling liquid medicine;
(5) and (3) sterilization: sterilizing at 121 deg.C for 15min, detecting leakage, testing by lamp, and packaging.
Comparative example
Prescription: dexmedetomidine hydrochloride injection (10 ten thousand)
| Dexmedetomidine hydrochloride (based on dexmedetomidine) | 20g |
| Sodium chloride | 1800g |
| Water for injection | Adding to 200L |
| Total amount of | 200L |
The preparation method comprises the following steps:
(1) preparation: adding about 90% of the prepared amount of water for injection into a dosing tank, starting a stirrer, reducing the temperature of the water for injection to 50-70 ℃, adding the sodium chloride with the formula amount, and stirring for 5min to completely dissolve the sodium chloride. Adding dexmedetomidine hydrochloride, stirring for 10min to dissolve and mix uniformly;
(2) and (3) volume fixing: adding injection water to a theoretical preparation amount, stirring for 15min, starting a self circulation pipeline of the dispensing system, circularly stirring for 15min, respectively sampling, and cooling and maintaining the temperature of liquid medicine at 30-40 ℃;
(3) detecting the pH value of the liquid medicine to be 5.3, and the content to be 99.3%;
(4) encapsulating: after the detection is qualified, filling the liquid medicine into a cleaned and dried medium borosilicate glass ampoule, and sealing by fusing;
(5) and (3) sterilization: sterilizing at 121 deg.C for 15min, detecting leakage, testing by lamp, and packaging.
In order to illustrate the advantages of the preparation method of the present invention, indexes of examples and comparative examples were compared and examined, and the results were as follows:
1. the pH values of the respective steps were measured and compared, and the results are shown in Table 1.
TABLE 1 comparison of pH values in the respective procedures
| Sample (I) | After preparation | After encapsulation and before sterilization | After sterilization |
| Preparation examples | 5.3 | 5.3 | 5.3 |
| Comparative example | 5.3 | 5.6 | 5.8 |
As can be seen from table 1, the pH values of the dexmedetomidine hydrochloride injection prepared by filling and sealing the polypropylene ampoule before and after sterilization are not different from those after preparation and are all stably maintained at 5.3, and the pH values of the dexmedetomidine hydrochloride injection prepared by filling and sealing the glass ampoule before and after sterilization are obviously increased compared with those after preparation, which indicates that the dexmedetomidine hydrochloride injection prepared by filling and sealing the polypropylene ampoule instead of the glass ampoule can stabilize the quality of the dexmedetomidine hydrochloride injection and does not affect the quality of the product.
2. The various indexes of the packaged finished product (0 hours) and the sample under the acceleration condition (the sample is placed under the condition of 40 +/-2 ℃/RH 75% +/-5%) are detected, and the results are shown in Table 2.
TABLE 20 comparison of results with results of accelerated examination for 6 months
Therefore, after the dexmedetomidine hydrochloride injection prepared by the polypropylene ampoule is subjected to accelerated inspection for 6 months, all indexes are stable; the pH of the glass ampoule sample was increased and the other indicators were unchanged.
3. Comparison of visible foreign matter and lamp inspection yield
The detection results of visible foreign matters in the production process (200 detection in each time, 3 times of detection before, during and after) and the lamp detection rejection rate are collected, and the results are shown in table 3.
Table 3 comparison of the foreign matter and the lamp inspection yield
Therefore, the dexmedetomidine hydrochloride injection prepared by the polypropylene ampoule has fewer unqualified foreign matters and higher lamp inspection qualified rate.
It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.
Claims (6)
1. A preparation method of dexmedetomidine hydrochloride injection is characterized by comprising the following steps:
(1) adding water for injection into a container, adding sodium chloride, stirring to dissolve completely, adding dexmedetomidine hydrochloride, and stirring and mixing;
(2) adding injection water to the theoretical preparation amount, stirring, starting a self circulation pipeline of the dispensing system, and circularly stirring and mixing;
(3) detecting the pH value and the content of the liquid medicine;
(4) and after the detection is qualified, the polypropylene particles are subjected to bottle making in a sterile environment by adopting blowing, filling and sealing integrated equipment, and then the bottle is sealed after the liquid medicine is filled.
2. The method for preparing dexmedetomidine hydrochloride injection according to claim 1, characterized in that the amount of water for injection in step (1) is 80-90% of the amount of the formulation.
3. The method for preparing dexmedetomidine hydrochloride injection according to claim 1, characterized in that the time for mixing and stirring in step (2) is 10-30 min.
4. The method for preparing dexmedetomidine hydrochloride injection as claimed in claim 1, characterized in that the pH value in step (3) is 5-6 and the content is 99.0-99.9%.
5. The method for preparing dexmedetomidine hydrochloride injection according to any one of claims 1 to 4, characterized by further comprising sterilization, leak detection, lamp inspection and packaging after sealing.
6. The method for preparing dexmedetomidine hydrochloride injection as set forth in claim 5, characterized in that the sterilization temperature is 120-130 ℃ and the sterilization time is 10-20 min.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110633537.1A CN113116815A (en) | 2021-06-07 | 2021-06-07 | Preparation method of dexmedetomidine hydrochloride injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110633537.1A CN113116815A (en) | 2021-06-07 | 2021-06-07 | Preparation method of dexmedetomidine hydrochloride injection |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN113116815A true CN113116815A (en) | 2021-07-16 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202110633537.1A Pending CN113116815A (en) | 2021-06-07 | 2021-06-07 | Preparation method of dexmedetomidine hydrochloride injection |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN113116815A (en) |
Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2013202575B1 (en) * | 2012-01-04 | 2013-05-16 | Hospira, Inc. | Dexmedetomidine premix formulation |
| CN103281902A (en) * | 2012-01-04 | 2013-09-04 | 赫思公司 | Dexmedetomidine premix formulation |
| JP2013203675A (en) * | 2012-03-28 | 2013-10-07 | Terumo Corp | Diluted dexmedetomidine preparation |
| CN105147603A (en) * | 2015-10-23 | 2015-12-16 | 广西裕源药业有限公司 | Preparation technology for sodium chloride injection packaged in plastic bottles |
| CN105168122A (en) * | 2015-09-24 | 2015-12-23 | 辰欣药业股份有限公司 | Dexmedetomidine hydrochloride injection and preparation process thereof |
| CN106038538A (en) * | 2015-04-17 | 2016-10-26 | 江苏恒瑞医药股份有限公司 | Premixed preparation for dexmedetomidine |
| CN109568259A (en) * | 2018-12-31 | 2019-04-05 | 辰欣药业股份有限公司 | A kind of liquid drugs injection and preparation method thereof containing s-ropivacaine mesylate |
-
2021
- 2021-06-07 CN CN202110633537.1A patent/CN113116815A/en active Pending
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2013202575B1 (en) * | 2012-01-04 | 2013-05-16 | Hospira, Inc. | Dexmedetomidine premix formulation |
| CN103281902A (en) * | 2012-01-04 | 2013-09-04 | 赫思公司 | Dexmedetomidine premix formulation |
| JP2013203675A (en) * | 2012-03-28 | 2013-10-07 | Terumo Corp | Diluted dexmedetomidine preparation |
| CN106038538A (en) * | 2015-04-17 | 2016-10-26 | 江苏恒瑞医药股份有限公司 | Premixed preparation for dexmedetomidine |
| CN105168122A (en) * | 2015-09-24 | 2015-12-23 | 辰欣药业股份有限公司 | Dexmedetomidine hydrochloride injection and preparation process thereof |
| CN105147603A (en) * | 2015-10-23 | 2015-12-16 | 广西裕源药业有限公司 | Preparation technology for sodium chloride injection packaged in plastic bottles |
| CN109568259A (en) * | 2018-12-31 | 2019-04-05 | 辰欣药业股份有限公司 | A kind of liquid drugs injection and preparation method thereof containing s-ropivacaine mesylate |
Non-Patent Citations (1)
| Title |
|---|
| COLLIN R. ANDERSON 等: "Stability of dexmedetomidine 4 mg/mL in polypropylene syringes", 《AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY》 * |
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Application publication date: 20210716 |