CN116919906A - Optimized preparation method of dexlansoprazole freeze-dried powder injection - Google Patents
Optimized preparation method of dexlansoprazole freeze-dried powder injection Download PDFInfo
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- CN116919906A CN116919906A CN202210342273.9A CN202210342273A CN116919906A CN 116919906 A CN116919906 A CN 116919906A CN 202210342273 A CN202210342273 A CN 202210342273A CN 116919906 A CN116919906 A CN 116919906A
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- dexlansoprazole
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- 229960003568 dexlansoprazole Drugs 0.000 title claims abstract description 31
- MJIHNNLFOKEZEW-RUZDIDTESA-N dexlansoprazole Chemical compound CC1=C(OCC(F)(F)F)C=CN=C1C[S@@](=O)C1=NC2=CC=CC=C2N1 MJIHNNLFOKEZEW-RUZDIDTESA-N 0.000 title claims abstract description 30
- 238000002360 preparation method Methods 0.000 title claims abstract description 30
- 238000002347 injection Methods 0.000 title claims abstract description 16
- 239000007924 injection Substances 0.000 title claims abstract description 16
- 239000000843 powder Substances 0.000 title claims abstract description 15
- 238000000034 method Methods 0.000 claims abstract description 20
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 30
- 238000001035 drying Methods 0.000 claims description 16
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 16
- 239000008215 water for injection Substances 0.000 claims description 16
- 239000000243 solution Substances 0.000 claims description 13
- 238000003756 stirring Methods 0.000 claims description 13
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 12
- 229930195725 Mannitol Natural products 0.000 claims description 12
- MBBZMMPHUWSWHV-BDVNFPICSA-N N-methylglucamine Chemical compound CNC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO MBBZMMPHUWSWHV-BDVNFPICSA-N 0.000 claims description 12
- 235000010355 mannitol Nutrition 0.000 claims description 12
- 239000000594 mannitol Substances 0.000 claims description 12
- 229960003194 meglumine Drugs 0.000 claims description 12
- 238000004108 freeze drying Methods 0.000 claims description 11
- 238000007710 freezing Methods 0.000 claims description 7
- 230000008014 freezing Effects 0.000 claims description 7
- 238000011049 filling Methods 0.000 claims description 4
- 230000001502 supplementing effect Effects 0.000 claims description 4
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 abstract description 47
- 229910052799 carbon Inorganic materials 0.000 abstract description 19
- 239000012535 impurity Substances 0.000 abstract description 9
- 239000002245 particle Substances 0.000 abstract description 5
- -1 dexlansoprazole compound Chemical class 0.000 abstract 1
- 239000003814 drug Substances 0.000 description 7
- 239000008176 lyophilized powder Substances 0.000 description 6
- 239000000203 mixture Substances 0.000 description 6
- 238000005303 weighing Methods 0.000 description 4
- 229940079593 drug Drugs 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 239000002158 endotoxin Substances 0.000 description 3
- 230000036512 infertility Effects 0.000 description 3
- MJIHNNLFOKEZEW-UHFFFAOYSA-N lansoprazole Chemical compound CC1=C(OCC(F)(F)F)C=CN=C1CS(=O)C1=NC2=CC=CC=C2N1 MJIHNNLFOKEZEW-UHFFFAOYSA-N 0.000 description 3
- 229960003174 lansoprazole Drugs 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 208000021302 gastroesophageal reflux disease Diseases 0.000 description 2
- 238000011835 investigation Methods 0.000 description 2
- 238000011068 loading method Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 239000002510 pyrogen Substances 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 238000001179 sorption measurement Methods 0.000 description 2
- HYZJCKYKOHLVJF-UHFFFAOYSA-N 1H-benzimidazole Chemical compound C1=CC=C2NC=NC2=C1 HYZJCKYKOHLVJF-UHFFFAOYSA-N 0.000 description 1
- FVVDKUPCWXUVNP-UHFFFAOYSA-M Aminosalicylate sodium anhydrous Chemical compound [Na+].NC1=CC=C(C([O-])=O)C(O)=C1 FVVDKUPCWXUVNP-UHFFFAOYSA-M 0.000 description 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 1
- ZZZCUOFIHGPKAK-UHFFFAOYSA-N D-erythro-ascorbic acid Natural products OCC1OC(=O)C(O)=C1O ZZZCUOFIHGPKAK-UHFFFAOYSA-N 0.000 description 1
- 206010063655 Erosive oesophagitis Diseases 0.000 description 1
- 206010029155 Nephropathy toxic Diseases 0.000 description 1
- 206010029350 Neurotoxicity Diseases 0.000 description 1
- QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 description 1
- 206010044221 Toxic encephalopathy Diseases 0.000 description 1
- 229930003268 Vitamin C Natural products 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 238000004043 dyeing Methods 0.000 description 1
- 201000006549 dyspepsia Diseases 0.000 description 1
- 230000003628 erosive effect Effects 0.000 description 1
- 208000024798 heartburn Diseases 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000007694 nephrotoxicity Effects 0.000 description 1
- 231100000417 nephrotoxicity Toxicity 0.000 description 1
- 230000007135 neurotoxicity Effects 0.000 description 1
- 231100000228 neurotoxicity Toxicity 0.000 description 1
- 238000013386 optimize process Methods 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 229940126409 proton pump inhibitor Drugs 0.000 description 1
- 239000000612 proton pump inhibitor Substances 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 235000019154 vitamin C Nutrition 0.000 description 1
- 239000011718 vitamin C Substances 0.000 description 1
- 150000003751 zinc Chemical class 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Communicable Diseases (AREA)
- Oncology (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)
- Medicinal Preparation (AREA)
Abstract
The invention discloses an optimized preparation method of a freeze-dried powder injection of dexlansoprazole, which adopts a process without an active carbon adding step, and the obtained freeze-dried powder injection of the dexlansoprazole can avoid the influence of element impurities and insoluble particles introduced by active carbon on a dexlansoprazole compound.
Description
Technical Field
The invention belongs to the field of medicines, and particularly relates to an optimized preparation method of a freeze-dried powder injection of dexlansoprazole.
Background
Dexlansoprazole is a drug developed and marketed by the martial arts company of japan for treating gastroesophageal reflux. The medicine is enantiomer of proton pump inhibitor lansoprazole, also called as dexlansoprazole, and is used for treating heartburn and erosive esophagitis with different degrees, which are related to non-erosive gastroesophageal reflux disease.
The chemical name of the dexlansoprazole is (R) -2- [ [ [ 3-methyl-4- (2, 2-trifluoro ethoxy) -2-pyridyl ] methyl ] -sulfinyl ] benzimidazole, and the structure of the dexlansoprazole is shown as a formula (I):
because the active carbon has the functions of removing impurities, decoloring, adsorbing pyrogen, assisting filtration and the like, the active carbon is widely applied to the process of the freeze-dried powder of the dexlansoprazole. In the actual preparation process, the active carbon has the following defects. Firstly, the pH value, chloride and sulfate in the activated carbon are unqualified or the carbon particles are too fine, so that the solution is not easy to filter after dyeing, and the quality of the preparation is affected. Secondly, zinc salt and ferric salt in the activated carbon are unqualified, for example, the ferric salt content is higher, so that certain medicines in transfusion such as vitamin C, sodium p-aminosalicylate and the like can be changed in color. Third, poor or unacceptable decolorizing power results in increased impurity levels in the formulation. Fourth, the active carbon itself contains more impurities which can pollute the liquid medicine, often causes clarity and unqualified particles of the preparation, and also affects the stability of the preparation, so that the active carbon for the first-level needle is necessarily selected when preparing large transfusion. Fifth, the activated carbon can absorb moisture and air to reduce its adsorption capacity due to the influence of production environment, packaging, transportation and storage conditions, and if the activated carbon is not subjected to activation treatment before use, the ability of the activated carbon to adsorb pyrogens and impurities can be affected, and the quality of the preparation can be affected. Therefore, the necessary pretreatment is carried out according to the specific situation before the use, but the treatment is more complicated.
Aiming at lansoprazole lyophilized powder, the prior art discloses some preparation methods, CN107998084B discloses lansoprazole lyophilized powder and a preparation method thereof, patent CN104758259A discloses a lyophilized preparation taking dexlansoprazole as an active ingredient and a preparation method thereof, and patent CN109381435A discloses a dexlansoprazole lyophilized powder injection, a preparation method and application thereof. Activated carbon is added in the series of methods to remove impurities, decolorize, and the like, which inevitably introduces some possible risks of the activated carbon, such as: (1) The source and production process of the activated carbon raw material are various, so that the activated carbon may contain different element impurities. Some elemental impurities are toxic, including neurotoxicity, nephrotoxicity, and the like; (2) Activated carbon may introduce insoluble particles into the formulation, which are 1-50 μm in size and invisible to the naked eye, but may cause difficult to find and potentially serious harm to the human body because they can flow with blood but cannot be metabolized; (3) The active carbon has a certain adsorption effect on the medicine, and can possibly cause a certain influence on the main medicine of the dexlansoprazole. In order to eliminate the above adverse effects caused by the activated carbon, it is highly desirable to design a process for preparing the freeze-dried powder of dexlansoprazole which does not involve the activated carbon.
In the further research and development work of the freeze-dried powder preparation method based on ZL202110267166.X, the process is unexpectedly found that under the condition of no addition of active carbon, the process has no obvious influence on various indexes of a sample, particularly the control on bacterial endotoxin and sterility, and simultaneously a series of potential risks possibly brought by the active carbon are avoided.
Disclosure of Invention
The invention aims to provide an optimized preparation method of a freeze-dried powder injection of dexlansoprazole, which mainly aims to avoid a series of risks caused by the step of adding activated carbon.
The invention also provides a preparation method of the dexlansoprazole lyophilized powder injection, which is characterized by comprising the following steps:
1. adding mannitol and meglumine into water for injection, stirring for dissolving, adding sodium hydroxide, stirring for dissolving, and adding the prescription amount of dexlansoprazole into the solution for stirring for dissolving;
2. adjusting the pH of the solution by using sodium hydroxide solution, and supplementing the water for injection to the total amount:
3. and (5) filling and freeze-drying.
In an alternative embodiment, wherein the water for injection is cooled down to below 35 ℃ in advance, preferably to below 30 ℃.
In an alternative embodiment, wherein the pH is adjusted to 11.5-12.5, preferably 11.8-12.2.
In an alternative embodiment, the freeze-drying process includes pre-freezing, vacuuming, primary drying, and secondary drying.
In an alternative embodiment, wherein the prefreezing temperature is-30 to-40 ℃ for 1 to 3 hours.
In an alternative embodiment, wherein said primary drying: the temperature is raised to-20 to-10 ℃, kept for 0.5 to 2 hours, raised to-10 to 0 ℃, kept for 1 to 3 hours, and raised to-5 to 5 ℃.
In an alternative embodiment, wherein said secondary drying: the temperature is raised to 20-40 ℃ and kept for 3-5 hours.
In an alternative embodiment, the prefreezing temperature is-30 to-40 ℃ for 1 to 3 hours; vacuumizing; primary drying: raising the temperature to-20 to-10 ℃, keeping the temperature for 0.5 to 2 hours, raising the temperature to-10 to 0 ℃, keeping the temperature for 1 to 3 hours, and raising the temperature to-5 to 5 ℃; and (3) secondary drying: the temperature is raised to 20-40 ℃ and kept for 3-5 hours.
In an alternative embodiment, freeze drying: pre-freezing the product to below-35 ℃ and keeping for 2 hours; vacuumizing; primary drying: raising the temperature to-15 ℃, keeping for 1 hour, raising the temperature to-5 ℃, keeping for 2 hours, and raising the temperature to 0 ℃; and (3) secondary drying: the temperature was raised to 30℃and maintained for 4 hours.
The preparation method of the dexlansoprazole freeze-dried powder injection has no obvious influence on various indexes of a sample under the condition of not adding active carbon, particularly controls bacterial endotoxin and sterility, and avoids a series of potential risks possibly brought by the active carbon.
Detailed description of the preferred embodiments
Example 1 preparation of lyophilized powder for injection
1. Scheme (scheme 1) of ZL202110267166.X for preparing dexlansoprazole lyophilized powder for injection
The freeze-dried powder injection of the dexlansoprazole is prepared according to the prescription of the table 1.
Table 1 prescription composition table
Names of raw and auxiliary materials | Prescription quantity |
Dexlansoprazole | 400.0g |
Mannitol (mannitol) | 534.0g |
Meglumine (meglumine) | 134.0g |
Sodium hydroxide | 56.0g |
Activated carbon | 40.0g |
Water for injection to | 40.0kg |
The preparation process comprises the following steps:
1. weighing 80% of water for injection, and keeping the temperature of the water for injection below 30 ℃ for later use;
2. sequentially weighing mannitol and meglumine according to a prescription, stirring to dissolve all mannitol and meglumine in water for injection, adding sodium hydroxide with a prescription amount, stirring to dissolve all mannitol and meglumine, adding dexlansoprazole with a prescription amount in the solution, and stirring to dissolve all the dexlansoprazole;
3. adjusting the pH of the solution to 11.5-12.2 with 0.5mol/L sodium hydroxide solution, and supplementing water for injection (below 30deg.C) to the total amount;
4. adding 0.1% active carbon, stirring for 15min, filtering, and removing active carbon;
5. detecting an intermediate, and calculating the loading;
6. filling, half-plugging, freeze-drying in a freeze dryer, and freezing the mixture in a freezing process shown in Table 2.
TABLE 2 Freeze drying Process Table
2. The optimized process scheme (scheme 2) of the invention prepares the freeze-dried powder injection of the dexlansoprazole
The freeze-dried powder injection of the dexlansoprazole is prepared according to the prescription of the table 3.
Table 3 prescription composition table
Names of raw and auxiliary materials | Prescription quantity |
Dexlansoprazole | 800.0g |
Mannitol (mannitol) | 1068.0g |
Meglumine (meglumine) | 268.0g |
Sodium hydroxide | 112.0g |
Water for injection to | 80.0kg |
The preparation process comprises the following steps:
1. weighing 80% of water for injection, and keeping the temperature of the water for injection below 30 ℃ for later use;
2. sequentially weighing mannitol and meglumine according to a prescription, stirring to dissolve all mannitol and meglumine in water for injection, adding sodium hydroxide with a prescription amount, stirring to dissolve all mannitol and meglumine, adding dexlansoprazole with a prescription amount in the solution, and stirring to dissolve all the dexlansoprazole;
3. adjusting the pH of the solution to 11.5-12.2 with 0.5mol/L sodium hydroxide solution, and supplementing water for injection (below 30deg.C) to the total amount;
4. detecting an intermediate, and calculating the loading;
5. filling, half-plugging, freeze-drying in a freeze dryer, and freezing the mixture in a freezing process shown in Table 4.
Table 4 freeze drying process table
Example 2 investigation of two preparation Processes
According to the invention, the preparation process of ZL202110267166.X is optimized, active carbon is not added any more, and whether the process without adding active carbon is reasonable is judged by examining various indexes of finished products prepared by the front and rear preparation processes.
The optimized preparation process scheme 2 and the scheme (scheme 1) of ZL202110267166.X respectively prepare freeze-dried powder injection. The results of the sample investigation are shown in Table 5.
Table 5 process comparison
After freeze-drying the freeze-dried samples of the two schemes, the yield, the character, the clarity, the color, the pH, the related impurity content, the enantiomer, the moisture, the visible foreign matters, the insoluble particles, the bacterial endotoxin, the sterility and the like of the freeze-dried samples of the two schemes are not obviously different, which indicates that the preparation process related to the invention can still obtain the effect equivalent to the process of adding the active carbon without adding the active carbon.
It should be understood that the foregoing description is only of the preferred embodiments of the present invention and is not intended to limit the scope of the invention, but is intended to cover any and all modifications, equivalents, and alternatives falling within the spirit and principles of the invention.
Claims (9)
1. An optimized preparation method of a freeze-dried powder injection of dexlansoprazole is characterized by comprising the following steps:
(1) Adding mannitol and meglumine into water for injection, stirring for dissolving, adding sodium hydroxide with a prescription amount for stirring for dissolving, and adding dexlansoprazole with a prescription amount into the solution for stirring for dissolving;
(2) Adjusting the pH of the solution by using sodium hydroxide solution, and supplementing the water for injection to the full amount;
(3) And (5) filling and freeze-drying.
2. The preparation method according to claim 1, wherein the water for injection is cooled to below 35 ℃, preferably below 30 ℃ in advance.
3. The preparation method according to any one of claims 1-2, wherein the pH is adjusted to 11.5-12.5, preferably 11.8-12.2.
4. A method of preparation according to any one of claims 1 to 3 wherein the freeze drying process comprises prefreezing, evacuating, primary drying, secondary drying.
5. The method according to claim 4, wherein the prefreezing temperature is-30 to-40 ℃ for 1 to 3 hours.
6. The method of claim 4, wherein the primary drying: the temperature is raised to-20 to-10 ℃, kept for 0.5 to 2 hours, raised to-10 to 0 ℃, kept for 1 to 3 hours, and raised to-5 to 5 ℃.
7. The method of claim 4, wherein the secondary drying: the temperature is raised to 20-40 ℃ and kept for 3-5 hours.
8. The method according to claim 4, wherein the prefreezing temperature is-30 to-40 ℃ and is maintained for 1 to 3 hours; vacuumizing; primary drying: raising the temperature to-20 to-10 ℃, keeping the temperature for 0.5 to 2 hours, raising the temperature to-10 to 0 ℃, keeping the temperature for 1 to 3 hours, and raising the temperature to-5 to 5 ℃; and (3) secondary drying: the temperature is raised to 20-40 ℃ and kept for 3-5 hours.
9. The method of claim 8, wherein the step of freeze-drying: pre-freezing the product to below-35 ℃ and keeping for 2 hours; vacuumizing; primary drying: raising the temperature to-15 ℃, keeping for 1 hour, raising the temperature to-5 ℃, keeping for 2 hours, and raising the temperature to 0 ℃; and (3) secondary drying: the temperature was raised to 30℃and maintained for 4 hours.
Priority Applications (1)
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CN202210342273.9A CN116919906A (en) | 2022-04-02 | 2022-04-02 | Optimized preparation method of dexlansoprazole freeze-dried powder injection |
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CN202210342273.9A Pending CN116919906A (en) | 2022-04-02 | 2022-04-02 | Optimized preparation method of dexlansoprazole freeze-dried powder injection |
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Country or region after: China Address after: No. 5-1 Jianshe Road, Nanjing Economic and Technological Development Zone, Nanjing City, Jiangsu Province, 210046 Applicant after: Nanjing Bode Biopharmaceutical Co.,Ltd. Address before: 210046 No. 5, Jianshe Road, Nanjing Economic and Technological Development Zone, Jiangsu Province Applicant before: Shenghe (China) Pharmaceutical Co.,Ltd. Country or region before: China |
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