CN101664385B - Ibutilide fumarate injection and preparation method thereof - Google Patents
Ibutilide fumarate injection and preparation method thereof Download PDFInfo
- Publication number
- CN101664385B CN101664385B CN 200910181034 CN200910181034A CN101664385B CN 101664385 B CN101664385 B CN 101664385B CN 200910181034 CN200910181034 CN 200910181034 CN 200910181034 A CN200910181034 A CN 200910181034A CN 101664385 B CN101664385 B CN 101664385B
- Authority
- CN
- China
- Prior art keywords
- injection
- fumarate
- water
- preparation
- preparing
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to ibutilide fumarate injection which comprises the following components by weight percent in volume (mg/ml): 0.093-0.107 ibutilide fumarate, 0.2-1.0 sodium bicarbonate, 0.5-2.0 sodium bisulfite and 6.0-9.0 sodium chloride, wherein, water for injection is used for constant volume. The ibutilide fumarate injection of the invention has good thermostability; and the injection can be still in a stable status after hot pressing sterilization, thus improving sterility assurance level, clinical safety and quality stability.
Description
Technical field
The present invention relates to a kind of injection, particularly relate to Ibutilide fumarate injection and preparation method thereof.
Background technology
Ibolite fumarate, molecular formula: C
20H
36N
2O
3S1/2C
4H
4O
4Molecular weight: 442.62, its structural formula is as follows:
The molecular structure of Ibolite fumarate
Ibolite fumarate is a kind of Novel ion channel activity III class antiarrhythmic drug, and principal indication is for turning again in the recent period (atrial fibrillation or the atrial flutter of the course of disease≤90d) occur.The atrial fibrillation that clinical usefulness is shown effect in the near future or room are pounced on and are reversed into sinus rhythm.
Ibolite fumarate is generally unstable after sterilization more than 100 ℃ in aqueous solution, and the at present production procedure of Ibutilide fumarate injection (Ibutilide Fumarate Injection) is: supplementary material dissolving-preparating liquid-aseptic embedding-leak detection-visible foreign matters inspection-packing.Existing production technology has:
One) method 1
1) prescription forms: Ibolite fumarate; Hydrochloric acid solution; Water for injection.
2) production technology operating process: take by weighing the recipe quantity Ibolite fumarate, after being dissolved in water for injection, regulate about pH value to 4.5 with the hydrochloric acid solution of 1.0mol/L, add 0.1% needle-use activated carbon, heating in water bath stirs, filtering decarbonization, add to the full amount of water for injection, order is with behind 0.8 μ m and the 0.22 μ m filtering with microporous membrane, and filling and sealing enters the 10mL ampoule under the aseptic condition, through leak detection, visible foreign matters inspection, packing, after the assay was approved and get final product.
Two) method 2
1) prescription forms: Ibolite fumarate; Sodium acetate; Sodium chloride; Water for injection.
2) production technology operating process: 1. preparation: take by weighing recipe quantity Ibolite fumarate, sodium chloride, that sodium acetate injects water is an amount of, gentle agitation makes dissolving; With about salt acid for adjusting pH to 4.6; After the intermediate detection is qualified, through the filter membrane filtration of 0.65um, 0.22um, treat embedding.2. embedding: check the feed liquid clarity, qualified rear embedding.3. leak detection: intermediate products, are sent between turnover after cleaning through leak detection.4. clarity test: intermediate products by checking, are picked out the visible foreign matters defective products such as color lump, cilium under 1000lx-1500lx illumination, inspect by random samples through quality supervision person and send between turnover after qualified.5. pack: intermediate products are packed through after the assay was approved.
But also there is following problems in above technique:
Ibolite fumarate adds small-volume injection that appropriate amount of auxiliary materials makes in process of production, not adopting the pressure sterilizing method, but adopt sterile filling, is because general through pressure sterilizing, Ibolite fumarate is degraded easily, content, unstable product quality.Existing medicine registration management and pharmaceutical control and administration rules are paid attention to the aseptic assurance of injection especially, and adopt pressure sterilizing technique sterility assurance level to be higher than sterile filling, so the aseptic assurance of small-volume injection should be adopted pressure sterilizing as far as possible.And behind the Ibutilide fumarate injection process high temperature sterilize that the existing technique of employing is made, Ibolite fumarate (C
20H
36N
2O
3S1/2C
4H
4O
4) content decrease, be lower than labelled amount (labelled amount 93.0%～107.0%).In order to improve sterility assurance level, be necessary to improve by prescription adjustment, production technology, make Ibutilide fumarate injection can adopt pressure sterilizing technique, thereby improve the sterility assurance level of product, can guarantee again the quality stability of Ibutilide fumarate injection simultaneously.
Summary of the invention
The purpose of this invention is to provide a kind of Ibutilide fumarate injection, the problem of the poor heat stability that exists with the injection that solves prior art, guarantee that injection still can be in steady statue through behind the pressure sterilizing, can improve sterility assurance level, thereby the raising clinical safety can guarantee its quality stability again.
Another object of the present invention provides the preparation method of Ibutilide fumarate injection.
The invention provides a kind of Ibutilide fumarate injection, its by weight percent by volume (mg/ml) made by following compositions: percent by volume (mg/ml) is made by following compositions by weight: Ibolite fumarate 0.093-0.107; Sodium bicarbonate 0.2～1.0; Sodium sulfite 0.5～2.0; Sodium chloride 6.0～9.0; Use the water for injection standardize solution.
Preferably, its by weight percent by volume (mg/ml) made by following compositions: Ibolite fumarate 0.093-0.107; Sodium bicarbonate 0.5～0.6; Sodium sulfite 1.0～2.0; Sodium chloride 7.0～8.0; Use the water for injection standardize solution.
The present invention also provides the method for the above-mentioned Ibutilide fumarate injection of preparation, comprises the steps:
1) solvent pretreatment: in preparing tank, put into the water for injection that accounts for amount of preparation 50%, be cooled to room temperature, pass into CO
2To saturated;
2) preparation: take by weighing sodium bicarbonate, sodium sulfite, sodium chloride and inject water, stir and make dissolving, get adjuvant solution; Take by weighing the Ibolite fumarate of formula ratio, inject water, stir and make fully dissolving, get material solution;
3) adjuvant solution, material solution being added step 1 successively) in the described container, the supplementary injection water stirs to preparing full dose, regulates pH to 4.0～5.0, ultrafiltration;
4) filter through filter, pressure sterilizing is adopted in the filling CO 2 embedding, carries out at last the leak detection of color water and clarity test, and get final product.
Wherein, described step 3) middle is the hydrochloric acid adjusting pH value of 0.1～0.5mol/l with concentration.
Described step 4) filters through 0.65 μ m and 0.22 μ m filter in.
Described step 4) adopts 100～120 ℃, 10～50 minutes pressure sterilizings in.
Preferably, adopt 115 ℃, 30 minutes pressure sterilizings described step 4).
Described step 4) under 1000lx～1500lx illumination, checks clarity in.
Ibutilide fumarate injection of the present invention and preparation method thereof has following beneficial effect:
1) sodium bicarbonate of selecting in the Ibutilide fumarate injection of the present invention is stabilizing agent, sodium sulfite is antioxidant, two kinds of adjuvants all can improve the stability of Ibutilide fumarate injection, sodium bicarbonate plays again the pH cushioning effect simultaneously, Ibolite fumarate is in the metastable pH value environment, and sodium chloride then is isoosmotic adjusting agent.In addition, sodium bicarbonate and sodium sulfite all are conducive to the stable of Ibolite fumarate molecular structure;
2) in the preparation method of Ibutilide fumarate injection of the present invention, pass into CO during the solvent pretreatment
2To the saturated oxygen of removing in the solvent, avoid as far as possible Ibolite fumarate contact oxygen and oxidized; Adopt hyperfiltration technique can remove pyrogen and impurity etc. in the injection process for preparation;
3) injection embedding process adopts and fills CO
2Embedding, but deaeration is oxidized to avoid as far as possible Ibolite fumarate contact oxygen;
4) Ibutilide fumarate injection is no more than 1.5% through content decrease behind the pressure sterilizing, and pH value, visible foreign matters, related substance etc. all meet the national drug standards simultaneously.
5) Ibutilide fumarate injection of the present invention is through the variation (referring to table 1) of content, pH value behind the pressure sterilizing.
Table 1 Ibutilide fumarate injection is through the variation of content, pH value behind the pressure sterilizing
| Content (%) before the sterilization | Content (%) after the sterilization | PH value before the sterilization | PH value after the sterilization |
| 100 | 93.0％～107.0％ | 4.0～5.5 | 4.0～5.5 |
The specific embodiment
Following examples are used for explanation the present invention, but are not used for limiting the scope of the invention.
Embodiment 1
Ibutilide fumarate injection of the present invention is made by following composition: Ibolite fumarate 1000mg; Sodium bicarbonate 2000mg; Sodium sulfite 5000mg; Sodium chloride 80000mg; Inject water to 10000 milliliters.
Its preparation method is as follows:
1) solvent pretreatment: in No. 1 preparing tank, put into about 5000 milliliters water for injection, be cooled to room temperature, pass into CO
2Surveyed pH value to saturated, and be about 6.0 in about 15～30 minutes.
2) injection preparation: the sodium bicarbonate, sodium sulfite, the sodium chloride that 1. take by weighing recipe quantity inject about 2000 milliliters of water, and gentle agitation makes dissolving, gets adjuvant solution; 2. take by weighing the Ibolite fumarate of recipe quantity, inject about 1000 milliliters of water, stir and make fully dissolving, get material solution; 3. adjuvant solution, material solution are successively added in No. 1 batch tank, the supplementary injection water is to disposing 10000 milliliters of full doses, and stir about 15 minutes is to evenly, with about salt acid for adjusting pH to 4.6, after ultrafiltration, pumps in No. 2 preparing tanks to get medicinal liquid.
3) medicinal liquid detect qualified after, after 0.65 μ m, 0.22 μ m filter filter, treat embedding in the input embedding non-conservation tank.
4) embedding: check medicinal liquid clarity, qualified after, defective products is chosen in the filling CO 2 embedding at any time in the embedding process, the intermediate products after the embedding are sent in the sterilization leak detection cabinet.
5) sterilization leak detection: intermediate products adopt 115 ℃, 30 minutes pressure sterilizings, and the vacuum leak hunting of color water after cleaning up, is delivered between turnover.
6) clarity test: intermediate products by checking a clarity, are picked out the visible foreign matters defective products such as white point, white piece, cilium under 1000lx～1500lx illumination, inspect by random samples after qualified to be packaged through quality supervision person.
7) packing: intermediate products elder generations lettering, after put into packing box, put into the product inspection quality certification by case and pack, after the assay was approved warehouse-in.Packing specification: box/part in 1 milligram/bottle * 2 bottles/capsule * 10 capsules/middle box * 9.
Complete of product detects, and the result shows that product meets the national drug standards fully, sees Table 2
Table 2
Embodiment 2
Ibutilide fumarate injection of the present invention is made by following raw material: Ibolite fumarate 1000mg; 10000 milligrams of sodium bicarbonate; 20000 milligrams of sodium sulfitees; 70000 milligrams in sodium chloride; Inject water to 10000 milliliters.
Its preparation method is as follows:
1) solvent pretreatment: in No. 1 preparing tank, put into about 5000 milliliters water for injection, be cooled to room temperature, pass into CO
2Surveyed pH value to saturated, and be about 6.0 in about 15～30 minutes.
2) injection preparation: the sodium bicarbonate, sodium sulfite, the sodium chloride that 1. take by weighing recipe quantity inject about 2000 milliliters of water, and gentle agitation makes dissolving, gets adjuvant solution; 2. take by weighing the Ibolite fumarate of recipe quantity, inject about 1000 milliliters of water, stir and make fully dissolving, get material solution; 3. adjuvant solution, material solution are successively added in No. 1 batch tank tank, the supplementary injection water is to preparing 10000 milliliters of full doses, and stir about 15 minutes is to evenly, with about salt acid for adjusting pH to 4.6, after ultrafiltration, pumps in No. 2 preparing tanks to get medicinal liquid.
3) medicinal liquid detect qualified after, after 0.65 μ m, 0.22 μ m filter filter, treat embedding in the input embedding non-conservation tank.
4) embedding: check medicinal liquid clarity, qualified after, defective products is chosen in the filling CO 2 embedding at any time in the embedding process, the intermediate products after the embedding are sent in the pressure sterilizing leak detection cabinet.
5) sterilization leak detection: intermediate products adopt 115 ℃, 30 minutes pressure sterilizings, and the vacuum leak hunting of color water after cleaning up, is delivered between turnover.
6) clarity test: intermediate products by checking a clarity, are picked out the visible foreign matters defective products such as white point, white piece, cilium under 1000lx～1500lx illumination, inspect by random samples after qualified to be packaged through quality supervision person.
7) packing: intermediate products elder generations lettering, after put into packing box, put into the product inspection quality certification by case and pack, after the assay was approved warehouse-in.Packing specification: box/part in 1 milligram/bottle * 2 bottles/capsule * 10 capsules/middle box * 9.
Complete of product detects, and the result shows that product meets the national drug standards fully, sees Table 3:
Table 3
Embodiment 3
Ibutilide fumarate injection of the present invention is made by following raw material: Ibolite fumarate 1000mg; 5000 milligrams of sodium bicarbonate; 10000 milligrams of sodium sulfitees; 75000 milligrams in sodium chloride; Inject water to 10000 milliliters.
Its preparation method is as follows:
1) solvent pretreatment: in dense preparing tank, put into about 5000 milliliters water for injection, be cooled to room temperature, pass into CO
2Surveyed pH value to saturated, and be about 6.0 in about 15～30 minutes.
2) injection preparation: the sodium bicarbonate, sodium sulfite, the sodium chloride that 1. take by weighing recipe quantity inject about 1000 milliliters of water, and gentle agitation makes dissolving, gets adjuvant solution; 2. take by weighing the Ibolite fumarate of recipe quantity, inject about 1000 milliliters of water, stir and make fully dissolving, get material solution; 3. adjuvant solution, material solution are successively added in No. 1 preparing tank, the supplementary injection water is to preparing 10000 milliliters of full doses, and stir about 15 minutes is to evenly, with about salt acid for adjusting pH to 4.6, after ultrafiltration, pumps in No. 2 preparing tanks to get medicinal liquid.
3) medicinal liquid detect qualified after, after 0.65 μ m, 0.22 μ m filter filter, treat embedding in the input embedding non-conservation tank.
4) embedding: check medicinal liquid clarity, qualified after, defective products is chosen in the filling CO 2 embedding at any time in the embedding process, the intermediate products after the embedding are sent in the sterilization leak detection cabinet.
5) sterilization leak detection: intermediate products adopt 115 ℃, 30 minutes pressure sterilizings, and the vacuum leak hunting of color water after cleaning up, is delivered between turnover.
6) clarity test: intermediate products by checking a clarity, are picked out the visible foreign matters defective products such as white point, white piece, cilium under 1000lx～1500lx illumination, inspect by random samples after qualified to be packaged through quality supervision person.
7) packing: intermediate products elder generations lettering, after put into packing box, put into the product inspection quality certification by case and pack, after the assay was approved warehouse-in.Packing specification: box/part in 1 milligram/bottle * 2 bottles/capsule * 10 capsules/middle box * 9.
Complete of product detects, and the result shows that product meets the national drug standards fully, sees Table 4:
Table 4
Experimental example 1
By prescription and process modification, Ibutilide fumarate injection is no more than 1.5% through content decrease behind the pressure sterilizing, and pH value, visible foreign matters, related substance etc. all meet the national drug standards simultaneously.The results are shown in Table 5.
Table 5 Ibutilide fumarate injection is through the variation of content, pH value behind the pressure sterilizing
| Embodiment | Feed intake and indicate content (%) | Content (%) after the sterilization | PH value before the sterilization | PH value after the sterilization |
| Embodiment 1 | 100 | 99.28 | 4.6 | 4.6 |
| Embodiment 2 | 100 | 99.36 | 4.6 | 4.7 |
| Embodiment 3 | 100 | 99.52 | 4.6 | 4.6 |
Experimental example 2 study on the stability
Accelerated stability test
After 6 months accelerated tests, character, pH value, related substance, visible foreign matters, five indexs of investigating project of content all meet the regulation in the Ibutilide fumarate injection national drug standards without significant change as shown in Table 6.The result shows that prescription and production technology Ibutilide fumarate injection stability that employing is new are better.
Table 6 Accelerated stability test result
The stable content analysis
Detect the sample that keeps sample behind six months Accelerated stability tests, indices all meets the national drug standards, the 6th the end of month sample changes of contents be respectively 1.22%, 1.21%, 1.24%, average out to (1.22 ± 0.02) %, RSD=1.64.Further verified the reliability of manufacturing condition.
Experimental example 3
The full testing result of embodiment 1-3 gained injection products
Table 7 embodiment 1 testing result (0 month)
Table 8 embodiment 2 testing results (0 month)
Table 9 embodiment 3 testing results (0 month)
Detect the sample that keeps sample behind six months Accelerated stability tests, the results are shown in Table 10, table 11, table 12.
Table 10 embodiment 1 testing result (6 months)
Table 11 embodiment 2 testing results (6 months)
Table 12 embodiment 3 testing results (6 months)
Claims (6)
1. an Ibutilide fumarate injection is characterized in that percent by volume is made by following compositions by weight: Ibolite fumarate 0.093～0.107; Sodium bicarbonate 0.2～1.0; Sodium sulfite 0.5～2.0; Sodium chloride 6.0～9.0; Use the water for injection standardize solution, unit is mg/ml; Its preparation method comprises the steps:
1) solvent pretreatment: in preparing tank, put into the water for injection that accounts for amount of preparation 50%, be cooled to room temperature, pass into CO
2To saturated;
2) preparation: take by weighing sodium bicarbonate, sodium sulfite, sodium chloride and inject water, stir and make dissolving, get adjuvant solution; Take by weighing the Ibolite fumarate of formula ratio, inject water, stir and make fully dissolving, get material solution;
3) adjuvant solution, material solution being added step 1 successively) in the described container, the supplementary injection water stirs to preparing full dose, regulates pH to 4.0～5.0, ultrafiltration;
4) filter through filter, fill CO
2Embedding is adopted 100～120 ℃, 10～50 minutes pressure sterilizings, and be get final product.
2. Ibutilide fumarate injection according to claim 1 is characterized in that, percent by volume is made by following compositions by weight: Ibolite fumarate 0.093～0.107; Sodium bicarbonate 0.5～0.6; Sodium sulfite 1.0～2.0; Sodium chloride 7.0～8.0; Use the water for injection standardize solution, unit is mg/ml.
3. prepare the method for claim 1 or 2 described Ibutilide fumarate injections, it is characterized in that, comprise the steps:
1) solvent pretreatment: in preparing tank, put into the water for injection that accounts for amount of preparation 50%, be cooled to room temperature, pass into CO
2To saturated;
2) preparation: take by weighing sodium bicarbonate, sodium sulfite, sodium chloride and inject water, stir and make dissolving, get adjuvant solution; Take by weighing the Ibolite fumarate of formula ratio, inject water, stir and make fully dissolving, get material solution;
3) adjuvant solution, material solution being added step 1 successively) in the described container, the supplementary injection water stirs to preparing full dose, regulates pH to 4.0～5.0, ultrafiltration;
4) filter through filter, fill CO
2Embedding is adopted 100～120 ℃, 10～50 minutes pressure sterilizings, and be get final product.
4. the method for preparing Ibutilide fumarate injection according to claim 3 is characterized in that, described step 3) in be the hydrochloric acid adjusting pH value of 0.1～0.5mol/l with concentration.
5. the method for preparing Ibutilide fumarate injection according to claim 3 is characterized in that, described step 4) in filter through 0.65 μ m and 0.22 μ m filter.
6. the method for preparing Ibutilide fumarate injection according to claim 3 is characterized in that, described step 4) 115 ℃, 30 minutes pressure sterilizings of middle employing.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200910181034 CN101664385B (en) | 2009-10-28 | 2009-10-28 | Ibutilide fumarate injection and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200910181034 CN101664385B (en) | 2009-10-28 | 2009-10-28 | Ibutilide fumarate injection and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101664385A CN101664385A (en) | 2010-03-10 |
| CN101664385B true CN101664385B (en) | 2013-04-10 |
Family
ID=41801271
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200910181034 Active CN101664385B (en) | 2009-10-28 | 2009-10-28 | Ibutilide fumarate injection and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101664385B (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101843607B (en) * | 2010-06-10 | 2011-09-07 | 浙江九旭药业有限公司 | Composition containing ibutilide fumarate and preparation method and application thereof |
| CN102485221B (en) * | 2010-12-02 | 2013-07-17 | 天津药物研究院 | Sublingual pharmaceutical composition containing ibutilide and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1733714A (en) * | 2005-07-12 | 2006-02-15 | 浙江九旭药业有限公司 | Fumaric acid ibutilide synthesis method |
| CN1977828A (en) * | 2005-12-02 | 2007-06-13 | 韩苏 | Injection preparation and use |
-
2009
- 2009-10-28 CN CN 200910181034 patent/CN101664385B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1733714A (en) * | 2005-07-12 | 2006-02-15 | 浙江九旭药业有限公司 | Fumaric acid ibutilide synthesis method |
| CN1977828A (en) * | 2005-12-02 | 2007-06-13 | 韩苏 | Injection preparation and use |
Non-Patent Citations (2)
| Title |
|---|
| 张汝华，等.注射剂和滴眼剂.《工业药剂学》.2001,第250-264页. * |
| 范治云,等.富马酸伊布利特安全性评价研究.《药品评价》.2005,第2卷(第6期),第432页正文第2段. * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101664385A (en) | 2010-03-10 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN103768091B (en) | Sodium bicarbonate injection and its preparation method | |
| CN110638751A (en) | Stable sugammadex sodium injection and preparation method thereof | |
| CN103550143A (en) | Preparation method of levetiracetam injection | |
| CN103655469A (en) | Prescription and preparation technology of lipoic acid injection combination | |
| CN103989630B (en) | Moxifloxacin hydrochloride injection and preparation method thereof | |
| CN101664385B (en) | Ibutilide fumarate injection and preparation method thereof | |
| CN102626409A (en) | Pharmaceutical composition containing 18 amino acids | |
| CN113876697A (en) | Dopamine hydrochloride injection and preparation process thereof | |
| CN102462659B (en) | Citicoline sodium injection and preparation method thereof | |
| CN103006554A (en) | Ornidazole injection and preparation method thereof | |
| CN102144963B (en) | Citicoline sodium glucose injecta and preparation process thereof | |
| CN102525893B (en) | Phenylephrine hydrochloride injection and preparation process thereof | |
| CN115487140A (en) | Coenzyme Q10 injection and preparation method thereof | |
| CN102085180B (en) | Dobutamine hydrochloride injection and preparation method thereof | |
| CN105030702B (en) | One kind sodium pharmaceutical composition containing heparin and preparation method thereof | |
| CN1557302A (en) | Carbazochrome Sodium Sulfonate infusion and its preparation method | |
| CN112569184A (en) | Tirofiban hydrochloride injection and preparation method thereof | |
| CN104337760B (en) | A kind of Maxamine injection and preparation method thereof | |
| CN103239392B (en) | Ornidazole injection preparation and preparation method thereof | |
| CN111265475A (en) | Isoniazid injection and preparation method thereof | |
| CN104721223B (en) | A kind of injection pharmaceutical composition of compound electrolyte and preparation method thereof | |
| CN110314132B (en) | Ornithine aspartate injection and preparation method thereof | |
| CN113116921B (en) | Sodium bicarbonate injection and preparation method thereof | |
| CN108210451B (en) | Stable breviscapine injection and preparation process thereof | |
| CN115634196B (en) | Stable-quality anisodine hydrobromide injection and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| ASS | Succession or assignment of patent right |
Owner name: MAANSHAN FENGYUAN PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: ANHUI BBCA PHARMACEUTICAL CO., LTD. Effective date: 20130305 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| COR | Change of bibliographic data |
Free format text: CORRECT: ADDRESS; FROM: 233010 BENGBU, ANHUI PROVINCE TO: 243000 MAANSHAN, ANHUI PROVINCE |
|
| TA01 | Transfer of patent application right |
Effective date of registration: 20130305 Address after: 243000 No. 1503, Mei Shan Road, Ma'anshan economic and Technological Development Zone, Anhui Applicant after: Maanshan Fengyuan Pharmaceutical Co.,Ltd. Address before: 233010 No. 2001 Tu Shan Road, Anhui, Bengbu Applicant before: Anhui BBCA Pharmaceutical Co., Ltd. |
|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant |