CN102652755A - Mannitol sodium chloride injection and preparation method thereof - Google Patents
Mannitol sodium chloride injection and preparation method thereof Download PDFInfo
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- CN102652755A CN102652755A CN2012101433326A CN201210143332A CN102652755A CN 102652755 A CN102652755 A CN 102652755A CN 2012101433326 A CN2012101433326 A CN 2012101433326A CN 201210143332 A CN201210143332 A CN 201210143332A CN 102652755 A CN102652755 A CN 102652755A
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Abstract
The invention provides a brand new mannitol sodium chloride injection and a preparation method which is suitable for the same. According to the preparation method disclosed by the invention, the sterilization problem that the mannitol sodium chloride injection can not endure F0 which is not less than 8 can be solved by adding an appropriate amount of stabilizer, adopting corresponding sterilization conditions and controlling the pH value, the problem that 5-hydroxymethylfurfural in the injection is easy to exceed the standard during the production and the storage processes of the product is well solved, and the 5-hydroxymethylfurfural is effectively controlled.
Description
Technical field
The present invention relates to a kind of Glycerin Fructose sodium chloride injection and method for preparing.
Background technology
In at present clinical there be the medicine of reduction intracranial pressure commonly used: formula mannitol injection liquid, Glycerin Fructose sodium chloride injection.
Formula mannitol injection liquid is used to treat the cerebral edema that a variety of causes causes, reduces intracranial pressure, prevents cerebral hernia, and its determined curative effect, onset that reduces intracranial pressure is rapid, and the weak point of holding time is mainly used in acute illness patient's treatment.Clinical use is extensive, but formula mannitol injection liquid is a supersaturated solution, under temperature situation on the low side; Commonly in medicinal liquid, separate out the mannitol crystal; When crystal occurs, need medicinal liquid be heated to crystal and dissolve fully and could use, and dissolving is slower, inconvenience in the clinical use.
The Glycerin Fructose sodium chloride injection is a kind of hypertonic preparation, through the high osmosis dehydration, the brain moisture is reduced, and reduces intracranial pressure.Glycerin Fructose sodium chloride injection diuresis is lower than formula mannitol injection liquid; Can alleviate the kidney burden; So the Glycerin Fructose sodium chloride injection has few and electrolyte balance disturbed few characteristics to renal function injury, makes it more be suitable for the patient who is used in chronic high cranium pressure, renal insufficiency or needs the long period dehydration.Can not occur under the Glycerin Fructose sodium chloride injection lower temperature separating out the crystal phenomenon, solve formula mannitol injection liquid low temperature and separated out phenomenon, convenient clinical use.
Glycerin Fructose sodium chloride injection poor stability on the market shows that mainly 5 hydroxymethyl furfural is higher now, even producing and exceeding standard in storage period, does not meet the regulation of Chinese Pharmacopoeia, has reduced the safety of medication.
The Glycerin Fructose sodium chloride injection poor stability that the method that CN102188437A and 200510070626.0 patents are announced is produced; Show that mainly 5 hydroxymethyl furfural is higher; Even, do not meet the regulation of Chinese Pharmacopoeia producing and exceeding standard in storage period, reduced the safety of medication.The stabilizing agent that proposes among the CN101991589A to use is disodium edetate, calcium disodium edetate, trisodium citrate, potassium citrate; Wherein disodium edetate, calcium disodium edetate are mainly used in melts combine becomes stable and soluble complex; To remove the solution metal ion; Trisodium citrate, potassium citrate are used for stablizing pH as the pH stabilizing agent, and be limited to the fructose protective effect.We find that through test best stabilizing agent should be sodium sulfite, sodium sulfite, sodium pyrosulfite, sodium thiosulfate, can effectively slow down the generation of 5 hydroxymethyl furfural.
Summary of the invention
The present invention proposes a kind of Glycerin Fructose sodium chloride injection and method for preparing, has solved its stability problem, guarantees drug safety.
The by weight/volume that each raw material of the Glycerin Fructose sodium chloride injection that the present invention proposes, adjuvant are formed is:
The pH value regulator is an amount of, and making the pH value range of accommodation is 3.0-6.0;
Surplus is a water for injection.
The by weight/volume that each raw material of the Glycerin Fructose sodium chloride injection that the present invention proposes, adjuvant are formed is:
The pH value regulator is an amount of, and making the pH value range of accommodation is 4.2-4.6;
Surplus is a water for injection.
Wherein said stabilizing agent is a kind of in sodium sulfite, sodium sulfite, sodium pyrosulfite, the sodium thiosulfate, preferred sodium sulfite.Described pH value regulator is: a kind of in hydrochloric acid, sulphuric acid, sulfurous acid, citric acid, the lactic acid, and preferred hydrochloric acid.The pH value range of accommodation is 3.0-6.0, preferred 4.2-4.6.
The method for preparing of Glycerin Fructose sodium chloride injection of the present invention is following:
(1) take by weighing each raw material and adjuvant in proportion, subsequent use;
(2) 20%-95% with glycerol, sodium chloride adding water for injection total amount dissolves;
(3) in above-mentioned solution, after the dissolving of adding stabilizing agent, add the fructose dissolving;
(4) in above-mentioned solution, adding pH value regulator adjusting pH value is 3.0-6.0, adds to the full amount of water for injection, and adds active carbon, and stirring and evenly mixing is measured glycerol, sodium chloride, fructose sign content at 95.0-105.0%;
(5) with above-mentioned medicinal liquid coarse filtration, fine straining, fill is sealed, moist heat sterilization F0 >=8, lamp inspection, packing.
The method for preparing of Glycerin Fructose sodium chloride injection of the present invention is preferably following:
(1) take by weighing each raw material and adjuvant in proportion, subsequent use;
(2) glycerol, sodium chloride being added 50% of water for injection total amount dissolves;
(3) in above-mentioned solution, after the dissolving of adding stabilizing agent, add the fructose dissolving;
(4) in above-mentioned solution, adding pH value regulator adjusting pH value is 4.2-4.6, adds to the full amount of water for injection, and adds active carbon, and stirring and evenly mixing is measured glycerol, sodium chloride, fructose sign content at 95.0-105.0%;
(5) with above-mentioned medicinal liquid coarse filtration, fine straining, fill is sealed, 121 ℃ of moist heat sterilizations 8 minutes, lamp inspection, packing.
Among the present invention, all there is fundamental influence in the pH value of the consumption of stabilizing agent, sterilising conditions and injection to the performance indications of final products.Stabilizing agent can slow down the generation of 5 hydroxymethyl furfural, and the inventor gropes to find that stabilizing agent can only suitably add, the very few Stabilization that do not have of addition through test of many times; It is more serious that addition too much causes pH value to descend easily, and the pH value of controlling solution is brought bigger difficulty, and pH value descends can quicken the fructose degraded conversely again.The present invention is under fixed sterilising conditions and pH value condition, and adopting sodium sulfite is that stabilizing agent has carried out investigating and measuring 5 hydroxymethyl furfural content, result of the test such as table 1 to its consumption.
Table 1 sodium sulfite consumption is selected test
Can know that by table 1 result when the addition of sodium sulfite during at 0.04%-0.08%, 5 hydroxymethyl furfural content is lower; When the bisulfite sodium content is 0.08%; 5 hydroxymethyl furfural content is minimum, and the addition of sodium sulfite is when 0.08%-0.01%, the no longer significant change of 5 hydroxymethyl furfural content; Therefore the addition of stabilizing agent is 0.04%-0.08% (g/ml), preferred 0.08% (g/ml).
At the sodium sulfite consumption is 0.08%, and using the pH value regulator to regulate pH value is under 4.0 the condition, 5 hydroxymethyl furfural content is investigated and measured to sterilising conditions.Because these article are packaged as transfusion with bottle (bag), so sterilising conditions is set at 121 ℃ of moist heat sterilizations 12 minutes, 32 minutes three kinds of situation of 8 minutes, 115 ℃ moist heat sterilizations of 121 ℃ of moist heat sterilizations, do following sterilising conditions screening test, result of the test such as table 2.
Table 2 sterilising conditions screening test
| Sample | 121 ℃ of moist heat sterilizations 8 minutes | 121 ℃ of moist heat sterilizations 12 minutes | 115 ℃ of moist heat sterilizations 32 minutes |
| Character | Colourless clear liquid | Colourless clear liquid | Colourless clear liquid |
| 5 hydroxymethyl furfural | 0.17 | 0.26 | 0.48 |
| PH value | 3.9 | 3.8 | 3.6 |
| Particulate matter | Up to specification | Up to specification | Up to specification |
| Pyrogen | Up to specification | Up to specification | Up to specification |
| Aseptic | Up to specification | Up to specification | Up to specification |
| Sodium chloride indicates content (%) | 98.0 | 97.3 | 97.5 |
| Fructose indicates content (%) | 98.4 | 97.8 | 96.2 |
| Glycerol indicates content (%) | 97.7 | 97.1 | 96.8 |
Can know by the result; Adopt the master slave mode sterilization in 8 fens of 121 ℃ of moist heat sterilizations; Meet country for high-capacity injection sterilization F0 at least should >=8 the registration requirement; The 5 hydroxymethyl furfural content that obtains is minimum, and product character, pH value, content etc. all meet national corresponding requirements, so the master slave mode sterilization in 8 fens of 121 ℃ of moist heat sterilizations of this test and Selection.
At the sodium sulfite consumption is under 8 minutes the condition of 0.08%, 121 ℃ of moist heat sterilization, and 5 hydroxymethyl furfural content, result of the test such as table 3 are investigated and measured to pH value.
Table 3 pH selects test
Can be known that by the result regulate pH when the 4.2-4.6 scope with the pH value regulator, after 8 minutes, measured 5 hydroxymethyl furfural content is minimum through 121 ℃ of moist heat sterilizations, therefore definite best pH is 4.2-4.6.
In sum; The present invention proposes a kind of brand-new Glycerin Fructose sodium chloride injection and the method for preparing that adapts with it; Through adding an amount of stabilizing agent; And through adopting corresponding sterilising conditions and, solved the Glycerin Fructose sodium chloride injection and can not tolerate the sterilization problem of F0 >=8, and solved the problem that the 5 hydroxymethyl furfural of these article injection in production and storage is prone to exceed standard well to the control of pH value; The stability of the prepared product of the present invention obviously is superior to the commercially available prod, and 5 hydroxymethyl furfural has obtained effective control.
The specific embodiment
Experiment and embodiment are used to further specify but are not limited to the present invention below.
Embodiment 1
A kind of Glycerin Fructose sodium chloride injection, each raw material of this injection, adjuvant consist of:
1mol/L hydrochloric acid is regulated pH value to 4.3;
Water for injection adds to 1000ml.
Its concrete steps are:
(1) take by weighing each raw material and adjuvant in proportion, subsequent use;
(2) glycerol, sodium chloride being added 20% of water for injection total amount dissolves;
(3) in above-mentioned solution, after the dissolving of adding sodium sulfite, add the fructose dissolving;
(4) in above-mentioned solution, adding 1mol/L hydrochloric acid adjusting pH value is 4.3, adds to the full amount of water for injection, and adds active carbon, and stirring and evenly mixing is measured glycerol, sodium chloride, fructose sign content at 95.0-105.0%;
(5) with above-mentioned medicinal liquid coarse filtration, fine straining, fill is sealed, 121 ℃ of moist heat sterilizations 8 minutes, lamp inspection, packing.
Embodiment 2
A kind of Glycerin Fructose sodium chloride injection, each raw material of this injection, adjuvant consist of:
1mol/L hydrochloric acid is regulated pH value to 4.6;
Water for injection adds to 1000ml.
Its concrete steps are:
(1) take by weighing each raw material and adjuvant in proportion, subsequent use;
(2) glycerol, sodium chloride being added 50% of water for injection total amount dissolves;
(3) in above-mentioned solution, after the dissolving of adding sodium sulfite, add the fructose dissolving;
(4) in above-mentioned solution, adding 1mol/L hydrochloric acid adjusting pH value is 4.6, adds to the full amount of water for injection, and adds active carbon, and stirring and evenly mixing is measured glycerol, sodium chloride, fructose sign content at 95.0-105.0%;
(5) with above-mentioned medicinal liquid coarse filtration, fine straining, fill is sealed, 121 ℃ of moist heat sterilizations 8 minutes, lamp inspection, packing.
Embodiment 3
A kind of Glycerin Fructose sodium chloride injection, each raw material of this injection, adjuvant consist of:
1mol/L sulfurous acid for adjusting pH value to 4.2;
Water for injection adds to 1000ml.
Its concrete steps are:
(1) take by weighing each raw material and adjuvant in proportion, subsequent use;
(2) glycerol, sodium chloride being added 95% of water for injection total amount dissolves;
(3) in above-mentioned solution, after the dissolving of adding sodium sulfite, add the fructose dissolving;
(4) in above-mentioned solution, adding 1mol/L sulfurous acid for adjusting pH value is 4.2, adds to the full amount of water for injection, and adds active carbon, and stirring and evenly mixing is measured glycerol, sodium chloride, fructose sign content at 95.0-105.0%;
(5) with above-mentioned medicinal liquid coarse filtration, fine straining, fill is sealed, 121 ℃ of moist heat sterilizations 8 minutes, lamp inspection, packing.
Embodiment 4
A kind of Glycerin Fructose sodium chloride injection, each raw material of this injection, adjuvant consist of:
1mol/L Fructus Citri Limoniae acid for adjusting pH value to 4.4;
Water for injection adds to 1000ml.
Its concrete steps are:
(1) take by weighing each raw material and adjuvant in proportion, subsequent use;
(2) glycerol, sodium chloride being added 55% of water for injection total amount dissolves;
(3) in above-mentioned solution, after the dissolving of adding sodium pyrosulfite, add the fructose dissolving;
(4) in above-mentioned solution, adding 1mol/L Fructus Citri Limoniae acid for adjusting pH value is 4.4, adds to the full amount of water for injection, and adds active carbon, and stirring and evenly mixing is measured glycerol, sodium chloride, fructose sign content at 95.0-105.0%;
(5) with above-mentioned medicinal liquid coarse filtration, fine straining, fill is sealed, 121 ℃ of moist heat sterilizations 8 minutes, lamp inspection, packing.
Embodiment 5
A kind of Glycerin Fructose sodium chloride injection, each raw material of this injection, adjuvant consist of:
1mol/L hydrochloric acid is regulated pH value to 6.0;
Water for injection adds to 1000ml.
Its concrete steps are:
(1) take by weighing each raw material and adjuvant in proportion, subsequent use;
(2) glycerol, sodium chloride being added 70% of water for injection total amount dissolves;
(3) in above-mentioned solution, after the dissolving of adding sodium thiosulfate, add the fructose dissolving;
(4) in above-mentioned solution, adding 1mol/L hydrochloric acid adjusting pH value is 6.0, adds to the full amount of water for injection, and adds active carbon, and stirring and evenly mixing is measured glycerol, sodium chloride, fructose sign content at 95.0-105.0%;
(5) with above-mentioned medicinal liquid coarse filtration, fine straining, fill is sealed, 121 ℃ of moist heat sterilizations 8 minutes, lamp inspection, packing.
According to the product of the present invention of the embodiment of the invention 1 preparation and commercially available article by two XI XC of Chinese Pharmacopoeia method quicken, long term test, the result is following:
Table 4 Glycerin Fructose sodium chloride injection accelerated test result
Other indexs do not have significant change.
Table 5 Glycerin Fructose sodium chloride injection long-term test results
Can know through above table 4 and 5; The invention solves the Glycerin Fructose sodium chloride injection and can not tolerate the sterilization problem of F0 >=8; And solved well the Glycerin Fructose sodium chloride injection produce and storage in the 5 hydroxymethyl furfural problem that is prone to exceed standard; The stability of preparing product of the present invention obviously is superior to the commercially available prod, and acceleration, long-term test results obviously are superior to CN101991589A, and 5 hydroxymethyl furfural has obtained effective control.
Claims (7)
1. Glycerin Fructose sodium chloride injection is characterized in that: the by weight/volume that each raw material of this injection, adjuvant are formed is:
The pH value regulator is an amount of, and making the pH value range of accommodation is 3.0-6.0;
Surplus is a water for injection;
Described stabilizing agent is a kind of in sodium sulfite, sodium sulfite, sodium pyrosulfite, the sodium thiosulfate.
2. Glycerin Fructose sodium chloride injection according to claim 1 is characterized in that: the by weight/volume that the raw material of this injection, adjuvant are formed is:
The pH value regulator is an amount of, and making the pH value range of accommodation is 4.2-4.6;
Surplus is a water for injection;
Described stabilizing agent is a kind of in sodium sulfite, sodium sulfite, sodium pyrosulfite, the sodium thiosulfate.
3. Glycerin Fructose sodium chloride injection according to claim 1 and 2 is characterized in that: described pH value regulator is a kind of in hydrochloric acid, sulphuric acid, sulfurous acid, citric acid, the lactic acid.
4. prepare claim 1 or 2 described Glycerin Fructose sodium chloride injections, it is characterized in that: its concrete steps are:
(1) take by weighing each raw material and adjuvant in proportion, subsequent use;
(2) 20%-95% with glycerol, sodium chloride adding water for injection total amount dissolves;
(3) in above-mentioned solution, after the dissolving of adding stabilizing agent, add the fructose dissolving;
(4) in above-mentioned solution, adding pH value regulator adjusting pH value is 3.0-6.0, adds to the full amount of water for injection, and adds active carbon, and stirring and evenly mixing is measured glycerol, sodium chloride, fructose sign content at 95.0-105.0%;
(5) with above-mentioned medicinal liquid coarse filtration, fine straining, fill is sealed, moist heat sterilization F0 >=8, lamp inspection, packing.
5. the method for preparing of Glycerin Fructose sodium chloride injection according to claim 4 is characterized in that: its concrete steps are:
(1) take by weighing each raw material and adjuvant in proportion, subsequent use;
(2) glycerol, sodium chloride being added 50% of water for injection total amount dissolves;
(3) in above-mentioned solution, after the dissolving of adding stabilizing agent, add the fructose dissolving;
(4) in above-mentioned solution, adding pH value regulator adjusting pH value is 4.2-4.6, adds to the full amount of water for injection, and adds active carbon, and stirring and evenly mixing is measured glycerol, sodium chloride, fructose sign content at 95.0-105.0%;
(5) with above-mentioned medicinal liquid coarse filtration, fine straining, fill is sealed, 121 ℃ of moist heat sterilizations 8 minutes, lamp inspection, packing.
6. according to the method for preparing of claim 4 or 5 described Glycerin Fructose sodium chloride injections, it is characterized in that: described stabilizing agent is a kind of in sodium sulfite, sodium sulfite, sodium pyrosulfite, the sodium thiosulfate.
7. the method for preparing of Glycerin Fructose sodium chloride injection according to claim 6 is characterized in that: described stabilizing agent is a sodium sulfite.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105534892A (en) * | 2016-02-02 | 2016-05-04 | 常州市庆发工业气体有限公司 | Method for preparing high-stability fructose for fructose injection |
| CN115778898A (en) * | 2022-12-19 | 2023-03-14 | 华夏生生药业(北京)有限公司 | Glycerol fructose injection and production process thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1864693A (en) * | 2005-05-18 | 2006-11-22 | 曾列丹 | A glycerin and fructose injection and preparation method thereof |
| CN101991589A (en) * | 2009-08-11 | 2011-03-30 | 四川科伦药物研究有限公司 | Glycerol fructose injection and preparation method thereof |
-
2012
- 2012-05-10 CN CN 201210143332 patent/CN102652755B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1864693A (en) * | 2005-05-18 | 2006-11-22 | 曾列丹 | A glycerin and fructose injection and preparation method thereof |
| CN101991589A (en) * | 2009-08-11 | 2011-03-30 | 四川科伦药物研究有限公司 | Glycerol fructose injection and preparation method thereof |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105534892A (en) * | 2016-02-02 | 2016-05-04 | 常州市庆发工业气体有限公司 | Method for preparing high-stability fructose for fructose injection |
| CN115778898A (en) * | 2022-12-19 | 2023-03-14 | 华夏生生药业(北京)有限公司 | Glycerol fructose injection and production process thereof |
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Address after: 276800 No. 39, Fuyang Road, Shandong, Rizhao City Applicant after: China Ren Pharmaceutical (Rizhao) Co., Ltd. Address before: 276800 No. 39, Fuyang Road, Shandong, Rizhao City Applicant before: Shandong Jiejing Pharmaceutical Co., Ltd. |
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Inventor after: Shu Wen Inventor after: Su Ying Inventor after: Li Fukui Inventor after: Jiang Youwei Inventor after: Li Haixia Inventor before: Liu Wei Inventor before: Li Fukui Inventor before: Jiang Youwei Inventor before: Su Ying |
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Free format text: CORRECT: APPLICANT; FROM: SHANDONG JIEJING PHARMACEUTICAL CO., LTD. TO: HUAREN PHARMACEUTICAL (RIZHAO) CO., LTD. Free format text: CORRECT: INVENTOR; FROM: LIU WEI LI FUKUI JIANG YOUWEI SU YING TO: SHU WEN SU YING LI FUKUI JIANG YOUWEI LI HAIXIA |
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