CN108653204B - Polyene phosphatidyl choline injection pharmaceutical composition and preparation method thereof - Google Patents
Polyene phosphatidyl choline injection pharmaceutical composition and preparation method thereof Download PDFInfo
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- CN108653204B CN108653204B CN201810854765.XA CN201810854765A CN108653204B CN 108653204 B CN108653204 B CN 108653204B CN 201810854765 A CN201810854765 A CN 201810854765A CN 108653204 B CN108653204 B CN 108653204B
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- injection
- phosphatidyl choline
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- polyene
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- 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
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- 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
- A61K31/66—Phosphorus compounds
- A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
- A61K31/685—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
Abstract
The invention provides a polyene phosphatidyl choline injection pharmaceutical composition and a preparation method thereof, the composition comprises polyene phosphatidyl choline, methoxy polyethylene glycol-phosphatidyl ethanolamine, N-tri (hydroxymethyl) methylglycine, arginine, cholesterol, water for injection, soybean oil, an antioxidant and the like, and the polyene phosphatidyl choline injection pharmaceutical composition does not become turbid when diluted in clinical use, improves the safety of clinical application and improves the medication compliance of patients.
Description
Technical Field
The invention relates to a polyene phosphatidyl choline injection pharmaceutical composition and a preparation method thereof, belonging to the field of pharmaceutical preparations.
Background
The polyene phosphatidylcholine is a high-purity phosphatidylcholine extracted from soybean phospholipids, contains a large amount of unsaturated fatty acids, mainly comprises linoleic acid (about 70%), linolenic acid and oleic acid, and is called polyene phosphatidylcholine because of being rich in various unsaturated fatty acids. Polyene phosphatidyl choline is an 'essential' phospholipid which cannot be synthesized in human body, is a liver cell membrane protective agent and can treat various acute and chronic liver diseases. The ultramicro structure of liver cell membrane and cell mitochondrion is damaged, the phospholipid is lost and the cell respiration and energy synthesis are insufficient, and exogenous phospholipid is supplemented, unsaturated phospholipid is introduced into the liver cell membrane structure to replace endogenous saturated phospholipid, so that the membrane fluidity and the activity of a transmembrane transport system are enhanced, and the damaged membrane structure is recovered. The polyene phosphatidyl choline is a liver protection drug with a certain curative effect at present. The injection is the main clinical application formulation of the medicine.
CN1602878A provides a polyene phosphatidyl choline injection, and the auxiliary materials relate to sodium cholate, sodium deoxycholate, sodium dehydrocholate, benzyl alcohol and the like. CN1781488A provides a polyene phosphatidyl choline infusion solution, and the auxiliary materials relate to xylitol, glucose, vitamins, sodium pantothenate, nicotinamide, poloxamer, deoxycholic acid, polyoxyethylene (40) castor oil, an antioxidant, sodium chloride serving as an isotonic agent and the like. CN1961886A provides a polyene phosphatidyl choline injection, and the auxiliary materials relate to sodium cholate, sodium deoxycholate, sodium dehydrocholate, preservative, antioxidant and the like. CN101244070A provides a polyene phosphatidyl choline high-capacity injection, wherein the cosolvent is selected from deoxycholic acid, sodium hydroxide and absolute ethyl alcohol, the isotonic agent is selected from glucose, xylitol, mannitol, sorbitol and dextran, and the antioxidant is selected from vitamin E and the like. CN101756895A provides a polyene phosphatidyl choline intravenous preparation, and the auxiliary materials comprise sodium cholate and xylitol. CN101152189A provides a polyene phosphatidyl choline injection, the auxiliary materials of which include benzyl alcohol, cholic acid, tween, ethanol, propylene glycol, glycerol, sodium hydroxide, sodium carbonate, and antioxidant 2, 6-di-tert-butyl-p-cresol, tert-butyl-4-hydroxy anisole, vitamin E, etc. CN101669902A provides a polyene phosphatidyl choline injection, the auxiliary materials of which mainly comprise solubilizer and preservative, wherein the solubilizer is selected from sodium cholate, sodium deoxycholate and sodium dehydrocholate; the antiseptic is benzyl alcohol. CN102631313A provides a polyene phosphatidyl choline intravenous administration preparation, which comprises a medicinal solution and an auxiliary solution, wherein the organic solvent for injection is selected from polyethylene glycol, propylene glycol, glycerol, absolute ethyl alcohol and the like, the stabilizing agent is selected from vitamin E, butyl hydroxy anisole, citric acid, EDTA-2Na and the like, the cosolvent is cholic acid, and the isotonic regulator is selected from glycerol, sorbitol, mannitol, glucose and the like. CN103705446A provides a polyene phosphatidyl choline injection, which contains solubilizer, antiseptic and stabilizer, wherein the solubilizer is selected from deoxycholic acid, sodium deoxycholate, dehydrocholic acid, sodium dehydrocholic acid, cholic acid or sodium cholate, and the stabilizer is selected from amino acid or sodium salt thereof or tris (hydroxymethyl) aminomethane. CN104080460A provides a sodium deoxycholate free injectable composition containing phosphatidylcholine comprising phosphatidylcholine, ethanol, propylene glycol and/or benzyl alcohol, polysorbate and/or polyethylene glycol 15-hydroxystearate; and the balance of water or water for injection. CN103816118A provides a polyene phosphatidyl choline injection composition, which is prepared by taking polyene phosphatidyl choline, methoxypolyethylene glycol-phosphatidyl ethanolamine, cholesterol, water for injection, soybean oil and glycine-HCl buffer solution as raw materials through compound compatibility. CN105997854A provides a polyene phosphatidyl choline injection composition, which comprises polyene phosphatidyl choline, benzyl alcohol, tert-butyl hydroxy anisole, 2, 6-di-tert-butyl-p-cresol, cholic acid, ethanol, sodium hydroxide and water for injection.
Polyene phosphatidyl choline is a phospholipid drug, contains hydrophilic parts such as phosphoric acid and choline and hydrophobic parts of fatty acid chains in molecules, belongs to a surface active substance, and has a series of interface and colloid properties such as interface adsorption, micelle formation, liposome, emulsification and the like. The polyene phosphatidyl choline is easy to oxidize and sensitive to light and heat due to the rich unsaturated fatty acids, is insoluble in water like other phospholipids, but can expand in water to form a colloidal solution, and the aqueous solution property is not easy to stabilize.
The polyene phosphatidyl choline injection is yellow clear liquid with higher concentration, and is generally diluted by 5 percent glucose solution and then intravenously administered in clinical application, but the polyene phosphatidyl choline injection is turbid in the dilution preparation process, so that the polyene phosphatidyl choline injection cannot be used. This phenomenon is caused by the fact that the properties of the aqueous solution of polyene phosphatidylcholine are not easy to stabilize, and at present, no good solution exists, for example, the commercially available polyene phosphatidylcholine injection (which is easy to recover) only warns "only using clear solution" in the specification; the above prior art patents also do not address the solution of this problem. Therefore, the existing polyene phosphatidyl choline injection which generates turbidity when diluted in clinical use is a problem to be solved in the field at present.
Disclosure of Invention
The inventor obtains the polyene phosphatidyl choline injection medicine composition through a large number of prescription researches and repeated experiments, and can well solve the problem that the polyene phosphatidyl choline injection is turbid when diluted.
The technical scheme of the invention is as follows:
provides a polyene phosphatidyl choline injection pharmaceutical composition, each 10L of injection contains:
further, the polyene phosphatidyl choline injection pharmaceutical composition contains, per 10L of injection:
in one embodiment, the polyene phosphatidylcholine injection pharmaceutical composition comprises, per 10L injection:
in another embodiment, the polyene phosphatidylcholine injection pharmaceutical composition comprises, per 10L injection:
the invention also provides a preparation method of the polyene phosphatidyl choline injection pharmaceutical composition, which comprises the following steps: mixing polyene phosphatidyl choline, methoxypolyethylene glycol-phosphatidyl ethanolamine, cholesterol, soybean oil and an antioxidant according to the prescription amount, dissolving by using ultrasound, controlling the temperature of the solution below 40 ℃, adding N-tri (hydroxymethyl) methylglycine, arginine according to the prescription amount and water for injection with the total preparation amount being 40%, stirring to obtain a clear liquid, roughly filtering by using active carbon for injection, adding water to a sufficient amount, uniformly stirring, filtering by using a microporous membrane, filling into an ampoule after the inspection is qualified, filling nitrogen, sealing by melting, and sterilizing to obtain the compound.
The antioxidant is selected from one or more of vitamin E, vitamin C and 2, 6-di-tert-butyl-4-methylphenol.
The polyene phosphatidyl choline injection pharmaceutical composition prepared according to the technical scheme of the invention is stable yellow clear liquid, and the product properties, pH value, content and related substances before and after the activated carbon adsorption and sterilization are detected in the preparation process have no obvious change, which indicates that the polyene phosphatidyl choline is not obviously affected by the filtration and sterilization operations in the invention; through stability inspection of the product of the invention (standing for 10 days under the conditions of 4500Lx +/-500 Lx illumination intensity and high temperature of 40 ℃), the results show that the characters, pH values, contents and related substances of the polyene phosphatidyl choline injection pharmaceutical composition have no obvious changes; the indexes have no obvious change in long-term stability inspection (storage condition is 18 months at 2-8 ℃), which shows that the product has good stability.
The polyene phosphatidyl choline injection pharmaceutical composition prepared by the invention does not become turbid when diluted by water for injection or 5% glucose injection, and the obtained diluent is still stable yellow clear liquid; the product is diluted by water with different pH values or 5% glucose solution with different pH values within the range of 2-9, and the turbidity phenomenon can not occur, and the diluted solution is clear and transparent without generating particles.
The inventor finds that the addition of N-tris (hydroxymethyl) methylglycine and arginine in a specific ratio is important for solving the technical problem of the invention, and turbidity is easy to occur when one of the N-tris (hydroxymethyl) methylglycine and the arginine is diluted; moreover, the weight ratio of arginine to N-tris (hydroxymethyl) methylglycine is suitably in the range of 1:1 to 1:6, and turbidity may also occur when diluted outside this range.
For example, 500mL of an injection is prepared according to a prescription of 30g of polyene phosphatidylcholine, 1.5g of methoxypolyethylene glycol-phosphatidylethanolamine, 2g of cholesterol, 1.5g of N-tris (hydroxymethyl) methylglycine, 0.75g of arginine, 250mL of water for injection, 200mL of soybean oil and 250mg of antioxidant 2, 6-di-tert-butyl-4-methylphenol; 10mL of injection is taken for dilution test each time, and is respectively diluted by 5 times with 5% glucose injection, water for injection, 5% glucose solution with different pH values within the range of pH2-9 and water with different pH values within the range of pH2-9, the obtained diluted solution is not turbid, the solution is still yellow transparent clear solution after being placed for 3 days, and the stability is good.
In the above example, when the same dilution test was carried out without removing N-tris (hydroxymethyl) methylglycine and the remainder was unchanged, turbidity appeared in most of the test; if arginine was removed and the same dilution test was carried out, turbidity appeared in some of the tests.
In the above example, the amount of N-tris (hydroxymethyl) methylglycine was changed to 0.5g (arginine still 0.75g), and the remainder was unchanged, and turbidity appeared in most dilution tests; when the amount of arginine was changed to 0.2g (1.5 g for N-tris (hydroxymethyl) methylglycine), and the remainder was unchanged, turbidity appeared in part of the dilution test.
Taking a commercially available polyene phosphatidyl choline injection (easy to recover), and carrying out the same dilution test, wherein part of the dilution liquid has obvious turbidity; if appropriate amounts of arginine and N-tris (hydroxymethyl) methylglycine (1: 4 by weight) were added to the easy recovery solution before the same dilution test was performed, all dilutions were not cloudy.
Therefore, the N-tri (hydroxymethyl) methylglycine and the arginine and the specific proportion thereof have important effect on keeping polyene phosphatidyl choline injection from becoming turbid when diluted.
The polyene phosphatidyl choline injection pharmaceutical composition and the preparation method thereof provided by the invention have the following advantages:
1. the prepared polyene phosphatidyl choline injection pharmaceutical composition has good clarity and high stability, does not generate turbidity when being diluted by water for injection or 5 percent glucose solution, and is safer for clinical use;
2. the whole preparation process does not need nitrogen protection, the production process is simple and easy to implement, and industrialization is easy to realize.
Detailed Description
EXAMPLE 1 preparation of polyene Phosphatidylcholine injection pharmaceutical composition
The prescription for preparing 10L of polyene phosphatidyl choline injection pharmaceutical composition comprises the following steps:
the preparation method comprises the following steps: mixing the polyene phosphatidyl choline, the methoxypolyethylene glycol-phosphatidyl ethanolamine, the cholesterol, the soybean oil and the antioxidant 2, 6-di-tert-butyl-4-methylphenol according to the prescription amount, dissolving the mixture by using ultrasonic waves, controlling the temperature of the solution below 40 ℃, adding the N-tri (hydroxymethyl) methylglycine, the arginine and 4L of water for injection according to the prescription amount, stirring the mixture until the clear liquid is obtained, roughly filtering the solution by using active carbon for injection, adding water to the solution to be sufficient, uniformly stirring the solution, filtering the solution by using a microporous membrane, filling the solution into an ampoule after the inspection is qualified, filling the ampoule, filling nitrogen, sealing the ampoule by melting, and sterilizing the product, thus obtaining the compound.
EXAMPLE 2 preparation of polyene Phosphatidylcholine injection pharmaceutical compositions
The prescription for preparing 10L of polyene phosphatidyl choline injection pharmaceutical composition comprises the following steps:
the preparation method comprises the following steps: mixing the polyene phosphatidyl choline, the methoxypolyethylene glycol-phosphatidyl ethanolamine, the cholesterol, the soybean oil and the antioxidant vitamin C according to the prescription amount, dissolving by using ultrasound, controlling the temperature of the solution below 40 ℃, adding the N-tri (hydroxymethyl) methylglycine, the arginine and 4L of water for injection according to the prescription amount, stirring to obtain a clear liquid, roughly filtering by using active carbon for injection, adding water to a sufficient amount, uniformly stirring, filtering by using a microporous membrane, filling into an ampoule after the inspection is qualified, filling nitrogen, sealing by melting, and sterilizing to obtain the compound vitamin C injection.
EXAMPLE 3-8 preparation of polyene Phosphatidylcholine injection pharmaceutical compositions
The prescription of each example is shown in the following table (10L polyene phosphatidyl choline injection pharmaceutical composition is prepared):
wherein the antioxidant in the embodiments 3 and 8 is vitamin C, the antioxidant in the embodiments 4 and 5 is 2, 6-di-tert-butyl-4-methylphenol, and the antioxidant in the embodiments 6 and 7 is vitamin E.
The preparation method is the same as that of example 1.
Test example 1 clarity examination of Diluent
Samples of polyene phosphatidylcholine injection pharmaceutical compositions prepared in examples 1, 3, 5 and 8, samples of polyene phosphatidylcholine injection (prepared in advance) prepared in accordance with the above-mentioned prior art patent example 1, and samples of polyene phosphatidylcholine injection (easy recovery) on the market were diluted 5-fold with 5% glucose injection, water for injection, 5% glucose solutions of different pH (three pH levels of pH2, pH6 and pH 9) and water of different pH (three pH levels of pH2, pH6 and pH 9), and the clarity of the dilutions was examined. The results are as follows:
as can be seen from the above table, the polyene phosphatidyl choline injection pharmaceutical composition prepared by the invention does not generate turbidity when diluted by water for injection or 5% glucose injection, and the obtained diluted solution is still stable yellow clear liquid; the mixture is diluted by water with different pH degrees or 5% glucose solutions with different pH degrees within the range of 2-9, the turbidity phenomenon can not occur, and the diluted solution is clear and transparent without generating particles; the polyene phosphatidyl choline injection in the prior art has a plurality of turbid phenomena during dilution.
Claims (4)
1. A polyene phosphatidyl choline injection pharmaceutical composition is characterized in that each 10L of injection contains:
the polyene phosphatidyl choline injection pharmaceutical composition is prepared by the following method: mixing the polyene phosphatidyl choline, the methoxypolyethylene glycol-phosphatidyl ethanolamine, the cholesterol, the soybean oil and the antioxidant 2, 6-di-tert-butyl-4-methylphenol according to the prescription amount, dissolving the mixture by using ultrasonic waves, controlling the temperature of the solution below 40 ℃, adding the N-tri (hydroxymethyl) methylglycine, the arginine and 4L of water for injection according to the prescription amount, stirring the mixture until the clear liquid is obtained, roughly filtering the solution by using active carbon for injection, adding water to the solution to be sufficient, uniformly stirring the solution, filtering the solution by using a microporous membrane, filling the solution into an ampoule after the inspection is qualified, filling the ampoule, filling nitrogen, sealing the ampoule by melting, and sterilizing the product, thus obtaining the compound.
2. A polyene phosphatidyl choline injection pharmaceutical composition is characterized in that each 10L of injection contains:
the polyene phosphatidyl choline injection pharmaceutical composition is prepared by the following method: mixing the polyene phosphatidyl choline, the methoxypolyethylene glycol-phosphatidyl ethanolamine, the cholesterol, the soybean oil and the antioxidant vitamin C according to the prescription amount, dissolving by using ultrasound, controlling the temperature of the solution below 40 ℃, adding the N-tri (hydroxymethyl) methylglycine, the arginine and 4L of water for injection according to the prescription amount, stirring to obtain a clear liquid, roughly filtering by using active carbon for injection, adding water to a sufficient amount, uniformly stirring, filtering by using a microporous membrane, filling into an ampoule after the inspection is qualified, filling nitrogen, sealing by melting, and sterilizing to obtain the compound vitamin C injection.
3. A polyene phosphatidyl choline injection pharmaceutical composition is characterized in that each 10L of injection contains:
the polyene phosphatidyl choline injection pharmaceutical composition is prepared by the following method: mixing the polyene phosphatidyl choline, the methoxypolyethylene glycol-phosphatidyl ethanolamine, the cholesterol, the soybean oil and the antioxidant 2, 6-di-tert-butyl-4-methylphenol according to the prescription amount, dissolving the mixture by using ultrasonic waves, controlling the temperature of the solution below 40 ℃, adding the N-tri (hydroxymethyl) methylglycine, the arginine and 4L of water for injection according to the prescription amount, stirring the mixture until the clear liquid is obtained, roughly filtering the solution by using active carbon for injection, adding water to the solution to be sufficient, uniformly stirring the solution, filtering the solution by using a microporous membrane, filling the solution into an ampoule after the inspection is qualified, filling the ampoule, filling nitrogen, sealing the ampoule by melting, and sterilizing the product, thus obtaining the compound.
4. A polyene phosphatidyl choline injection pharmaceutical composition is characterized in that each 10L of injection contains:
the polyene phosphatidyl choline injection pharmaceutical composition is prepared by the following method: mixing the polyene phosphatidyl choline, the methoxypolyethylene glycol-phosphatidyl ethanolamine, the cholesterol, the soybean oil and the antioxidant vitamin C according to the prescription amount, dissolving by using ultrasound, controlling the temperature of the solution below 40 ℃, adding the N-tri (hydroxymethyl) methylglycine, the arginine and 4L of water for injection according to the prescription amount, stirring to obtain a clear liquid, roughly filtering by using active carbon for injection, adding water to a sufficient amount, uniformly stirring, filtering by using a microporous membrane, filling into an ampoule after the inspection is qualified, filling nitrogen, sealing by melting, and sterilizing to obtain the compound vitamin C injection.
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101152189A (en) * | 2007-10-12 | 2008-04-02 | 成都翰朗生物科技有限公司 | Polyene phosphatidyl choline injection and method for preparing the same |
| CN102631313A (en) * | 2011-11-10 | 2012-08-15 | 上海天氏利医药科技有限公司 | Polyene phosphatidyl choline intravenous administration preparation and preparation method thereof |
| CN103705446A (en) * | 2012-10-08 | 2014-04-09 | 正大天晴药业集团股份有限公司 | Polyene phosphatidyl choline injection, and preparation method thereof |
| CN103816118A (en) * | 2014-02-14 | 2014-05-28 | 西藏海思科药业集团股份有限公司 | Polyene phosphatidyl choline composition for injection and preparation method thereof |
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- 2018-08-01 CN CN201810854765.XA patent/CN108653204B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101152189A (en) * | 2007-10-12 | 2008-04-02 | 成都翰朗生物科技有限公司 | Polyene phosphatidyl choline injection and method for preparing the same |
| CN102631313A (en) * | 2011-11-10 | 2012-08-15 | 上海天氏利医药科技有限公司 | Polyene phosphatidyl choline intravenous administration preparation and preparation method thereof |
| CN103705446A (en) * | 2012-10-08 | 2014-04-09 | 正大天晴药业集团股份有限公司 | Polyene phosphatidyl choline injection, and preparation method thereof |
| CN103816118A (en) * | 2014-02-14 | 2014-05-28 | 西藏海思科药业集团股份有限公司 | Polyene phosphatidyl choline composition for injection and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| "多烯磷脂酰胆碱注射液配伍禁忌的文献分析";杨惠等;《中国药师》;20171231;第20卷(第6期);第1104-1105,1122页 * |
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