CN106361689A - Fudosteine oral solution and preparation method thereof - Google Patents
Fudosteine oral solution and preparation method thereof Download PDFInfo
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- CN106361689A CN106361689A CN201610845399.2A CN201610845399A CN106361689A CN 106361689 A CN106361689 A CN 106361689A CN 201610845399 A CN201610845399 A CN 201610845399A CN 106361689 A CN106361689 A CN 106361689A
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- CN
- China
- Prior art keywords
- fudosteine
- solution
- oral solution
- purified water
- add
- Prior art date
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- KINWYTAUPKOPCQ-YFKPBYRVSA-N Fudosteine Chemical compound OC(=O)[C@@H](N)CSCCCO KINWYTAUPKOPCQ-YFKPBYRVSA-N 0.000 title claims abstract description 51
- 229950006783 fudosteine Drugs 0.000 title claims abstract description 50
- 229940100688 oral solution Drugs 0.000 title claims abstract description 33
- 238000002360 preparation method Methods 0.000 title claims description 15
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 57
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 36
- 239000003755 preservative agent Substances 0.000 claims abstract description 5
- 230000002335 preservative effect Effects 0.000 claims abstract description 5
- 239000008213 purified water Substances 0.000 claims description 35
- 238000003756 stirring Methods 0.000 claims description 14
- 239000003814 drug Substances 0.000 claims description 10
- 239000001509 sodium citrate Substances 0.000 claims description 10
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims description 10
- 229940079593 drug Drugs 0.000 claims description 9
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims description 8
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims description 8
- 239000000600 sorbitol Substances 0.000 claims description 8
- 235000010356 sorbitol Nutrition 0.000 claims description 8
- 239000012467 final product Substances 0.000 claims description 7
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 6
- 125000003118 aryl group Chemical group 0.000 claims description 6
- 239000003795 chemical substances by application Substances 0.000 claims description 6
- 230000000694 effects Effects 0.000 claims description 6
- NOOLISFMXDJSKH-UHFFFAOYSA-N p-menthan-3-ol Chemical compound CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 claims description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 5
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims description 4
- CYDQOEWLBCCFJZ-UHFFFAOYSA-N 4-(4-fluorophenyl)oxane-4-carboxylic acid Chemical compound C=1C=C(F)C=CC=1C1(C(=O)O)CCOCC1 CYDQOEWLBCCFJZ-UHFFFAOYSA-N 0.000 claims description 4
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 4
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims description 4
- 244000290333 Vanilla fragrans Species 0.000 claims description 4
- 235000009499 Vanilla fragrans Nutrition 0.000 claims description 4
- 235000012036 Vanilla tahitensis Nutrition 0.000 claims description 4
- 239000004310 lactic acid Substances 0.000 claims description 4
- 235000014655 lactic acid Nutrition 0.000 claims description 4
- 239000001540 sodium lactate Substances 0.000 claims description 4
- 229940005581 sodium lactate Drugs 0.000 claims description 4
- 235000011088 sodium lactate Nutrition 0.000 claims description 4
- 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 3
- 235000016623 Fragaria vesca Nutrition 0.000 claims description 3
- 235000011363 Fragaria x ananassa Nutrition 0.000 claims description 3
- 229930195725 Mannitol Natural products 0.000 claims description 3
- 239000000594 mannitol Substances 0.000 claims description 3
- 235000010355 mannitol Nutrition 0.000 claims description 3
- FTLYMKDSHNWQKD-UHFFFAOYSA-N (2,4,5-trichlorophenyl)boronic acid Chemical compound OB(O)C1=CC(Cl)=C(Cl)C=C1Cl FTLYMKDSHNWQKD-UHFFFAOYSA-N 0.000 claims description 2
- -1 Aspartane Chemical compound 0.000 claims description 2
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims description 2
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 claims description 2
- 240000009088 Fragaria x ananassa Species 0.000 claims description 2
- 239000004376 Sucralose Substances 0.000 claims description 2
- 229930006000 Sucrose Natural products 0.000 claims description 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 2
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims description 2
- 239000000872 buffer Substances 0.000 claims description 2
- 235000011167 hydrochloric acid Nutrition 0.000 claims description 2
- 229940085605 saccharin sodium Drugs 0.000 claims description 2
- HELHAJAZNSDZJO-OLXYHTOASA-L sodium L-tartrate Chemical compound [Na+].[Na+].[O-]C(=O)[C@H](O)[C@@H](O)C([O-])=O HELHAJAZNSDZJO-OLXYHTOASA-L 0.000 claims description 2
- 239000001433 sodium tartrate Substances 0.000 claims description 2
- 229960002167 sodium tartrate Drugs 0.000 claims description 2
- 235000011004 sodium tartrates Nutrition 0.000 claims description 2
- 235000019408 sucralose Nutrition 0.000 claims description 2
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 0.000 claims description 2
- 239000005720 sucrose Substances 0.000 claims description 2
- 239000011975 tartaric acid Substances 0.000 claims description 2
- 235000002906 tartaric acid Nutrition 0.000 claims description 2
- 240000004307 Citrus medica Species 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
- 235000011083 sodium citrates Nutrition 0.000 claims 1
- 235000000346 sugar Nutrition 0.000 claims 1
- 239000000796 flavoring agent Substances 0.000 abstract 1
- 235000013355 food flavoring agent Nutrition 0.000 abstract 1
- 235000003599 food sweetener Nutrition 0.000 abstract 1
- 239000006174 pH buffer Substances 0.000 abstract 1
- 239000003765 sweetening agent Substances 0.000 abstract 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 27
- 239000000523 sample Substances 0.000 description 6
- ZFXYFBGIUFBOJW-UHFFFAOYSA-N theophylline Chemical group O=C1N(C)C(=O)N(C)C2=C1NC=N2 ZFXYFBGIUFBOJW-UHFFFAOYSA-N 0.000 description 4
- 239000003172 expectorant agent Substances 0.000 description 3
- 230000003419 expectorant effect Effects 0.000 description 3
- ULGZDMOVFRHVEP-RWJQBGPGSA-N Erythromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)C(=O)[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 ULGZDMOVFRHVEP-RWJQBGPGSA-N 0.000 description 2
- PWKSKIMOESPYIA-BYPYZUCNSA-N L-N-acetyl-Cysteine Chemical compound CC(=O)N[C@@H](CS)C(O)=O PWKSKIMOESPYIA-BYPYZUCNSA-N 0.000 description 2
- 208000018569 Respiratory Tract disease Diseases 0.000 description 2
- GBFLZEXEOZUWRN-VKHMYHEASA-N S-carboxymethyl-L-cysteine Chemical compound OC(=O)[C@@H](N)CSCC(O)=O GBFLZEXEOZUWRN-VKHMYHEASA-N 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 229960004308 acetylcysteine Drugs 0.000 description 2
- OJGDCBLYJGHCIH-UHFFFAOYSA-N bromhexine Chemical compound C1CCCCC1N(C)CC1=CC(Br)=CC(Br)=C1N OJGDCBLYJGHCIH-UHFFFAOYSA-N 0.000 description 2
- 229960003870 bromhexine Drugs 0.000 description 2
- 229960004399 carbocisteine Drugs 0.000 description 2
- 239000000945 filler Substances 0.000 description 2
- 210000001035 gastrointestinal tract Anatomy 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 229960000278 theophylline Drugs 0.000 description 2
- 244000025254 Cannabis sativa Species 0.000 description 1
- 229930186147 Cephalosporin Natural products 0.000 description 1
- 229920002261 Corn starch Polymers 0.000 description 1
- 206010011224 Cough Diseases 0.000 description 1
- 244000307700 Fragaria vesca Species 0.000 description 1
- 239000005715 Fructose Substances 0.000 description 1
- 229930091371 Fructose Natural products 0.000 description 1
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 description 1
- 206010062717 Increased upper airway secretion Diseases 0.000 description 1
- 229930182555 Penicillin Natural products 0.000 description 1
- JGSARLDLIJGVTE-MBNYWOFBSA-N Penicillin G Chemical compound N([C@H]1[C@H]2SC([C@@H](N2C1=O)C(O)=O)(C)C)C(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-MBNYWOFBSA-N 0.000 description 1
- 244000046052 Phaseolus vulgaris Species 0.000 description 1
- 235000010627 Phaseolus vulgaris Nutrition 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 239000004098 Tetracycline Substances 0.000 description 1
- 230000001133 acceleration Effects 0.000 description 1
- 235000010358 acesulfame potassium Nutrition 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 235000021028 berry Nutrition 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 150000001720 carbohydrates Chemical class 0.000 description 1
- 229940124587 cephalosporin Drugs 0.000 description 1
- 150000001780 cephalosporins Chemical class 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 239000008120 corn starch Substances 0.000 description 1
- 238000005260 corrosion Methods 0.000 description 1
- 150000001944 cysteine derivatives Chemical class 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000002845 discoloration Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 239000000428 dust Substances 0.000 description 1
- 229960003276 erythromycin Drugs 0.000 description 1
- 229940066493 expectorants Drugs 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 210000002175 goblet cell Anatomy 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 206010020718 hyperplasia Diseases 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 238000011031 large-scale manufacturing process Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 231100000053 low toxicity Toxicity 0.000 description 1
- 206010025482 malaise Diseases 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 210000004877 mucosa Anatomy 0.000 description 1
- 210000003097 mucus Anatomy 0.000 description 1
- 229940049954 penicillin Drugs 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 208000026435 phlegm Diseases 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 210000002345 respiratory system Anatomy 0.000 description 1
- 239000012488 sample solution Substances 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 235000011121 sodium hydroxide Nutrition 0.000 description 1
- 239000002689 soil Substances 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 150000005846 sugar alcohols Chemical class 0.000 description 1
- PXQLVRUNWNTZOS-UHFFFAOYSA-N sulfanyl Chemical class [SH] PXQLVRUNWNTZOS-UHFFFAOYSA-N 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 229960002180 tetracycline Drugs 0.000 description 1
- 229930101283 tetracycline Natural products 0.000 description 1
- 235000019364 tetracycline Nutrition 0.000 description 1
- 150000003522 tetracyclines Chemical class 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a fudosteine oral solution. Every 10 mL of the fudosteine oral solution contains 80 mg of fudosteine, 300-600 mg of glycerol, 5-50 mg of a pH buffer pair, 200-500 mg of a sweetening agent, 5-50 mg of a flavoring agent and the balance pure water, wherein the pH value of the fudosteine oral solution is 4.5-5.5. As formula adjustment is carried out and no preservative is added, the safety of a sample is greatly improved, and the taste is good.
Description
Technical field
The present invention relates to pharmaceutical technology field, more particularly to a kind of Fudosteine oral solution and preparation method thereof.
Background technology
Respiratory tract disease, particularly tracheitiies, are a kind of common prone diseases, more in the number of patients of China, especially
It is that child and gerontal patient are a lot of in the winter time.The patient of respiratory tract disease generally has the symptom of cough, and at present clinic in should
With more widely having chemical drugss such as bromhexine, acetylcysteine, Carbocisteine etc. of phlegm-dispelling functions, all have
There is a different degrees of glutinous expectorant adjustment effect, but have following defects that free in (1) molecular structure in its pharmacology or clinical practice
Sulfydryl can adsorb gastrointestinal tract mucin, can produce gastrointestinal tract local damage, side effect is larger after being administered orally；(2) can weaken penicillin,
The antibacterial activity of cephalosporins, erythromycin, tetracycline etc., unsuitable use in conjunction；(3) physiological disposition of theophylline can be affected,
Should not share with theophylline.
Fudosteine is a kind of new expectorant, belongs to cysteine derivative.Exist first in December 17 calendar year 2001
Japan's listing, its basic pharmacological action is goblet cell hyperplasia inhibitory action and makes mucinous two mercapto keys in bronchial secretion
The mucus to respiratory tract for the abstriction, the adjustment effect of mucosa normal condition, are a kind of expectorants of high-efficiency low-toxicity it is contemplated that will become
Renewal product for the similar medicine such as bromhexine, acetylcysteine, Carbocisteine.
Fudosteine is a kind of relatively stable compound, when it separately exists in the air, even if humidity is higher
Very stable, and no metachromatism occurs.But, when commonly used filler in itself and solid preparation, such as various saccharides, fibre
The plain class of dimension, sugar alcohols can occur variable color when using together, not only affect the outward appearance of sample, sometimes also can cause the fall of content
Low.
At present, domestic only tablet, granule, capsule listing.Ai Shi Pharmaceutical Co., Ltd is detailed in cn1155373c
Carefully elaborate prescription composition and its preparation technology of a kind of Fudostein Tablets, in its prescription composition, filler is corn starch or soil
Bean starch is although sample variable color will not be caused, but compressibility and poor fluidity, easy moisture absorption and affect the steady in a long-term of preparation,
A large amount of dust is easily caused to be unfavorable for labor protection in large-scale production process.
Therefore, the present invention develops Fudosteine oral solution, on the one hand effectively prevent the generation of discoloration, another
Aspect passes through formula adjustment, and the Fudosteine oral solution of the present invention does not contain preservative, substantially increases safety, and mouth
Take liquid preparation and there is absorption soon, effect is rapid to be particularly well-suited to old age and child patient it is easy to divided dose, taking convenience, and
And the indication of Fudosteine sickness rate in old man and child is high.
Content of the invention
In order to overcome the deficiencies in the prior art and fill up dosage form blank, it is an object of the invention to provide a kind of Fudosteine
Oral administration solution, is adjusted by formula, on the premise of without preservative, so that oral administration solution stability is greatly improved, and extends and protects
Matter phase, and taste good.
Fudosteine oral solution of the present invention is it is characterised in that contain in every 10ml Fudosteine oral solution:
Fudosteine 80mg
Glycerol 300-600mg
Ph buffers to 5-50mg
Sweeting agent 200-500mg
Aromatic 0.5-10mg
Plus purified water is settled to 10ml
In described Fudosteine oral solution, glycerol consumption is higher than 30%, need not add preservative, you can reach preferably anti-corrosion
Effect, and its ph value is 4.5-5.5.
Described Fudosteine oral solution it is characterised in that: described glycerol consumption be 30%-60%, preferably 35%-
50%.
Described Fudosteine oral solution it is characterised in that: described ph regulator include citric acid, sodium citrate,
Two or more in lactic acid, sodium lactate, tartaric acid, sodium tartrate, hydrochloric acid, sodium hydroxide.
Described Fudosteine oral solution it is characterised in that: described sweeting agent includes sucrose, Fructose, Sorbitol, sweet
One or more of dew alcohol, sucralose, Aspartane, maltose alcohol, saccharin sodium.
Described Fudosteine oral solution it is characterised in that: described aromatic includes Mentholum, vanilla, grass
One or more of certain kind of berries essence, Fructus Citri tangerinae essence, Fructus Citri Limoniae essence.
Described Fudosteine oral solution is it is characterised in that preparation process is as follows:
(1) crude drug plus appropriate purified water are made drug solution a；
(2) sweeting agent plus appropriate purified water are made solution b；
(3) solution a is slowly added to solution b, stirs, add recipe quantity glycerol, obtain solution c；
(4) add ph regulator in solution c, add purified water to the 90% about of total amount, adjust ph to 4.5-5.5, add
Aromatic, plus purified water, to full dose, stirs, and filters, obtains solution d；
(5) solution d is tested, subpackage, obtain final product Fudosteine oral solution.
Specific embodiment:
Specific embodiment only further explains and describes the present invention, is not necessarily to be construed as any limitation of the invention.
Embodiment 1
Prescription forms:
Fudosteine 80g
Glycerol 300g
Sorbitol 300g
Citric acid 20g
Sodium citrate 5g
Mentholum 3g
Purified water is to 10l
Preparation technology:
(1) Fudosteine plus appropriate purified water are made drug solution a；
(2) Sorbitol plus appropriate purified water are made solution b；
(3) solution a is slowly added to solution b, stirs, add recipe quantity glycerol, obtain solution c；
(4) add citric acid, sodium citrate in solution c, add purified water to the 90% about of total amount, adjust ph to 4.5-
5.5, add Mentholum, plus purified water, to full dose, stirs, filter, obtain solution d；
(5) solution d is tested, subpackage, obtain final product Fudosteine oral solution.
Embodiment 2
Prescription forms:
Fudosteine 80g
Glycerol 400g
Maltose alcohol 300g
Citric acid 20g
Sodium citrate 5g
Fructus Citri Limoniae essence 5g
Purified water is to 10l
Preparation technology:
(1) Fudosteine plus appropriate purified water are made drug solution a；
(2) maltose alcohol plus appropriate purified water are made solution b；
(3) solution a is slowly added to solution b, stirs, add recipe quantity glycerol, obtain solution c；
(4) add citric acid, sodium citrate in solution c, add purified water to the 90% about of total amount, adjust ph to 4.5-
5.5, add Fructus Citri Limoniae essence, plus purified water, to full dose, stirs, filter, obtain solution d；
(5) solution d is tested, subpackage, obtain final product Fudosteine oral solution.
Embodiment 3
Prescription forms:
Fudosteine 80g
Glycerol 300g
Sorbitol 400g
Lactic acid 20g
Sodium lactate 5g
Mentholum 3g
Purified water is to 10l
Preparation technology:
(1) Fudosteine plus appropriate purified water are made drug solution a；
(2) Sorbitol plus appropriate purified water are made solution b；
(3) solution a is slowly added to solution b, stirs, add recipe quantity glycerol, obtain solution c；
(4) add lactic acid, sodium lactate in solution c, add purified water to the 90% about of total amount, adjust ph to 4.5-5.5, then
Add Mentholum, plus purified water, to full dose, stirs, filter, obtain solution d；
(5) solution d is tested, subpackage, obtain final product Fudosteine oral solution.
Embodiment 4
Prescription forms:
Fudosteine 80g
Glycerol 300g
Mannitol 300g
Citric acid 20g
Sodium citrate 5g
Vanilla 3g
Purified water is to 10l
Preparation technology:
(1) Fudosteine plus appropriate purified water are made drug solution a；
(2) Mannitol plus appropriate purified water are made solution b；
(3) solution a is slowly added to solution b, stirs, add recipe quantity glycerol, obtain solution c；
(4) add citric acid, sodium citrate in solution c, add purified water to the 90% about of total amount, adjust ph to 4.5-
5.5, add vanilla, plus purified water, to full dose, stirs, filter, obtain solution d；
(5) solution d is tested, subpackage, obtain final product Fudosteine oral solution.
Embodiment 5
Prescription forms:
Fudosteine 80g
Glycerol 400g
Sorbitol 200g
Citric acid 20g
Sodium citrate 5g
Strawberry essence 3g
Purified water is to 10l
Preparation technology:
(1) Fudosteine plus appropriate purified water are made drug solution a；
(2) Sorbitol plus appropriate purified water are made solution b；
(3) solution a is slowly added to solution b, stirs, add recipe quantity glycerol, obtain solution c；
(4) add citric acid, sodium citrate in solution c, add purified water to the 90% about of total amount, adjust ph to 4.5-
5.5, add strawberry essence, plus purified water, to full dose, stirs, filter, obtain solution d；
(5) solution d is tested, subpackage, obtain final product Fudosteine oral solution.
Stability study:
By the Fudosteine oral solution of embodiment 1-5 of preparation in 40 DEG C ± 2 DEG C, under conditions of rh75% ± 5%, place 6
Month, respectively at sampling in 1,2,3,6 months, detection, the results are shown in Table 1-3.
Table 1 embodiment sample accelerated test ph result
Table 2 embodiment sample accelerated test relevant material (%) result
Table 3 embodiment sample accelerated test content (%) result
Results of stability shows, under embodiment 1-5 sample solution acceleration environment place 6 months, ph value, about material, contain
Amount all no significant changes, sample is stable, and therefore, the Fudosteine oral solution of the present invention has good stability.
Claims (6)
1. a kind of Fudosteine oral solution is it is characterised in that contain in every 10ml Fudosteine oral solution:
Fudosteine 80mg
Glycerol 300-600mg
Ph buffers to 5-50mg
Sweeting agent 200-500mg
Aromatic 0.5-10mg
Plus purified water is settled to 10ml
In described Fudosteine oral solution, glycerol consumption is higher than 30%, can be without interpolation preservative, you can reach preferably anti-
Rotten effect, and its ph value is 4.5-5.5.
2. Fudosteine oral solution according to claim 1 it is characterised in that: described glycerol consumption be 30%-60%,
Preferably 35%-50%.
3. Fudosteine oral solution according to claim 1 it is characterised in that: described ph regulator includes citron
Acid, sodium citrate, lactic acid, sodium lactate, tartaric acid, sodium tartrate, hydrochloric acid, two or more in sodium hydroxide.
4. Fudosteine oral solution according to claim 1 it is characterised in that: described sweeting agent includes sucrose, really
One or more of sugar, Sorbitol, Mannitol, sucralose, Aspartane, maltose alcohol, saccharin sodium.
5. Fudosteine oral solution according to claim 1 it is characterised in that: described aromatic include Mentholum,
One or more of vanilla, strawberry essence, Fructus Citri tangerinae essence, Fructus Citri Limoniae essence.
6. the Fudosteine oral solution according to claim 1-5 is it is characterised in that preparation process is as follows:
(1) crude drug plus appropriate purified water are made drug solution a；
(2) sweeting agent plus appropriate purified water are made solution b；
(3) solution a is slowly added to solution b, stirs, add recipe quantity glycerol, obtain solution c；
(4) add ph regulator in solution c, add purified water to the 90% about of total amount, adjust ph to 4.5-5.5, add
Aromatic, plus purified water, to full dose, stirs, and filters, obtains solution d；
(5) solution d is tested, subpackage, obtain final product Fudosteine oral solution.
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| CN201610845399.2A CN106361689A (en) | 2016-09-24 | 2016-09-24 | Fudosteine oral solution and preparation method thereof |
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| CN201610845399.2A CN106361689A (en) | 2016-09-24 | 2016-09-24 | Fudosteine oral solution and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109925300A (en) * | 2017-12-19 | 2019-06-25 | 北京盈科瑞创新药物研究有限公司 | A kind of Fudosteine Neulized inhalation pharmaceutical solutions and preparation method thereof |
| CN112057418A (en) * | 2020-09-24 | 2020-12-11 | 广州帝奇医药技术有限公司 | Fudosteine oral liquid and preparation method thereof |
| CN113975262A (en) * | 2021-09-07 | 2022-01-28 | 北京四环科宝制药有限公司 | Pharmaceutical composition containing fudosteine and preparation method thereof |
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|---|---|---|---|---|
| CN1511033A (en) * | 2001-05-25 | 2004-07-07 | ������ҩ��ʽ���� | Liquid drug preparations |
| CN105434340A (en) * | 2015-12-18 | 2016-03-30 | 北京万全德众医药生物技术有限公司 | P-toluene sulfonic acid edoxaban oral solution and preparing method thereof |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1511033A (en) * | 2001-05-25 | 2004-07-07 | ������ҩ��ʽ���� | Liquid drug preparations |
| CN105434340A (en) * | 2015-12-18 | 2016-03-30 | 北京万全德众医药生物技术有限公司 | P-toluene sulfonic acid edoxaban oral solution and preparing method thereof |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109925300A (en) * | 2017-12-19 | 2019-06-25 | 北京盈科瑞创新药物研究有限公司 | A kind of Fudosteine Neulized inhalation pharmaceutical solutions and preparation method thereof |
| CN112057418A (en) * | 2020-09-24 | 2020-12-11 | 广州帝奇医药技术有限公司 | Fudosteine oral liquid and preparation method thereof |
| CN113975262A (en) * | 2021-09-07 | 2022-01-28 | 北京四环科宝制药有限公司 | Pharmaceutical composition containing fudosteine and preparation method thereof |
| CN113975262B (en) * | 2021-09-07 | 2024-08-30 | 安徽四环科宝制药有限公司 | Pharmaceutical composition containing Fudosteine and preparation method thereof |
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