CN115317471A - Ritodrine hydrochloride raw material medicine and preparation method of tablets thereof - Google Patents
Ritodrine hydrochloride raw material medicine and preparation method of tablets thereof Download PDFInfo
- Publication number
- CN115317471A CN115317471A CN202210517312.4A CN202210517312A CN115317471A CN 115317471 A CN115317471 A CN 115317471A CN 202210517312 A CN202210517312 A CN 202210517312A CN 115317471 A CN115317471 A CN 115317471A
- Authority
- CN
- China
- Prior art keywords
- ritodrine hydrochloride
- raw material
- hydroxyphenyl
- ritodrine
- preparation
- 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.)
- Pending
Links
- IOVGROKTTNBUGK-SJKOYZFVSA-N (1S,2R)-ritodrine Chemical compound N([C@H](C)[C@@H](O)C=1C=CC(O)=CC=1)CCC1=CC=C(O)C=C1 IOVGROKTTNBUGK-SJKOYZFVSA-N 0.000 title claims abstract description 45
- 229960000720 ritodrine hydrochloride Drugs 0.000 title claims abstract description 41
- 239000002994 raw material Substances 0.000 title claims abstract description 29
- 239000003814 drug Substances 0.000 title claims abstract description 23
- 238000002360 preparation method Methods 0.000 title claims abstract description 22
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims abstract description 23
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 19
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 9
- 238000000034 method Methods 0.000 claims abstract description 9
- -1 1- (4-hydroxyphenyl) -2- [2- (4-hydroxyphenyl) ethylamino ] propan-1-one hydrobromide Chemical compound 0.000 claims abstract description 8
- 239000008215 water for injection Substances 0.000 claims abstract description 7
- 239000003054 catalyst Substances 0.000 claims abstract description 6
- 230000000640 hydroxylating effect Effects 0.000 claims abstract description 6
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical group ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 claims description 47
- 229920002472 Starch Polymers 0.000 claims description 18
- 235000019698 starch Nutrition 0.000 claims description 18
- 239000008107 starch Substances 0.000 claims description 18
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical group CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 16
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 14
- 239000008187 granular material Substances 0.000 claims description 11
- 239000013078 crystal Substances 0.000 claims description 9
- 239000000243 solution Substances 0.000 claims description 9
- 238000002156 mixing Methods 0.000 claims description 8
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 7
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical group [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims description 7
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical group [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims description 7
- 235000019359 magnesium stearate Nutrition 0.000 claims description 7
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 7
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 7
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 7
- 239000011591 potassium Substances 0.000 claims description 7
- 229910052700 potassium Inorganic materials 0.000 claims description 7
- 239000002002 slurry Substances 0.000 claims description 7
- 239000011734 sodium Substances 0.000 claims description 7
- 229910052708 sodium Inorganic materials 0.000 claims description 7
- 238000001704 evaporation Methods 0.000 claims description 6
- 238000007605 air drying Methods 0.000 claims description 5
- 229940079593 drug Drugs 0.000 claims description 4
- 239000000314 lubricant Substances 0.000 claims description 4
- 239000000463 material Substances 0.000 claims description 4
- 229960001634 ritodrine Drugs 0.000 claims description 4
- 238000007873 sieving Methods 0.000 claims description 4
- WNCXDNZVUJLFPD-UHFFFAOYSA-N 1-(4-hydroxyphenyl)-2-[2-(4-hydroxyphenyl)ethylamino]propan-1-one Chemical compound C=1C=C(O)C=CC=1C(=O)C(C)NCCC1=CC=C(O)C=C1 WNCXDNZVUJLFPD-UHFFFAOYSA-N 0.000 claims description 3
- 125000004203 4-hydroxyphenyl group Chemical group [H]OC1=C([H])C([H])=C(*)C([H])=C1[H] 0.000 claims description 3
- 235000019441 ethanol Nutrition 0.000 claims description 3
- 238000001914 filtration Methods 0.000 claims description 3
- 238000007689 inspection Methods 0.000 claims description 3
- 238000004806 packaging method and process Methods 0.000 claims description 3
- 239000008213 purified water Substances 0.000 claims description 3
- 239000007779 soft material Substances 0.000 claims description 3
- 239000007787 solid Substances 0.000 claims description 3
- 230000001954 sterilising effect Effects 0.000 claims description 3
- 238000005303 weighing Methods 0.000 claims description 3
- 238000004080 punching Methods 0.000 claims description 2
- 238000010992 reflux Methods 0.000 claims description 2
- 229940032147 starch Drugs 0.000 claims description 2
- 238000003756 stirring Methods 0.000 claims description 2
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 2
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims 2
- 239000008186 active pharmaceutical agent Substances 0.000 claims 1
- 230000003113 alkalizing effect Effects 0.000 claims 1
- 229940088679 drug related substance Drugs 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 abstract description 5
- 239000000126 substance Substances 0.000 abstract description 4
- 239000000203 mixture Substances 0.000 description 3
- 239000000047 product Substances 0.000 description 3
- 239000007864 aqueous solution Substances 0.000 description 2
- 210000004027 cell Anatomy 0.000 description 2
- 238000002425 crystallisation Methods 0.000 description 2
- 230000008025 crystallization Effects 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 230000008020 evaporation Effects 0.000 description 2
- WVDDGKGOMKODPV-UHFFFAOYSA-N hydroxymethyl benzene Natural products OCC1=CC=CC=C1 WVDDGKGOMKODPV-UHFFFAOYSA-N 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 238000006467 substitution reaction Methods 0.000 description 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 102000030621 adenylate cyclase Human genes 0.000 description 1
- 108060000200 adenylate cyclase Proteins 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 239000000614 adrenergic beta-2 receptor agonist Substances 0.000 description 1
- 229940124627 adrenergic β2 receptor agonist Drugs 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 235000019445 benzyl alcohol Nutrition 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 238000011010 flushing procedure Methods 0.000 description 1
- 230000033444 hydroxylation Effects 0.000 description 1
- 238000005805 hydroxylation reaction Methods 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 239000013067 intermediate product Substances 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 238000000746 purification Methods 0.000 description 1
- 102000005962 receptors Human genes 0.000 description 1
- 108020003175 receptors Proteins 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 210000002460 smooth muscle Anatomy 0.000 description 1
- 239000007858 starting material Substances 0.000 description 1
- 229940127230 sympathomimetic drug Drugs 0.000 description 1
- 210000004325 uterine smooth muscle cell Anatomy 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
- A61P21/02—Muscle relaxants, e.g. for tetanus or cramps
Abstract
The invention discloses a ritodrine hydrochloride raw material medicine, relating to the technical field of chemical preparation, and the raw material medicine comprises the following raw materials: 1- (4-hydroxyphenyl) -2- [2- (4-hydroxyphenyl) ethylamino ] propan-1-one hydrobromide, hydrochloric acid, a pH value regulator, water for injection, an extracting agent, a hydroxylating agent and a catalyst. The ritodrine hydrochloride tablet has the advantages that the production process of the raw material medicine is optimized, the ritodrine hydrochloride prepared by the method has short period and low cost, the production efficiency and the yield are greatly improved, the ritodrine hydrochloride is prepared into the tablet, the dosage is accurate, the content is uniform, the medicine content difference in the tablet is small, and the number of tablets is taken as a dosage unit; the chemical stability is better because the volume is smaller and compact, and the influence of factors such as outside air, light, moisture and the like is less.
Description
Technical Field
The invention relates to the technical field of chemical preparation, in particular to a ritodrine hydrochloride bulk drug and a preparation method of tablets thereof.
Background
Ritodrine hydrochloride, also known as hydroxy-benzylephedrine, is chemically p-hydroxy-alpha- [1- [ (p-hydroxyphenylethyl) amino ] ethyl ] benzyl alcohol hydrochloride. Modern pharmacological research shows that ritodrine is a beta-sympathomimetic drug, belongs to adrenergic beta 2 receptor agonist, has the main action position combined with beta 2 receptors on uterine smooth muscle cell membranes to activate adenylate cyclase, increase the concentration of cAMP in cells, reduce the concentration of free calcium in cells and relax the uterine smooth muscles. The existing ritodrine hydrochloride has longer period in the preparation process and larger difference of the drug content in the tablet, and is easily influenced by external factors.
Disclosure of Invention
The invention aims to provide a ritodrine hydrochloride raw material medicine and a preparation method of tablets thereof, and aims to solve the problems in the background art.
In order to achieve the purpose, the invention provides the following technical scheme:
the ritodrine hydrochloride raw material medicine comprises the following raw materials: 1- (4-hydroxyphenyl) -2- [2- (4-hydroxyphenyl) ethylamino ] propan-1-one hydrobromide, hydrochloric acid, pH regulator, water for injection, extractant, hydroxylating agent and catalyst.
On the basis of the technical scheme, the invention also provides the following optional technical scheme:
in one alternative: the concentration of the hydrochloric acid is 37%.
In one alternative: the injection water is purified water, the pH value regulator is a saturated sodium carbonate solution, the extracting agent is dichloromethane, the hydroxylating agent is absolute ethyl alcohol, and the catalyst is potassium borohydride.
In one alternative: the preparation method of the raw material medicine comprises the following steps: step S1: dissolving 1- (4-hydroxyphenyl) -2- [2- (4-hydroxyphenyl) ethylaminopropan-1-one hydrobromide in water for injection; step S2: adding hydrochloric acid in a dropwise manner to separate out hydrochloride crystals of the 1- (4-hydroxyphenyl) -2- [2- (4-hydroxyphenyl) ethylamino ] propan-1-one, filtering, and adding water to dissolve the crystals; and step S3: the aqueous solution of the crystals was basified with saturated sodium carbonate solution to pH9-10. Extracting with dichloromethane, evaporating dichloromethane, adding anhydrous ethanol and potassium borohydride into residue, and refluxing for 1.5h; and step S4: and (3) evaporating to remove ethanol, adding water, extracting with dichloromethane, and evaporating to remove dichloromethane to obtain white solid ritodrine.
A preparation method of ritodrine hydrochloride tablets is characterized in that the ritodrine hydrochloride raw material medicine is used as a raw material for preparation, and the preparation method comprises the following specific steps: the method comprises the following steps: dismantling the raw materials and sterilizing the surface; step two: respectively sieving ritodrine hydrochloride, starch and microcrystalline cellulose with a sieve of 80 meshes and sieving sodium carboxymethyl starch and magnesium stearate with a sieve of 100 meshes, and weighing and uniformly mixing the ritodrine hydrochloride, the starch, the microcrystalline cellulose and the sodium carboxymethyl starch to obtain a mixed material; step three: preparing 5% starch slurry by a slurry punching method, preparing a soft material, granulating by a screen with 18 meshes, and carrying out forced air drying on wet granules for 4 hours to obtain dry granules; step four: granulating the dry granules by using a 18-mesh screen, adding magnesium stearate accounting for 0.5 percent of the weight of the dry granules as a lubricant, and uniformly mixing; step five: calculating the tablet weight of the product inspection result, tabletting by using a shallow punch of 8mm on Bronsted and packaging to obtain the ritodrine hydrochloride tablet product.
In one alternative: and the mixing in the second step is carried out under the condition that the stirring speed is 200 r/min.
In one alternative: the temperature of the forced air drying in the third step is 55 ℃.
Compared with the prior art, the invention has the following beneficial effects:
the ritodrine hydrochloride tablet has the advantages that the production process of the raw material medicine is optimized, the ritodrine hydrochloride prepared by the method has short period and low cost, the production efficiency and the yield are greatly improved, the ritodrine hydrochloride is prepared into the tablet, the dosage is accurate, the content is uniform, the medicine content difference in the tablet is small, and the number of tablets is taken as a dosage unit; the chemical stability is better, because the volume is smaller and compact, the influence of factors such as outside air, light, moisture and the like is less; is convenient to carry, transport and take; the production has high mechanization and automation degree, large yield, low cost and price and easy reaching of sanitary standard.
Drawings
FIG. 1 is a flow chart of a preparation process of raw materials of ritodrine hydrochloride.
Fig. 2 is a process flow diagram of the preparation process of ritodrine hydrochloride tablets.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail below with reference to the accompanying drawings and embodiments. The examples are given solely for the purpose of illustration and are not intended to limit the scope of the invention. Any obvious modifications or variations can be made without departing from the spirit or scope of the present invention.
Preparation of ritodrine hydrochloride raw material medicine
The specific raw materials are as follows:
| composition of matter | Ratio (g) |
| 1- (4-hydroxyphenyl) -2- [2- (4-hydroxyphenyl) ethylamino]Propan-1-one hydrobromide salt | 23.7g（0.064mol） |
| 37% hydrochloric acid | 55ml |
| Saturated sodium carbonate solution | Proper amount of |
| Purified water | 55ml |
| Methylene dichloride | Proper amount of |
| Anhydrous ethanol | 160ml |
| Potassium borohydride | 4.79g（0.088mol） |
Wherein:
1- (4-hydroxyphenyl) -2- [2- (4-hydroxyphenyl) ethylamino ] propan-1-one hydrobromide: the starting material was synthesized.
37% hydrochloric acid: crystallization solvent plays a role in crystallization.
Saturated sodium carbonate solution: the pH value regulator plays a role in regulating the pH value.
Dichloromethane: the extractant plays a role in purification.
Anhydrous ethanol: a hydroxylating agent.
Potassium borohydride: the catalyst plays a role in promoting hydroxylation.
Water for injection: and (3) solvents of raw materials and auxiliary materials.
Referring to the attached figure 1, the preparation method of ritodrine hydrochloride raw material medicine comprises the following steps:
dissolving the 1- (4-hydroxyphenyl) -2- [2- (4-hydroxyphenyl) ethylamino propan-1-one hydrobromide (23.7 g,0.064 mol) in 55ml of water, adding 37% hydrochloric acid of the same volume dropwise to precipitate crystals of the hydrochloride of 1- (4-hydroxyphenyl) -2- [2- (4-hydroxyphenyl) ethylamino ] propan-1-one, filtering, dissolving the crystals in water, and alkalifying the aqueous solution of the crystals with a saturated sodium carbonate solution to pH9 to 10. Extracted with dichloromethane, the dichloromethane was evaporated, and the residue was added with anhydrous ethanol (160 ml) and potassium borohydride (4.79g, 0.088 mol) and refluxed for 1.5h. The ethanol is removed by evaporation, 80ml of water is added, dichloromethane is used for extraction, and the dichloromethane is removed by evaporation to obtain 12.5g of white solid ritodrine, with the yield of 80%.
The quality detection aiming at ritodrine hydrochloride raw material medicines is as follows:
preparation of ritodrine hydrochloride tablets
The composition of the 10mg specification raw materials is as follows:
the composition of 20mg specification raw materials is as follows:
wherein
1) Ritodrine hydrochloride: and (3) a main medicine.
2) Starch, microcrystalline cellulose: a diluent.
3) Sodium carboxymethyl starch: a disintegrating agent.
4) 5% of starch slurry: and (3) an adhesive.
Magnesium stearate: lubricant agent
Referring to the attached figure 2, the preparation method of the ritodrine hydrochloride tablet comprises the following steps:
1. dismantling the external package of the raw and auxiliary materials, sterilizing the surface of the external package, and transferring the external package into a D-level clean area;
2. the ritodrine hydrochloride, the starch and the microcrystalline cellulose are respectively sieved by a 80-mesh sieve, and the sodium carboxymethyl starch and the magnesium stearate are sieved by a 100-mesh sieve for later use.
3. Weighing ritodrine hydrochloride, starch package, microcrystalline cellulose and sodium carboxymethyl starch respectively, and mixing uniformly for later use;
4. preparing 5% starch slurry by a slurry flushing method, preparing a soft material, granulating by a screen with 18 meshes, and performing forced air drying on wet granules at 55 ℃ for 4 hours;
5. granulating the dry granules by using a 18-mesh screen, adding magnesium stearate accounting for 0.5 percent of the weight of the dry granules as a lubricant, and uniformly mixing;
6. calculating the tablet weight according to the intermediate product inspection result, and tabletting by using a 8mm shallow punch;
packaging, fully inspecting and warehousing finished products.
The quality detection aiming at the ritodrine hydrochloride tablets is as follows:
the above description is only for the specific embodiments of the present disclosure, but the scope of the present disclosure is not limited thereto, and any person skilled in the art can easily conceive of the changes or substitutions within the technical scope of the present disclosure, and all the changes or substitutions should be covered within the scope of the present disclosure. Therefore, the protection scope of the present disclosure shall be subject to the protection scope of the claims.
Claims (7)
1. The ritodrine hydrochloride raw material medicine is characterized by comprising the following raw materials: 1- (4-hydroxyphenyl) -2- [2- (4-hydroxyphenyl) ethylamino ] propan-1-one hydrobromide, hydrochloric acid, pH regulator, water for injection, extractant, hydroxylating agent and catalyst.
2. The ritodrine hydrochloride drug substance of claim 1, wherein the concentration of the hydrochloric acid is 37%.
3. The ritodrine hydrochloride bulk drug according to claim 1, characterized in that the water for injection is purified water, the PH regulator is a saturated sodium carbonate solution, the extractant is dichloromethane, the hydroxylating agent is absolute ethanol, and the catalyst is potassium borohydride.
4. The ritodrine hydrochloride raw material medicine according to claim 3, characterized in that the preparation method of the raw material medicine is as follows:
step S1: dissolving 1- (4-hydroxyphenyl) -2- [2- (4-hydroxyphenyl) ethylamino propane-1-one hydrobromide in water for injection;
step S2: adding hydrochloric acid in a dropwise manner to precipitate hydrochloride crystals of 1- (4-hydroxyphenyl) -2- [2- (4-hydroxyphenyl) ethylamino ] propan-1-one, filtering, and adding water to dissolve the crystals;
and step S3: alkalizing the water solution of the crystal by using a saturated sodium carbonate solution until the pH value is 9-10, extracting by using dichloromethane, evaporating to remove the dichloromethane, adding absolute ethyl alcohol and potassium borohydride into the residue, and refluxing for 1.5 hours;
and step S4: distilling off ethanol, adding water, extracting with dichloromethane, and distilling off dichloromethane to obtain white solid ritodrine.
5. A preparation method of ritodrine hydrochloride tablets is characterized in that the ritodrine hydrochloride raw material medicine of any one of claims 1 to 4 is used as a raw material for preparation, and the preparation method comprises the following specific steps:
the method comprises the following steps: dismantling the raw materials and sterilizing the surface;
step two: respectively sieving ritodrine hydrochloride, starch and microcrystalline cellulose with a sieve of 80 meshes, sieving carboxymethyl starch sodium and magnesium stearate with a sieve of 100 meshes, weighing and uniformly mixing the ritodrine hydrochloride, the starch, the microcrystalline cellulose and the carboxymethyl starch sodium to obtain a mixed material;
step three: preparing 5% starch slurry by a slurry punching method, preparing a soft material, granulating by a screen with 18 meshes, and carrying out forced air drying on wet granules for 4 hours to obtain dry granules;
step four: granulating the dry granules by using a 18-mesh screen, adding magnesium stearate accounting for 0.5 percent of the weight of the dry granules as a lubricant, and uniformly mixing;
step five: calculating the tablet weight of the product inspection result, tabletting by using a 8mm shallow punch and packaging to obtain the ritodrine hydrochloride tablet product.
6. The method for preparing ritodrine hydrochloride tablets according to claim 5, wherein the mixing in the second step is performed at a stirring speed of 200 r/min.
7. The preparation method of ritodrine hydrochloride tablets according to claim 5, characterized in that the temperature of forced air drying in step three is 55 ℃.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210517312.4A CN115317471A (en) | 2022-05-13 | 2022-05-13 | Ritodrine hydrochloride raw material medicine and preparation method of tablets thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210517312.4A CN115317471A (en) | 2022-05-13 | 2022-05-13 | Ritodrine hydrochloride raw material medicine and preparation method of tablets thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN115317471A true CN115317471A (en) | 2022-11-11 |
Family
ID=83916437
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210517312.4A Pending CN115317471A (en) | 2022-05-13 | 2022-05-13 | Ritodrine hydrochloride raw material medicine and preparation method of tablets thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN115317471A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115181030A (en) * | 2022-05-14 | 2022-10-14 | 海南久常制药有限公司 | Ritodrine hydrochloride raw material medicine and preparation method of injection thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5449694A (en) * | 1992-07-01 | 1995-09-12 | Meiji Seika Kabushiki Kaisha | (-)-ritodrine, therapeutic compositions and use, and method of preparation |
| CN102060716A (en) * | 2009-11-15 | 2011-05-18 | 海南中化联合制药工业股份有限公司 | Ritodrine hydrochloride preparation method |
| CN107382753A (en) * | 2017-07-24 | 2017-11-24 | 广东众生药业股份有限公司 | A kind of preparation method of high-purity hydrochloric acid ritodrine |
-
2022
- 2022-05-13 CN CN202210517312.4A patent/CN115317471A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5449694A (en) * | 1992-07-01 | 1995-09-12 | Meiji Seika Kabushiki Kaisha | (-)-ritodrine, therapeutic compositions and use, and method of preparation |
| CN102060716A (en) * | 2009-11-15 | 2011-05-18 | 海南中化联合制药工业股份有限公司 | Ritodrine hydrochloride preparation method |
| CN107382753A (en) * | 2017-07-24 | 2017-11-24 | 广东众生药业股份有限公司 | A kind of preparation method of high-purity hydrochloric acid ritodrine |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115181030A (en) * | 2022-05-14 | 2022-10-14 | 海南久常制药有限公司 | Ritodrine hydrochloride raw material medicine and preparation method of injection thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN100439360C (en) | Crystals including a malic acid salt of a 3-pyrrole substituted 2-indolinone, and compositions thereof | |
| JP5870220B2 (en) | 5-({[2-Amino-3- (4-carbamoyl-2,6-dimethyl-phenyl) -propionyl]-[1- (4-phenyl-1H-imidazol-2-yl) -ethyl] -amino} Novel crystals of -methyl) -2-methoxy-benzoic acid and production method | |
| CN1066727C (en) | Salts of an anti-migraine indole derivative | |
| CN115317471A (en) | Ritodrine hydrochloride raw material medicine and preparation method of tablets thereof | |
| CN101671305A (en) | Method for resolution of levorotatory enantiomer and dexiotropic enantiomer of medetomidine | |
| EP2076496A1 (en) | Aminomethyl-2-imidazoles with affinity with the trace amine associated receptors | |
| FI89598C (en) | FREQUENCY REFRIGERATION OF A WATER FRAME, CRYSTALLINE SODIUM SALT OF 5-CHLORO-3- (2-TENOYL) -2-OXINDOL-1-CARBOXAMIDE SOM LAEMPAR SIG FOER ANVAENDNING SOM ANALGETISKT ELLER ANTIINFLAMMATORISKT MEDEL | |
| LU82105A1 (en) | TRANS-5-ARYL-2,3,4,4A-5-9B-HEXAHYDRO-1H-PYRIDO (4,3-B) SUBSTITUTED INDOLES IN POSITION 2 DEXTROGYRES, METHODS AND INTERMEDIATE COMPOUNDS FOR OBTAINING THEM AND PHARMACEUTICAL COMPOSITION CONTAINING THEM | |
| US20140243553A1 (en) | Amorphous asiatic tromethamine salt and preparation method thereof | |
| JPH01131156A (en) | Piperidine derivative | |
| CN108059601A (en) | A kind of technique for preparing 3- amino-1-adamantane alcohols | |
| NO337950B1 (en) | Process for the preparation of imidazole compounds and salts and pseudopolymorphs thereof | |
| NO119949B (en) | ||
| US7138140B2 (en) | Suplatast tosilate crystals | |
| US3030371A (en) | Process for the preparation of d-and l-aryl-(2-pyridyl)-amino alkanes | |
| CN102600091B (en) | Itopride hydrochloride dispersible tablet composition | |
| CN113461551A (en) | 3-amino-1-adamantanol and preparation method and application thereof | |
| CN101857591B (en) | Hydrochloric acid tiagabine crystal formations and preparation method thereof | |
| CN111423412A (en) | Crystalline form of d-rabeprazole sodium anhydride | |
| CN102391188B (en) | Ornidazole hydrate crystal, preparation method thereof and crystal-containing composition tablets | |
| CN111072512A (en) | Preparation and detection method of high-purity high-melting-point sodium pantothenate | |
| CN115181030A (en) | Ritodrine hydrochloride raw material medicine and preparation method of injection thereof | |
| CN103360340B (en) | Synthetic method for N-(2-chloroethyl) hexamethyleneimine hydrochloride | |
| CN101155775A (en) | Stable atomoxetine hydrochloride, a process for the preparation thereof, and an analytical control of its stability | |
| CN103435501B (en) | A kind of Salt formation crystallization method of ethambutol hydrochloride |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination |