CN116919907A - Rumepirone orally disintegrating tablet and preparation method thereof - Google Patents
Rumepirone orally disintegrating tablet and preparation method thereof Download PDFInfo
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- CN116919907A CN116919907A CN202210338143.8A CN202210338143A CN116919907A CN 116919907 A CN116919907 A CN 116919907A CN 202210338143 A CN202210338143 A CN 202210338143A CN 116919907 A CN116919907 A CN 116919907A
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- Prior art keywords
- meipai
- orally disintegrating
- disintegrating tablet
- mannitol
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- Pending
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- 239000006191 orally-disintegrating tablet Substances 0.000 title claims abstract description 18
- 238000002360 preparation method Methods 0.000 title claims abstract description 14
- 239000003814 drug Substances 0.000 claims abstract description 19
- 239000004480 active ingredient Substances 0.000 claims abstract 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 30
- 229930195725 Mannitol Natural products 0.000 claims description 30
- 239000000594 mannitol Substances 0.000 claims description 30
- 235000010355 mannitol Nutrition 0.000 claims description 30
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 24
- 238000000034 method Methods 0.000 claims description 15
- 238000007873 sieving Methods 0.000 claims description 15
- 229920002785 Croscarmellose sodium Polymers 0.000 claims description 14
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims description 14
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims description 13
- 235000019359 magnesium stearate Nutrition 0.000 claims description 12
- 239000000203 mixture Substances 0.000 claims description 12
- 108010011485 Aspartame Proteins 0.000 claims description 11
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 11
- 239000000605 aspartame Substances 0.000 claims description 11
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims description 11
- 235000010357 aspartame Nutrition 0.000 claims description 11
- 229960003438 aspartame Drugs 0.000 claims description 11
- 229960001681 croscarmellose sodium Drugs 0.000 claims description 11
- 239000003085 diluting agent Substances 0.000 claims description 8
- 239000000843 powder Substances 0.000 claims description 8
- 239000000796 flavoring agent Substances 0.000 claims description 7
- 235000013355 food flavoring agent Nutrition 0.000 claims description 7
- 239000002245 particle Substances 0.000 claims description 7
- 230000000750 progressive effect Effects 0.000 claims description 7
- 238000000227 grinding Methods 0.000 claims description 6
- 239000004376 Sucralose Substances 0.000 claims description 5
- 235000019408 sucralose Nutrition 0.000 claims description 5
- 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 5
- 239000001767 crosslinked sodium carboxy methyl cellulose Substances 0.000 claims description 3
- 239000000314 lubricant Substances 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
- 229940085605 saccharin sodium Drugs 0.000 claims description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 2
- 239000007884 disintegrant Substances 0.000 claims 1
- 201000000980 schizophrenia Diseases 0.000 abstract description 6
- 229940079593 drug Drugs 0.000 abstract description 5
- 230000000694 effects Effects 0.000 abstract description 5
- 208000019505 Deglutition disease Diseases 0.000 abstract description 3
- 239000002775 capsule Substances 0.000 abstract description 3
- 230000007547 defect Effects 0.000 abstract description 2
- LHAPOGAFBLSJJQ-GUTACTQSSA-N iti007 Chemical compound CC1=CC=C(S(O)(=O)=O)C=C1.C([C@@H]1N2CCN(C=3C=CC=C(C2=3)[C@@H]1C1)C)CN1CCCC(=O)C1=CC=C(F)C=C1 LHAPOGAFBLSJJQ-GUTACTQSSA-N 0.000 abstract description 2
- 230000007774 longterm Effects 0.000 abstract 1
- 230000000052 comparative effect Effects 0.000 description 7
- VYFYYTLLBUKUHU-UHFFFAOYSA-N dopamine Chemical compound NCCC1=CC=C(O)C(O)=C1 VYFYYTLLBUKUHU-UHFFFAOYSA-N 0.000 description 4
- QZAYGJVTTNCVMB-UHFFFAOYSA-N serotonin Chemical compound C1=C(O)C=C2C(CCN)=CNC2=C1 QZAYGJVTTNCVMB-UHFFFAOYSA-N 0.000 description 4
- 239000003826 tablet Substances 0.000 description 4
- 102000004980 Dopamine D2 Receptors Human genes 0.000 description 3
- 108090001111 Dopamine D2 Receptors Proteins 0.000 description 3
- HOKKHZGPKSLGJE-GSVOUGTGSA-N N-Methyl-D-aspartic acid Chemical compound CN[C@@H](C(O)=O)CC(O)=O HOKKHZGPKSLGJE-GSVOUGTGSA-N 0.000 description 3
- 230000009471 action Effects 0.000 description 3
- 235000019605 sweet taste sensations Nutrition 0.000 description 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 229960003638 dopamine Drugs 0.000 description 2
- 210000000214 mouth Anatomy 0.000 description 2
- 230000003518 presynaptic effect Effects 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 230000000698 schizophrenic effect Effects 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 1
- 108010078791 Carrier Proteins Proteins 0.000 description 1
- 102000004076 Dopamine D1 Receptors Human genes 0.000 description 1
- 108090000511 Dopamine D1 Receptors Proteins 0.000 description 1
- 206010013911 Dysgeusia Diseases 0.000 description 1
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 description 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 1
- 108010054200 NR2B NMDA receptor Proteins 0.000 description 1
- 208000012902 Nervous system disease Diseases 0.000 description 1
- 208000025966 Neurological disease Diseases 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
- 230000001270 agonistic effect Effects 0.000 description 1
- 230000000561 anti-psychotic effect Effects 0.000 description 1
- 239000003693 atypical antipsychotic agent Substances 0.000 description 1
- 229940127236 atypical antipsychotics Drugs 0.000 description 1
- 230000003542 behavioural effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000002659 cell therapy Methods 0.000 description 1
- 235000009508 confectionery Nutrition 0.000 description 1
- 230000006735 deficit Effects 0.000 description 1
- 238000007907 direct compression Methods 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 239000003651 drinking water Substances 0.000 description 1
- 235000020188 drinking water Nutrition 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 229930195712 glutamate Natural products 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 230000003834 intracellular effect Effects 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000001404 mediated effect Effects 0.000 description 1
- 239000008108 microcrystalline cellulose Substances 0.000 description 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 1
- 229940016286 microcrystalline cellulose Drugs 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 210000002200 mouth mucosa Anatomy 0.000 description 1
- 230000026731 phosphorylation Effects 0.000 description 1
- 238000006366 phosphorylation reaction Methods 0.000 description 1
- 230000001242 postsynaptic effect Effects 0.000 description 1
- 239000002464 receptor antagonist Substances 0.000 description 1
- 229940044551 receptor antagonist Drugs 0.000 description 1
- 108020003175 receptors Proteins 0.000 description 1
- 102000005962 receptors Human genes 0.000 description 1
- 230000019491 signal transduction Effects 0.000 description 1
- 230000011664 signaling Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000000152 swallowing effect Effects 0.000 description 1
- 230000001839 systemic circulation Effects 0.000 description 1
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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
-
- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
Abstract
The invention discloses Lu Meipai protuberance orally disintegrating tablets for treating adult schizophrenia and a preparation method thereof, belonging to the technical field of medicines. Caplyta which is currently marketed abroad ® (Lu Meipai long capsule) has the defects of inconvenient use, dysphagia and the like, and has obvious problem of medication compliance for patients with the schizophrenia needing long-term medication. The invention takes rumeipirone as the active ingredient of the medicine and prepares the orally disintegrating tablet by the direct tabletting technology. The Lu Meipai orally disintegrating tablet prepared by the invention has the advantages of good taste and convenient administration, has good effect on improving the compliance of patients to take medicine, and has good stability.
Description
Technical Field
The invention relates to a Lu Meipai protuberance orally disintegrating tablet for treating adult schizophrenia, which has good taste and convenient administration, and a preparation method thereof, and belongs to the technical field of medicines.
Background
Lu Meipai is an atypical antipsychotic, and is a unique property of a second-generation new antipsychotic according to the action target of Lu Meipai and the binding rate of dopamine D2 receptor. Unlike other schizophrenic drugs, lu Meipai has partial agonistic activity on presynaptic dopamine D2 receptors, reduces presynaptic dopamine release, and antagonizes postsynaptic dopamine D2 receptors. These properties allow Lu Meipai to effectively reduce dopamine signaling. Lu Meipai also targets the dopamine D1 receptor, and the secondary auxiliary effect of D1 receptor activation is an increaseGlutamatergic N-methyl-D-aspartate (NMDA) GluN2B receptor phosphorylation, while NMDA-mediated glutamate signaling pathway plays an important role in the impairment of schizophrenic patients. Lu Meipai is capable of modulating 5-hydroxytryptamine by inhibiting 5-hydroxytryptamine transporter proteins and as 5-H A2 Receptor antagonists are useful in the treatment of behavioral disorders of schizophrenia and other neurological diseases.
Rumepirone capsules (trade name Caplyta) which are the under-flag products of Intra-Cellular Therapies company ® ) Approved for marketing in 2019 for treatment of adult schizophrenia. However, the dosage form has the defects of inconvenient use, dysphagia and the like. Because of uncertainty of the onset time of schizophrenia and poor compliance of patients in onset, the administration of rufipirone to patients is needed as soon as possible, so that it is necessary to prepare the rufipirone into orally disintegrating tablets which are convenient to carry, are beneficial to take and can take effect rapidly. The oral solid quick-release medicine preparation, in particular to an oral quick-dissolving and quick-disintegrating medicine tablet, which is characterized in that the tablet is placed on the tongue or other parts of the oral cavity, can be quickly dissolved or disintegrated under the condition of no water taking, partial medicine enters the gastrointestinal tract through natural swallowing action, and partial medicine enters the systemic circulation through oral mucosa absorption. The advantages are quick release, quick action and high bioavailability, and the solid quick release preparation is especially suitable for patients with dysphagia, old and children and patients without drinking water. The orally disintegrating tablet has the advantages of convenient administration and reliable effect. The invention takes rumeipirone as an active ingredient and prepares the orally disintegrating tablet through a powder direct compression process. The process is simple, and has good effect on improving the medicine taking compliance of patients.
Disclosure of Invention
The invention aims to provide the lumepiquat chloride orally disintegrating tablet which is rapid in disintegration, favorable for absorption, quicker in onset of action, better in taste, lower in production cost and simple and feasible in preparation process compared with capsules.
The technical scheme of the invention for achieving the purpose is as follows:
the invention provides a rumeperide orally disintegrating tablet which comprises the following components in percentage by weight: 20% of Lu Meipai, 50-65% of diluent, 1-5% of disintegrating agent and 0.5-2% of flavoring agent, wherein the filler is one or more of mannitol, lactose and microcrystalline cellulose PH101, and mannitol is particularly preferred. The disintegrating agent is cross-linked sodium carboxymethyl cellulose, and the flavoring agent is one or more of aspartame, sucralose and saccharin sodium.
The Lu Meipai protuberance orally disintegrating tablet is prepared by the following steps:
(1) Crushing Lu Meipai to obtain powder with an average particle size of 1-5 mu m, grinding the flavoring agent, sieving with a 60-mesh sieve, and sieving the diluent with a 60-mesh sieve for later use;
(2) Uniformly mixing Lu Meipai with part of hydrophilic diluents by adopting an equal-amount progressive mixing method, and then adding crosslinked sodium carboxymethyl cellulose and the rest of hydrophilic diluents to uniformly mix;
(3) And (3) adding the talcum powder and the lubricant into the mixed medicine obtained in the step (2), sieving, mixing uniformly, and tabletting to obtain the Lu Meipai protuberance orally disintegrating tablet.
Detailed Description
The present invention will be described in further detail with reference to the following examples, with the understanding that the examples are illustrative of the present invention and are not to be construed as limiting the invention.
Example 1:
| prescription composition | Weight percent (%) |
| Lu Meipai long | 20 |
| Mannitol (mannitol) | 55 |
| Croscarmellose sodium | 4.5 |
| Aspartame | 1.5 |
| Talc powder | 18 |
| Magnesium stearate | 1 |
| Totals to | 100.0 |
The preparation method comprises the following steps:
(1) Crushing Lu Meipai to obtain powder with the average particle size of 1-5 mu m, grinding aspartame, sieving with a 60-mesh sieve, and sieving mannitol with a 60-mesh sieve for later use;
(2) Uniformly mixing Lu Meipai with part of mannitol by an equal-amount progressive mixing method, and then adding croscarmellose sodium, the rest mannitol and aspartame to uniformly mix;
(3) Adding talcum powder and magnesium stearate into the mixed medicine obtained in the step (2), uniformly mixing, and tabletting.
Example 2:
| prescription composition | Weight percent (%) |
| Lu Meipai long | 20 |
| Mannitol (mannitol) | 50 |
| Croscarmellose sodium | 4.5 |
| Aspartame | 1.5 |
| Talc powder | 23 |
| Magnesium stearate | 1 |
| Totals to | 100.0 |
The preparation method comprises the following steps:
(1) Crushing Lu Meipai to obtain powder with the average particle size of 1-5 mu m, grinding aspartame, sieving with a 60-mesh sieve, and sieving mannitol with a 60-mesh sieve for later use;
(2) Uniformly mixing Lu Meipai with part of mannitol by an equal-amount progressive mixing method, and then adding croscarmellose sodium, the rest mannitol and aspartame to uniformly mix;
(3) Adding talcum powder and magnesium stearate into the mixed medicine obtained in the step (2), uniformly mixing, and tabletting.
Example 3:
| prescription composition | Weight percent (%) |
| Lu Meipai long | 20 |
| Mannitol (mannitol) | 55 |
| Croscarmellose sodium | 4.5 |
| Sucralose | 2 |
| Talc powder | 175 |
| Magnesium stearate | 1 |
| Totals to | 100.0 |
The preparation method comprises the following steps:
(1) Crushing Lu Meipai to obtain powder with an average particle size of 1-5 mu m, grinding sucralose, sieving with a 60-mesh sieve, and sieving mannitol with a 60-mesh sieve for later use;
(2) Uniformly mixing Lu Meipai with part of mannitol by an equal-amount progressive mixing method, and then adding croscarmellose sodium, the rest mannitol and sucralose to uniformly mix;
(3) Adding talcum powder and magnesium stearate into the mixed medicine obtained in the step (2), uniformly mixing, and tabletting.
Comparative example 1:
| prescription composition | Weight percent (%) |
| Lu Meipai long | 20 |
| Mannitol (mannitol) | 45 |
| Croscarmellose sodium | 4.5 |
| Aspartame | 3 |
| Talc powder | 26.5 |
| Magnesium stearate | 1 |
| Totals to | 100.0 |
The preparation method comprises the following steps:
(1) Crushing Lu Meipai to obtain powder with the average particle size of 1-5 mu m, grinding aspartame, sieving with a 60-mesh sieve, and sieving mannitol with a 60-mesh sieve for later use;
(2) Uniformly mixing Lu Meipai with part of mannitol by an equal-amount progressive mixing method, and then adding croscarmellose sodium, the rest mannitol and aspartame to uniformly mix;
(3) Adding talcum powder and magnesium stearate into the mixed medicine obtained in the step (2), uniformly mixing, and tabletting.
Comparative example 2:
| prescription composition | Weight percent (%) |
| Lu Meipai long | 20 |
| Mannitol (mannitol) | 55 |
| Croscarmellose sodium | 4.5 |
| Talc powder | 19.5 |
| Magnesium stearate | 1 |
| Totals to | 100.0 |
The preparation method comprises the following steps:
(1) Crushing Lu Meipai to obtain powder with the average particle diameter of 1-5 mu m, and sieving mannitol with a 60-mesh sieve for later use;
(2) Uniformly mixing Lu Meipai with part of mannitol by adopting an equal-amount progressive mixing method, and then adding croscarmellose sodium and the rest mannitol to uniformly mix;
(3) Adding talcum powder and magnesium stearate into the mixed medicine obtained in the step (2), uniformly mixing, and tabletting.
Table 1 mouth feel and disintegration time limit results summary of rumepiquat chloride oral disintegrating tablet
| Sample name | Mouthfeel of the product | Disintegration time/s |
| Example 1 | Has sweet taste, good taste, and no gritty feel | 17 |
| Example 2 | Has sweet taste, good taste, and no gritty feel | 18 |
| Example 3 | Has sweet taste, good taste, and no gritty feel | 16 |
| Comparative example 1 | Sweet and slightly bad taste with gritty feel | 56 |
| Comparative example 2 | Bitter and astringent, and has poor taste and gritty feel | 67 |
Table 2 summary of stability results of Lu Meipai oral disintegrating tablets
The mouthfeel of the example samples 1, 2 and 3 is superior to that of the comparative example samples 1 and 2, and the disintegration time is within 20 s; examples samples 1, 2, 3 were compared in stability with comparative examples 1, 2, and the related substances were superior to comparative examples 1, 2.
The above embodiments are illustrative of the present invention, and not limiting, and any simple modifications of the present invention fall within the scope of the present invention.
Claims (6)
1. The preparation method of the rufipirone orally disintegrating tablet is characterized in that the Lu Meipai orally disintegrating tablet mainly comprises active ingredients of Lu Meipai, mannitol, croscarmellose sodium, talcum powder, magnesium stearate and flavoring agent, and the preparation method comprises the following steps:
(1) Crushing Lu Meipai to obtain powder with an average particle size of 1-5 mu m, grinding a flavoring agent, sieving with a 60-mesh sieve, and sieving mannitol with a 60-mesh sieve for later use;
(2) Uniformly mixing Lu Meipai with part of hydrophilic diluents by adopting an equal-amount progressive mixing method, and then adding crosslinked sodium carboxymethyl cellulose and the rest of hydrophilic diluents to uniformly mix;
and (3) adding the talcum powder and the lubricant into the mixed medicine obtained in the step (2), sieving, mixing uniformly, and tabletting to obtain the Lu Meipai protuberance orally disintegrating tablet.
2. The method for preparing an orally disintegrating tablet of Lu Meipai according to claim 1, wherein the active ingredient Lu Meipai comprises 20% by weight of water, 50-65% by weight of hydrophilic diluent, 1-5% by weight of disintegrant and 0.5-2.0% by weight of flavoring agent.
3. The method of claim 1, wherein the hydrophilic diluent is mannitol.
4. The method of claim 1, wherein the flavoring agent comprises one or more of aspartame, sucralose, and saccharin sodium.
5. The method of claim 1, wherein the lubricant is magnesium stearate.
6. The method for preparing the Lu Meipai orally disintegrating tablet according to claim 1, wherein the method comprises the following steps: in the step (3), a direct tabletting technology is adopted for tabletting.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210338143.8A CN116919907A (en) | 2022-04-01 | 2022-04-01 | Rumepirone orally disintegrating tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210338143.8A CN116919907A (en) | 2022-04-01 | 2022-04-01 | Rumepirone orally disintegrating tablet and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN116919907A true CN116919907A (en) | 2023-10-24 |
Family
ID=88381311
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210338143.8A Pending CN116919907A (en) | 2022-04-01 | 2022-04-01 | Rumepirone orally disintegrating tablet and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN116919907A (en) |
-
2022
- 2022-04-01 CN CN202210338143.8A patent/CN116919907A/en active Pending
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