CN115707471A - Clonazepam orally disintegrating tablet and preparation method thereof - Google Patents
Clonazepam orally disintegrating tablet and preparation method thereof Download PDFInfo
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- CN115707471A CN115707471A CN202110953521.9A CN202110953521A CN115707471A CN 115707471 A CN115707471 A CN 115707471A CN 202110953521 A CN202110953521 A CN 202110953521A CN 115707471 A CN115707471 A CN 115707471A
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- Prior art keywords
- clonazepam
- orally disintegrating
- disintegrating tablet
- lactose
- starch
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- DGBIGWXXNGSACT-UHFFFAOYSA-N clonazepam Chemical compound C12=CC([N+](=O)[O-])=CC=C2NC(=O)CN=C1C1=CC=CC=C1Cl DGBIGWXXNGSACT-UHFFFAOYSA-N 0.000 title claims abstract description 34
- 229960003120 clonazepam Drugs 0.000 title claims abstract description 34
- 239000006191 orally-disintegrating tablet Substances 0.000 title claims abstract description 30
- 238000002360 preparation method Methods 0.000 title abstract description 16
- 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 claims abstract description 15
- 239000008101 lactose Substances 0.000 claims abstract description 15
- 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 claims abstract description 9
- 239000007884 disintegrant Substances 0.000 claims abstract description 7
- 239000000945 filler Substances 0.000 claims abstract description 6
- 239000000314 lubricant Substances 0.000 claims abstract description 5
- 230000000750 progressive effect Effects 0.000 claims abstract description 3
- 238000005550 wet granulation Methods 0.000 claims abstract 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 14
- 239000000463 material Substances 0.000 claims description 10
- 238000007873 sieving Methods 0.000 claims description 10
- 239000003826 tablet Substances 0.000 claims description 10
- 229920002472 Starch Polymers 0.000 claims description 8
- 210000000214 mouth Anatomy 0.000 claims description 8
- 239000008107 starch Substances 0.000 claims description 8
- 235000019698 starch Nutrition 0.000 claims description 8
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 7
- 238000000034 method Methods 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
- 229920002261 Corn starch Polymers 0.000 claims description 6
- 239000008120 corn starch Substances 0.000 claims description 6
- 238000001035 drying Methods 0.000 claims description 6
- 238000002156 mixing Methods 0.000 claims description 6
- 239000000080 wetting agent Substances 0.000 claims description 6
- 229930006000 Sucrose Natural products 0.000 claims description 3
- 239000005720 sucrose Substances 0.000 claims description 3
- 229920001353 Dextrin Polymers 0.000 claims description 2
- 239000004375 Dextrin Substances 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
- 235000019425 dextrin Nutrition 0.000 claims description 2
- 229920001592 potato starch Polymers 0.000 claims description 2
- 239000007779 soft material Substances 0.000 claims description 2
- 239000002671 adjuvant Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 abstract description 5
- 229940079593 drug Drugs 0.000 abstract description 3
- 238000005516 engineering process Methods 0.000 abstract description 2
- 238000009776 industrial production Methods 0.000 abstract 1
- 239000000203 mixture Substances 0.000 description 14
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 12
- 229920002785 Croscarmellose sodium Chemical class 0.000 description 6
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical class [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 6
- 229960001681 croscarmellose sodium Drugs 0.000 description 6
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 description 6
- 238000004090 dissolution Methods 0.000 description 6
- 235000019359 magnesium stearate Nutrition 0.000 description 6
- 230000000694 effects Effects 0.000 description 5
- 239000008187 granular material Substances 0.000 description 5
- BTCSSZJGUNDROE-UHFFFAOYSA-N gamma-aminobutyric acid Chemical compound NCCCC(O)=O BTCSSZJGUNDROE-UHFFFAOYSA-N 0.000 description 4
- 239000002245 particle Substances 0.000 description 4
- 239000002994 raw material Substances 0.000 description 4
- 206010013911 Dysgeusia Diseases 0.000 description 3
- OGNSCSPNOLGXSM-UHFFFAOYSA-N (+/-)-DABA Natural products NCCC(N)C(O)=O OGNSCSPNOLGXSM-UHFFFAOYSA-N 0.000 description 2
- 206010010904 Convulsion Diseases 0.000 description 2
- 102000004300 GABA-A Receptors Human genes 0.000 description 2
- 108090000839 GABA-A Receptors Proteins 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 2
- 208000028017 Psychotic disease Diseases 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 235000009508 confectionery Nutrition 0.000 description 2
- 230000036461 convulsion Effects 0.000 description 2
- 229960000913 crospovidone Drugs 0.000 description 2
- 230000003001 depressive effect Effects 0.000 description 2
- 208000028659 discharge Diseases 0.000 description 2
- 239000012738 dissolution medium Substances 0.000 description 2
- 229960003692 gamma aminobutyric acid Drugs 0.000 description 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical class OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 2
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 230000036961 partial effect Effects 0.000 description 2
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 description 2
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 description 2
- 238000010298 pulverizing process Methods 0.000 description 2
- 239000011734 sodium Substances 0.000 description 2
- 229910052708 sodium Inorganic materials 0.000 description 2
- QMGVPVSNSZLJIA-FVWCLLPLSA-N strychnine Chemical compound O([C@H]1CC(N([C@H]2[C@H]1[C@H]1C3)C=4C5=CC=CC=4)=O)CC=C1CN1[C@@H]3[C@]25CC1 QMGVPVSNSZLJIA-FVWCLLPLSA-N 0.000 description 2
- 235000019605 sweet taste sensations Nutrition 0.000 description 2
- 206010001497 Agitation Diseases 0.000 description 1
- 108010062745 Chloride Channels Proteins 0.000 description 1
- 102000011045 Chloride Channels Human genes 0.000 description 1
- 206010053398 Clonic convulsion Diseases 0.000 description 1
- 208000019505 Deglutition disease Diseases 0.000 description 1
- 102000027484 GABAA receptors Human genes 0.000 description 1
- 108091008681 GABAA receptors Proteins 0.000 description 1
- QMGVPVSNSZLJIA-UHFFFAOYSA-N Nux Vomica Natural products C1C2C3C4N(C=5C6=CC=CC=5)C(=O)CC3OCC=C2CN2C1C46CC2 QMGVPVSNSZLJIA-UHFFFAOYSA-N 0.000 description 1
- CWRVKFFCRWGWCS-UHFFFAOYSA-N Pentrazole Chemical compound C1CCCCC2=NN=NN21 CWRVKFFCRWGWCS-UHFFFAOYSA-N 0.000 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- 241001279009 Strychnos toxifera Species 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 230000001773 anti-convulsant effect Effects 0.000 description 1
- 239000001961 anticonvulsive agent Substances 0.000 description 1
- 229960003965 antiepileptics Drugs 0.000 description 1
- 150000001557 benzodiazepines Chemical class 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 210000003169 central nervous system Anatomy 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 230000001055 chewing effect Effects 0.000 description 1
- 230000001186 cumulative effect Effects 0.000 description 1
- 235000014113 dietary fatty acids Nutrition 0.000 description 1
- 238000009792 diffusion process Methods 0.000 description 1
- 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 description 1
- 238000007922 dissolution test Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 229940126534 drug product Drugs 0.000 description 1
- 230000001667 episodic effect Effects 0.000 description 1
- 239000000194 fatty acid Substances 0.000 description 1
- 229930195729 fatty acid Natural products 0.000 description 1
- 239000010419 fine particle Substances 0.000 description 1
- 238000010579 first pass effect Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 210000001222 gaba-ergic neuron Anatomy 0.000 description 1
- 230000002102 hyperpolarization Effects 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 230000002722 inhibitory effect on epilepsy Effects 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 230000000670 limiting effect Effects 0.000 description 1
- 238000011866 long-term treatment Methods 0.000 description 1
- 230000001404 mediated effect Effects 0.000 description 1
- 239000002609 medium Substances 0.000 description 1
- 230000003340 mental effect Effects 0.000 description 1
- 210000004877 mucosa Anatomy 0.000 description 1
- 210000002569 neuron Anatomy 0.000 description 1
- 239000002858 neurotransmitter agent Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 230000002829 reductive effect Effects 0.000 description 1
- 210000003296 saliva Anatomy 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 239000000741 silica gel Substances 0.000 description 1
- 229910002027 silica gel Inorganic materials 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 229960005453 strychnine Drugs 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- -1 sucrose fatty acid ester Chemical class 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
- 210000000225 synapse Anatomy 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 238000011282 treatment Methods 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention belongs to the technical field of medicines, and relates to clonazepam orally disintegrating tablets and a preparation method thereof. The orally disintegrating tablet comprises the following components in percentage by mass: 0.5-2% of clonazepam, 75-95% of filler, 5-15% of disintegrant and 1-2% of lubricant; the preparation process can adopt the equal progressive addition mode premixing of clonazepam and lactose and the wet granulation technology. The invention aims to provide an orally disintegrating tablet containing clonazepam, which has a simple preparation process, is convenient to take and is suitable for industrial production.
Description
Technical Field
The invention belongs to the field of medicinal preparations, and particularly relates to clonazepam orally disintegrating tablets and a preparation method of the orally disintegrating tablets.
Background
Clonazepam is an anticonvulsant of benzodiazepine class (epilepsia 30286). The composition has effects in resisting various animal depressive psychosis 30286, clonic convulsion due to pentylenetetrazol, maximal electroconvulsive convulsion, strychnine and Sinomentoxin convulsion, etc. Has inhibitory effect on epilepsy 30286of various types. Clonazepam inhibits both episodic discharge of the depressive psychosis 30286and diffusion of discharge activity to surrounding tissues. The medicine acts on benzodiazepine receptor (BZR) of central nervous system, and can strengthen the combination of central inhibitory neurotransmitter gamma-aminobutyric acid (GABA) and GABAA receptor, promote chlorine channel opening and cell hyperpolarization, enhance synapse inhibition mediated by GABAergic neuron, and reduce excitability of neuron. Clonazepam may cause dependency.
At present, the dosage forms of clonazepam on the market at home are tablets and injections. The invention is an orally disintegrating tablet, which is a new formulation emerging in recent years, does not need water or only needs a little water, does not need chewing, is placed on the tongue surface, is rapidly disintegrated and dispersed into fine particles when meeting saliva, can be placed under the stomach by virtue of swallowing power to take effect, can be placed under the tongue, and can take effect through mucosa absorption after rapid disintegration. Has the characteristics of quick absorption, high bioavailability, reduced side effect, avoidance of partial first pass effect, convenient administration and the like. Is especially suitable for patients with dysphagia such as the elderly, children, mental patients, etc., and has improved compliance, and improved effectiveness and emergency of clinical treatment. The orally disintegrating tablet is more easily accepted by patients with long-term treatment.
Disclosure of Invention
The invention provides a preparation method of clonazepam orally disintegrating tablets.
The clonazepam orally disintegrating tablet provided by the invention takes clonazepam as an active ingredient, and a filler, a disintegrant, a lubricant and the like as auxiliary materials, and comprises the following components in percentage by weight:
the preparation process of the orally disintegrating tablet comprises the following steps: premixing clonazepam and lactose in an equivalent progressive manner, adding the rest of the internal auxiliary materials in the prescription amount, and sieving with a 80-mesh sieve for 3 times; using water as wetting agent to prepare soft material, sieving and granulating; drying at 50 deg.C to water content of 2.0-4.0%, sieving, and grading; adding lubricant and disintegrant, mixing, and tabletting.
The filler of the orally disintegrating tablet can be one or a mixture of more of lactose, sucrose, microcrystalline cellulose, dextrin and starch, and the weight percentage is 75-85%.
The invention relates to an orally disintegrating tablet, wherein the weight ratio of clonazepam to lactose is 1:20-1:60, preferably 1.
The starch auxiliary material of the orally disintegrating tablet can be one or a mixture of more of corn starch, partial pre-crosslinked starch and potato starch.
The disintegrating agent of the orally disintegrating tablet can be one or more of microcrystalline cellulose, low-substituted hydroxypropyl methylcellulose, croscarmellose sodium, crospolyvinylpyrrolidone and croscarmellose sodium, preferably one or more of low-substituted hydroxypropyl methylcellulose, croscarmellose sodium, crospolyvinylpyrrolidone and sodium carboxymethyl starch, and accounts for 5-15 wt%.
The lubricant of the orally disintegrating tablet can be one or a mixture of more of magnesium stearate, talcum powder, superfine silica gel powder, sucrose fatty acid ester and the like, preferably the magnesium stearate accounts for 1 to 2 percent by weight.
The orally disintegrating tablet related to the invention has the weight of 100-200mg, the hardness of 15-60N, preferably 20-40N, good mouthfeel, and the disintegration time of 15-60s, preferably 15-40s, measured by an oral cavity disintegration tester.
Detailed Description
The present invention will be described in further detail with reference to examples. It should not be understood that the scope of the above-described subject matter of the present invention is limited to the following examples. All the technologies realized based on the above-mentioned contents of the present invention belong to the scope of the present invention. The following examples further illustrate the benefits of the present invention, and the examples are for illustrative purposes only and do not limit the scope of the present invention, and variations and modifications apparent to those of ordinary skill in the art in light of the present disclosure are intended to be included within the scope of the present invention.
Example 1
Clonazepam orally disintegrating tablets (1000 tablets)
The preparation method comprises the following steps:
1. pulverizing the raw materials for 20s, sieving with 100 mesh sieve, and sieving with 100 mesh sieve respectively.
2. The prescribed amount of clonazepam was mixed incrementally in equal proportion to lactose 1.
3. The mixture of clonazepam and lactose and the auxiliary materials added in the prescription, such as corn starch, microcrystalline cellulose 12 and croscarmellose sodium, are sieved by a 80-mesh sieve and mixed for 3 times.
4. Adding water as wetting agent into the above mixture, making into soft mass, and granulating.
5. Drying at 50 deg.C until water content is 2.0-4.0%, and grading.
6. Calculating the yield, converting the dosage of the added croscarmellose sodium and magnesium stearate, and uniformly mixing the obtained mixture with the granules.
7. Tabletting, wherein the weight of the tablet is 100 mg, and the hardness is controlled to be 20-40N.
The experimental results are as follows: the process for preparing orally disintegrating tablets by the method has good particle fluidity and compressibility. Slightly sweet in mouth, no bad taste, and oral cavity disintegration time of 28s.
Example 2
Clonazepam orally disintegrating tablets (1000 tablets)
The preparation method comprises the following steps:
1. the raw material medicines are crushed for 20s and sieved by a 100-mesh sieve, and the auxiliary materials are respectively sieved by the 100-mesh sieve.
2. The prescribed amount of clonazepam was mixed with lactose 1 in equal amounts in increments in the ratio of.
3. The mixture of clonazepam and lactose and the auxiliary materials added in the prescription, such as corn starch, microcrystalline cellulose 12 and low-substituted hydroxypropyl cellulose, are sieved by a 80-mesh sieve and mixed for 3 times.
4. Adding water as wetting agent into the above mixture, making soft mass, and granulating.
5. Drying at 50 deg.C until water content is 2.0-4.0%, and grading.
6. Calculating the yield, converting the dosage of the externally added low-substituted hydroxypropyl cellulose and magnesium stearate, and mixing with the granules
The granules are mixed evenly.
7. Tabletting, the weight of the tablet is 100 mg, and the hardness is controlled to be 20-40N.
The experimental results are as follows: the process for preparing orally disintegrating tablets by the method has good particle fluidity and compressibility. Slightly sweet in mouth, no bad taste, and oral cavity disintegration time of 50s. Compared with example 1, example 2 replaces the disintegrant and the disintegration time is extended.
Example 3
Clonazepam orally disintegrating tablets (1000 tablets)
The preparation method comprises the following steps:
1. the raw material medicines are crushed for 20s and sieved by a 100-mesh sieve, and the auxiliary materials are respectively sieved by the 100-mesh sieve.
2. The prescribed amount of clonazepam was mixed incrementally in equal proportion to lactose 1.
3. The mixture of clonazepam and lactose and the auxiliary materials of corn starch, microcrystalline cellulose 12 and crospovidone added in the prescription are sieved by a 80-mesh sieve and mixed for 3 times.
4. Adding water as wetting agent into the above mixture, making into soft mass, and granulating.
5. Drying at 50 deg.C until water content is 2.0-4.0%, and grading.
6. Calculating the yield, converting the consumption of the added crospovidone and magnesium stearate, and uniformly mixing the obtained product with the granules.
7. Tabletting, wherein the weight of the tablet is 200mg, and the hardness is controlled to be 20-40N.
The experimental results are as follows: the method has good particle fluidity and compressibility during preparation of orally disintegrating tablet. Slight numb in mouth, no bad taste, and oral cavity disintegration time of 37s. Compared with example 1, example 3 replaces the disintegrant and the disintegration time is slightly prolonged.
Example 4
Clonazepam orally disintegrating tablets (1000 tablets)
The preparation method comprises the following steps:
1. pulverizing the raw materials for 20s, sieving with 100 mesh sieve, and sieving with 100 mesh sieve respectively.
2. The prescribed amount of clonazepam was mixed incrementally in equal proportion to lactose 1.
3. The mixture of clonazepam and lactose and the auxiliary materials added in the prescription, such as corn starch, microcrystalline cellulose 12, sodium carboxymethyl starch and croscarmellose sodium, are sieved by a 80-mesh sieve and mixed for 3 times.
4. Adding water as wetting agent into the above mixture, making soft mass, and granulating.
5. Drying at 50 deg.C until water content is 2.0-4.0%, and grading.
6. Calculating the yield, converting the dosage of the added magnesium stearate, and uniformly mixing the obtained product with the granules.
7. Tabletting, wherein the weight of the tablet is 200mg, and the hardness is controlled to be 20-40N.
The experimental results are as follows: the method has good particle fluidity and compressibility during preparation of orally disintegrating tablet. Has sweet taste, no adverse taste, and oral disintegration time of 21s. In example 4, the two disintegrants are used in combination, and disintegrate faster than in example 1.
Investigation of dissolution test:
taking the samples of examples 1-4 and the original drug product, the dissolution curve is determined: because the four dissolution curves of the reference preparation are all rapid dissolution, the rotation speed is 75rpm, the volume of the dissolution medium is 900ml, the sampling time points are 5, 10, 15, 30, 45 and 60min by adopting a main medium of 0.1M hydrochloric acid as the dissolution medium and adopting a paddle method to measure, the cumulative dissolution of each time point is calculated, and the results are shown in the following table:
experimental results show that the dissolution results of the samples in examples 1-4 are similar to those of the original medicine, the samples are all fast in dissolution, the oral disintegration speed is within 1min, and the samples have sweet taste and have the advantages of fast disintegration, good mouthfeel, strong compliance and the like.
Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention, and that variations, modifications, substitutions and alterations can be made to the above embodiments by those of ordinary skill in the art within the scope of the present invention.
Claims (6)
1. The clonazepam orally disintegrating tablet comprises the following components in percentage by weight:
2. the clonazepam orally disintegrating tablet of claim 1, wherein the filler is selected from one or more of lactose, sucrose, microcrystalline cellulose, dextrin, and starch.
3. The clonazepam orally disintegrating tablet of claim 1, which is prepared by the following process: premixing clonazepam and lactose in an equivalent progressive manner, adding the rest of the internal auxiliary materials in the prescription amount, and sieving with a 80-mesh sieve for 3 times; using water as a wetting agent to prepare a soft material, sieving and granulating; drying at 50 deg.C to water content of 2.0-4.0%, sieving, and grading; adding lubricant and disintegrant, mixing, and tabletting.
4. The filler according to claim 2 or 3, wherein the filler is selected from starch adjuvant, selected from one or more of corn starch, partially pre-crosslinked starch and potato starch.
5. The method according to claim 1 or 3, wherein the weight ratio of clonazepam premixed with lactose is 1:20-1:60.
6. the clonazepam orally disintegrating tablet according to claim 1 or 3, which adopts a wet granulation process, has a tablet weight of 100-200mg and a hardness of 15-60N, and has a disintegration time of 15-60s as measured by an oral cavity disintegration tester.
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| CN202110953521.9A CN115707471A (en) | 2021-08-19 | 2021-08-19 | Clonazepam orally disintegrating tablet and preparation method thereof |
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| CN202110953521.9A CN115707471A (en) | 2021-08-19 | 2021-08-19 | Clonazepam orally disintegrating tablet and preparation method thereof |
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