CN111419809A - Sublingual tablet pharmaceutical composition for acute spastic pain and preparation method thereof - Google Patents
Sublingual tablet pharmaceutical composition for acute spastic pain and preparation method thereof Download PDFInfo
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- CN111419809A CN111419809A CN202010337857.8A CN202010337857A CN111419809A CN 111419809 A CN111419809 A CN 111419809A CN 202010337857 A CN202010337857 A CN 202010337857A CN 111419809 A CN111419809 A CN 111419809A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/05—Phenols
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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Abstract
The invention discloses a sublingual tablet pharmaceutical composition for acute spasmodic pain, which comprises the following components: 75-85mg of phloroglucinol as a raw material, 60-100 mg of a filler, 10-30 mg of a disintegrating agent, 0.5-5 mg of a lubricant, 0.5-5 mg of a glidant and 0.5-20 mg of a flavoring agent, and the preparation method comprises the following steps: sieving the raw materials, filler, disintegrant and correctant, adding glidant and lubricant, and directly tabletting; the low-temperature vacuum drying is adopted, the moisture in the tablets is controlled, the oxidation is prevented, the vacuum drying temperature is 30-80 ℃, and the vacuum drying is carried out for 2.5-4h, so that the production process is more suitable for commercial production compared with the freeze-dried tablets; the hardness of the tablet is increased, and the tablet is convenient for a patient to carry during traveling and is not broken; convenient administration and better compliance.
Description
Technical Field
The invention relates to a pain medicament, in particular to a sublingual tablet medicinal composition for acute spastic pain and a preparation method thereof.
Background
The chemical name of phloroglucinol is 1,3,5 trihydroxy benzene dihydrate, and the molecular formula is C6H6O3•2H2O, molecular weight 162.14. The chemical structural formula is as follows:
phloroglucinol is a pure smooth muscle spasmolytic and is used for acute spastic pain caused by dysfunction of the digestive system and biliary tract; acute spasmodic urinary tract, bladder, renal colic; spasmodic pain in the gynecology; adjuvant treatment of uterine contractions during pregnancy.
Phloroglucinol, a myotropic non-atropine non-papaverine pure smooth muscle spasmolytic, can directly act on the smooth muscle of gastrointestinal tract and genitourinary tract, and is clinically used for treating acute spastic pain caused by body dysfunction. Compared with other smooth muscle spasmolytic drugs, the compound has the greatest characteristic of no choline resistance, can not generate a series of choline resistance like adverse reactions while relieving the smooth muscle spasm, can not cause symptoms such as hypotension, heart rate acceleration, arrhythmia and the like, and has little influence on cardiovascular function. Since it acts only on spastic smooth muscle, it has little effect on normal smooth muscle. The half-life period of the phloroglucinol is about 15 minutes, and the blood concentration is reduced quickly and then slowly within 4 hours after administration, so that the phloroglucinol is safe for pregnant women and fetuses.
The original ground oral phloroglucinol freeze-dried tablet is produced by L abosoracire L, L afon company, and has the characteristics that the medicine can be quickly dissolved and absorbed to achieve the aim of quick absorption.
Disclosure of Invention
The invention aims to provide a sublingual tablet pharmaceutical composition for acute spastic pain and a preparation method thereof.
The technical scheme adopted by the invention is as follows:
a sublingual tablet pharmaceutical composition for acute spasmodic pain, characterized by: the composition comprises the following components: 75-85mg of phloroglucinol as a raw material, 60-100 mg of a filler, 10-30 mg of a disintegrating agent, 0.5-5 mg of a lubricant, 0.5-5 mg of a glidant and 0.5-20 mg of a flavoring agent.
The bulk drug is phloroglucinol dihydrate, the filler is at least one of mannitol, anhydrous lactose, microcrystalline cellulose and calcium hydrophosphate, the disintegrant is at least one of croscarmellose sodium, crospovidone, sodium carboxymethyl starch and low-substituted hydroxypropyl cellulose, the lubricant is at least one of magnesium stearate and sodium stearyl fumarate, the glidant is at least one of silicon dioxide and talcum powder, and the flavoring agent is at least one of sucralose, aspartame and mint essence.
Preferably, the composition consists of the following components: 80.00mg of phloroglucinol dihydrate, 40.08mg of mannitol, 40.08mg of microcrystalline cellulose, 18.20mg of crospovidone, 1.82mg of silicon dioxide, 1.82mg of magnesium stearate and 1.84mg of aspartame.
A preparation method of a sublingual tablet pharmaceutical composition for acute spasmodic pain is characterized in that: the method comprises the following steps:
step 1: sieving the raw materials, filler, disintegrant and correctant, adding glidant and lubricant, and directly tabletting;
step 2: and (3) carrying out low-temperature vacuum drying, controlling the moisture in the tablets, preventing oxidation, and carrying out vacuum drying at the temperature of 30-80 ℃ for 2.5-4 h.
Preferably, the vacuum drying temperature is 40-60 ℃.
Preferably, the tablet has a final moisture content of no more than 3%.
Preferably, the tablet has a final moisture of no more than 2%.
The invention has the advantages that: compared with the freeze-dried tablet, the production process is more suitable for commercial production; the hardness of the tablet is increased, and the tablet is convenient for a patient to carry during traveling and is not broken; convenient administration and better compliance.
Detailed Description
Example 1
A sublingual tablet pharmaceutical composition for acute spasmodic pain comprises the following components: 80.00mg of phloroglucinol dihydrate, 80.16mg of mannitol, 18.20mg of crospovidone, 1.82mg of silicon dioxide, 1.82mg of magnesium stearate and 1.84mg of aspartame.
A preparation method of a sublingual tablet pharmaceutical composition for acute spasmodic pain comprises the following steps:
step 1: weighing phloroglucinol dihydrate, mannitol, crospovidone and aspartame, sieving with a 40-mesh sieve, adding silicon dioxide, mixing for 3 minutes, adding magnesium stearate, mixing for 3 minutes, and directly tabletting;
step 2: and (3) performing low-temperature vacuum drying to control the moisture in the tablets and prevent oxidation, and performing vacuum drying at the vacuum drying temperature of 40 ℃ for 4 hours.
The tablet prepared by the prescription process has the hardness: 40-50N; friability: 0.3 percent; disintegration time limit: 10.3 seconds, final moisture was not more than 2%.
The water content of the tablet prepared by direct tabletting is about 10 percent, the water content in the tablet is controlled by adopting an unconventional low-temperature vacuum drying mode, and the water content can be controlled to be below 3 percent, so that the unstable risk of easy oxidative degradation caused by high water content of the product is reduced, and the tablet has the characteristics of low probability of breakage, high disintegration speed (the disintegration time limit is only about 10 seconds), high dissolution and release speed (the dissolution amount in 5min is more than 95 percent), good taste, simple preparation process, industrialized production and low production cost, and has the characteristics of good stability, and safety and effectiveness which are beneficial to medicine application.
Compared with the freeze-dried tablet, the production process is more suitable for commercial production; the hardness of the tablet is increased, and the tablet is convenient for a patient to carry during traveling and is not broken; convenient administration and better compliance. The freeze-dried tablet is taken by dissolving in a small cup of water for drinking or sublingual administration for obtaining better effect, but the freeze-dried tablet is crushed after being pinched, so that the particles are scattered and can be taken only by a small cup of water, otherwise, the dosage is inaccurate, and the administration is inconvenient to take immediately under the state of emergency pain.
Example 2
A sublingual tablet pharmaceutical composition for acute spasmodic pain, characterized by: the composition comprises the following components: 80.00mg of phloroglucinol dihydrate, 40.08mg of mannitol, 40.08mg of microcrystalline cellulose, 18.20mg of crospovidone, 1.82mg of silicon dioxide, 1.82mg of magnesium stearate and 1.84mg of aspartame.
A preparation method of a sublingual tablet pharmaceutical composition for acute spasmodic pain comprises the following steps:
step 1: weighing phloroglucinol dihydrate, mannitol, microcrystalline cellulose, crospovidone and aspartame, sieving with a 40-mesh sieve, adding silicon dioxide, mixing for 3 minutes, adding magnesium stearate, mixing for 3 minutes, and directly tabletting;
step 2: and (3) performing low-temperature vacuum drying to control the moisture in the tablets and prevent oxidation, and performing vacuum drying at the vacuum drying temperature of 40 ℃ for 4 hours.
The tablet prepared by the prescription process has the hardness: 60-70N; friability: 0.1 percent; disintegration time limit: 15.0 seconds, final moisture was not more than 3%.
The water content of the tablet prepared by direct tabletting is about 10 percent, the water content in the tablet is controlled by adopting an unconventional low-temperature vacuum drying mode, and the water content can be controlled to be below 3 percent, so that the unstable risk of easy oxidative degradation caused by high water content of the product is reduced, and the tablet has the characteristics of low probability of breakage, high disintegration speed (the disintegration time limit is only about 10 seconds), high dissolution and release speed (the dissolution amount in 5min is more than 95 percent), good taste, simple preparation process, industrialized production and low production cost, and has the characteristics of good stability, and safety and effectiveness which are beneficial to medicine application.
Compared with the freeze-dried tablet, the production process is more suitable for commercial production; the hardness of the tablet is increased, and the tablet is convenient for a patient to carry during traveling and is not broken; convenient administration and better compliance. The freeze-dried tablet is taken by dissolving in a small cup of water for drinking or sublingual administration for obtaining better effect, but the freeze-dried tablet is crushed after being pinched, so that the particles are scattered and can be taken only by a small cup of water, otherwise, the dosage is inaccurate, and the administration is inconvenient to take immediately under the state of emergency pain.
Example 3
A sublingual tablet pharmaceutical composition for acute spasmodic pain, characterized by: the composition comprises the following components: 80.00mg of phloroglucinol dihydrate, 75mg of mannitol, 17mg of crospovidone, 2.2mg of silicon dioxide, 2.2mg of magnesium stearate and 3mg of aspartame.
A preparation method of a sublingual tablet pharmaceutical composition for acute spasmodic pain comprises the following steps:
step 1: weighing phloroglucinol dihydrate, mannitol, crospovidone and aspartame, sieving with a 40-mesh sieve, adding silicon dioxide, mixing for 3 minutes, adding magnesium stearate, mixing for 3 minutes, and directly tabletting;
step 2: and (3) controlling the moisture in the tablet by adopting low-temperature vacuum drying to prevent oxidation, and performing vacuum drying at the vacuum drying temperature of 60 ℃ for 2.5h, wherein the final moisture of the tablet is not more than 2%.
The water content of the tablet prepared by direct tabletting is about 10 percent, the water content in the tablet is controlled by adopting an unconventional low-temperature vacuum drying mode, and the water content can be controlled to be below 3 percent, so that the unstable risk of easy oxidative degradation caused by high water content of the product is reduced, and the tablet has the characteristics of low probability of breakage, high disintegration speed (the disintegration time limit is only about 10 seconds), high dissolution and release speed (the dissolution amount in 5min is more than 95 percent), good taste, simple preparation process, industrialized production and low production cost, and has the characteristics of good stability, and safety and effectiveness which are beneficial to medicine application.
Compared with the freeze-dried tablet, the production process is more suitable for commercial production; the hardness of the tablet is increased, and the tablet is convenient for a patient to carry during traveling and is not broken; convenient administration and better compliance. The freeze-dried tablet is taken by dissolving in a small cup of water for drinking or sublingual administration for obtaining better effect, but the freeze-dried tablet is crushed after being pinched, so that the particles are scattered and can be taken only by a small cup of water, otherwise, the dosage is inaccurate, and the administration is inconvenient to take immediately under the state of emergency pain.
Since the phloroglucinol sublingual tablet of the present application is characterized in that the moisture content of the pressed tablet is about 10%, the moisture content is higher, the tablet is easy to oxidize, and the product quality is unstable, the following formula (see table 1) is examined on the drying mode and the drying temperature, including air drying and vacuum drying, the temperature is examined from 40 ℃ to 80 ℃, and the results are respectively shown in tables 2 to 8 when the samples prepared before and after drying and the original orally-taken freeze-dried tablet are compared on the relevant quality characteristics.
TABLE 1 prescription composition
TABLE 2 comparison of key indices of samples prepared in different drying modes and drying temperatures with those of lyophilized tablets
TABLE 3 comparison of appearance of the samples prepared in different drying modes and drying temperatures with those of the lyophilized tablets and the substances involved
Note: in the table, "NA" indicates no detection, and the relevant substances are not detected because the moisture content of the tablets is more than 5% after the tablets are dried by air blowing at different temperatures for 4 hours.
And (4) conclusion: as a result of the studies in tables 2 and 3, it was found that the water content was difficult to remove by forced air drying, and the related substances of the prepared samples were significantly higher than those of the lyophilized tablets. The vacuum drying can well control the moisture, and the related substances of the prepared sample are equivalent to those of the original grinding after the moisture is less than 3 percent. Further, vacuum drying is preferable because the active ingredient, resorcinol, is prevented from being oxidized by air.
When the phloroglucinol tablets are dried in vacuum, the moisture can be controlled not to exceed 3 percent, and the good effect of reducing the moisture and preventing oxidation is achieved. More preferably, the flakes are finally vacuum dried to a moisture content of no more than 2%. The effect factor results are shown in table 4.
TABLE 4 comparison of samples prepared at different temperatures of vacuum drying with lyophilized tablets for influencing the appearance of the factors and the substances involved
And (4) conclusion: and (3) carrying out influence factor stability investigation by adopting the tablets with the water content not more than 2% after vacuum drying, wherein the self-grinding is consistent with the impurity spectrum of the original grinding freeze-dried tablets, and the impurity level is lower than that of the original grinding freeze-dried tablets.
The dissolution of the self-ground sublingual tablets prepared after vacuum drying for 4 hours at 40 ℃ is compared with the dissolution of the original ground oral freeze-dried tablets shown in the following tables 5 to 8.
TABLE 5.40 deg.C comparison of dissolution data for tablets prepared after 4h vacuum drying with lyophilized tablets in medium pH1.0
TABLE 6.40 deg.C comparison of dissolution data for tablets prepared after vacuum drying for 4h with lyophilized tablets pH4.5
TABLE 7.40 deg.C comparison of dissolution data for tablets prepared after 4h vacuum drying with lyophilized tablets in medium pH6.8
TABLE 8.40 deg.C dissolution data of the prepared tablets and lyophilized tablets after vacuum drying for 4h in aqueous medium
And (4) conclusion: as can be seen from tables 5 to 8, the sublingual tablet samples prepared by the present invention have an in vitro dissolution ratio compared with the original oral lyophilized product: the dissolution rates of 5min self-grinding samples of a pH1.0 medium, a pH4.5 medium, a pH6.8 medium and an aqueous medium all reach over 95 percent, and the dissolution rates of all the media are obviously superior to those of freeze-dried tablets, so that the quick effect is facilitated.
In summary, the following steps: the phloroglucinol sublingual tablet prepared by the invention overcomes the defects of great weight (about 700mg of tablet weight), small hardness (about 40N), fragile (unqualified friability) and difficult packaging and storage of the original ground oral lyophilized tablet, and is not beneficial to carrying and taking by patients. The pressed phloroglucinol sublingual tablet has the weight of about 184mg, the hardness of about 70N, good friability, easy storage and transportation, convenient carrying by patients and buccal administration at any time. Meanwhile, the preparation process is simple, the operation steps and the period of freeze drying are not needed, and the production cost is saved. The phloroglucinol tablet prepared by adopting the direct compression process has the same stability as freeze-drying, is quicker in disintegration and dissolution than the original tablet, takes effect quickly, and is suitable for relieving acute pain. And the tablet is pressed, so that the hardness is improved, the friability is improved, and the tablet is not easy to break.
Claims (7)
1. A sublingual tablet pharmaceutical composition for acute spasmodic pain, characterized by: the composition comprises the following components: 75-85mg of phloroglucinol as a raw material, 60-100 mg of a filler, 10-30 mg of a disintegrating agent, 0.5-5 mg of a lubricant, 0.5-5 mg of a glidant and 0.5-20 mg of a flavoring agent.
2. The sublingual tablet pharmaceutical composition for acute spasmodic pain and the preparation method thereof according to claim 1, wherein the sublingual tablet pharmaceutical composition comprises: the bulk drug is phloroglucinol dihydrate, the filler is at least one of mannitol, anhydrous lactose, microcrystalline cellulose and calcium hydrophosphate, the disintegrant is at least one of croscarmellose sodium, crospovidone, sodium carboxymethyl starch and low-substituted hydroxypropyl cellulose, the lubricant is at least one of magnesium stearate and sodium stearyl fumarate, the glidant is at least one of silicon dioxide and talcum powder, and the flavoring agent is at least one of sucralose, aspartame and mint essence.
3. The sublingual tablet pharmaceutical composition for acute spasmodic pain according to claim 1, wherein: the composition comprises the following components: 80.00mg of phloroglucinol dihydrate, 40.08mg of mannitol, 40.08mg of microcrystalline cellulose, 18.20mg of crospovidone, 1.82mg of silicon dioxide, 1.82mg of magnesium stearate and 1.84mg of aspartame.
4. The method for preparing a sublingual tablet pharmaceutical composition for acute spasmodic pain according to claim 1, wherein: the method comprises the following steps:
step 1: sieving the raw materials, filler, disintegrant and correctant, adding glidant and lubricant, and directly tabletting;
step 2: and (3) carrying out low-temperature vacuum drying, controlling the moisture in the tablets, preventing oxidation, and carrying out vacuum drying at the temperature of 30-80 ℃ for 2.5-4 h.
5. The method for preparing a sublingual tablet composition for acute spasmodic pain according to claim 4, wherein: the vacuum drying temperature is 40-60 ℃.
6. The method for preparing a sublingual tablet composition for acute spasmodic pain according to claim 4, wherein: the final moisture content of the tablet is not more than 3%.
7. The method for preparing a sublingual tablet composition for acute spasmodic pain according to claim 4, wherein: the final moisture content of the tablet is not more than 2%.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101209249A (en) * | 2006-12-26 | 2008-07-02 | 海南高升医药科技开发有限公司 | Spaston orally disintegrating tablets and preparation thereof |
| CN101461788A (en) * | 2007-12-18 | 2009-06-24 | 上海医药工业研究院 | Phloroglucine orally disintegrating tablet and preparation method thereof |
| CN103120652A (en) * | 2012-12-30 | 2013-05-29 | 湖南湘药制药有限公司 | Phloroglucin orally disintegrating tablet and preparation method thereof |
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- 2020-04-26 CN CN202010337857.8A patent/CN111419809A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101209249A (en) * | 2006-12-26 | 2008-07-02 | 海南高升医药科技开发有限公司 | Spaston orally disintegrating tablets and preparation thereof |
| CN101461788A (en) * | 2007-12-18 | 2009-06-24 | 上海医药工业研究院 | Phloroglucine orally disintegrating tablet and preparation method thereof |
| CN103120652A (en) * | 2012-12-30 | 2013-05-29 | 湖南湘药制药有限公司 | Phloroglucin orally disintegrating tablet and preparation method thereof |
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