CN116211812A - Breviscapine tablet and preparation method thereof - Google Patents

Breviscapine tablet and preparation method thereof Download PDF

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Publication number
CN116211812A
CN116211812A CN202310294103.2A CN202310294103A CN116211812A CN 116211812 A CN116211812 A CN 116211812A CN 202310294103 A CN202310294103 A CN 202310294103A CN 116211812 A CN116211812 A CN 116211812A
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tablet
breviscapine
sieving
weight
parts
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赵剑
梁亮
王伟
巫玥
葛鹏程
蒋涛
耿志
吴�荣
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Wuhu Luye Pharmaceutical Co Ltd
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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
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/00—Medicinal preparations containing organic active ingredients
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    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • 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
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A—HUMAN NECESSITIES
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Abstract

The invention discloses a breviscapine tablet and a preparation method thereof, relates to the technical field of medicines, and in particular relates to a breviscapine tablet and a preparation method thereof. The tablet is prepared from the following components in parts by weight: 10 to 30 percent of breviscapine, 10 to 50 percent of D-mannitol, 5 to 20 percent of PEG600010, 10 to 30 percent of PEG4000, 10 to 30 percent of dry starch, 10 to 30 percent of dextrin and 0.1 to 1.5 percent of magnesium stearate. In addition, the invention also discloses a preparation method of the tablet. The breviscapine tablet has the characteristics of excellent dissolution rate and stability.

Description

Breviscapine tablet and preparation method thereof
Technical Field
The invention relates to a pharmaceutical composition and a preparation method thereof, in particular to a breviscapine tablet and a preparation method thereof.
Background
Breviscapine (breviscapine) is flavonoid active substance extracted and separated from erigeron breviscapus Erigeron breviscapus (vant.) hand-Mazz of Compositae, and its main ingredient is scutellarin (C) 21 H 18 O 12 ). Modern pharmacological and pharmacodynamic researches show that the breviscapine has the efficacy of reducing cerebrovascular resistance, increasing cerebral blood flow, improving microcirculation, resisting platelet aggregation and the like. Erigeron breviscapus is widely used for treating cerebral ischemia, cerebral hemorrhage sequelae, high viscosity blood, cerebral thrombosis, coronary heart disease, angina pectoris and other diseases clinically.
Patent CN 106806896A discloses a preparation method of a breviscapine-phospholipid complex, which comprises mixing breviscapine and lecithin according to a volume ratio, stirring at 45-50 ℃ for 1-2 hours, pouring the stirred mixture into a mixed solvent, and refluxing and heating at 55-65 ℃ for 3-5 hours to obtain a yellow micro-cementate substance, namely the breviscapine-phospholipid complex, and the preparation method is characterized by providing the dispersibility of the breviscapine. The particle size of the product is in the nanometer scale, and the dispersibility is good. The patent number CN 107213132B discloses a controlled release tablet of a erigeron breviscapus osmotic pump and a preparation method thereof, wherein the tablet core and a semipermeable membrane technology (the tablet core comprises, by weight, 40-150 parts of erigeron breviscapus, 10-100 parts of a penetrating agent, 2.5-20 parts of an adhesive, 2.5-30 parts of a solubilizer, 5-20 parts of a suspension aid, 0-50 parts of a filler and 0-5 parts of a lubricant, and the semipermeable membrane comprises, by weight, 3-40 parts of a high polymer material, 0.01-3 parts of a pore-forming agent and 0-3 parts of a plasticizer) are adopted to prepare the controlled release tablet of the erigeron breviscapus osmotic pump, so that the utilization rate of the erigeron breviscapus is improved. Patent number CN 106580898B discloses a erigeron breviscapus dispersible tablet and a preparation method thereof, wherein the erigeron breviscapus dispersible tablet is prepared from erigeron breviscapus, calcium hydrophosphate, microcrystalline cellulose, croscarmellose sodium, sodium dodecyl sulfate and the like, so that the dissolution rate and uniformity of the erigeron breviscapus are improved.
In addition to the above patent, the related patent also discloses the preparation of breviscapine dripping pill, breviscapine chitosan composite hydrogel, breviscapine nano liposome, etc. In recent years, technical researches on improving the bioavailability of the breviscapine are increasingly carried out, such as the research on the preparation process of the beta-cyclodextrin inclusion compound of the breviscapine, which is carried out by scholars such as Wang Junhua, and the like, and the beta-cyclodextrin inclusion compound of the breviscapine is prepared by adopting a colloid mill method so as to improve the in-vivo dissolution rate of the breviscapine; jie Junbo and the like, and a coacervation method is adopted to prepare the breviscapine chitosan-sodium alginate microcapsule, thereby improving the bioavailability and the stability of the breviscapine.
The existing market variety of erigeron breviscapus is mainly erigeron breviscapus injection, erigeron breviscapus tablet, and erigeron breviscapus granule. Because breviscapine is dissolved in pyridine and dilute alkali solution, is slightly dissolved in methanol, is slightly dissolved in hot water, ethanol and ethyl acetate, and is almost insoluble in organic solvents such as water, diethyl ether, chloroform, benzene, acetone and the like. Although the administration mode of the erigeron breviscapus injection has the advantages of relatively quick absorption, high bioavailability and the like, the patient has poor use compliance, and the preparation process, storage and transportation of the corresponding quality and the like are relatively complex. The erigeron flavonoids have poor water solubility and fat solubility, and the bioavailability of the erigeron flavonoids corresponding to the oral preparation products is extremely low; according to literature reports, the dissolution rate of the traditional breviscapine tablet does not meet the requirement in 6 months of accelerated stability investigation, and the oral bioavailability is only about 0.40%, so that the clinical curative effect of the preparation is seriously restricted.
Disclosure of Invention
The 1 st object of the present invention is to provide a tablet of erigeron breviscapus having a high dissolution rate of erigeron breviscapus.
The 2 nd object of the present invention is a process for preparing the above-mentioned erigeron breviscapus tablet.
The technical scheme for solving the technical problems is as follows:
the breviscapine tablet is prepared from the following components in parts by weight:
Figure BDA0004142578730000031
in a preferred embodiment of the invention, the invention provides a breviscapine tablet which is prepared from the following components in parts by weight:
Figure BDA0004142578730000032
in a preferred embodiment of the invention, the invention provides a breviscapine tablet which is prepared from the following components in parts by weight:
Figure BDA0004142578730000041
in a preferred embodiment of the invention, the invention provides a breviscapine tablet which is prepared from the following components in parts by weight:
Figure BDA0004142578730000042
the preparation method of the breviscapine tablet provided by the invention comprises the following steps:
step (1) respectively crushing and sieving the raw materials and the auxiliary materials for standby;
respectively weighing breviscapine, D-mannitol, polyethylene glycol 6000 and polyethylene glycol 4000, uniformly mixing, placing in an oil bath pan, heating to 170 ℃ and stirring the materials to a molten state, keeping the temperature unchanged, uniformly and slowly pouring the molten state into an ice bath, vigorously stirring to fully cool, taking solid in the ice bath, drying, crushing and sieving;
and (3) taking the screened fine powder in the step (2), adding starch, dextrin and magnesium stearate, uniformly mixing, tabletting and coating.
In a preferred scheme of the invention, the preparation method of the breviscapine tablet provided by the invention, wherein the sieving in the step (1) means sieving through a 80-mesh sieve.
In a preferred scheme of the invention, the preparation method of the breviscapine tablet provided by the invention, wherein the sieving in the step (2) means sieving through a 120-mesh sieve.
In a preferred scheme of the invention, the preparation method of the breviscapine tablet provided by the invention, wherein the drying in the step (2) means freeze drying for 3-5 hours, and the moisture content is controlled to be less than or equal to 5.0%.
In the preferred scheme of the invention, the preparation method of the breviscapine tablet provided by the invention, wherein the weight difference of the control tablet in the step (3) is not more than +/-7.0%, the pressure is controlled to be 12-16kN, and the thickness of the control tablet is 1.85-2.15mm.
Compared with the prior art, the dissolution rate of the invention still meets the requirements in the 6-month accelerated stability investigation, while the common tablet is not met, and the sticking and punching phenomenon of the tablet tabletting is reduced.
Detailed Description
Embodiments of the present invention are further described below by way of examples, which do not limit the scope of the invention. Under the guidance of the invention, the optimization and improvement of certain technical features still fall within the protection scope of the invention.
In the embodiment of the invention, the dissolution rate, the dispersion uniformity, the weight difference and the microorganism limit of the tablet are tested according to the Chinese pharmacopoeia of 2020 edition.
Disintegration time limit: checking according to the Chinese pharmacopoeia disintegration time limit method of 2020 edition (general rule 0921), wherein the inner diameter of the sieve mesh of the stainless steel wire mesh is 710 μm, and the water temperature is 15-25 ℃; test 6 tablets were taken and should be completely disintegrated and passed through the screen within 3 minutes.
Dissolution test: dissolution measurement example 1 by reference to the first method in the chinese pharmacopoeia code 0931
Figure BDA0004142578730000061
Step (1) pulverizing PEG4000 and PEG6000, respectively sieving raw materials and auxiliary materials with a 80-mesh sieve for later use
Weighing breviscapine, D-mannitol, polyethylene glycol 6000 and polyethylene glycol 4000, uniformly mixing, placing in an oil bath pan, heating to 170 ℃, continuously stirring the materials to a molten state, keeping the temperature unchanged, uniformly and slowly pouring the molten state into an ice bath, vigorously stirring to fully cool, taking solid in the ice bath, freeze-drying for 4 hours, crushing, and sieving with a 100-mesh sieve;
step (3) taking the screened fine powder in the step (2), adding dry starch, dextrin and magnesium stearate, and uniformly mixing;
tabletting, controlling the weight difference of tablets to be not more than +/-6.5%, controlling the pressure to be 13kN and controlling the thickness of the tablets to be 2mm, and coating to obtain the product
Example 2
Figure BDA0004142578730000071
Step (1) pulverizing PEG4000 and PEG6000, respectively sieving raw materials and auxiliary materials with a 80-mesh sieve for later use
Weighing breviscapine, D-mannitol, polyethylene glycol 6000 and polyethylene glycol 4000, uniformly mixing, placing in an oil bath pan, heating to 170 ℃, continuously stirring the materials to a molten state, keeping the temperature unchanged, uniformly and slowly pouring the molten state into an ice bath, vigorously stirring to fully cool, taking solid in the ice bath, freeze-drying for 4 hours, crushing, and sieving with a 100-mesh sieve;
step (3) taking the screened fine powder in the step (2), adding dry starch, dextrin and magnesium stearate, and uniformly mixing;
tabletting, controlling the weight difference of tablets to be not more than +/-6.5%, controlling the pressure to be 13kN and controlling the thickness of the tablets to be 2mm, and coating to obtain the product
Example 3
Figure BDA0004142578730000081
Step (1) pulverizing PEG4000 and PEG6000, respectively sieving raw materials and auxiliary materials with a 80-mesh sieve for later use
Weighing breviscapine, D-mannitol, polyethylene glycol 6000 and polyethylene glycol 4000, uniformly mixing, placing in an oil bath pan, heating to 170 ℃, continuously stirring the materials to a molten state, keeping the temperature unchanged, uniformly and slowly pouring the molten state into an ice bath, vigorously stirring to fully cool, taking solid in the ice bath, freeze-drying for 4 hours, crushing, and sieving with a 100-mesh sieve;
step (3) taking the screened fine powder in the step (2), adding dry starch, dextrin and magnesium stearate, and uniformly mixing;
tabletting, controlling the weight difference of tablets to be not more than +/-6.5%, controlling the pressure to be 13kN and controlling the thickness of the tablets to be 2mm, and coating to obtain the product
Comparative example 1
Figure BDA0004142578730000091
Step (1) respectively sieving the raw materials and the auxiliary materials with a 80-mesh sieve for standby
Step (2) taking a proper amount of starch to prepare starch slurry, uniformly mixing the starch slurry with breviscapine, the residual starch and dextrin, granulating, drying for 4 hours, crushing and sieving with a 100-mesh sieve;
step (3) taking the screened fine powder in the step (2), adding magnesium stearate, and uniformly mixing;
and (4) tabletting, wherein the weight difference of the tablets is controlled to be not more than +/-6.5%, the pressure is controlled to be 13kN, the thickness of the tablets is controlled to be 2mm, and the product is obtained by coating.
Comparative example 2
Figure BDA0004142578730000092
Figure BDA0004142578730000101
Step (1) pulverizing PEG4000, and respectively sieving raw and auxiliary materials with a 80-mesh sieve for later use
Weighing breviscapine, D-mannitol and polyethylene glycol 4000, uniformly mixing, placing in an oil bath, heating to 170 ℃, continuously stirring the materials to a molten state, keeping the temperature unchanged, uniformly and slowly pouring the molten state into an ice bath, vigorously stirring to fully cool, taking solid matters in the ice bath, freeze-drying for 4 hours, crushing, and sieving with a 100-mesh sieve;
step (3) taking the screened fine powder in the step (2), adding dry starch, dextrin and magnesium stearate, and uniformly mixing;
tabletting, controlling the weight difference of tablets to be not more than +/-6.5%, controlling the pressure to be 13kN and controlling the thickness of the tablets to be 2mm, and coating to obtain the product
Comparative example 3
Figure BDA0004142578730000102
Step (1) pulverizing PEG6000, and respectively sieving raw and auxiliary materials with a 80-mesh sieve for later use
Weighing breviscapine, D-mannitol and polyethylene glycol 6000, uniformly mixing, placing in an oil bath, heating to 170 ℃, continuously stirring the materials to a molten state, keeping the temperature unchanged, uniformly and slowly pouring the molten state into an ice bath, vigorously stirring to fully cool, taking solid matters in the ice bath, freeze-drying for 4 hours, crushing, and sieving with a 100-mesh sieve;
step (3) taking the screened fine powder in the step (2), adding dry starch, dextrin and magnesium stearate, and uniformly mixing;
tabletting, controlling the weight difference of tablets to be not more than +/-6.5%, controlling the pressure to be 13kN and controlling the thickness of the tablets to be 2mm, and coating to obtain the product
Test example 1
Table 1 comparison of technical parameters of examples and comparative examples
Figure BDA0004142578730000111
The results show that the granules in examples 1-3 have good fluidity and consistently tablet hardness, and the dispersibility of the tablets meets the requirements of the relevant regulations of the Chinese pharmacopoeia.
Test example 2
Comparing the dissolution rates of the erigeron breviscapus tablets prepared in the examples 1 and 2 of the invention with that of the common tablets (comparative examples 1, 2 and 3, prepared according to the standard prescription and process of the erigeron breviscapus tablets in Chinese pharmacopoeia), the dissolution rates are shown in Table 2
TABLE 2
Figure BDA0004142578730000121
The above results indicate that the dissolution rates of inventive examples 1, 2 are significantly better than comparative examples 1, 2, 3.
Test example 3
In order to detect the stability of the present invention, accelerated sample retention tests were performed in comparison with comparative examples 1, 2, and 3, the results are shown in tables 3, 4, 5, 6, 7, and 8
TABLE 3 Table 3
Figure BDA0004142578730000122
Figure BDA0004142578730000131
TABLE 4 Table 4
Figure BDA0004142578730000132
TABLE 5
Figure BDA0004142578730000133
TABLE 6
Figure BDA0004142578730000141
TABLE 7
Figure BDA0004142578730000142
TABLE 8
Figure BDA0004142578730000143
/>
Figure BDA0004142578730000151
Remarks: dissolution limit defines: not less than 70%
And (3) content measurement: not less than 20.0mg per tablet
The results show that in the stability test, the dissolution rate of the invention still meets the requirements in the 6-month accelerated stability test, and the common tablet does not meet the requirements. Meanwhile, the breviscapine tablet has better dispersion uniformity and obviously better disintegration time limit than the common tablet; and the content uniformity of the erigeron breviscapus tablet is good.

Claims (9)

1. The breviscapine tablet is prepared from the following components in parts by weight:
Figure FDA0004142578720000011
2. a tablet of breviscapine according to claim 1, characterized in that: the tablet is prepared from the following components in parts by weight:
Figure FDA0004142578720000012
3. a tablet of breviscapine according to claim 1, characterized in that: the tablet is prepared from the following components in parts by weight:
Figure FDA0004142578720000013
/>
Figure FDA0004142578720000021
4. a tablet of breviscapine according to claim 1, characterized in that: the tablet is prepared from the following components in parts by weight:
Figure FDA0004142578720000022
5. a process for preparing a tablet of breviscapine as claimed in any one of claims 1 to 4, comprising the steps of:
step (1) respectively crushing and sieving the raw materials and the auxiliary materials for standby;
respectively weighing breviscapine, D-mannitol, polyethylene glycol 6000 and polyethylene glycol 4000, uniformly mixing, placing in an oil bath pan, heating to 170 ℃ and stirring the materials to a molten state, keeping the temperature unchanged, uniformly and slowly pouring the molten state into an ice bath, vigorously stirring to fully cool, taking solid matters in the ice bath, drying, crushing and sieving;
and (3) taking the screened fine powder in the step (2), adding dry starch, dextrin and magnesium stearate, uniformly mixing, tabletting and coating.
6. The method for preparing a tablet of breviscapine according to claim 5, wherein: the sieving in the step (1) refers to sieving through an 80-mesh sieve.
7. The method for preparing a tablet of breviscapine according to claim 5, wherein: the sieving in the step (2) refers to sieving through a 120-mesh sieve.
8. The method for preparing a tablet of breviscapine according to claim 5, wherein: wherein the drying in the step (2) refers to freeze drying for 3-5 hours, and the moisture content is controlled to be less than or equal to 5.0%.
9. The method for preparing a tablet of breviscapine according to claim 5, wherein: wherein the weight difference of the control sheets in the step (3) is not more than +/-7.0%, the pressure is controlled to be 12-16kN, and the thickness of the control sheets is 1.85-2.15mm.
CN202310294103.2A 2023-03-22 2023-03-22 Breviscapine tablet and preparation method thereof Pending CN116211812A (en)

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