CN106580898B - A kind of erigeron breviscapus dispersion tablet and preparation method - Google Patents
A kind of erigeron breviscapus dispersion tablet and preparation method Download PDFInfo
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- CN106580898B CN106580898B CN201611166390.5A CN201611166390A CN106580898B CN 106580898 B CN106580898 B CN 106580898B CN 201611166390 A CN201611166390 A CN 201611166390A CN 106580898 B CN106580898 B CN 106580898B
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- 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
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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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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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
- A61K9/2009—Inorganic compounds
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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
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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
Abstract
The present invention provides a kind of erigeron breviscapus dispersion tablet, which be formulated by the component of following parts by weight: Breviscapinun 30-50, calcium monohydrogen phosphate 20-60, microcrystalline cellulose 50-100, croscarmellose sodium 4-12, lauryl sodium sulfate 0.5-3, the 30 volume % ethanol water of volume %~50 20-50, sodium bicarbonate 5-12, superfine silica gel powder 0.5-5 and magnesium stearate 0.3-5.In addition, the invention also discloses the preparation methods of the dispersible tablet.Dispersible tablet of the invention has the characteristics that dissolution rate, the uniformity are superior.
Description
Technical field
The invention belongs to Chinese medicine/natural medicine technical fields, relate in particular to a kind of for treating cardiovascular and cerebrovascular disease
Erigeron breviscapus dispersion tablet and preparation method thereof.
Background technique
Cardiovascular disease is that one kind seriously threatens the mankind, the especially common disease of middle-aged and the old's health, have high illness rate,
The characteristics of high disability rate and high mortality, even if the treatment means that application is most advanced, perfect at present, it would still be possible to have 50% or more
Cerebrovascular accident survivor life cannot take care of oneself completely, and the number that cardiovascular and cerebrovascular disease is died of in the whole world every year is up to 15,000,000
It is the first to occupy the various causes of the death by people.
In the 1970s, Chinese herbal medicine movement is gone all out in the whole nation, it is single that Yunnan institute of materia medica expatriate personnel go deep into civil collection
Side, discovery fleabane flower can be used for treating brain hemiparalysis.Fleabane flower is recorded in " the southern regions of the Yunnan Province book on Chinese herbal medicine " book earliest.Yunnan institute of materia medica
Flavone constituents-Breviscapinun is isolated on this basis, mainly contains scutellarin (4 ', 5,6,7- kaempferols-
7-O- glucuronide), a small amount of oil lamp A prime and other flavones ingredients, clinical test prove that the extract of this plant is used for
The diseases such as treatment brain hemiparalysis, coronary heart disease, cerebral thrombosis, cerebral hemorrhage, cerebral embolism, microcirculation disorder have significant curative effect.
Breviscapinun has extensive formulation application, comprising:
1. injection
Kunming pharmaceutical factory has applied for the Chinese patent CN93106319.1 of breviscapine injection for 1993.Injection effect
It is reliable rapidly, it is not influenced by pH, enzyme, food etc., no first pass effect, whole body or local positioning effect can be played, it is unsuitable to be suitable for
Oral drugs and the patient that cannot be taken orally, but injection development and production process are complicated, and safety and organism adaptation are poor, cost
It is higher.
2. tablet
Patent CN200410014387.2 discloses a kind of Breviscapine and preparation method thereof, including chewable tablets and mouth
Lozenge.Though its original intention is the better pharmacological action for playing Breviscapinun, clinical use range is expanded, its emphasis is tablet
More convenient for transporting, carrying.
Patent CN03135878.0 discloses a kind of erigeron breviscapus dispersion tablet and preparation method thereof, solves injection, general
The disadvantages of carrying of logical tablet, transport and adaptability problem.Breviscapinun is flavones ingredient, is practically insoluble in water, ordinary tablet
Agent influences fully absorbing for drug because being disintegrated slowly, and dispersible tablet refers to can be disintegrated rapidly evenly dispersed a kind of in water
Agent, is a kind of quick-effective preparation developed in recent years, and dispersible tablet has general tablet difficult on dissolution rate and dispersing uniformity
With and the advantages of.
Since two thousand, the research in relation to erigeron breviscapus dispersion tablet is increasing, and erigeron breviscapus dispersion tablet has dispersion
The advantages that state is good, and disintegration time is short, and drug-eluting is rapid.Chinese patent literature CN02153445 reports " Breviscapinun point
Discrete piece and preparation method thereof ", CN03135878 disclose " erigeron breviscapus dispersion tablet and preparation method thereof ", the former is Breviscapinun
First prescription of dispersible tablet and preparation patent, the latter give raising on drug content, the lactose in auxiliary material are carried out
Replacement, expands the scope of application of patient.Erigeron breviscapus dispersion tablet technology is very mature.
In addition to above-mentioned dosage form, the dosage forms such as effervescent tablet, dry suspensoid agent, dripping pill are also disclosed in related patents.All
In Breviscapine, tablet and injection account for 90% or more of kind sum.Various preparation techniques are no longer to hinder fleabane flower
The barrier of plain clinical application, but how to improve drug quality and direction is also important for the development of preparation.
Summary of the invention
Present inventor is when studying erigeron breviscapus dispersion tablet, it was surprisingly found that a kind of auxiliary material combination makes
Obtain available longer dispersible tablet stable period.
The purpose of the present invention is to provide a kind of longer erigeron breviscapus dispersion tablets stable period.
The purpose of the present invention is to provide the preparation methods of above-mentioned erigeron breviscapus dispersion tablet.
In one embodiment of the present invention, the present invention provides a kind of erigeron breviscapus dispersion tablet, the dispersible tablet be by
The component of following parts by weight is formulated:
In a preferred embodiment of the invention, the present invention provides a kind of erigeron breviscapus dispersion tablet, the dispersible tablet be by
The component of following parts by weight is formulated:
In more preferred of the invention, the present invention provides a kind of erigeron breviscapus dispersion tablet, which is
It is formulated by the component of following parts by weight:
In a preferred embodiment of the invention, a kind of erigeron breviscapus dispersion tablet provided by the invention, wherein the crystallite
The preferred model of cellulose can be M101；The ethanol water is the ethanol water of 30 volume %.
In particularly preferred embodiment of the invention, the present invention provides a kind of erigeron breviscapus dispersion tablet, the dispersible tablets
It is to be formulated by the component of following parts by weight:
In particularly preferred embodiment of the invention, the present invention provides a kind of erigeron breviscapus dispersion tablet, the dispersible tablets
It is to be formulated by the component of following parts by weight:
In particularly preferred embodiment of the invention, the present invention provides a kind of erigeron breviscapus dispersion tablet, the dispersible tablets
It is to be formulated by the component of following parts by weight:
On the other hand, the present invention provides the preparation method of above-mentioned erigeron breviscapus dispersion tablet, include the following steps:
(1) raw material and auxiliary material are sieved for subsequent use respectively；
(2) Breviscapinun, calcium monohydrogen phosphate, microcrystalline cellulose, croscarmellose sodium and dodecyl sulphate are weighed
Sodium is uniformly mixed；
(3) softwood is made in the mixture that step (2) obtains with the 30 volume % ethanol waters of volume %~50, pelletized,
Dry, sodium bicarbonate, superfine silica gel powder and magnesium stearate is added in whole grain, mixes；
(4) tabletting is packed to obtain the final product.
In a preferred embodiment of the invention, above-mentioned erigeron breviscapus dispersion tablet preparation method provided by the invention, wherein
Step (1) sieving, which refers to, to be sieved with 100 mesh sieve.
In a preferred embodiment of the invention, above-mentioned erigeron breviscapus dispersion tablet preparation method provided by the invention, wherein
Step (3) granulation referred to that 20 meshes were pelletized.
In a preferred embodiment of the invention, above-mentioned erigeron breviscapus dispersion tablet preparation method provided by the invention, wherein
Step (3) described drying refers to 40-70 DEG C of drying 3~5 hours, moisture content≤3.0%.
In a preferred embodiment of the invention, above-mentioned erigeron breviscapus dispersion tablet preparation method provided by the invention, wherein
Whole grain described in step (3) referred to 20 mesh sieves.
In a preferred embodiment of the invention, above-mentioned erigeron breviscapus dispersion tablet preparation method provided by the invention, wherein
Control tablet weight variation is no more than ± 6.0% in step (4), and pressure is controlled in 12-18kN, control sheet thickness 3.35mm-3.65mm.
Compared with prior art, erigeron breviscapus dispersion tablet provided by the invention have it is following the utility model has the advantages that
1. the dissolution rate and dispersing uniformity of erigeron breviscapus dispersion tablet of the invention are more excellent, and dissolution rate than ordinary tablet with
And commercially available dispersible tablet is all good.
2. reducing the probability of tabletting sticking.
3. long-term storage is stablized, either the content of dissolution rate or Breviscapinun can meet medicinal requirement.
Specific embodiment
Embodiment of the present invention is further described below by embodiment, which, which is not constituted, protects model to the present invention
The restriction enclosed.Under the teachings of the present invention, certain technical characteristics are optimized and is improved and still fall within protection model of the invention
In enclosing.
In embodiments of the invention, according to 2015 editions Chinese Pharmacopoeias, to the dissolution rate of dispersible tablet, dispersing uniformity,
Weight differential, microbial limit are tested.
Dispersing uniformity: it is checked according to 2015 editions Chinese Pharmacopoeia disintegration time limited methods (general rule 0921), the sieve of stainless steel cloth
Hole internal diameter is 710 μm, and water temperature is 15~25 DEG C；Test sample 6 are taken, is not all disintegrated and passes through sieve within Ying 3 minutes.
Dissolution test: dissolution rate is measured referring to the first method in pharmacopeia general rule 0931.
Embodiment 1
Erigeron breviscapus dispersion tablet, prescription (are made 1000)
The preparation method comprises the following steps:
1. supplementary material is sieved with 100 mesh sieve respectively, it is spare；
2. weighing Breviscapinun, calcium monohydrogen phosphate, microcrystalline cellulose (M101), croscarmellose sodium, dodecyl
Sodium sulphate is put into Wet mixed granulating machine, is uniformly mixed；
3. softwood, the granulation of 20 meshes is made with the mixture that 30 volume % ethanol waters obtain step 2；
4. wet granular is dry at 40~70 DEG C or less, 20 mesh sieves are crossed；
5. sodium bicarbonate, superfine silica gel powder, the magnesium stearate of recipe quantity are added in dry particl, mix；
6. tabletting, control tablet weight variation is no more than ± 6.0%, and pressure is controlled in 12kN, control sheet thickness 3.45mm.Packaging is
Obtain this product.
Embodiment 2
Erigeron breviscapus dispersion tablet, prescription (are made 1000)
The preparation method comprises the following steps:
1. supplementary material is sieved with 100 mesh sieve respectively, it is spare；
2. weighing Breviscapinun, calcium monohydrogen phosphate, microcrystalline cellulose (M101), croscarmellose sodium, dodecyl
Sodium sulphate is put into Wet mixed granulating machine, is uniformly mixed；
3. softwood, the granulation of 20 meshes is made with the mixture that 30 volume % ethanol waters obtain step 2；
4. wet granular is dry at 40~70 DEG C or less, 20 mesh sieves are crossed；
5. sodium bicarbonate, superfine silica gel powder, the magnesium stearate of recipe quantity are added in dry particl, mix；
6. tabletting, control tablet weight variation is no more than ± 6.0%, and pressure is controlled in 12kN, control sheet thickness 3.45mm.Packaging is
Obtain this product.
Embodiment 3
Erigeron breviscapus dispersion tablet, prescription (are made 1000)
The preparation method comprises the following steps:
1. supplementary material is sieved with 100 mesh sieve respectively, it is spare；
2. weighing Breviscapinun, calcium monohydrogen phosphate, microcrystalline cellulose (M101), croscarmellose sodium, dodecyl
Sodium sulphate is put into Wet mixed granulating machine, is uniformly mixed；
3. softwood, the granulation of 20 meshes is made with the mixture that 30 volume % ethanol waters obtain step 2；
4. wet granular is dry at 40~70 DEG C or less, 20 mesh sieves are crossed；
5. sodium bicarbonate, superfine silica gel powder, the magnesium stearate of recipe quantity are added in dry particl, mix；
6. tabletting, control tablet weight variation is no more than ± 6.0%, and pressure is controlled in 12kN, control sheet thickness 3.35mm.Packaging is
Obtain this product.
Comparative example 1
Erigeron breviscapus dispersion tablet, prescription (are made 1000)
The preparation method comprises the following steps:
1. supplementary material is sieved with 100 mesh sieve respectively, it is spare；
2. it is wet to weigh Breviscapinun, lactose, microcrystalline cellulose (M101), carboxyrnethyl starch sodium, lauryl sodium sulfate investment
In method hybrid particles machine, it is uniformly mixed；
3. softwood, the granulation of 20 meshes is made with the mixture that 30 volume % ethanol waters obtain step 2；
4. wet granular is dry at 40~70 DEG C or less, 20 mesh sieves are crossed；
5. superfine silica gel powder, the magnesium stearate of recipe quantity are added in dry particl, mix；
6. tabletting, control tablet weight variation is no more than ± 6.0%, and pressure is controlled in 12kN, control sheet thickness 3.55mm.Packaging is
Obtain this product.
Comparative example 2
Erigeron breviscapus dispersion tablet, prescription (are made 1000)
The preparation method comprises the following steps:
1. supplementary material is sieved with 100 mesh sieve respectively, it is spare；
2. weighing Breviscapinun, calcium monohydrogen phosphate, microcrystalline cellulose (M101), carboxyrnethyl starch sodium, lauryl sodium sulfate to throw
Enter in Wet mixed granulating machine, is uniformly mixed；
3. softwood, the granulation of 20 meshes is made with the mixture that 30 volume % ethanol waters obtain step 2；
4. wet granular is dry at 40~70 DEG C or less, 20 mesh sieves are crossed；
5. superfine silica gel powder, the magnesium stearate of recipe quantity are added in dry particl, mix；
6. tabletting, control tablet weight variation is no more than ± 6.0%, and pressure is controlled in 13kN, control sheet thickness 3.40mm.Packaging is
Obtain this product.
Comparative example 3
Erigeron breviscapus dispersion tablet, prescription (are made 1000)
The preparation method comprises the following steps:
1. supplementary material is sieved with 100 mesh sieve respectively, it is spare；
2. weighing Breviscapinun, starch, microcrystalline cellulose (M101), crosslinked polyethylene pyrrole network alkanone, dodecyl sulphate
Sodium is put into Wet mixed granulating machine, is uniformly mixed；
3. softwood, the granulation of 20 meshes is made with the mixture that 30 volume % ethanol waters obtain step 2；
4. wet granular is dry at 40~70 DEG C or less, 20 mesh sieves are crossed；
5. superfine silica gel powder, the magnesium stearate of recipe quantity are added in dry particl, mix；
6. tabletting, control tablet weight variation is no more than ± 6.0%, and pressure is controlled in 12kN, control sheet thickness 3.41mm.Packaging is
Obtain this product.
Test example 1
The comparison of the technical parameter of 1 embodiment of table and comparative example
The good fluidity of particle, hardness are moderate in embodiment 1-3 as the result is shown, and the dispersing uniformity of tablet meets medicine
The prescribed requirement of allusion quotation.
Compare dispersible tablet, the erigeron breviscapus dispersion tablet (embodiment 2 in patent CN03135878 of the preparation of the embodiment of the present invention 2
Method be made), ordinary tablet (according to " pharmacopeia " at square standard prepare) dissolution rate, be shown in Table 2:
The dissolution of the erigeron breviscapus dispersion tablet and ordinary tablet of 2 embodiment of the present invention 2 of table, patent CN03135878 embodiment 2
Degree compares
The above results show: the dispersion tablet dissolution of the embodiment of the present invention 2 is better than ordinary tablet, while a little higher than patent
The dissolution rate of 2 dispersible tablet of CN03135878 embodiment.
Test example 2
The embodiment of the present invention 2 is compared with the prescription after rejecting calcium monohydrogen phosphate, sodium bicarbonate, and accelerated test (accelerates examination
40 DEG C ± 2 DEG C of condition are tested, RH75% ± 5%) it the results are shown in Table 3:
The influence of 3 calcium monohydrogen phosphate of table and sodium bicarbonate to erigeron breviscapus dispersion tablet dissolution rate and content
As the result is shown: the dissolution rate and dispersing uniformity of the prescription of phosphoric acid hydrogen calcium and sodium bicarbonate are superior to not phosphoric acid
The prescription of hydrogen calcium and sodium bicarbonate, illustrate the addition of calcium monohydrogen phosphate and sodium bicarbonate improve erigeron breviscapus dispersion tablet dissolution rate and
Dispersing uniformity.
Test example 3
One embodiment 2 in the embodiment of the present invention 1 and patent CN03135878 has the advantage that as a comparison
1. reducing the adherency on wet granulator, the cleaning amount of labour is reduced；
2. using calcium monohydrogen phosphate to reduce pregelatinized starch as filler largely takes the risk done harm to huamn body；
3. reducing the probability that sticking occurs in tableting processes.
Test example 4
In order to detect stability of the invention for a long time, as a comparison with one embodiment 2 in CN03135878, carry out
Keep sample test for a long time, the results are shown in Table 4:
Remarks: 70% dissolution rate limit regulation: must not be lower than
Dispersing uniformity: disintegration passes through sieve in 3 minutes
Assay: every must not be less than 32.4mg
As the result is shown: in stability test, dissolution rate of the invention still conformed to requirement at 36 months, other inventions are molten
Out-degree is undesirable at 36 months；Dispersing uniformity of the invention is superior to other inventions；With the content of other inventions
The content of comparison, the embodiment of the present invention 1 and embodiment 3 has the difference (p < 0.01) of extremely significant property, and embodiment 2 has aobvious
It writes sex differernce (p < 0.05).The stability of erigeron breviscapus dispersion tablet is at 36 months 24 months or more hereinafter, and stabilization of the invention
Property data can prop up 36 months stability, be better than General Decentralized tablet stability.
Claims (6)
1. a kind of erigeron breviscapus dispersion tablet, which be formulated by the component of following parts by weight:
2. a kind of erigeron breviscapus dispersion tablet, which be formulated by the component of following parts by weight:
3. a kind of erigeron breviscapus dispersion tablet, which be formulated by the component of following parts by weight:
4. the preparation method of dispersible tablet as claimed in any one of claims 1-3, includes the following steps:
(1) raw material and auxiliary material are sieved for subsequent use respectively；
(2) it is mixed that Breviscapinun, calcium monohydrogen phosphate, microcrystalline cellulose, croscarmellose sodium and lauryl sodium sulfate are weighed
It closes uniform；
(3) softwood is made in the mixture that step (2) obtains with ethanol water, pelletized, dry, whole grain, addition sodium bicarbonate,
Superfine silica gel powder and magnesium stearate mix；
(4) tabletting is packed to obtain the final product.
5. preparation method as claimed in claim 4, wherein step (1) sieving, which refers to, to be sieved with 100 mesh sieve.
6. preparation method as claimed in claim 4, wherein step (3) granulation referred to that 20 meshes were pelletized.
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| CN107213132B (en) * | 2017-05-26 | 2021-02-02 | 合肥华方医药科技有限公司 | Breviscapine osmotic pump controlled release tablet and preparation method thereof |
| CN112618504B (en) * | 2020-11-19 | 2022-08-16 | 云南生物谷药业股份有限公司 | Medicinal composition containing erigeron breviscapus extract and borneol and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1416817A (en) * | 2002-11-29 | 2003-05-14 | 北京天衡药物研究院 | Breviscapine dispersing tablet and its prepn |
| CN1807440A (en) * | 2006-01-26 | 2006-07-26 | 周卓和 | Sodium menadiol diphosphate ester and its pharmaceutical formulation |
| CN103494786A (en) * | 2013-10-18 | 2014-01-08 | 山东省医药工业研究所 | Medicinal composition containing moxifloxacin hydrochloride |
-
2016
- 2016-12-15 CN CN201611166390.5A patent/CN106580898B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1416817A (en) * | 2002-11-29 | 2003-05-14 | 北京天衡药物研究院 | Breviscapine dispersing tablet and its prepn |
| CN1807440A (en) * | 2006-01-26 | 2006-07-26 | 周卓和 | Sodium menadiol diphosphate ester and its pharmaceutical formulation |
| CN103494786A (en) * | 2013-10-18 | 2014-01-08 | 山东省医药工业研究所 | Medicinal composition containing moxifloxacin hydrochloride |
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