CN101756920A - Dispersible tablet taking arctiin as active component - Google Patents
Dispersible tablet taking arctiin as active component Download PDFInfo
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- CN101756920A CN101756920A CN200810243539A CN200810243539A CN101756920A CN 101756920 A CN101756920 A CN 101756920A CN 200810243539 A CN200810243539 A CN 200810243539A CN 200810243539 A CN200810243539 A CN 200810243539A CN 101756920 A CN101756920 A CN 101756920A
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- arctiin
- dispersible tablet
- crospolyvinylpyrrolidone
- lactose
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Abstract
The invention provides a dispersible tablet taking arctiin as an active component and a preparation method thereof. A prescription of every 1000 dispersible tablets comprises the following components: 50-200 grams of the arctiin, 10-60 grams of croscarmellose sodium, 5-20 grams of crospolyvinylpyrrolidone, 40-200 grams of lactose, 40-200 grams of microcrystalline celluloses, 1-10 grams of superfine silica gel powder and a proper amount of polyvidone K30. The invention also discloses the preparation method of the dispersible tablet. The invention has simple and easily operated process; and in addition, the prepared dispersible tablet has stable quality, is convenient to take and can be used for antiviral therapy.
Description
Technical field
The invention belongs to technical field of medicine, be specifically related to Arctiin dispersible tablet and preparation method thereof.
Background technology
According to " record of Chinese pharmacopoeia version in 2005, Fructus Arctii (Fructus Arctii) is the dry mature fruit of feverfew Fructus Arctii (Arctium lappa L.), nature and flavor suffering, hardship, cold; Effect is a dispelling wind and heat pathogens, lung qi dispersing rash, resolving toxin and disinhibiting the throat; Be usually used in treating anemopyretic cold, cough with copious phlegm, measles, rubella, laryngopharynx swelling and pain, mumps erysipelas, carbuncle sore tumefacting virus.Fructus Arctii contains the number of chemical composition, mainly contains fatty oil, lignanoid, sugar, protein, volatile oil, vitamin, alkaloid etc.Arctiin (Arctiin) is the main active of Fructus Arctii, and its content is more than 5%, its molecular formula: C
27H
34O
11, molecular weight: 534.6, chemical structural formula is as follows:
Modern pharmacological research finds that Arctiin is the infection effective ingredient.Experiment in vitro is the result show, Arctiin can directly suppress or inactivating influenza virus, produces stronger anti-influenza A virus effect, and various bacteria and fungus are had stronger inhibition or killing action; Arctiin has relexation to isolated rat trachea, colon, pulmonary artery, thoracic aorta and guinea pig trachea; These pharmacological actions have disclosed Fructus Arctii and have been used to separate the pharmacodynamics basis that the harmony in the exterior antiviral therapy is used.
That uses in the Chinese patent medicine at present is the Fructus Arctii medicinal substances extract, and adopts the clear and definite middle pharmaceutically active ingredient of drug effect to be prepared into medicine, can reduce dosage, improves the drug quality controllability, prolong product storage period, keeps efficacy stability.Chinese invention patent application " application of Arctiin in preparation treatment rhinitis and sinusitis medicine " (CN200510019353.7) disclose a kind of treat rhinitis and sinusitis contain the Arctiin oral formulations, comprise capsule, pill, granule, tablet and water preparation.Dispersible tablet is as a kind of new oral formulation, can wash by water and take or buccal or swallow, the patient's bath that had both helped gulping down the sheet difficulty is taken, also help under anhydrous condition, taking medicine, the patient who is suitable for old man, child or dysphagia takes medicine, patient takes medicine under the multiple situation such as also conveniently travel outdoors, and administering mode is flexible.The big advantage of another of dispersible tablet be disintegrate fast, be easy to absorb: generally disintegrate fully in 3 minutes in warm water of dispersible tablet, form homodisperse suspension, so it is fast and abundant that, active component rapid than ordinary tablet or capsule stripping absorbs, and can improve bioavailability of medicament.In addition, dispersible tablet has kept that the conventional tablet production technology is simple, better stability of preparation, medicine is portable and advantages such as transportation, convenient storage.Our research design be the dispersible tablet of active component with the Arctiin, can be advantageously used in clinical treatment.
Summary of the invention
The purpose of this invention is to provide a kind of is the dispersible tablet and preparation method thereof of active component with the Arctiin.The Arctiin dispersible tablet of the present invention's design has the convenience of taking medicine, simple, the stay-in-grade advantage of technology.
The active component of dispersible tablet of the present invention is an Arctiin.
Arctiin dispersible tablet of the present invention contains the Arctiin of dose therapeutically effective and is fit to the pharmaceutic adjuvant of preparation dispersible tablet.
Every of Arctiin dispersible tablet of the present invention contains Arctiin 50～150mg, and the pharmaceutic adjuvant of described suitable preparation dispersible tablet comprises efficient disintegrating agent, filler, fluidizer and binding agent.
The used pharmaceutic adjuvant of Arctiin dispersible tablet of the present invention is selected from, efficient disintegrating agent: cross-linking sodium carboxymethyl cellulose (CCNa) and crospolyvinylpyrrolidone (PVPP), filler: lactose and microcrystalline Cellulose, binding agent: 30 POVIDONE K 30 BP/USP 30, fluidizer: micropowder silica gel.
The prescription of Arctiin dispersible tablet of the present invention is composed as follows:
Arctiin 50～150g
Cross-linking sodium carboxymethyl cellulose 10～60g
Crospolyvinylpyrrolidone 5～20g
Lactose 40～200g
Microcrystalline Cellulose 40～200g
30 POVIDONE K 30 BP/USP 30 solution are an amount of
Micropowder silica gel 1～10g
Make 1000
The prescription composition of Arctiin dispersible tablet of the present invention is preferably as follows:
Arctiin 100g
Cross-linking sodium carboxymethyl cellulose 30g
Crospolyvinylpyrrolidone 10g
Lactose 150g
Microcrystalline Cellulose 150g
30 POVIDONE K 30 BP/USP 30 solution are an amount of
Micropowder silica gel 5g
Make 1000
The preparation method of Arctiin dispersible tablet of the present invention may further comprise the steps:
(1) Arctiin sieving for standby.
(2) cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, lactose and microcrystalline Cellulose sieve respectively, and be standby.
(3) get Arctiin and cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, lactose and the microcrystalline Cellulose mix homogeneously of above-mentioned recipe quantity.
(4) it is an amount of to get 30 POVIDONE K 30 BP/USP 30 solution, adds mixed pelletization in (3) batch mixing, drying, granulate.
(5) micropowder silica gel is added granule, mix homogeneously, tabletting.
The specific embodiment
Be that the dispersible tablet of active component is described further with the Arctiin to the present invention by the following examples, but the present invention is not limited to the content of the following example:
Embodiment 1
Prescription: composition consumption
Arctiin 100g
Cross-linking sodium carboxymethyl cellulose 20g
Crospolyvinylpyrrolidone 5g
Lactose 60g
Microcrystalline Cellulose 200g
5% 30 POVIDONE K 30 BP/USP, 30 alcoholic solutions are an amount of
Micropowder silica gel 2g
Make 1000
Preparation method:
(1) get Arctiin and cross 120 sieves, standby.
(2) get cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, lactose and microcrystalline Cellulose and cross 100 mesh sieves respectively, standby.
(3) Arctiin and cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, lactose and the microcrystalline Cellulose that takes by weighing recipe quantity fully stirs mix homogeneously.
(4) alcoholic solution of preparation 5% 30 POVIDONE K 30 BP/USP 30 is got mixing in an amount of adding (3) batch mixing, crosses 30 mesh sieves and granulates, and 50～60 ℃ of dryings are through 20 mesh sieve granulate.
(5) micropowder silica gel is added above-mentioned dried particles, mix homogeneously, tabletting.
Embodiment 2
Prescription: composition consumption
Arctiin 150g
Cross-linking sodium carboxymethyl cellulose 20g
Crospolyvinylpyrrolidone 10g
Lactose 100g
Microcrystalline Cellulose 160g
5% 30 POVIDONE K 30 BP/USP, 30 alcoholic solutions are an amount of
Micropowder silica gel 4g
Make 1000
Preparation method:
(1) get Arctiin and cross 120 mesh sieves, standby.
(2) cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, lactose and microcrystalline Cellulose are crossed 100 mesh sieves respectively, and be standby.
(3) Arctiin and cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, lactose and the microcrystalline Cellulose that takes by weighing recipe quantity fully stirs mix homogeneously.
(4) alcoholic solution of preparation 5% 30 POVIDONE K 30 BP/USP 30 is got mixing in an amount of adding (3) batch mixing, crosses 30 mesh sieves and granulates, and 50～60 ℃ of dryings are through 20 mesh sieve granulate.
(5) micropowder silica gel is added above-mentioned dried particles, mix homogeneously, tabletting.
Embodiment 3
Prescription: composition consumption
Arctiin 100g
Cross-linking sodium carboxymethyl cellulose 30g
Crospolyvinylpyrrolidone 10g
Lactose 150g
Microcrystalline Cellulose 150g
5% 30 POVIDONE K 30 BP/USP, 30 alcoholic solutions are an amount of
Micropowder silica gel 5g
Make 1000
Preparation method:
(1) get Arctiin and cross 120 mesh sieves, standby.
(2) get cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, lactose and microcrystalline Cellulose and cross 100 mesh sieves respectively, standby.
(3) Arctiin and cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, lactose and the microcrystalline Cellulose that takes by weighing recipe quantity fully stirs mix homogeneously.
(4) alcoholic solution of preparation 5% 30 POVIDONE K 30 BP/USP 30 is got mixing in an amount of adding (3) batch mixing, crosses 30 mesh sieves and granulates, and 50～60 ℃ of dryings are through 20 mesh sieve granulate.
(5) micropowder silica gel is added above-mentioned dried particles, mix homogeneously, tabletting.
Embodiment 4
Observe the preparation situation of embodiment 1,2,3 samples, the compressibility of more particulate flowability, slice, thin piece and hardness the results are shown in Table 1.
The preparation situation of table 1 embodiment 1,2,3 samples
As can be seen from the above results, embodiment 2 and 3 preparation situation are better, and embodiment 3 is even more ideal.
Embodiment 5
Stipulate the dispersing uniformity of the Arctiin dispersible tablet sample that mensuration embodiment 1,2,3 makes, the performance of further relatively writing out a prescription down according to two appendix I of Chinese Pharmacopoeia version in 2005 A item.Take a sample 2 respectively for every batch, put jolting in 20 ℃ ± 1 ℃ water of 100ml, all disintegrates and in 3 minutes by No. 2 sieves.The finely dispersed time of three batch samples sees Table 2.The dispersing uniformity of acetonideexample 1～3 sample is all qualified, but embodiment 3 is better.
The jitter time of table 2 embodiment 1,2,3 samples
Embodiment 6
According to above result of study, the present invention is that the prescription of the dispersible tablet of active component is write out a prescription optimum with embodiment 3 with the Arctiin.Select the sample of embodiment 3 to carry out preparation influence factor test.
Placed 10 days placing respectively under 4500Lx ± 500Lx illumination, 60 ℃ ± 2 ℃ high temperature and 25 ℃ of relative humidity 92.5% ± 5% conditions, in the sampling in the 0th, 5,10 day of placing, indexs such as the character of test sample, hydroscopicity, dispersing uniformity, related substance and content the results are shown in Table 3.
Table 3 preparation influence factor result of the test
Result of the test shows: this product is investigated 5 days and 10 days under 4500Lx ± 500Lx strong illumination and 60 ℃ of hot conditionss, every detection index and relatively do not have significant change in 0 day.This product was placed under super-humid conditions 5 days and 10 days, and because of the hydroscopicity height causes the soft distortion of tablet appearance, jitter time also changes.Research prompting Arctiin dispersible tablet of the present invention is better to high temperature and high light stability, but packing should guard against damp.
Claims (8)
1. active component is the dispersible tablet of Arctiin.
2. the Arctiin dispersible tablet of claim 1 is characterized in that containing the Arctiin of dose therapeutically effective and the pharmaceutic adjuvant of suitable preparation dispersible tablet.
3. claim 1 or 2 Arctiin dispersible tablet is characterized in that every contains Arctiin 50～200mg.
4. the Arctiin dispersible tablet of claim 1～3 is characterized in that pharmaceutic adjuvant comprises efficient disintegrating agent, filler, fluidizer and binding agent.
5. the Arctiin dispersible tablet of claim 4 is characterized in that pharmaceutic adjuvant is selected from, efficient disintegrating agent: cross-linking sodium carboxymethyl cellulose and crospolyvinylpyrrolidone, filler: lactose and microcrystalline Cellulose, binding agent: 30 POVIDONE K 30 BP/USP 30, fluidizer: micropowder silica gel.
6. the Arctiin dispersible tablet of claim 4, it is composed as follows to it is characterized in that writing out a prescription:
Arctiin 50～200g
Cross-linking sodium carboxymethyl cellulose 10～60g
Crospolyvinylpyrrolidone 5～20g
Lactose 40～200g
Microcrystalline Cellulose 40～200g
30 POVIDONE K 30 BP/USP 30 solution are an amount of
Micropowder silica gel 1～10g
Make 1000.
7. the Arctiin dispersible tablet of claim 4, it is composed as follows to it is characterized in that writing out a prescription:
Arctiin 100g
Cross-linking sodium carboxymethyl cellulose 30g
Crospolyvinylpyrrolidone 10g
Lactose 150g
Microcrystalline Cellulose 150g
30 POVIDONE K 30 BP/USP 30 solution are an amount of
Micropowder silica gel 5g
Make 1000.
8. the Arctiin dispersible tablet of claim 4 is characterized in that preparation method may further comprise the steps:
(1) Arctiin, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, lactose and microcrystalline Cellulose difference sieving for standby,
(2) with Arctiin, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, lactose and the microcrystalline Cellulose mix homogeneously of recipe quantity,
(3) it is an amount of to get 30 POVIDONE K 30 BP/USP 30 solution, adds mixed pelletization in the above-mentioned batch mixing, drying, and granulate,
(4) micropowder silica gel is added granule mix homogeneously, tabletting.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810243539A CN101756920A (en) | 2008-12-23 | 2008-12-23 | Dispersible tablet taking arctiin as active component |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810243539A CN101756920A (en) | 2008-12-23 | 2008-12-23 | Dispersible tablet taking arctiin as active component |
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| Publication Number | Publication Date |
|---|---|
| CN101756920A true CN101756920A (en) | 2010-06-30 |
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| CN200810243539A Pending CN101756920A (en) | 2008-12-23 | 2008-12-23 | Dispersible tablet taking arctiin as active component |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108902976A (en) * | 2018-08-14 | 2018-11-30 | 江苏真蒡生物科技有限公司 | A kind of preparation method of arctiin effervescent tablet |
-
2008
- 2008-12-23 CN CN200810243539A patent/CN101756920A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108902976A (en) * | 2018-08-14 | 2018-11-30 | 江苏真蒡生物科技有限公司 | A kind of preparation method of arctiin effervescent tablet |
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Open date: 20100630 |