CN103933002A - Scutellaria baicalensis total flavonoid sustained release tablet and preparation method thereof - Google Patents
Scutellaria baicalensis total flavonoid sustained release tablet and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a scutellaria baicalensis total flavonoid sustained release tablet and a preparation method thereof, belonging to the field of Chinese medicine preparations. The scutellaria baicalensis total flavonoid sustained release tablet consists of the following components in percentage by weight: 20-50% of a scutellaria baicalensis total flavonoid extract, 20-40% of a sustained release framework material and 10-50% of pharmaceutical adjuvants, wherein the scutellaria baicalensis total flavonoid extract is determined through an ultraviolet spectrophotometry and contains not less than 60% of total flavonoid in terms of baicalin; a high performance liquid chromatography (HPLC) determines that content of a baicalin monomer is not less than 40%. In addition, the invention also discloses a method for preparing the scutellaria baicalensis total flavonoid sustained release tablet. The method mainly comprises the processes of extracting and separating the scutellaria baicalensis total flavonoid extract and preparing the sustained release tablet. Compared to a current commercial scutellaria baicalensis tablet, the scutellaria baicalensis total flavonoid sustained release tablet disclosed by the invention can significantly reduce a drug release speed, prolong release time and keep a stable blood concentration; moreover, the sustained release tablet can reduce administration time, reduce side effect and improve a medication compliance of patients.
Description
Technical field
The invention belongs to Chinese medicine preparation technical field, be specifically related to a kind of Radix Scutellariae total flavones slow releasing tablet and preparation method thereof.
Background technology
Radix Scutellariae is the dry root of labiate Radix Scutellariae Scutellaria baicalensis Georgi, and bitter in the mouth is cold in nature, has heat clearing and damp drying, eliminating fire and detoxication, hemostasis, antiabortive effect.For hygropyrexia, heat-damp in summer, vomiting and nausea uncomfortable in chest, damp and hot feeling of fullness, dysentery, jaundice, cough due to lung-heat, high hot excessive thirst, heat in blood is told nosebleed, carbuncle sore tumefacting virus, frequent fetal movement.
Radix Scutellariae chemical composition is mainly the flavone compound taking baicalin (baicalin) as representative, as baicalin, wogonoside, baicalin, wogonin, Norwogonin, oroxylin A, oroxylin A glycosides and luteolin etc.In addition, Radix Scutellariae also contains phenethanol glucosides class, lignanoid's glucosides class, terpenoid, glucose, aminoacid, volatile oil and trace element etc.As the main pharmacodynamics component in Radix Scutellariae, that skullcapflavone compound has is antibacterial, antiviral, antiinflammatory, antioxidation, removing free radical, blood pressure lowering, protect the liver, the effect such as antipyretic, analgesia, protection cardiovascular and cerebrovascular vessel and neuron.The discovery Radix Scutellariae total flavoness such as Zeng Chaozhen have good fungistatic effect (Zeng Chaozhen to gold-coloured staphylococci, bacillus subtilis, escherichia coli, aspergillus niger and penicillium sp, Liu Zhixiang, Han Lei. the research of Radix Scutellariae total flavones extractive technique and bacteriostatic activity thereof. time precious traditional Chinese medical science traditional Chinese medicines, 2009,20 (6): 1342-1343), Nagai etc. have reported that skullcapflavone composition can reduce virus replication (the Nagai T of influenza infection mice by suppressing the fusion of viral inclusion body/lysosome membrane, Moriguchi R, Suzuki Y, Tomimori T, Yamada H.Mode of action of the anti-influenza virus activity of plant flavonoid, 5, 7, 4-trihydroxy-8-methoxyflavone, from the roots of Scutellaria baicalensis.Antiviral Research, 1995, 26 (1): 11-25), baicalin performance also goes out activity (the Chen F of certain SARS coronary virus resistant, Chan KH, Jiang Y, Kao RYT, Lu HT, Fan KW, Cheng VCC, Tsui WHW, Hung IFN, Lee TSW, Guan Y, Peiris JSM, Yuen KY.In vitro susceptibility of10clinical isolates of SARS coronavirus to selected antiviral compounds.Journal of Clinical Virology, 2004, 31 (1): 69-75), Kim etc. find that skullcapflavone is by suppressing iNOS, COX-2, PGE2, IL-1 β, IL-2, IL-6, the expression of IL-12 and TNF-α and there is powerful antiinflammatory action (Kim EH, Shim B, Kang S, Jeong G, Lee J, Yu YB, Chun M.Anti-inflammatory effects of Scutellaria baicalensis extract via suppression of immune modulators and MAP kinase signaling molecules.Journal of Ethnopharmacology, 2009,126 (2): 320-331), Kuang Zao garden etc. reported baicalin can suppress the effect of Chlamydia pneumoniae and Cell protection (Huang Yanshou, etc. the research of the anti-Chlamydia pneumoniae of baicalin for Kuang Zao garden, Wu Wei. Chinese microecology magazine, 2005,17 (2): 87-88), the effect that the discovery skullcapflavones such as Gao have all shown good antioxidation and removed free radical in multiple antioxidant system, this effect presents dose-dependence (Gao ZH, Huang KX, Yang XL, Xu HB.Free radical scavenging and antioxidant activities of flavonoids extracted from the radix of Scutellaria baicalensis Georgi.Biochimica et Biophysica Acta (BBA)-General Subjects, 1999,1472 (3): 643-650).In addition, Chinese patent CN101711796A discloses the purposes of skullcapflavone at the anti-enterovirus infection medicine of preparation treatment; Chinese patent CN101797246A discloses the application of radix scutellariae and flavonoid against sub-type infection of influenza virus A (H 1 N 1), and baicalin, baicalin and Radix Scutellariae total flavones extract are being prepared the novel H1N1 of resisiting influenza virus A type, H1N1 and the medicine of H3N2 hypotype and the application of hygienic article.
About the extraction of skullcapflavone class chemical composition separates, domestic existing detailed patent and bibliographical information.Chinese patent CN101961384A discloses a kind of extracting method of baical skullcap root flavonoids fractions, after adopting 60%-70% alcoholic solution to preheat, after feeding intake, takes supersound extraction according to certain rate of charge; Chinese patent CN101461844 discloses a kind of multiplefrequency combined ultrasound method for leaching scutellaria flavone, within the scope of 10～150kHz, selects the ul-trasonic irradiation of two or three different frequencies in the mixture of Radix Scutellariae and alcoholic solution; Chinese patent CN1241447 discloses a kind of aqueous two-phase and has distributed the method for extracting skullcapflavone class material in conjunction with the back extraction of organic solvent alternating temperature, adopt containing oxirane-expoxy propane random copolymer (EOPO) and alcoholic solution leaching skullcapflavone class, again with EOPO/ ammonium sulfate aqueous two-phase system, by regulating phase formation agent composition to make Flavonoid substances mainly be distributed in the upper phase containing EOPO, then concentrated and purification, recycling alternating temperature reverse extraction technology separates and purifies; Wang Chunmin etc. have reported the research of purification with macroreticular resin Radix Scutellariae total flavones technique, and set up the Determination Method of Flavone Content (Wang Chunmin adopting with baicalin reference substance, Liu Gang, Fei Yan, Deng. the research [J] of Flavonoids by Macroporous Adsorption Resin purification Radix Scutellariae total flavones technique. Chinese herbal medicine, 2010,41 (1): 58-60; Liu Ying, Wei Yuanfeng, Jiang Wei, etc. the preliminary study [J] of macroporous resin to skullcapflavone absorption. Hubei College Of Traditional Chinese Medicine's journal, 2005,7 (2): 28-29); Liang Ying conducts in-depth research skullcapflavone lixiviate kinetics and extracting technology, determined optimum extraction technological parameter (Liang Ying. skullcapflavone lixiviate kinetics and extracting technology research [D]. Beijing: China Agricultural University, 2005).
Visible, and flavonoids in Radix Scutellariae shows pharmacological activity widely, possesses potential new drug development prospect.Although extract the research report of purification aspect about skullcapflavone class chemical composition a lot, about its preparation, particularly the research of slow releasing preparation is very few.Commercially available scutellaria tablet or Fufang Huangqin Tablets by HPLC need to be taken 3～4 times every day at present, and the inconvenience that causes to a certain extent patient to take, meanwhile, has certain stimulation with Fufang Huangqin Tablets by HPLC after scutellaria tablet to gastric mucosa, affects patient's compliance.Therefore, be necessary to invent a kind of novel form of Radix Scutellariae total flavones, to facilitate patient's medication, improve and improve its compliance.Slow releasing preparation is after administration, and medicine can be in the given time discharges with zero level or the speed that approaches zero level, to maintain effective blood drug level, thereby plays long-acting; And Radix Scutellariae total flavones as extracting the active component obtaining from radix scutellariae medicinal materials, its main component baicalin is eliminated soon in vivo, and the holdup time is short, the suitable slow releasing preparation that is developed to.
Summary of the invention
The object of this invention is to provide a kind of Radix Scutellariae total flavones slow releasing tablet and preparation method thereof, described Radix Scutellariae total flavones slow releasing tablet is to be different from the release Mechanisms of conventional tablet, can reduce drug release rate, extend release time, the blood drug level of held stationary, can reduce the number of times of taking medicine, reduce side effects of pharmaceutical drugs, improve the compliance of patient's medication.
The present invention relates to a kind of Radix Scutellariae total flavones slow releasing tablet and preparation method thereof, composed of the following components:
A, Radix Scutellariae total flavones extract 20～50% (weight)
B, sustained-release matrix material 20～40% (weight)
C, pharmaceutic adjuvant 10～60% (weight)
Preferably, by weight percentage, Radix Scutellariae total flavones extract accounts for 30～40%, and sustained-release matrix material accounts for 20～30%, and pharmaceutic adjuvant accounts for 30～45%.
Total flavones in Radix Scutellariae total flavones extract of the present invention is measured and is no less than 60% (weight) with its content of baicalin in UV-VIS spectrophotometry, measures its baicalin content of monomer be no less than 40% (weight) through HPLC.Radix Scutellariae total flavones extract assay step is: get need testing solution, suitably, after dilution, measure absorbance at 278nm wavelength place, in baicalin, calculate the content of total flavones.
Described sustained-release matrix material is one or more in hydroxypropyl methylcellulose K1500, hydroxypropyl methylcellulose K750, ethyl cellulose or sodium carboxymethyl cellulose.Preferably, sustained-release matrix material is hydroxypropyl methylcellulose K750.
Wherein, described pharmaceutic adjuvant is filler, lubricant, surfactant or binding agent.
Preferably, filler is one or more of microcrystalline Cellulose, lactose or starch; Lubricant is one or more in Pulvis Talci, magnesium stearate or calcium stearate; Surfactant is the one in sodium lauryl sulphate or tween 80; Binding agent is the one in 70% alcoholic solution or polyvinylpyrrolidone.
Another object of the present invention is to provide described Radix Scutellariae total flavones slow releasing tablet preparation method.
A kind of Radix Scutellariae total flavones slow releasing tablet of the present invention preparation method, comprises the following steps:
1) extraction and purification process: get radix scutellariae medicinal materials, section, measures water boiling and extraction 2 times, each 1.5 hours with 10 times, merge extractive liquid,, with absorption with macroporous adsorbent resin, first use 4 times of water gaging eccysis decontaminations, then with 8 times amount 50～80% alcoholic solution eluting, collect alcohol eluen, concentrated, dry, obtain Radix Scutellariae total flavones extract.
2) preparation process: get Radix Scutellariae total flavones extract, sustained-release matrix material, filler and surfactant, mix, add binding agent and make soft material, cross 20 mesh sieves and granulate, dry, cross 18 mesh sieve granulate, add lubricant, mix, compacting in flakes, obtains Radix Scutellariae total flavones slow releasing tablet.
Preferably, step 1) medical material is through the processing of steam enzyme denaturing for described extraction, and the alcoholic solution concentration that eluting is used is for being 70%.
Preferably, step 1) described macroreticular resin is AB-8, D130 or ADS-17, optimum is AB-8.
The test of cumulative in vitro release rate shows, the preparation of Radix Scutellariae total flavones slow releasing tablet of the present invention in 2 hours is 10～30%, preparation in 4 hours is 40～60%, preparation in 10 hours is greater than 75%, reach the effect of slow release, compare with ordinary tablet, drug release process is slow and lasting.
Compared with prior art, Radix Scutellariae total flavones slow releasing tablet of the present invention has following significant progress:
After Radix Scutellariae total flavones slow releasing tablet of the present invention is taken, sustained release, can reduce the undulatory property of blood drug level, avoids peak valley phenomenon, and the blood drug level of held stationary reduces side effects of pharmaceutical drugs, reduces the number of times of taking medicine, and improves the compliance of patient's medication.In recent years, Sustained Release Preparations of Chinese Medicinal has become a focus of Chinese medicine preparation research, is representing the developing direction of following Chinese medicine preparation technology.
Brief description of the drawings
The preparation curve chart of Fig. 1 Radix Scutellariae total flavones slow releasing tablet and ordinary tablet.
Detailed description of the invention
The preparation of embodiment 1 Radix Scutellariae total flavones slow releasing tablet
1) Radix Scutellariae total flavones extraction and purification process:
Get radix scutellariae medicinal materials, section, measures water boiling and extraction 2 times, each 1.5 hours with 10 times, merge extractive liquid,, with absorption with macroporous adsorbent resin, first uses 4 times of water gaging eccysis decontaminations, then with 8 times amount 50% alcoholic solution eluting, collect alcohol eluen, concentrated, dry, obtain Radix Scutellariae total flavones extract.
2) Radix Scutellariae total flavones sustained-release tablet preparation technique:
Radix Scutellariae total flavones extract 200g
Hydroxypropyl methylcellulose K1500 200g
Microcrystalline Cellulose 590g
Sodium lauryl sulphate 5g
Pulvis Talci 5g
70% alcoholic solution is appropriate
Get a kind of reed mentioned in ancient books extractive of general flavone, hydroxypropyl methylcellulose K1500, microcrystalline Cellulose and sodium lauryl sulphate, mix, add 70% alcoholic solution moistening, make soft material, cross 20 mesh sieves and granulate, dry, cross 18 mesh sieve granulate, add Pulvis Talci, mix, compacting in flakes, obtains Radix Scutellariae total flavones slow releasing tablet.
The preparation of embodiment 2 Radix Scutellariae total flavones slow releasing tablet
1) Radix Scutellariae total flavones extraction and purification process:
Get radix scutellariae medicinal materials, section, measures water boiling and extraction 2 times, each 1.5 hours with 10 times, merge extractive liquid,, with absorption with macroporous adsorbent resin, first uses 4 times of water gaging eccysis decontaminations, then with 8 times amount 70% alcoholic solution eluting, collect alcohol eluen, concentrated, dry, obtain Radix Scutellariae total flavones extract.
2) Radix Scutellariae total flavones sustained-release tablet preparation technique:
Radix Scutellariae total flavones extract 200g
Hydroxypropyl methylcellulose K750 280g
Microcrystalline Cellulose 510g
Sodium lauryl sulphate 5g
Magnesium stearate 5g
70% alcoholic solution is appropriate
Get a kind of reed mentioned in ancient books extractive of general flavone, hydroxypropyl methylcellulose K750, microcrystalline Cellulose and sodium lauryl sulphate, mix, add 70% alcoholic solution moistening, make soft material, cross 20 mesh sieves and granulate, dry, cross 18 mesh sieve granulate, add magnesium stearate, mix, compacting in flakes, obtains Radix Scutellariae total flavones slow releasing tablet.
The preparation of embodiment 3 Radix Scutellariae total flavones slow releasing tablet
1) Radix Scutellariae total flavones extraction and purification process:
Get radix scutellariae medicinal materials, section, measures water boiling and extraction 2 times, each 1.5 hours with 10 times, merge extractive liquid,, with absorption with macroporous adsorbent resin, first uses 4 times of water gaging eccysis decontaminations, then with 8 times amount 70% alcoholic solution eluting, collect alcohol eluen, concentrated, dry, obtain Radix Scutellariae total flavones extract.
2) Radix Scutellariae total flavones sustained-release tablet preparation technique:
Radix Scutellariae total flavones extract 400g
Ethyl cellulose 300g
Microcrystalline Cellulose 180g
Lactose 100g
Tween 80 10g
Magnesium stearate 10g
Polyvinylpyrrolidone is appropriate
Get a kind of reed mentioned in ancient books extractive of general flavone, ethyl cellulose, microcrystalline Cellulose, lactose and tween 80, mix, add polyvinylpyrrolidone moistening, make soft material, cross 20 mesh sieves and granulate, dry, cross 18 mesh sieve granulate, add magnesium stearate, mix, compacting in flakes, obtains Radix Scutellariae total flavones slow releasing tablet.
The preparation of embodiment 4 Radix Scutellariae total flavones slow releasing tablet
1) Radix Scutellariae total flavones extraction and purification process:
Get radix scutellariae medicinal materials, section, measures water boiling and extraction 2 times, each 1.5 hours with 10 times, merge extractive liquid,, with absorption with macroporous adsorbent resin, first uses 4 times of water gaging eccysis decontaminations, then with 8 times amount 80% alcoholic solution eluting, collect alcohol eluen, concentrated, dry, obtain Radix Scutellariae total flavones extract.
2) Radix Scutellariae total flavones sustained-release tablet preparation technique:
Radix Scutellariae total flavones extract 500g
Hydroxypropyl methylcellulose K750 200g
Sodium carboxymethyl cellulose 100g
Lactose 185g
Sodium lauryl sulphate 5g
Calcium stearate 5g
Pulvis Talci 5g
Polyvinylpyrrolidone is appropriate
Get a kind of reed mentioned in ancient books extractive of general flavone, hydroxypropyl methylcellulose K750, sodium carboxymethyl cellulose, lactose and sodium lauryl sulphate, mix, add polyvinylpyrrolidone moistening, make soft material, cross 20 mesh sieves and granulate, dry, cross 18 mesh sieve granulate, add magnesium stearate, Pulvis Talci to mix, compacting in flakes, obtains Radix Scutellariae total flavones slow releasing tablet.
The preparation of embodiment 5 Radix Scutellariae total flavones slow releasing tablet
1) Radix Scutellariae total flavones extraction and purification process:
Get radix scutellariae medicinal materials, section, measures water boiling and extraction 2 times, each 1.5 hours with 10 times, merge extractive liquid,, with absorption with macroporous adsorbent resin, first uses 4 times of water gaging eccysis decontaminations, then with 8 times amount 60% alcoholic solution eluting, collect alcohol eluen, concentrated, dry, obtain Radix Scutellariae total flavones extract.
2) Radix Scutellariae total flavones sustained-release tablet preparation technique:
Radix Scutellariae total flavones extract 300g
Hydroxypropyl methylcellulose K1500 300g
Hydroxypropyl methylcellulose K750 100g
Starch 285g
Sodium lauryl sulphate 10g
Pulvis Talci 5g
70% alcoholic solution is appropriate
Get a kind of reed mentioned in ancient books extractive of general flavone, hydroxypropyl methylcellulose K750, hydroxypropyl methylcellulose K1500, starch and sodium lauryl sulphate, mix, add 70% alcoholic solution moistening, make soft material, cross 20 mesh sieves and granulate, dry, cross 18 mesh sieve granulate, add Pulvis Talci, mix, compacting in flakes, obtains Radix Scutellariae total flavones slow releasing tablet.
The preparation of embodiment 6 Radix Scutellariae total flavones slow releasing tablet
1) Radix Scutellariae total flavones extraction and purification process:
Get radix scutellariae medicinal materials, section, measures water boiling and extraction 2 times, each 1.5 hours, merge extractive liquid, with 10 times.Extracting solution, with absorption with macroporous adsorbent resin, is first used 4 times of water gaging eccysis decontaminations, then with 8 times of amount 70% alcoholic solution eluting, collects alcohol eluen, concentrated, dry, obtains Radix Scutellariae total flavones extract.
2) Radix Scutellariae total flavones sustained-release tablet preparation technique:
Radix Scutellariae total flavones extract 300g
Hydroxypropyl methylcellulose K1500 270g
Starch 240g
Lactose 180g
Sodium lauryl sulphate 5g
Pulvis Talci 5g
70% alcoholic solution is appropriate
Get Radix Scutellariae total flavones extract, hydroxypropyl methylcellulose K1500, starch, lactose and sodium lauryl sulphate, mix, add 70% alcoholic solution moistening, make soft material, cross 20 mesh sieves and granulate, dry, cross 18 mesh sieve granulate, add Pulvis Talci, mix, compacting in flakes, obtains Radix Scutellariae total flavones slow releasing tablet.
The preparation of embodiment 7 Radix Scutellariae total flavones slow releasing tablet
1) Radix Scutellariae total flavones extraction and purification process:
Get radix scutellariae medicinal materials, section, measures water boiling and extraction 2 times, each 1.5 hours with 10 times, merge extractive liquid,, with absorption with macroporous adsorbent resin, first uses 4 times of water gaging eccysis decontaminations, then with 8 times amount 65% alcoholic solution eluting, collect alcohol eluen, concentrated, dry, obtain Radix Scutellariae total flavones extract.
2) Radix Scutellariae total flavones sustained-release tablet preparation technique:
Radix Scutellariae total flavones extract 300g
Hydroxypropyl methylcellulose K1500 300g
Microcrystalline Cellulose 250g
Starch 135g
Sodium lauryl sulphate 5g
Pulvis Talci 5g
Magnesium stearate 5g
70% alcoholic solution is appropriate
Get a kind of reed mentioned in ancient books extractive of general flavone, hydroxypropyl methylcellulose K1500, microcrystalline Cellulose, starch and sodium lauryl sulphate, mix, add 70% alcoholic solution moistening, make soft material, cross 20 mesh sieves and granulate, dry, cross 18 mesh sieve granulate, add magnesium stearate, Pulvis Talci, mix, compacting in flakes, obtains Radix Scutellariae total flavones slow releasing tablet.
The preparation of embodiment 8 Radix Scutellariae total flavones slow releasing tablet
1) Radix Scutellariae total flavones extraction and purification process:
Get radix scutellariae medicinal materials, section, measures water boiling and extraction 2 times, each 1.5 hours with 10 times, merge extractive liquid,, with absorption with macroporous adsorbent resin, first uses 4 times of water gaging eccysis decontaminations, then with 8 times amount 75% alcoholic solution eluting, collect alcohol eluen, concentrated, dry, obtain Radix Scutellariae total flavones extract.
2) Radix Scutellariae total flavones sustained-release tablet preparation technique:
Radix Scutellariae total flavones extract 400g
Hydroxypropyl methylcellulose K750 200g
Lactose 380g
Tween 80 15g
Calcium stearate 5g
70% alcoholic solution is appropriate
Get a kind of reed mentioned in ancient books extractive of general flavone, hydroxypropyl methylcellulose K750, lactose and tween 80, mix, add 70% alcoholic solution moistening, make soft material, cross 20 mesh sieves and granulate, dry, cross 18 mesh sieve granulate, add stearic acid lid, mix, compacting in flakes, obtains Radix Scutellariae total flavones slow releasing tablet.
The preparation of embodiment 9 Radix Scutellariae total flavones slow releasing tablet
1) Radix Scutellariae total flavones extraction and purification process:
Get radix scutellariae medicinal materials, section, measures water boiling and extraction 2 times, each 1.5 hours, merge extractive liquid, with 10 times.Extracting solution, with absorption with macroporous adsorbent resin, is first used 4 times of water gaging eccysis decontaminations, then with 8 times of amount 70% alcoholic solution eluting, collects alcohol eluen, concentrated, dry, obtains Radix Scutellariae total flavones extract.
2) Radix Scutellariae total flavones sustained-release tablet preparation technique:
Radix Scutellariae total flavones extract 300g
Hydroxypropyl methylcellulose k1500 240g
Microcrystalline Cellulose 450g
Sodium lauryl sulphate 5g
Magnesium stearate 5g
70% alcoholic solution is appropriate
Get Radix Scutellariae total flavones extract, hydroxypropyl methylcellulose k1500, microcrystalline Cellulose and sodium lauryl sulphate, mix, add 70% alcoholic solution moistening, make soft material, cross 20 mesh sieves and granulate, dry, cross 18 mesh sieve granulate, add magnesium stearate, mix, compacting in flakes, obtains Radix Scutellariae total flavones slow releasing tablet.
The preparation of embodiment 10 Radix Scutellariae total flavones slow releasing tablet
1) Radix Scutellariae total flavones extraction and purification process:
Get radix scutellariae medicinal materials, section, measures water boiling and extraction 2 times, each 1.5 hours with 10 times, merge extractive liquid,, with absorption with macroporous adsorbent resin, first uses 4 times of water gaging eccysis decontaminations, then with 8 times amount 80% alcoholic solution eluting, collect alcohol eluen, concentrated, dry, obtain Radix Scutellariae total flavones extract.
2) Radix Scutellariae total flavones sustained-release tablet preparation technique:
Radix Scutellariae total flavones extract 500g
Sodium carboxymethyl cellulose 100g
Ethyl cellulose 300g
Starch 85g
Tween 80 5g
Pulvis Talci 10g
Polyvinylpyrrolidone is appropriate
Get a kind of reed mentioned in ancient books extractive of general flavone, Carboxymethyl cellulose sodium, ethyl cellulose, starch and tween 80, mix, add polyvinylpyrrolidone moistening, make soft material, cross 20 mesh sieves and granulate, dry, cross 18 mesh sieve granulate, add magnesium stearate, mix, compacting in flakes, obtains Radix Scutellariae total flavones slow releasing tablet.
The preparation of embodiment 11 Radix Scutellariae total flavones slow releasing tablet
1) Radix Scutellariae total flavones extraction and purification process:
Get radix scutellariae medicinal materials, section, measures water boiling and extraction 2 times, each 1.5 hours with 10 times, merge extractive liquid,, with absorption with macroporous adsorbent resin, first uses 4 times of water gaging eccysis decontaminations, then with 8 times amount 50% alcoholic solution eluting, collect alcohol eluen, concentrated, dry, obtain Radix Scutellariae total flavones extract.
2) Radix Scutellariae total flavones sustained-release tablet preparation technique:
Radix Scutellariae total flavones extract 450g
Hydroxypropyl methylcellulose K1500 200g
Sodium carboxymethyl cellulose 100g
Microcrystalline Cellulose 240g
Tween 80 5g
Magnesium stearate 5g
Polyvinylpyrrolidone is appropriate
Get a kind of reed mentioned in ancient books extractive of general flavone, hydroxypropyl methylcellulose K1500, sodium carboxymethyl cellulose, microcrystalline Cellulose and tween 80, mix, add polyvinylpyrrolidone moistening, make soft material, cross 20 mesh sieves and granulate, dry, cross 18 mesh sieve granulate, add magnesium stearate, mix, compacting in flakes, obtains Radix Scutellariae total flavones slow releasing tablet.
The preparation of embodiment 12 Radix Scutellariae total flavones slow releasing tablet
1) Radix Scutellariae total flavones extraction and purification process:
Get radix scutellariae medicinal materials, section, measures water boiling and extraction 2 times, each 1.5 hours with 10 times, merge extractive liquid,, with absorption with macroporous adsorbent resin, first uses 4 times of water gaging eccysis decontaminations, then with 8 times amount 70% alcoholic solution eluting, collect alcohol eluen, concentrated, dry, obtain Radix Scutellariae total flavones extract.
2) Radix Scutellariae total flavones sustained-release tablet preparation technique:
Radix Scutellariae total flavones extract 350g
Hydroxypropyl methylcellulose K1500 100g
Hydroxypropyl methylcellulose K750 50g
Sodium carboxymethyl cellulose 150g
Lactose 340g
Tween 80 5g
Pulvis Talci 5g
70% alcoholic solution is appropriate
Get a kind of reed mentioned in ancient books extractive of general flavone, hydroxypropyl methylcellulose K1500, hydroxypropyl methylcellulose K750, sodium carboxymethyl cellulose, lactose and tween 80, mix, add 70% alcoholic solution moistening, make soft material, cross 20 mesh sieves and granulate, dry, cross 18 mesh sieve granulate, add Pulvis Talci, mix, compacting in flakes, obtains Radix Scutellariae total flavones slow releasing tablet.
The preparation of embodiment 13 Radix Scutellariae total flavones slow releasing tablet
1) Radix Scutellariae total flavones extraction and purification process:
Get radix scutellariae medicinal materials, section, measures water boiling and extraction 2 times, each 1.5 hours with 10 times, merge extractive liquid,, with absorption with macroporous adsorbent resin, first uses 4 times of water gaging eccysis decontaminations, then with 8 times amount 80% alcoholic solution eluting, collect alcohol eluen, concentrated, dry, obtain Radix Scutellariae total flavones extract.
2) Radix Scutellariae total flavones sustained-release tablet preparation technique:
Radix Scutellariae total flavones extract 200g
Hydroxypropyl methylcellulose K750 150g
Sodium carboxymethyl cellulose 50g
Ethyl cellulose 50g
Microcrystalline Cellulose 300g
Lactose 200g
Starch 30g
Sodium lauryl sulphate 10g
Magnesium stearate 5g
Calcium stearate 5g
Polyvinylpyrrolidone is appropriate
Get a kind of reed mentioned in ancient books extractive of general flavone, hydroxypropyl methylcellulose K750, sodium carboxymethyl cellulose, ethyl cellulose, microcrystalline Cellulose and sodium lauryl sulphate, mix, add polyvinylpyrrolidone moistening, make soft material, cross 20 mesh sieves and granulate, dry, cross 18 mesh sieve granulate, add magnesium stearate, calcium stearate, mix, compacting in flakes, obtains Radix Scutellariae total flavones slow releasing tablet.
The preparation of embodiment 14 Radix Scutellariae total flavones slow releasing tablet
1) Radix Scutellariae total flavones extraction and purification process:
Get radix scutellariae medicinal materials, section, measures water boiling and extraction 2 times, each 1.5 hours with 10 times, merge extractive liquid,, with absorption with macroporous adsorbent resin, first uses 4 times of water gaging eccysis decontaminations, then with 8 times amount 60% alcoholic solution eluting, collect alcohol eluen, concentrated, dry, obtain Radix Scutellariae total flavones extract.
2) Radix Scutellariae total flavones sustained-release tablet preparation technique:
Radix Scutellariae total flavones extract 300g
Sodium carboxymethyl cellulose 350g
Ethyl cellulose 50g
Lactose 285g
Tween 80 5g
Pulvis Talci 10g
Polyvinylpyrrolidone is appropriate
Get a kind of reed mentioned in ancient books extractive of general flavone, sodium carboxymethyl cellulose, ethyl cellulose, microcrystalline Cellulose, lactose and tween 80, mix, add polyvinylpyrrolidone moistening, make soft material, cross 20 mesh sieves and granulate, dry, cross 18 mesh sieve granulate, add Pulvis Talci, mix, compacting in flakes, obtains Radix Scutellariae total flavones slow releasing tablet.
The preparation of embodiment 15 Radix Scutellariae total flavones slow releasing tablet
1) Radix Scutellariae total flavones extraction and purification process:
Get radix scutellariae medicinal materials, section, measures water boiling and extraction 2 times, each 1.5 hours with 10 times, merge extractive liquid,, with absorption with macroporous adsorbent resin, first uses 4 times of water gaging eccysis decontaminations, then with 8 times amount 70% alcoholic solution eluting, collect alcohol eluen, concentrated, dry, obtain Radix Scutellariae total flavones extract.
2) Radix Scutellariae total flavones sustained-release tablet preparation technique:
Radix Scutellariae total flavones extract 450g
Sodium carboxymethyl cellulose 200g
Microcrystalline Cellulose 340g
Sodium lauryl sulphate 5g
Calcium stearate 5g
70% alcoholic solution is appropriate
Get a kind of reed mentioned in ancient books extractive of general flavone, sodium carboxymethyl cellulose, microcrystalline Cellulose and sodium lauryl sulphate, mix, add 70% alcoholic solution moistening, make soft material, cross 20 mesh sieves and granulate, dry, cross 18 mesh sieve granulate, add calcium stearate, mix, compacting in flakes, obtains Radix Scutellariae total flavones slow releasing tablet.
Embodiment 16 Radix Scutellariae total flavones sustained-release tablets tests
According to Chinese Pharmacopoeia two annex XC dissolution method first methods of version (turning basket method) mensuration in 2010, get slow releasing tablet taking distilled water 900mL as dissolution medium, rotating speed is 100r/min, temperature is (37 ± 0.5) DEG C, respectively at 2,4,6,8,10,12h sampling 5mL (adding the isopyknic distilled water of isothermal) simultaneously, filters, suitably after dilution, measure general flavone content, calculate preparation, the results are shown in accompanying drawing 1.
Compared with ordinary tablet, the drug release process of the prepared Radix Scutellariae total flavones slow releasing tablet of embodiment 2,6,9 slowly and more lasting.
Claims (10)
1. a Radix Scutellariae total flavones slow releasing tablet, is characterized in that, composed of the following components by weight percentage:
A, skullcapflavone extract 20～50%
B, sustained-release matrix material 20～40%
C, pharmaceutic adjuvant 10～60%
Wherein,
Described sustained-release matrix material is one or more in hydroxypropyl methylcellulose K1500, hydroxypropyl methylcellulose K750, sodium carboxymethyl cellulose or ethyl cellulose;
Described pharmaceutic adjuvant is filler, lubricant, surfactant and binding agent.
2. Radix Scutellariae total flavones slow releasing tablet as claimed in claim 1, is characterized in that by weight percentage, Radix Scutellariae total flavones extract accounts for 30～40%, and sustained-release matrix material accounts for 20～30%, and pharmaceutic adjuvant accounts for 30～45%.
3. Radix Scutellariae total flavones slow releasing tablet as claimed in claim 1, it is characterized in that, Radix Scutellariae total flavones extract is no less than 60% in determined by ultraviolet spectrophotometry and with its total flavones percentage by weight of baicalin, measures its baicalin content of monomer be no less than 40% through HPLC.
4. Radix Scutellariae total flavones slow releasing tablet as claimed in claim 1, is characterized in that described sustained-release matrix material is hydroxypropyl methylcellulose K750.
5. the Radix Scutellariae total flavones slow releasing tablet as described in any one in claim 1-4, is characterized in that described filler is one or more in microcrystalline Cellulose, lactose or starch; Described lubricant is one or more in Pulvis Talci, magnesium stearate or calcium stearate; Described surfactant is sodium lauryl sulphate or tween 80; Described binding agent is 70% alcoholic solution or polyvinylpyrrolidone.
6. the Radix Scutellariae total flavones slow releasing tablet preparation method as described in any one in claim 1-5, is characterized in that comprising following technical process:
1) extraction and purification process: get radix scutellariae medicinal materials, section, measures water boiling and extraction 2 times, each 1.5 hours with 10 times, merge extractive liquid,, with absorption with macroporous adsorbent resin, first use 4 times of water gaging eccysis decontaminations, then with 8 times amount 50～80% alcoholic solution eluting, collect alcohol eluen, concentrated, dry, obtain Radix Scutellariae total flavones extract;
2) preparation process: get Radix Scutellariae total flavones extract, sustained-release matrix material, filler and surfactant, mix, add binding agent and make soft material, cross 20 mesh sieves and granulate, dry, cross 18 mesh sieve granulate, add lubricant, mix, compacting in flakes, obtains Radix Scutellariae total flavones slow releasing tablet.
7. method according to claim 6, is characterized in that: step 1) described medical material process steam enzyme denaturing processing for extraction.
8. method according to claim 6, is characterized in that: step 1) described eluting is 70% by alcoholic solution concentration.
9. method according to claim 6, is characterized in that: step 1) described macroreticular resin is AB-8, D130 or ADS-17.
10. method according to claim 9, is characterized in that described macroreticular resin is AB-8.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104623100A (en) * | 2015-01-20 | 2015-05-20 | 广西南宁科冠医药科技开发有限公司 | Golden camellia total flavone sustained release tablet and preparation method thereof |
| CN107519240A (en) * | 2017-10-13 | 2017-12-29 | 河南省三禾药业有限公司 | Scutellaria tablet and preparation method thereof |
| CN107899065A (en) * | 2017-11-29 | 2018-04-13 | 广西众昌树脂有限公司 | Medical adhesive compositions |
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| CN1556101A (en) * | 2003-12-31 | 2004-12-22 | 中国药科大学 | Extraction technology of Hanbaicalein, medicinal composition and preparation technology of medicine |
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| CN1556101A (en) * | 2003-12-31 | 2004-12-22 | 中国药科大学 | Extraction technology of Hanbaicalein, medicinal composition and preparation technology of medicine |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104623100A (en) * | 2015-01-20 | 2015-05-20 | 广西南宁科冠医药科技开发有限公司 | Golden camellia total flavone sustained release tablet and preparation method thereof |
| CN107519240A (en) * | 2017-10-13 | 2017-12-29 | 河南省三禾药业有限公司 | Scutellaria tablet and preparation method thereof |
| CN107899065A (en) * | 2017-11-29 | 2018-04-13 | 广西众昌树脂有限公司 | Medical adhesive compositions |
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Application publication date: 20140723 |