CN102058669A - Chinese magnoliavine fruit dispersible tablet and preparation method thereof - Google Patents
Chinese magnoliavine fruit dispersible tablet and preparation method thereof Download PDFInfo
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- CN102058669A CN102058669A CN2009102284416A CN200910228441A CN102058669A CN 102058669 A CN102058669 A CN 102058669A CN 2009102284416 A CN2009102284416 A CN 2009102284416A CN 200910228441 A CN200910228441 A CN 200910228441A CN 102058669 A CN102058669 A CN 102058669A
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- fructus schisandrae
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Abstract
The invention discloses a dispersible tablet for resisting hepatitis and liver cancer. The Chinese magnoliavine fruit dispersible tablet is characterized in that each of Chinese magnoliavine fruit dispersible tablet contains 0.1-2mg of Chinese magnoliavine fruit serving as a main active component; pharmaceutic adjuvants comprise the following components in percentage by weight: 0-95% of lactose, 0-95% of starch, 0-15% of microcrystalline cellulose, 0-7% of carboxymethyl sodium starch glycolate, 0-10% of cross-linked polyvinylpyrrolidone, 0.25-7% of magnesium stearate, 0.15-3% of superfine silica powder, 0.2-0.7% of polyvinylpyrrolidone, 1-2% of sodium dodecyl sulfate and a proper amount of tween-80.
Description
Technical field
The invention belongs to the Chinese medicine preparation technical field, relate to a kind of medicine that is used for anti-hepatitis and hepatocarcinoma, a kind of Fructus Schisandrae Chinensis dispersible tablet and preparation method thereof of more specifically saying so.
Background technology
Hepatitis B is difficult to radical cure, does not have specific drug in the treatment at present.So hepatitis B is Comprehensive Treatment from many aspects: 1, the strong will of gaining mastery over the enemy will be arranged, " anger is impairing the liver then " will keep happy mood; 2, virus active stage patient must lie up, and waits until stable disease, could be suitably movable when the transaminase does not raise; 3, the hepatitis B medication is as using military forces, and is harmful, invalid at least at most, at the oneself state of an illness, selects to take the medicine of antiviral agents, adjustment immune substance, drug for invigorating blood circulation and eliminating stasis, fibrosis and promotion liver cell regeneration under the expert instructs, the drug abuse of being sure not that patient does not choose the doctor; 4, keep living a regular life, rationally arrange diet, diet is based on light.
The hepatitis B refractory, but be not difficult to prevent.If we hold this pass of prevention, hepatitis B is just not fearful, and the prevention of hepatitis B comprises: 1, extensively carry out the inoculation work of Hepatitis B virus vaccine; 2, keep positive phychology and optimistic emotion, the confidence of firm Fighting Disease; 3, understand and grasp some preventive treatment knowledges of hepatitis B disease, form and adhere to rule of life good, science; 4, tobacco and wine are avoided in rational allocation nutrition and dietetic therapy, and the greasy thing of few edible oil is avoided constipation; 5, note daily life and Personal hygiene, according to temperature increase and decrease clothes, the various infection of active prevention; 6, actively cooperate medical treatment, medication under physician guidance, periodic review liver function.Behind the hepatitis B virus infection human body, if passive protective physical fitness is strong, immunologic function is normal, and treatment in time, and hepatitis B virus can be eliminated very soon so, and hepatitis B just can be cured in acute stage.In case but hepatitis B virus fails in time to remove, hepatitis B can transfer to chronic, and virus can be carried for a long time, checks to show as the hepatitis B antigen positive, Here it is our said hepatitis B virus carriers.If hepatitis B virus is movable in hepatocyte, duplicate breeding, then clinical symptoms can appear, common sympton has: the sensation uncomfortable liver area, have a dull ache, general lassitude, weak, loss of appetite, be sick in the stomach, detest oil, diarrhoea.Patient has low grade fever sometimes, jaundice may appear in serious patient, at this moment should in time go to see a doctor, if delay treatment, a few patients can develop into hepatitis gravis, shows as liver function injury and sharply increases the weight of, up to depletion, simultaneously with the infringement of multi-organ functions such as renal failure, the jaundice that continues to increase the weight of, oliguria, anuria, ascites, confusion, delirium, stupor can appear in patient.With the passing of time chronic viral hepatitis B ill, can be along the direction evolution of " hepatitis B-liver cirrhosis-hepatocarcinoma ", Here it is we " the hepatitis B trilogy " often said, so should take the treatment measure after the trouble hepatitis B, and make regular check on health.
Fructus Schisandrae Chinensis is commonly called as Fructus Zanthoxyli Plansipini, sliding weight of steelyard, medicine Fructus Schisandrae Chinensis, face rattan, five Fructus Armeniacae Mumes etc., and " the sweet acid of five tastes skin and flesh is worked hard in the nuclear, and saline taste is all arranged " carried in Tang etc. " Newly Revised Canon of Materia Medica ", so the name of Fructus Schisandrae Chinensis is arranged.Ancient medical book Cheng Ta Chi Zhu, profound and, can and, it is top grade to list in the Sheng Nong's herbal classic the earliest, herbal function is the power of strengthening by means of tonics, medical value is high.Fructus Schisandrae Chinensis is perennial fallen leaves liana, and plant can be for viewing and admiring.For magnoliaceae schisandra (Schisandra chinensis (Turcz.) Baill.) is practised title " Radix Schisandrae Bicoloris ", or schisandra chinensis (Schisandra sphenantheraRehd.etWils.) is practised the dry mature fruit that claims " Fructus Schisandrae Sphenantherae ".Treasure once called: " there is the branch in north and south five tastes the present, and southern product person color is red, northern product person darkish complexion, people's tonic must be good with northern product person ".It is two kinds that Chinese Pharmacopoeia version in 2000 is recorded Fructus Schisandrae Chinensis and Fructus Schisandrae Sphenantherae respectively.Fructus Schisandrae Chinensis only refers in particular to the dry mature fruit of Radix Schisandrae Bicoloris.And Fructus Schisandrae Sphenantherae refers in particular to the dry mature fruit of schisandra chinensis.
Summary of the invention
The objective of the invention is provides a kind of steady quality in order to overcome the limitation of existing Fructus Schisandrae Chinensis tablet, and disintegrate rapidly, the medicine stripping is rapid, infiltration rate is fast, bioavailability is high, curative effect is high, takes and Fructus Schisandrae Chinensis dispersible tablet easy to carry.Simultaneously, the present invention also provides the preparation method of described Fructus Schisandrae Chinensis dispersible tablet.
Purpose of the present invention is achieved by following technical proposals.
Unless otherwise indicated, the percent that is adopted among the present invention is percetage by weight.
Fructus Schisandrae Chinensis of the present invention (mainly referring to Fructus Schisandrae Chinensis BE sheet or Fructus Schisandrae Chinensis B sheet) dispersible tablet contains the Fructus Schisandrae Chinensis and the pharmaceutic adjuvant for the treatment of effective dose, and wherein pharmaceutic adjuvant comprises filler, disintegrating agent, lubricant, wetting agent, binding agent, surfactant.Tabletting method adopts wet granule compression tablet.
Because the key parameter of dispersible tablet is their disintegration rate and dispersed homogeneous degrees in water, is very important so select suitable pharmaceutic adjuvant.Dispersible tablet medicinal formula provided by the invention has fully taken into account this problem.
The used filler of the present invention includes and helps pressed powder shape material and make tablet have the excipient of certain intensity such as lactose, starch, microcrystalline Cellulose, pregelatinized Starch, calcium hydrogen phosphate, mannitol or the like, the mixture of one or more of preferred lactose, starch, microcrystalline Cellulose.Because viscosity is bigger behind the molten water of Fructus Schisandrae Chinensis, the inventor has selected lactose and microcrystalline Cellulose or starch and microcrystalline Cellulose as filler through repeatedly experiment.Mainly be because lactose is very stable in air, should not absorb water, inoperative with most drug, and compressibility is better, does not produce viscosity behind the molten water, and easy operating is grasped in the tablet manufacturing process, and good dissolution rate is arranged.And microcrystalline Cellulose has dilution, bonding, disintegrate triple role, and the suction speeding up disintegration of tablet that expands at once can well solve the bigger problem of viscosity behind the molten water of Fructus Schisandrae Chinensis.
The used disintegrating agent of the present invention is carboxymethyl starch sodium, crospolyvinylpyrrolidone, sodium glycerinate or the like, and the effect of disintegrating agent is to make surface area to increase, so that the very fast release of the active component of this tablet improves dissolution rate and bioavailability.The mixture of one or more of the preferred carboxymethyl starch sodium of the present invention, crospolyvinylpyrrolidone is used in combination.Particularly carboxymethyl starch sodium has stronger water absorption, but not exclusively water-soluble, thus tablet there is disintegration preferably, but improperly will prolong disintegration time with it, it is very important therefore selecting proper proportion.
The used lubricant of the present invention is one or more of magnesium stearate, micropowder silica gel, mainly is because micropowder silica gel lubricate not only can also promote disintegration of tablet; Magnesium stearate then can reduce the frictional force of slice, thin piece and mould circle, makes slice, thin piece bright and clean attractive in appearance.
The used binding agent of the present invention is that polyvinylpyrrolidone, used surfactant are one or more in tween 80, the sodium lauryl sulphate; Used wetting agent is that certain density ethanol water is waited for.
Fructus Schisandrae Chinensis dispersible tablet of the present invention is after process above-mentioned experiment and analysis relatively, and the preferred composition of determining is:
Every contains main Fructus Schisandrae Chinensis 0.1mg and pharmaceutic adjuvant, wherein pharmaceutic adjuvant is lactose 0～95% by weight percentage, starch 0～95%, microcrystalline Cellulose 0～15%, carboxymethyl starch sodium 0～7%, crospolyvinylpyrrolidone 0～10%, magnesium stearate 0.25～7%, micropowder silica gel 0.15～3%, polyvinylpyrrolidone 0.2～0.7%, sodium lauryl sulphate 1～2%, tween 80 are an amount of.For example Fructus Schisandrae Chinensis 10mg, lactose 6440mg, carboxymethyl starch sodium 350mg, micropowder silica gel 50mg, sodium lauryl sulphate 100mg magnesium stearate 50mg or the like.
Fructus Schisandrae Chinensis dispersible tablet preparation method of the present invention may further comprise the steps
1, principal agent and adjuvant are crossed 100 mesh sieves respectively, take by weighing Fructus Schisandrae Chinensis and fill out by recipe quantity: fill agent, add part disintegrating agent and fluidizer, cross 100 mesh sieve mix homogeneously;
2, add polyvinylpyrrolidone ethanol liquid system soft material, cross 30 mesh sieves and granulate;
3, granule is under 50 ℃～60 ℃ conditions dry 1 hour;
4, dried granule is crossed 40 mesh sieves, adds the disintegrating agent and the fluidizer of remainder, adds surfactant, magnesium stearate, mix homogeneously, and tabletting promptly gets required Fructus Schisandrae Chinensis dispersible tablet.
Fructus Schisandrae Chinensis dispersible tablet of the present invention is compared with existing conventional tablet, and the shown good effect that goes out is:
(1) can improve the dissolubility of principal agent, can form the heavy suspension of viscosity rapidly after promptly meeting water, can disperse to form fine particle in the rapid disintegrate of gastrointestinal tract, the medicine distribution area is increased, absorption point increases, and avoids conventional tablet and capsule too high in the gastrointestinal tract local drug concentration, stimulates shortcomings such as gastric mucosa.
(2) the Fructus Schisandrae Chinensis dispersible tablet has extremely strong disintegrate and dissolving out capability, oral after rapidly disintegrate, and homodisperse becomes fine particle, have incomparable disintegrate of ordinary tablet and stripping property ability, realized that medicine absorbs rapidly, the function of quick acting, improved the bioavailability of human body
(3) the Fructus Schisandrae Chinensis dispersible tablet can be made into different oral liquids or injection owing to increased dissolubility, has improved patient's adaptability, has satisfied clinical needs.
Comparative experiments with commercially available Fructus Schisandrae Chinensis sheet and Fructus Schisandrae Chinensis dispersible tablet of the present invention further specifies good effect of the present invention below:
Dispersible tablet of the present invention can be in 3 minutes disintegrate and reach homogeneously dispersed state fully, its effective ingredient Fructus Schisandrae Chinensis B cumulative leaching rate in the time of 10 minutes is more than 80%, specifically tests as follows:
1, the disintegrate situation of Fructus Schisandrae Chinensis dispersible tablet and Fructus Schisandrae Chinensis sheet relatively
The mensuration of dispersing uniformity: get 2 Fructus Schisandrae Chinensis dispersible tablets or common Fructus Schisandrae Chinensis sheet, place the jolting of 100ml water respectively, under 20 ℃ ± 1 ℃ temperature, all disintegrates and reach homogeneously dispersed state in 3 minutes are by No. 2 sieves.Result of the test sees the following form:
| Kind | Disintegration |
| The Fructus Schisandrae Chinensis dispersible tablet | 40 seconds |
| The Fructus Schisandrae Chinensis sheet | 330 seconds |
2, Fructus Schisandrae Chinensis dispersible tablet and Fructus Schisandrae Chinensis sheet stripping situation are relatively
The dissolution determination of Fructus Schisandrae Chinensis dispersible tablet of the present invention according to 2000 editions two appendix XC three therapeutic methods of traditional Chinese medicine samplings of Chinese Pharmacopoeia, is measured the accumulation stripping percentage rate (%) that supplies test agent with high performance liquid chromatograph.Result of the test sees the following form:
| Time (minute) | Dispersible tablet (embodiment) | Ordinary tablet |
| 5 | 90.5 | 40.6 |
| 10 | 92.8 | 48.5 |
| 20 | 94.1 | 53.2 |
| 30 | 96.9 | 74.6 |
| 45 | 98.4 | 79.3 |
| 60 | 99.7 | 82.8 |
Result of the test shows, Fructus Schisandrae Chinensis dispersible tablet 10 minutes dissolution rate (in Fructus Schisandrae Chinensis B) more preferably can arrive more than 90% up to more than 80%, obviously is better than ordinary tablet.
The specific embodiment
By concrete fact Example given below, can further be well understood to the present invention, but they not limitation of the invention.
Embodiment 1
Take by weighing Fructus Schisandrae Chinensis 10mg, lactose 6400mg, crospolyvinylpyrrolidone 380mg, micropowder silica gel 90mg, sodium lauryl sulphate 80mg, magnesium stearate 50mg.With Fructus Schisandrae Chinensis, lactose, partial cross-linked polyvinylpyrrolidone, part micropowder silica gel, mix homogeneously; Drip 4% polyvinylpyrrolidone, 90% ethanol liquid, mix to stir 15 minutes system soft materials, cross 30 mesh sieves and granulate, wet granular under 50 ℃～60 ℃ conditions dry 1 hour; Take out dried granule and cross 40 mesh sieve granulate, add the crospolyvinylpyrrolidone and the micropowder silica gel of remainder, add magnesium stearate, mix homogeneously, tabletting promptly gets required Fructus Schisandrae Chinensis dispersible tablet.
Embodiment 2
Take by weighing Fructus Schisandrae Chinensis 10mg, lactose 6380mg, carboxymethyl starch sodium 350mg, micropowder silica gel 60mg, sodium lauryl sulphate 150mg, magnesium stearate 50mg.With Fructus Schisandrae Chinensis, lactose, part of sodium carboxymethyl starch and part micropowder silica gel, mix homogeneously; Drip 4% polyvinylpyrrolidone, 90% ethanol liquid, mix to stir 15 minutes system soft materials, cross 30 mesh sieves and granulate, wet granular under 50 ℃～60 ℃ conditions dry 1 hour; Take out dried granule and cross 40 mesh sieve granulate, add the carboxymethyl starch sodium and the micropowder silica gel of remainder, add sodium lauryl sulphate and magnesium stearate, mix homogeneously, tabletting promptly gets required Fructus Schisandrae Chinensis dispersible tablet.
Embodiment 3
Take by weighing Fructus Schisandrae Chinensis 10mg, starch 6250mg, crospolyvinylpyrrolidone 700mg, magnesium stearate 40mg.With Fructus Schisandrae Chinensis, starch, partial cross-linked polyvinylpyrrolidone, mix homogeneously; Drip 4% polyvinylpyrrolidone, 90% ethanol liquid, mix to stir 15 minutes system soft materials, cross 30 mesh sieves and granulate, wet granular under 50 ℃～60 ℃ conditions dry 1 hour; Take out dried granule and cross 40 mesh sieve granulate, add the crospolyvinylpyrrolidone of remainder, add magnesium stearate, mix homogeneously, tabletting promptly gets required Fructus Schisandrae Chinensis dispersible tablet.
Embodiment 4
Take by weighing Fructus Schisandrae Chinensis 10mg, starch 6310mg, crospolyvinylpyrrolidone 550mg, micropowder silica gel 100mg, magnesium stearate 30mg.With Fructus Schisandrae Chinensis, starch, partial cross-linked polyvinylpyrrolidone and part micropowder silica gel, mix homogeneously; Drip 4% polyvinylpyrrolidone, 90% ethanol liquid, mix to stir 15 minutes system soft materials, cross 30 mesh sieves and granulate, wet granular under 50 ℃～60 ℃ conditions dry 1 hour; Take out dried granule and cross 40 mesh sieve granulate, add the crospolyvinylpyrrolidone and the micropowder silica gel of remainder, add magnesium stearate, mix homogeneously, tabletting promptly gets required Fructus Schisandrae Chinensis dispersible tablet.
Embodiment 5
Take by weighing Fructus Schisandrae Chinensis 10mg, starch 6300mg, crospolyvinylpyrrolidone 640mg, magnesium stearate 50mg.With Fructus Schisandrae Chinensis, starch, partial cross-linked polyvinylpyrrolidone, mix homogeneously; Drip 4% polyvinylpyrrolidone, 90% ethanol liquid, mix to stir 15 minutes system soft materials, cross 30 mesh sieves and granulate, wet granular under 50 ℃～60 ℃ conditions dry 1 hour; Take out dried granule and cross 40 mesh sieve granulate, add the crospolyvinylpyrrolidone of remainder, add magnesium stearate, mix homogeneously, tabletting promptly gets required Fructus Schisandrae Chinensis dispersible tablet.
Embodiment 6
Take by weighing Fructus Schisandrae Chinensis 10mg, starch 6610mg, carboxymethyl starch sodium 250mg, micropowder silica gel 90mg, magnesium stearate 40mg.With Fructus Schisandrae Chinensis, starch, part of sodium carboxymethyl starch, part micropowder silica gel, mix homogeneously; Drip 4% polyvinylpyrrolidone, 90% ethanol liquid, mix to stir 15 minutes system soft materials, cross 30 mesh sieves and granulate, wet granular under 50 ℃～60 ℃ conditions dry 1 hour; Take out dried granule and cross 40 mesh sieve granulate, add the carboxymethyl starch sodium and the micropowder silica gel of remainder, add magnesium stearate, mix homogeneously, tabletting promptly gets required Fructus Schisandrae Chinensis dispersible tablet.
Embodiment 7
Take by weighing Fructus Schisandrae Chinensis 10mg, lactose 5000mg, microcrystalline Cellulose 900mg, polyvinylpyrrolidone 50mg, carboxymethyl starch sodium 450mg, crospolyvinylpyrrolidone 450mg, micropowder silica gel 90mg, magnesium stearate 50mg.With Fructus Schisandrae Chinensis, lactose, polyvinylpyrrolidone, part of sodium carboxymethyl starch, microcrystalline Cellulose, partial cross-linked polyvinylpyrrolidone, part micropowder silica gel, mix homogeneously; Drip 4% polyvinylpyrrolidone, 90% ethanol liquid, mix to stir 15 minutes system soft materials, cross 30 mesh sieves and granulate, wet granular under 50 ℃～60 ℃ conditions dry 1 hour; Take out dried granule and cross 40 mesh sieve granulate, add carboxymethyl starch sodium, crospolyvinylpyrrolidone and the micropowder silica gel of remainder, add magnesium stearate, mix homogeneously, tabletting promptly gets required Fructus Schisandrae Chinensis dispersible tablet.
Embodiment 8
Take by weighing Fructus Schisandrae Chinensis 10mg, starch 5110mg, polyvinylpyrrolidone 30mg, carboxymethyl starch sodium 300mg microcrystalline Cellulose 700mg, crospolyvinylpyrrolidone 700mg, micropowder silica gel 110mg, magnesium stearate 40mg, tween 80 is an amount of.With Fructus Schisandrae Chinensis, lactose, polyvinylpyrrolidone, microcrystalline Cellulose, part of sodium carboxymethyl starch, partial cross-linked polyvinylpyrrolidone, part micropowder silica gel, mix homogeneously; It is an amount of to drip 4% polyvinylpyrrolidone, 90% ethanol and tween 80, mix to stir 15 minutes system soft materials, crosses 30 mesh sieves and granulates, wet granular under 50 ℃～60 ℃ conditions dry 1 hour; Take out dried granule and cross 40 mesh sieve granulate, add carboxymethyl starch sodium, crospolyvinylpyrrolidone and the micropowder silica gel of remainder, add magnesium stearate, mix homogeneously, tabletting promptly gets required Fructus Schisandrae Chinensis dispersible tablet.
Claims (5)
1. dispersible tablet that is used for anti-hepatitis and hepatocarcinoma, it is characterized in that, this dispersible tablet is made up of treatment effective amount of actives Fructus Schisandrae Chinensis and pharmaceutic adjuvant, and pharmaceutic adjuvant wherein is filler, disintegrating agent, lubricant, wetting agent, binding agent, surfactant.
2. Fructus Schisandrae Chinensis dispersible tablet as claimed in claim 1, wherein said filler are one or more of lactose, starch, microcrystalline Cellulose; Disintegrating agent is one or more in carboxymethyl starch sodium, crospolyvinylpyrrolidone, the sodium lauryl sulphate; Lubricant is one or more of magnesium stearate, micropowder silica gel; Binding agent is a polyvinylpyrrolidone; Wetting agent is certain density ethanol water; Surfactant is one or more a mixture of sodium lauryl sulphate, tween 80.
3. Fructus Schisandrae Chinensis dispersible tablet as claimed in claim 1 or 2, wherein, every contains main active Fructus Schisandrae Chinensis 0.1-2mg, and pharmaceutic adjuvant is lactose 0～95% by weight percentage, starch 0～95%, microcrystalline Cellulose 0～15%, carboxymethyl starch sodium 0～7%, crospolyvinylpyrrolidone 0～10%, magnesium stearate 0.25～7%, micropowder silica gel 0.15～3%, polyvinylpyrrolidone 0.2～0.7%, sodium lauryl sulphate 1～2%, tween 80 are an amount of.
4. Fructus Schisandrae Chinensis dispersible tablet as claimed in claim 1 is characterized in that, described dispersible tablet can be in 3 minutes disintegrate and reach homogeneously dispersed state fully, its effective ingredient Fructus Schisandrae Chinensis B cumulative leaching rate in the time of 10 minutes is more than 80%.
5. the preparation method of a Fructus Schisandrae Chinensis dispersible tablet is characterized in that, the process following steps:
(1) principal agent and adjuvant are crossed 100 mesh sieves respectively, take by weighing Fructus Schisandrae Chinensis and filler, add part disintegrating agent and fluidizer, cross 100 mesh sieve mix homogeneously by recipe quantity;
(2) add polyvinylpyrrolidone ethanol liquid system soft material, cross 30 mesh sieves and granulate;
(3) wet granular is under 50 ℃～60 ℃ conditions dry 1 hour;
(4) take out dried granule and cross 40 mesh sieves, add part disintegrating agent and fluidizer, add surfactant, magnesium stearate, mix homogeneously, tabletting promptly gets required Fructus Schisandrae Chinensis dispersible tablet.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105285938A (en) * | 2015-08-27 | 2016-02-03 | 高铭鸿 | Chinese magnoliavine fruit and jerusalem artichoke polysaccharide tables |
| CN105381040A (en) * | 2015-11-19 | 2016-03-09 | 哈尔滨圣吉药业股份有限公司 | Dispersible tablets with functions of harmonizing liver and benefiting gallbladder and preparation method thereof |
-
2009
- 2009-11-17 CN CN2009102284416A patent/CN102058669A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105285938A (en) * | 2015-08-27 | 2016-02-03 | 高铭鸿 | Chinese magnoliavine fruit and jerusalem artichoke polysaccharide tables |
| CN105381040A (en) * | 2015-11-19 | 2016-03-09 | 哈尔滨圣吉药业股份有限公司 | Dispersible tablets with functions of harmonizing liver and benefiting gallbladder and preparation method thereof |
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Application publication date: 20110518 |