CN1167424C - Notoginsenoside enteric tablet - Google Patents
Notoginsenoside enteric tablet Download PDFInfo
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- CN1167424C CN1167424C CNB001330667A CN00133066A CN1167424C CN 1167424 C CN1167424 C CN 1167424C CN B001330667 A CNB001330667 A CN B001330667A CN 00133066 A CN00133066 A CN 00133066A CN 1167424 C CN1167424 C CN 1167424C
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- enteric tablet
- notoginsenoside
- medicinal
- enteric
- ginsenoside
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention relates to a notoginsenoside enteric tablet which is mainly prepared from the raw material ingredients of 4 to 97 wt% of ginsenoside Rb, 1 to 30 wt% of sodium carboxymethyl starch, 1 to 40 wt% of coating compounding liquid of the enteric tablet, and 0.1 to 30 wt% of medicinal dimeticone. The notoginsenoside enteric tablet can effectively avoid the influence of gastric acid and can ensure the disintegration metabolism of medicines in the intestinal tract to produce medicine effect substances. The conventional film coating technology can be used for manufacturing the notoginsenoside enteric tablet which has low production cost and good medicine effect; thus, an enteric medicament with favorable curative effect on nervous system diseases and cardio-cerebrovascular diseases is provided for patients.
Description
The present invention relates to medicament enteric-coated, particularly Chinese herbal medicine extract oral enteric sheet.
Contain more rich ginsenoside in the Chinese medicine Radix Notoginseng, it has multiple pharmacological effect, and Recent study shows, the Ginsenoside Rb
1Under intestinal juice PH environment, produce pharmaceutically active substance through bacterial action catabolism, confirmed that this active substance has significant nervous system regulation and improves cardio and vascular function and antioxidation, clinical practice in calm, calm the nerves, purposes such as convulsion.Confirm the Ginsenoside Rb again
1Molecular side chain generation oxidation reaction in gastric acid, gastric acid has hindered the generation of effective substance, and ginsenoside's drug effect is significantly reduced.For notoginsenoside can be utilized by human better, make the Ginsenoside Rb
1Not influenced by gastric acid during oral formulations process stomach, developing a kind of effective film coating enteric coatel tablets is that the medical worker of educational circles pays close attention to.
The purpose of invention provides and a kind ofly can make the Ginsenoside Rb
1Effectively avoid the harmful effect of gastric acid, guarantee the Ginsenoside Rb
1Disintegrate metabolism in intestinal, the ginsenoside enteric tablet of generation effective substance.
Notoginsenoside enteric tablet of the present invention mainly is to be prepared from by the following raw materials by weight percent composition:
A) Ginsenoside Rb
14-97%
B) carboxymethyl starch sodium or low replacement-hydroxypropyl emthylcellulose 1-30%
C) enteric tablet coating liquor 1-40
D) medicinal simethicone or medicinal magnesium stearate 0.1-30%
Described a) Ginsenoside Rb
1Preferable range is: 18-50%.
Notoginsenoside enteric tablet of the present invention can also contain the pre-paying corn starch of medicinal mannitol that percentage by weight is 1-20% or cane sugar powder, 1-20% medicinal dextrin or pharmaceutical lactose, 1-20% or one or more any amount combination in the medical starch.
Described c) enteric tablet coating liquor can be general enteric tablet coating liquor.
Pre-paying corn starch is meant the corn starch of handling through medical usage, in making enteric coatel tablets filler and separating medium effect is arranged; Mannitol, dextrin have filling effect and seasoning effect; The Ginsenoside Rb
1Be medicament active composition, mainly extract from the Chinese medicine Radix Notoginseng in its source, also claims notoginsenoside Rb usually
1Carboxymethyl starch sodium is a surfactant, the effect that promotes medicine disintegrate in intestinal is arranged, and simethicone is a lubricant.All replace composition all corresponding effect.The coordinative role of this multiple components makes notoginsenoside enteric tablet of the present invention have the characteristic of the insoluble enteric of stomach.
Experiment showed, that three ginsenoside enteric tablets of the present invention discharge hardly under the simulated gastric fluid acid condition, in the simulated intestinal fluid acidic buffer, almost completely discharge, meet the prescription of enteric coatel tablets.
Known Ginsenoside Rb
1Nervous system regulation and improve cardio and vascular function and antioxidation is arranged, it is prepared into notoginsenoside enteric tablet of the present invention,, confirm neurasthenic clinical obvious effective rate more than 80% through the clinical application experiment 30 days of suiting the medicine to the illness; The clinical of female dimacteric syndrome there is rate between 47%-86%; To the clinical obvious effective rate of anxiety neurosis more than 82%.
Notoginsenoside enteric tablet of the present invention is made of conventional film coating procedure.
Through animal experiment, prove that notoginsenoside enteric tablet of the present invention has no side effect, no mutagenic action, oral safety.Be notoginsenoside enteric tablet pharmacological tests of the present invention below:
(1), the acute toxicity test of animal
1, the acute toxicity test of crude drug
1) mensuration of the oral maximum tolerated dose of mice (MTD), the result is 7200mg/kg.
2) measurement result of mouse peritoneal injection (iP) maximum tolerated dose (MTD) is 3600mg/kg.
2, mensuration (MTD) result of the oral maximum tolerated dose of mice of notoginsenoside enteric tablet is 4500mg/kg.
(2) notoginsenoside enteric tablet cures mainly relevant Pharmacodynamic test of active extract with function
1, to the effect of mice swimming stamina intensifying;
2, to the non-pressurized resisting oxygen lack of mice;
3, to the inhibitory action of mice autonomic activities;
4, to the prolongation effect length of one's sleep of mice amobarbital sodium;
5, to the inhibitory action of little auricle edema;
6, the inhibitory action of the writhing response that mice acetic acid is caused;
7, the analgesic activity of the pain that the mice electricity irritation is caused,
Above-mentioned seven pharmacodynamicss all obtain positive findings.
(3) notoginsenoside enteric tablet long term toxicity test
1, rat long term toxicity test proof is nontoxic.
2, prove clinical safe in utilization to leather dog (Beagle dog) long term toxicity test.
(4) the mutagenicity test result of notoginsenoside enteric tablet is negative, no mutagenic action.
Embodiment 1,
Take off column weight amount percentage ratio material composition, film coating procedure is made into notoginsenoside enteric tablet of the present invention routinely:
A) notoginsenoside Rb
14%
B) carboxymethyl starch sodium 28%
C) enteric tablet coating liquor 36%
D) medicinal simethicone 28%
Medicinal dextrin 4%.
Embodiment 2,
Take off column weight amount percentage ratio material composition, film coating procedure is made into notoginsenoside enteric tablet of the present invention routinely:
A) notoginsenoside Rb
118%
B) low replacement-hydroxypropyl emthylcellulose 23%
C) enteric tablet coating liquor 25%
D) medicinal magnesium stearate 15%
Pre-paying corn starch 19%.
Embodiment 3,
Take off column weight amount percentage ratio material composition, film coating procedure is made into notoginsenoside enteric tablet of the present invention routinely:
A) notoginsenoside Rb
150%
B) carboxymethyl starch sodium 15%
C) enteric tablet coating liquor 20%
D) medicinal magnesium stearate 10%
Medicinal mannitol 5%.
Embodiment 4,
Take off column weight amount percentage ratio material composition, film coating procedure is made into notoginsenoside enteric tablet of the present invention routinely:
A) notoginsenoside Rb
180%
B) low replacement-hydroxypropyl emthylcellulose 5%
C) enteric tablet coating liquor 5%
D) medicinal simethicone 2%
Medicinal mannitol and medicinal corn starch 8%.
Embodiment 5,
Take off column weight amount percentage ratio material composition, film coating procedure is made into notoginsenoside enteric tablet of the present invention routinely:
A) notoginsenoside Rb
195%
B) carboxymethyl starch sodium 2%
C) enteric tablet coating liquor 2.5%
D) medicinal simethicone 0.5%.
Embodiment 6,
Take off column weight amount percentage ratio material composition, film coating procedure is made into notoginsenoside enteric tablet of the present invention routinely:
A) Ginsenoside Rb
197%
B) low replacement-hydroxypropyl emthylcellulose 1.9%
C) enteric tablet coating liquor 1%
D) medicinal magnesium stearate 0.1%.
Embodiment 7,
Take off column weight amount percentage ratio material composition, film coating procedure is made into notoginsenoside enteric tablet of the present invention routinely:
A) Ginsenoside Rb
130%
B) low replacement-hydroxypropyl emthylcellulose 20%
C) enteric tablet coating liquor 30%
D) medicinal magnesium stearate 0.2%
Cane sugar powder and pharmaceutical lactose and medical starch 19.8%.
With the notoginsenoside enteric tablet of the foregoing description, respectively get 6 and make the release of release experiment proof in acid less than 10%, release is respectively 95%, 91%, 98%, 95%, 85% in buffer; Panaxoside Rg
1Recall rate average out to 95.3%.
Clinical effective is, contains the Ginsenoside Rb with every
1The 15mg meter, every day 3 times, each 2-4 sheet can be taken for a long time.
The invention is not restricted to the foregoing description.
Claims (5)
1, a kind of notoginsenoside enteric tablet is characterized in that mainly being prepared from by the following raw materials by weight percent composition:
A) Ginsenoside Rb
14-97%
B) carboxymethyl starch sodium or low replacement-carboxylic propyl methocel 1-30%
C) enteric tablet coating liquor 1-40%
D) medicinal simethicone or medicinal magnesium stearate 0.1-30%.
2,, it is characterized in that described a) Ginsenoside Rb according to the described ginsenoside enteric tablet of claim 1
1The scope of taking is: 18-50%.
3, a kind of notoginsenoside enteric tablet is characterized in that being prepared from by following raw materials by weight percent:
A) Ginsenoside Rb
118-50%
B) carboxymethyl starch sodium or low replacement-carboxylic propyl methocel 1-30%
C) enteric tablet coating liquor 1-40%
D) medicinal simethicone or medicinal magnesium stearate 0.1-30%
E) medicinal mannitol or cane sugar powder 1-20%.
4, a kind of notoginsenoside enteric tablet is characterized in that being prepared from by following raw materials by weight percent:
A) Ginsenoside Rb
118-50%
B) carboxymethyl starch sodium or low replacement-carboxylic propyl methocel 1-30%
C) enteric tablet coating liquor 1-40%
D) medicinal simethicone or medicinal magnesium stearate 0.1-30%
E) medicinal dextrin or pharmaceutical lactose 1-20%.
5, a kind of notoginsenoside enteric tablet is characterized in that being prepared from by following raw materials by weight percent:
A) Ginsenoside Rb
118-50%
B) carboxymethyl starch sodium or low replacement-carboxylic propyl methocel 1-30%
C) enteric tablet coating liquor 1-40%
D) medicinal simethicone or medicinal magnesium stearate 0.1-30%
E) pre-paying corn starch or medical starch 1-20%.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB001330667A CN1167424C (en) | 2000-11-18 | 2000-11-18 | Notoginsenoside enteric tablet |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB001330667A CN1167424C (en) | 2000-11-18 | 2000-11-18 | Notoginsenoside enteric tablet |
Publications (2)
Publication Number | Publication Date |
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CN1353992A CN1353992A (en) | 2002-06-19 |
CN1167424C true CN1167424C (en) | 2004-09-22 |
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ID=4595508
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CNB001330667A Expired - Fee Related CN1167424C (en) | 2000-11-18 | 2000-11-18 | Notoginsenoside enteric tablet |
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CN (1) | CN1167424C (en) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
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MY160074A (en) * | 2008-01-24 | 2017-02-15 | Raptor Therapeutics Inc | Protopanaxadiol-type ginsenoside compositions and uses thereof |
CN105106228B (en) * | 2015-08-12 | 2018-06-22 | 河北工业大学 | The pharmaceutical composition containing ginsenoside Rb1 as TMEM16A ion channel activators |
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2000
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Granted publication date: 20040922 Termination date: 20111118 |