CN1830460A - Xuesaitong (thrombus clearout) chewing tablet and its preparation method - Google Patents

Xuesaitong (thrombus clearout) chewing tablet and its preparation method Download PDF

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CN1830460A
CN1830460A CN 200510031328 CN200510031328A CN1830460A CN 1830460 A CN1830460 A CN 1830460A CN 200510031328 CN200510031328 CN 200510031328 CN 200510031328 A CN200510031328 A CN 200510031328A CN 1830460 A CN1830460 A CN 1830460A
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xuesaitong
clearout
thrombus
chewing tablet
radix notoginseng
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谭安德
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Individual
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Abstract

A Xuesaitong chewing tablet is proportionally prepared from notoginseng saponin, filler, flavouring, flowing aid, and adhesive through sieving, sequential mixing, granulating, drying, sieving, adding flowing aid, stirring and die pressing.

Description

Xuesaitong (thrombus clearout) chewing tablet and preparation method thereof
Technical field
The present invention relates to a kind of is pharmaceutical product of feature and preparation method thereof with the special lamellar dosage form of chewing, and specifically, relates to a kind of Xuesaitong (thrombus clearout) chewing tablet and preparation method thereof.
Background technology
Containing ginsenoside Rb1, Rg1 and arasaponin R1 etc. is that main Radix Notoginseng total arasaponins (glycosides) successfully is developed as the XUESAITONG PIAN product and is widely used in clinical, the clinical function of XUESAITONG PIAN is blood circulation promoting and blood stasis dispelling with curing mainly, it is active to promote blood circulation, anticoagulant and cerebral blood flow increasing amount, be used for the stasis of blood resistance of brain road, apoplectic hemiplegia, the resistance of the heart arteries and veins stasis of blood, obstruction of qi in the chest and cardialgia, cerebrovascular sequelae, angina pectoris belong to above-mentioned disease person.Radix Notoginseng total arasaponins shows as multiple pharmacologically active: 1, antiplatelet aggregation and thrombolytic effect: Radix Notoginseng total arasaponins can suppress the inductive rabbit platelet aggregation reaction of ADP, makes the interior cAMP content of platelet very high, reduces TXA 2Generation; 2, hemoposieis: Radix Notoginseng total arasaponins to cyclophosphamide and 60C 0The leukocyte of irradiation mice has restitution, still can promote the multi-functional bone marrow stem cell hypertrophy of hemopoietic, the effect of differentiation and migration; 3, to the influence of heart: Radix Notoginseng total arasaponins has negativity frequency and negative inotropic action to heart, and is dosage correlation, and is relevant with the blocking-up slow calcium channel, and its Main Ingredients and Appearance that suppresses the myocardial contraction effect is Rb 14, to the influence of blood pressure: Radix Notoginseng total arasaponins can obviously reduce dog arteriotony and total peripheral resistance; 5, antiarrhythmic effect: Radix Notoginseng total arasaponins all has protective effect to various drug-induced arrhythmia; 6, study of anti-atherogenic effect: Radix Notoginseng total arasaponins can suppress the rabbit aortic smooth muscle cells propagation of In vitro culture, can significantly suppress the facilitation of the clear on cell proliferation of low concentration hyperlipemia; 7, the Antishock function of anti-the ischemia: Radix Notoginseng total arasaponins can make cat, dog, mice at the downward live time that lives forever of anoxia condition, and the cardiac function of rabbit hemorrhagic shock is had protective effect, prolongs the time-to-live of shock animals; 8, to the influence of cerebral ischemia; Radix Notoginseng total arasaponins energy blood vessel dilating increases the brain vessel blood amount; 9, to neural effect: the Ginsenoside Rb 1Can obviously reduce the spontaneous activity of mice, the excitement that antagonism caffeine etc. causes strengthens the effect of central depressant thing; 10, antiinflammatory action: Radix Notoginseng total arasaponins all has inhibitory action to experimental capillary permeability increase, to the swollen inhibitory action that is formed with of rat foot; 11, to Immune Effects: Radix Notoginseng total arasaponins can make that leukocyte and lymphocyte increase in the phagocytic rate of mice hemolysis plaque number, M φ and phagocytic index, the blood, paralysis and death due to the reactive brain bone of the protection rat experiment paraphilia meningitis also can improve humoral immune function simultaneously; 12, to the influence of liver function: Radix Notoginseng total arasaponins is to CCl 4Cause the rats'liver damage to reach to CCl 4The isolated rat perfusion liver of damage is all had a protective effect, simultaneously hepatic ischemia-reperfusion injury is also had protective effect; 13, to the influence of renal function: the damage tool protective effect of Radix Notoginseng total arasaponins nephridial tissue 26S Proteasome Structure and Function during to renal ischemic reperfusion injury; 14, antitumor action: the ginsenoside Rb1 can make the tumor cell of cultivation be suppressed; 15, other effect: Radix Notoginseng total arasaponins has the effect that promotes growth, the effect of tool androgen sample, tool antiulcer, increase urine amount, inhibition rat Na +, K +The active effect of-ATP enzyme.In sum, it is extensive that Radix Notoginseng total arasaponins has a pharmacological action, its blood circulation promoting and blood stasis dispelling, and it is active to promote blood circulation, and the function of anticoagulant and cerebral blood flow increasing amount is definite, the advantage that the long-term prescription side effect is little.
Along with the prolongation of human average life and the decline of age growth swallow, the oral tablet administering mode becomes the problem that people pay close attention to, and according to estimates, has 50% people that swallow tablet or capsule are had any problem approximately, has influenced the compliance of Drug therapy.In old medicine and pharmacology field, in water, dissolving or suspend, can chew or can in mouth, very big requirement being arranged rapid dissolved solid preparation.Chewable tablet is as a kind of new dosage form, and it is by chewing in mouth or sucking and slowly taken, and can make medicine water and by oral not wherein, and it is sweet and fragrance, rapid-action, advantage that bioavailability is high arranged to have a sweet in the mouth.And the at present both at home and abroad commercially available XUESAITONG ordinary tablet that is mainly, its mouthfeel is poor, is bitterness, the inconvenience of swallowing, so far also there is not the chewable tablet preparation to occur, so be necessary to design a kind of taking convenience and mouthfeel is good, drug compliance is good, bioavailability is high Xuesaitong (thrombus clearout) chewing tablet preparation.
Summary of the invention
Inconvenient mouthfeel is poor in order to solve swallowing that the XUESAITONG conventional tablet exists in the prior art, drug compliance difference and the low problem of bioavailability, purpose of the present invention is that Xuesaitong (thrombus clearout) chewing tablet that a kind of taking convenience mouthfeel is good, drug compliance is good and bioavailability is high and preparation method thereof is provided.
The technical solution of Xuesaitong (thrombus clearout) chewing tablet of the present invention and preparation method thereof is as follows.
Xuesaitong (thrombus clearout) chewing tablet of the present invention is composed of the following components: weight portion is 50~100 parts a principal agent Radix Notoginseng total arasaponins, weight portion is the filler of 50-600 part, weight portion is the correctives of 5-600 part, and weight portion is 2~80 parts a fluidizer, and weight portion is 2~100 parts a binding agent.
The preparation method of Xuesaitong (thrombus clearout) chewing tablet of the present invention, be to follow these steps to order carry out: (1) crosses 100 mesh sieves respectively with each component; (2) principal agent Radix Notoginseng total arasaponins, filler, correctives were mixed 0.5~3 hour, add binding agent and make soft material, cross 16~24 mesh sieves and granulate,, cross 60 mesh sieves then and carry out granulate 55~60 ℃ of dryings 0.5~1.5 hour; (3) add fluidizer, mixing; (4) be pressed into the heavy slice, thin piece of 0.3~1.2g.
The beneficial effect of Xuesaitong (thrombus clearout) chewing tablet of the present invention and preparation method thereof is mainly reflected in: (1) is because the each clinical use amount of Radix Notoginseng total arasaponins is bigger, so once need use the multi-disc XUESAITONG PIAN, but the ordinary tablet volume is big, children and to swallow patient's medication that solid has difficulties extremely inconvenient always,, and after making chewable tablet, can make things convenient for patient's medication, drug compliance is good; (2) can be dissolved in saliva after putting into mouth and chewing, medicine can pass through oral cavity or intraesophageal mucosa absorption, bioavailability height; (3) adopt correctives in order to improve the taste sensation of tablet, be adjusted to people's physical ability as far as possible and accept, not only the sweet mouthfeel of taste is good, and has corrected bitterness, and fragrance is arranged; (4) need not drink water and also can take, taking convenience and being easy to carry; (5) medicine stability is good, and production technology is simple, cost is low.
The specific embodiment
The Radix Notoginseng total arasaponins that principal agent Radix Notoginseng total arasaponins described in the Xuesaitong (thrombus clearout) chewing tablet component of the present invention can adopt Yunnan Plant Pharmaceutical Industry Co., Ltd. to produce.
Filler described in the Xuesaitong (thrombus clearout) chewing tablet component of the present invention is as diluent, can select one of following or any two kinds or two or more mixture arbitrarily: 1. lactose, 2. sucrose, 3. mannitol, 4. sorbitol, 5. microcrystalline Cellulose, 6. glucose, 7. starch, 8. hydroxypropyl cellulose.Wherein preferably microcrystalline cellulose is a filler.
Correctives described in the Xuesaitong (thrombus clearout) chewing tablet component of the present invention is used for correcting because the poor taste that Radix Notoginseng total arasaponins or adjuvant bring, and can select one of following or any two kinds or two or more mixture arbitrarily: (1) cyclamate, (2) steviosin, (3) saccharin sodium, (4) vitamin C, (5) beta-schardinger dextrin-, (6) protein sugar, (7) sucrose, (8) mannonic acid, (9) galactobionic acid Galactonic acid, (10) gluconic acid, (11) calcium gluconate, (12) magnesium oxide, (13) calcium hydroxide, (14) calcium oxide, (15) aluminum sulfate, (16) meglumine, (17) xylitol, (18) acrylic resin.Wherein preferred xylitol and steviosin.
The fluidizer that is used for increasing drug flow described in the Xuesaitong (thrombus clearout) chewing tablet component of the present invention can be one of following or any two kinds or two or more mixture arbitrarily: 1. magnesium stearate, 2. micropowder silica gel, 3. Pulvis Talci, 4. Polyethylene Glycol, 5. stearic acid.Wherein preferred magnesium stearate.
Binding agent described in the Xuesaitong (thrombus clearout) chewing tablet component of the present invention can be one of following or any two kinds or two or more mixture arbitrarily: 1. ethanol, 2. 1~10% Polyethylene Glycol liquid, 3. 1~10% polyvinylpyrrolidone ethanol or aqueous solution, 4. 1~10% ethyl cellulose ethanol or aqueous solution, 5. 1~10% hydroxypropyl cellulose ethanol or aqueous solution, 6. 1~10% methylcellulose ethanol or aqueous solution, 7. dextrin, 8. starch.Wherein preferred alcohol is a binding agent.
In order to make the outward appearance of chewable tablet more beautiful, also can in the component of Xuesaitong (thrombus clearout) chewing tablet, add weight portion and be 2~80 parts food coloring, it is general human body acceptable pigment, as the Fructus Gardeniae blue pigment that adopts Wuhan Branch of the Chinese Academy of Sciences to produce.
Xuesaitong (thrombus clearout) chewing tablet of the present invention more preferably component consists of: Radix Notoginseng total arasaponins 50~100g, microcrystalline Cellulose 50~600g, hydroxypropyl cellulose 50~600g, xylitol 50~600g, steviosin 5~200g, magnesium stearate 2~80g, ethanol 2~100g makes 1000.
The preferred component of Xuesaitong (thrombus clearout) chewing tablet of the present invention consists of: Radix Notoginseng total arasaponins 100g, and microcrystalline Cellulose 250g, hydroxypropyl cellulose 50g, xylitol 250g, steviosin 13g, magnesium stearate 6g, ethanol 20g makes 1000.
The dosage of the film-making here can be adjusted on demand, owing to be chewable tablet, can make common sheet heavy prescription amount, also can be made into the special-shaped tablets more great, as can be made into polygon, capsule shape, circle, annular, ellipse, wheat grain shape, olive-type etc. than ordinary tablet.
The preparation method of Xuesaitong (thrombus clearout) chewing tablet of the present invention also can be crossed these steps of 100 mesh sieves (1) respectively before in described each component, with the principal agent Radix Notoginseng total arasaponins with beta-schardinger dextrin-wrap up, drying, beta-schardinger dextrin-plays a part flavoring.
The preparation method of Xuesaitong (thrombus clearout) chewing tablet of the present invention also can be pressed into heavy this step of slice, thin piece (4) of 0.3~1.2g afterwards described, again with the slice, thin piece sugar coating.
Embodiment 1:
Xuesaitong (thrombus clearout) chewing tablet is composed of the following components: Radix Notoginseng total arasaponins 100g, and microcrystalline Cellulose 250g, xylitol 250g, hydroxypropyl cellulose 50g, steviosin 13g, magnesium stearate 6g, ethanol 20g makes 1000.
The Xuesaitong (thrombus clearout) chewing tablet of preparation said components, carry out according to the following steps order: (1) crosses 100 mesh sieves respectively with each component; (2) principal agent Radix Notoginseng total arasaponins, filler microcrystalline Cellulose and hydroxypropyl cellulose, correctives xylitol and steviosin were mixed 2 hours, add binding agent ethanol and make soft material, cross 24 mesh sieves and granulate,, cross 60 mesh sieves then and carry out granulate 55~60 ℃ of dryings 1 hour; (3) add fluidizer magnesium stearate, mixing; (4) be pressed into the heavy slice, thin piece of 0.6~1.2g.
Embodiment 2:
Xuesaitong (thrombus clearout) chewing tablet is composed of the following components: Radix Notoginseng total arasaponins 50g, and microcrystalline Cellulose 100g, xylitol 150g, hydroxypropyl cellulose 25g, steviosin 6.5g, magnesium stearate 3g, ethanol 10g makes 1000.
The Xuesaitong (thrombus clearout) chewing tablet of preparation said components carries out according to the sequence of steps of previous embodiment 1.
Embodiment 3:
Xuesaitong (thrombus clearout) chewing tablet is composed of the following components: Radix Notoginseng total arasaponins 100g, and lactose 250g, xylitol 250g, hydroxypropyl cellulose 50g, steviosin 13g, magnesium oxide 12g, magnesium stearate 6g, ethanol 20g makes 1000.
The Xuesaitong (thrombus clearout) chewing tablet of preparation said components, carry out according to the following steps order: (1) crosses 100 mesh sieves respectively with each component; (2) principal agent Radix Notoginseng total arasaponins, filler lactose and hydroxypropyl cellulose, correctives xylitol and steviosin and magnesium oxide were mixed 2 hours, add binding agent ethanol and make soft material, cross 24 mesh sieves and granulate,, cross 60 mesh sieves then and carry out granulate 55~60 ℃ of dryings 1 hour; (3) add fluidizer magnesium stearate, mixing; (4) be pressed into the heavy slice, thin piece of 0.6~1.2g.
Embodiment 4:
Xuesaitong (thrombus clearout) chewing tablet is composed of the following components: Radix Notoginseng total arasaponins 50g, and lactose 100g, xylitol 150g, hydroxypropyl cellulose 25g, steviosin 6.5g, calcium gluconate 25g, magnesium stearate 3g, ethanol 10g makes 1000.
The Xuesaitong (thrombus clearout) chewing tablet of preparation said components, carry out according to the following steps order: (1) crosses 100 mesh sieves respectively with each component; (2) principal agent Radix Notoginseng total arasaponins, filler lactose and hydroxypropyl cellulose, correctives xylitol and steviosin and calcium gluconate were mixed 2 hours, add binding agent ethanol and make soft material, cross 24 mesh sieves and granulate,, cross 60 mesh sieves then and carry out granulate 55~60 ℃ of dryings 1 hour; (3) add fluidizer magnesium stearate, mixing; (4) be pressed into the heavy slice, thin piece of 0.3~1.2g.
Embodiment 5
Xuesaitong (thrombus clearout) chewing tablet is composed of the following components: Radix Notoginseng total arasaponins 100g, and sucrose 400g, hydroxypropyl cellulose 50g, steviosin 13g, magnesium oxide 12g, magnesium stearate 6g, ethanol 20g makes 1000.
The Xuesaitong (thrombus clearout) chewing tablet of preparation said components order according to the following steps carries out: (1) crosses 100 mesh sieves respectively with each component; (2) principal agent Radix Notoginseng total arasaponins, filler sucrose and hydroxypropyl cellulose, correctives steviosin and magnesium oxide were mixed 2 hours, add binding agent ethanol and make soft material, crossing 24 mesh sieves granulates, 55~60 ℃ of dryings 1 hour, cross 60 mesh sieves then and carry out granulate: (3) add the fluidizer magnesium stearate, and mixing (4) is pressed into the heavy slice, thin piece of 0.6~1.2g.
Embodiment 6:
Xuesaitong (thrombus clearout) chewing tablet is composed of the following components: Radix Notoginseng total arasaponins 100g, and mannitol 250g, xylitol 250g, hydroxypropyl cellulose 50g, steviosin 13g, calcium gluconate 50g, magnesium stearate 6g, ethanol 20g makes 1000.
The Xuesaitong (thrombus clearout) chewing tablet of preparation said components, order is carried out according to the following steps: (1) crosses 100 mesh sieves respectively with each component; (2) principal agent Radix Notoginseng total arasaponins, filler mannitol and hydroxypropyl cellulose, correctives xylitol and steviosin and calcium gluconate were mixed 2 hours, add binding agent ethanol and make soft material, cross 24 mesh sieves and granulate,, cross 60 mesh sieves then and carry out granulate 55~60 ℃ of dryings 1 hour; (3) add fluidizer magnesium stearate, mixing; (4) be pressed into the heavy slice, thin piece of 0.6~1.2g.
Embodiment 7:
Xuesaitong (thrombus clearout) chewing tablet is composed of the following components: Radix Notoginseng total arasaponins 100g, and beta-schardinger dextrin-300g, microcrystalline Cellulose 200g, ethanol 20g, magnesium stearate 6g makes 1000.
The Xuesaitong (thrombus clearout) chewing tablet of preparation said components, order is carried out according to the following steps: (1) with the principal agent Radix Notoginseng total arasaponins with the correctives beta-schardinger dextrin-wrap up, dry 8 hours, then together with other component mistake 100 mesh sieves respectively; (2) the beta-schardinger dextrin-wrappage of principal agent was mixed 2 hours with the filler microcrystalline Cellulose, add binding agent ethanol and make soft material, cross 24 mesh sieves and granulate,, cross 60 mesh sieve granulate then 55~60 ℃ of dryings 1 hour; (3) add fluidizer magnesium stearate, mixing; (4) be pressed into the heavy slice, thin piece of 0.6~1.2g.

Claims (9)

1, a kind of Xuesaitong (thrombus clearout) chewing tablet, it is characterized in that, it is composed of the following components: weight portion is 50~100 parts a principal agent Radix Notoginseng total arasaponins, weight portion is the filler of 50-600 part, weight portion is the correctives of 5-600 part, weight portion is 2~80 parts a fluidizer, and weight portion is 2~100 parts a binding agent.
2, Xuesaitong (thrombus clearout) chewing tablet according to claim 1, it is characterized in that filler is one of following or any two kinds or two or more mixture arbitrarily: 1. lactose, 2. sucrose, 3. mannitol, 4. sorbitol, 5. microcrystalline Cellulose, 6. glucose, 7. starch, 8. hydroxypropyl cellulose.
3, Xuesaitong (thrombus clearout) chewing tablet according to claim 1, it is characterized in that correctives can be one of following or any two kinds or two or more mixture arbitrarily: (1) cyclamate, (2) steviosin, (3) saccharin sodium, (4) vitamin C, (5) beta-schardinger dextrin-, (6) protein sugar, (7) sucrose, (8) mannonic acid, (9) galactobionic acid Galactonic acid, (10) gluconic acid, (11) calcium gluconate, (12) magnesium oxide, (13) calcium hydroxide, (14) calcium oxide, (15) aluminum sulfate, (16) meglumine, (17) xylitol, (18) acrylic resin.
4, Xuesaitong (thrombus clearout) chewing tablet according to claim 1 is characterized in that, fluidizer is one of following or any two kinds or two or more mixture arbitrarily: 1. magnesium stearate, 2. micropowder silica gel, 3. Pulvis Talci, 4. Polyethylene Glycol, 5. stearic acid.
5, Xuesaitong (thrombus clearout) chewing tablet according to claim 1, it is characterized in that binding agent is one of following or any two kinds or two or more mixture arbitrarily: 1. ethanol, 2. 1~10% Polyethylene Glycol liquid, 3. 1~10% polyvinylpyrrolidone ethanol or aqueous solution, 4. 1~10% ethyl cellulose ethanol or aqueous solution, 5. 1~10% hydroxypropyl cellulose ethanol or aqueous solution, 6. 1~10% methylcellulose ethanol or aqueous solution, 7. dextrin, 8. starch.
6, according to the described Xuesaitong (thrombus clearout) chewing tablet of claim 1 to 5, it is characterized in that component consists of: Radix Notoginseng total arasaponins 100g, microcrystalline Cellulose 250g, hydroxypropyl cellulose 50g, xylitol 250g, steviosin 13g, magnesium stearate 6g, ethanol 20g makes 1000.
7, a kind of preparation method of Xuesaitong (thrombus clearout) chewing tablet as claimed in claim 1 is characterized in that, is to follow these steps to order carry out: (1) crosses 100 mesh sieves respectively with each component; (2) principal agent Radix Notoginseng total arasaponins, filler, correctives were mixed 0.5~3 hour, add binding agent and make soft material, cross 16~24 mesh sieves and granulate,, cross 60 mesh sieves then and carry out granulate 55~60 ℃ of dryings 0.5~1.5 hour; (3) add fluidizer, mixing; (4) be pressed into the heavy slice, thin piece of 0.3~1.2g.
8, Xuesaitong (thrombus clearout) chewing tablet according to claim 1 is characterized in that, crosses these steps of 100 mesh sieves (1) respectively before in described each group, with the principal agent Radix Notoginseng total arasaponins with beta-schardinger dextrin-wrap up, drying.
9, according to claim 7 or 8 described Xuesaitong (thrombus clearout) chewing tablets, it is characterized in that, be pressed into heavy this step of slice, thin piece (4) of 0.3~1.2g afterwards described, again with the slice, thin piece sugar coating.
CN 200510031328 2005-03-11 2005-03-11 Xuesaitong (thrombus clearout) chewing tablet and its preparation method Pending CN1830460A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108030795A (en) * 2018-02-07 2018-05-15 宁夏天心医药有限责任公司 A kind of XUESHUANTONG ZHUSHEYE and preparation method thereof
CN115317495A (en) * 2022-09-09 2022-11-11 昆明理工大学 Application of notoginsenoside R1 in preparing medicine for treating biliary kidney injury

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108030795A (en) * 2018-02-07 2018-05-15 宁夏天心医药有限责任公司 A kind of XUESHUANTONG ZHUSHEYE and preparation method thereof
CN115317495A (en) * 2022-09-09 2022-11-11 昆明理工大学 Application of notoginsenoside R1 in preparing medicine for treating biliary kidney injury

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