CN1245168C - Storax and baras camphor oral disintegration tablet and its preparing process - Google Patents
Storax and baras camphor oral disintegration tablet and its preparing process Download PDFInfo
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Abstract
The present invention discloses a medicine with the functions of blood circulation activation for blood stasis dispersal, coronary artery blood vessel and cerebral blood vessel ectasia and heart and cerebral ischemia improvement, particularly an oral disintegration tablet for treating coronary heart diseases, angina pectoris, cerebral embolism, cerebral infarction, etc. The present invention aims to make up the deficiency of the existing preparation preparative technique and provide a storax and baras camphor oral disintegration tablet with the advantages of quick absorption, high biological availability, little intestinal canal residue, low side effect, liver first pass effect prevention and convenient application for extensive patients and medical workers and a preparing process thereof. The preparing process of the storax and baras camphor oral disintegration tablet comprises the steps that storax and baras camphor are used as raw materials and diluting agents, disintegrating agents, effervescent agents, corrigents, glidants, lubricating agents, etc. as auxiliary materials are added; the mixture is prepared in an ordinary tablet preparing technique.
Description
[technical field] the present invention relates to a kind of function of promoting blood circulation to disperse blood clots that has, and is used for dilating coronary blood vessel, cerebrovascular, improves the medicine of the heart, symptoms of cerebral ischemia, is a kind of oral formulations that feedstock production forms with styrax, Borneolum Syntheticum particularly.
[background technology] Styrax is the balsam that the trunk of Hamamelidaceae plant Styrax tree [LipuidambarorientalisMill] oozes out, form through processing and refining, have have one's ideas straightened out, broken dirty, analgesic effect, be used for that apoplexy syncope due to accumulation of phlegm, soldier are so fainted, breast abdomen cold type of pain, infantile convulsion and warm disease.Styrax lays particular emphasis on the cardiovascular system aspect to its Pharmacological action study in recent years, and has obtained encouraging progress for import Chinese medicine commonly used.Report storaxs pill for treating coronary heart disease such as Jiang Wende can prolong the time of mice anoxia enduring, significantly increase the CBSF (CSF) of myocardial infarction Canis familiaris L., decreased heart rate and heart artery-vein blood O2 difference (MA-VO
2), show that it resists myocardial ischemia and decreased heart rate, it is relevant to improve myocardium oxygen metabolism.Experiment shows Styrax and Borneolum Syntheticum like two components for working in the storax pill for treating coronary heart disease, and all the other components all fail to confirm its effect.Jia Junsheng etc. observe Subing drop pills white mice swimming and the caused myocardial ischemia submicroscopic structure change of injection of pituitrin are had obvious protective effect, and can resist the myocardial nutrition blood flow reduction that pituitrin causes, make the white mice cardiac muscle improve 12.08% to the uptake ratio of 86Rb, it resists myocardial ischemia may be relevant with its anti-coronary spasm effect; Su Bing solubilising solution shrinks at the stripped thoracic aorta bar of rabbit that external energy facedown norepinephrine causes, average suppression ratio reaches 75.07 ± 11.81%, tentatively proves its mechanism of action and antagonism alpha-adrenergic receptor excitement relevant [1].
And in recent years discover that Borneolum Syntheticum and other medicines compatibility can obviously be mentioned bioavailability of medicament, make being brought into play of better efficacy of medicine.Shake as Lu people's such as space research article introduction: Borneolum Syntheticum and other drug compatibility use, and can reach: 1. make medicine reach valid density in blood, improve drug effect; 2. when guaranteeing drug effect, reduce the toxic and side effects of medicine; 3. improve the percutaneous rate of Borneolum Syntheticum self, bring into play its coronary artery dilating, increase coronary flow, reduce the pharmacological action [2] of myocardial oxygen consumption.
Preparation with Styrax, Borneolum Syntheticum prescription commonly used is based on oral formulations such as storax pill for treating coronary heart disease, Subing drop pills.Owing to reasons such as technologies of preparing, exist that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor after most of oral formulations are taken, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect the effect of treatment.According to the document introduction of relevant drop pill, though said preparation also has the high advantage of bioavailability, the dissolve scattered time limit of relevant pharmaceutical production standard code is＜30min, exceeds more than the dissolve scattered time limit several times of oral cavity disintegration tablet of the present invention.
The pharmaceutical preparation that disclosed employing nanotechnology obtains in the Chinese patent No. 01100769.9 " nano storax medicine and preparation method thereof ", Styrax and Borneolum Syntheticum have wherein also been comprised, and introduce " this drug bioavailability height; therapeutic effect is remarkable ", but indexs such as its dissolve scattered time limit also can't be compared [3] with Su Bing oral cavity disintegration tablet involved in the present invention.
In addition, other oral formulations needs a large amount of water to send down when taking, and this makes the patient of many old peoples, infant or dysphagia, water intaking inconvenience be difficult to take.
[summary of the invention] the objective of the invention is to replenish existing is the deficiency of the oral formulations of raw material with Styrax, Borneolum Syntheticum, provide that a kind of absorption is fast, bioavailability is high, intestinal is residual few, side effect is low, avoid liver first-pass effect, and needn't drink water, in the oral cavity, only need tens seconds can rapid disintegrate or dissolving, can finish the Styrax of taking medicine, Borneolum Syntheticum oral cavity disintegration tablet (hereinafter to be referred as making oral cavity disintegration tablet) and preparation method thereof with saliva hypopharynx.
The oral cavity disintegration tablet that the present invention relates to is a main component with styrax, Borneolum Syntheticum, and the pharmaceutically acceptable auxiliaries with as diluent, disintegrating agent, effervescent, correctives, lubricant, fluidizer, binding agent is prepared from through tablet forming technique.
One. the oral cavity disintegration tablet that reaches of the present invention of filling a prescription is made up of following raw material and adjuvant:
Raw material---styrax 10～60mg, Borneolum Syntheticum 5～30mg;
Diluent---20～100mg;
Disintegrating agent---2～40mg;
Effervescent---5～50mg;
Correctives---3～20mg;
Lubricant---2～10mg mg;
Fluidizer---5～10mg;
Binding agent---0～30mg.
Each consumption former, adjuvant is an every content in the prescription, adhesive look concrete condition also can, wherein:
Diluent---mannitol and/or crospolyvinylpyrrolidone and/or lactose
Disintegrating agent---pregelatinized Starch
Any mixture in effervescent---sodium bicarbonate and tartaric acid, citric acid, fumaric acid, the vitamin C;
Correctives---Fructus Citri Limoniae essence and/or aspartame
Lubricant---magnesium stearate
Fluidizer---micropowder silica gel
Binding agent---starch or cellulose.
Two. preparation method
Direct powder compression
The first step correctly takes by weighing each former, adjuvant according to the component dosage that prescription requires;
Second step was dried back pulverizing, sieving for standby respectively with Borneolum Syntheticum and each diluent, disintegrating agent;
The 3rd goes on foot effervescent respectively at oven dry below 45 ℃, sieving for standby behind the pulverizing;
The 4th step absorbed afterwards styrax with the Borneolum Syntheticum ground and mixed with one of them adjuvant, respectively with each adjuvant except that lubricant, fluidizer with the equivalent method mix homogeneously that progressively increases;
The 5th step added lubricant and fluidizer, mix homogeneously, and the gained direct powder compression forms.
The wet granule compression tablet method
The first step correctly takes by weighing each former, adjuvant according to the component dosage that prescription requires;
Second step was dried back pulverizing, sieving for standby respectively with Borneolum Syntheticum and each diluent, disintegrating agent;
The 3rd goes on foot effervescent respectively at oven dry below 45 ℃, sieving for standby behind the pulverizing;
The 4th step absorbed afterwards styrax with the Borneolum Syntheticum ground and mixed with one of them adjuvant, again with other each adjuvant except that effervescent with the equivalent method mix homogeneously that progressively increases;
The 5th step was divided into two parts with above mixed material, respectively with sodium bicarbonate and sour mix homogeneously after, with the granulation of 65～75% ethanol, under 40～55 ℃ condition, dry, tabletting promptly behind the granulate.
[beneficial effect] tablet is a kind of conventional dosage forms, because of its steady quality, dosage accurately, take, easy to carry, mechanization degree is high, low one of the at present the most frequently used dosage form that becomes of production cost, but because of the tablet extrusion forming, disintegrate is slow, bioavailability is lower, and part patient swallows comparatively difficult, thereby promoting the use of to a certain extent of tablet is restricted.The oral administration solid quick releasing formulation becomes a focus, particularly oral cavity disintegration tablet of new drug development in recent years for this reason, because of its taking convenience, rapid-action, bioavailability is high, the good emphasis that becomes tablet exploitation of mouthfeel.
Oral cavity disintegration tablet is meant not to be needed water or only needs low amounts of water, need not to chew, and tablet places lingual surface, meets after saliva separates rapidly or collapse, and borrows and swallows power, and medicine can be gone into the tablet of stomach onset.The characteristics of oral cavity disintegration tablet are that absorption is fast, bioavailability is high, intestinal is residual few, side effect is low, avoid liver first-pass effect etc., therefore, oral cavity disintegration tablet is applicable to onset rapidly, and valid density and poisoning concentration differ bigger medicine, and some war wound emergency treatment medicines, NSAID (non-steroidal anti-inflammatory drug), spasmolytic Bendectin and analgesic etc. all relatively are fit to make oral cavity disintegration tablet.Other medicine such as blood drug level are in for a long time than plateau, then easily produce drug resistance, make oral cavity disintegration tablet and then can overcome this problem, produce excellent curative.
Oral cavity disintegration tablet needn't be used water delivery service, and saliva can make its disintegrate or dissolving, both can swallow by conventional tablet, can be placed in the water again to take after the disintegrate, also can not need to take medicine with water swallow.Especially provide convenience for old man, children's, dysphagia or the inconvenient person that fetches water take medicine,, then can improve the drug compliance of child patient greatly, solved the problem [4] that it is difficult that infant is taken medicine if adopt certain method to improve its mouthfeel in the preparation.
According to the disclosed description introduction of No. 03148531.6 patent " FUFANG DANSHEN KOUQIANG BENGJIEPIAN and preparation method ", oral cavity disintegration tablet has the leap of essence than the disintegration rate of drop pill and ordinary tablet, the disintegrate of oral cavity disintegration tablet generally in 30 seconds, is no more than 1 minute at most.And the dissolve scattered time limit of drop pill Chinese Pharmacopoeia regulation is in 30 minutes, and be all molten loose [5] about 5 minutes the disintegration of conventional tablet Chinese Pharmacopoeia regulation.
The principal indication of Su Bing class oral formulations such as coronary disease Soviet Union ice pellets is a treatment coronary heart disease, angina pectoris, cerebral thrombosis, diseases such as cerebral infarction, Most patients is an old group, even there wherein have quite a few patient to swallow food to be not very convenient, and that most of oral formulations also exist dissolve scattered time limit is long, dissolution is low, absorb relatively poor, problems such as liver sausage first pass effect and bioavailability are lower, therefore the oral cavity disintegration tablet that reaches of the present invention, absorb fast with it, the bioavailability height, intestinal is residual few, side effect is low, avoid good characteristics such as liver first-pass effect and taking convenience, it is more outstanding that its advantage just seems.
Be described further with the preparation method of several specific embodiments below [specific embodiment] the oral cavity disintegration tablet that reaches of the present invention:
Embodiment one
Prescription:
Raw material---styrax 20g, Borneolum Syntheticum 10g;
Diluent---mannitol 100g, crospolyvinylpyrrolidone 10g;
Disintegrating agent---partially pregelatinized starch (kind reaching) 8.5g;
Effervescent---sodium bicarbonate 20g, tartaric acid 16g;
Fluidizer---micropowder silica gel 10g;
Correctives---Fructus Citri Limoniae essence 5g; Aspartame 1.5g;
Lubricant---magnesium stearate 4g.
Add up to weight 205g, make 1000 altogether, every heavy 205mg contains styrax 20mg, Borneolum Syntheticum 10mg.
Preparation method: present embodiment adopts the direct powder compression preparation.
The first step correctly takes by weighing each former, adjuvant according to the component dosage that prescription requires;
Second step crossed 100 mesh sieves with borneol and grinding; Respectively at 45 ℃ of oven dry, it is standby that pulverizing is crossed 100 mesh sieves for mannitol, partially pregelatinized starch (kind reaching);
The 3rd step dried sodium bicarbonate, tartaric acid down respectively at 45 ℃, pulverizing, and it is standby to cross 100 mesh sieves;
The 4th step absorbed the back with the Borneolum Syntheticum ground and mixed with mannitol with styrax, respectively with adjuvants such as partially pregelatinized starch, sodium bicarbonate, tartaric acid, crospolyvinylpyrrolidone, Fructus Citri Limoniae essence, aspartame with the equivalent method mix homogeneously that progressively increases;
The 5th step added magnesium stearate and micropowder silica gel, and mix homogeneously adopts THP flower basket type tablet machine and diameter 8mm punch die direct compression to form.
Embodiment two
Prescription:
Raw material---styrax 20g, Borneolum Syntheticum 10g;
Diluent---mannitol 50g, crospolyvinylpyrrolidone 10g, lactose 50g;
Disintegrating agent---partially pregelatinized starch (kind reaching) 8.5g;
Effervescent---sodium bicarbonate 20g, citric acid 16g;
Fluidizer---micropowder silica gel 10g;
Correctives---Fructus Citri Limoniae essence 5g; Aspartame 1.5g;
Lubricant---magnesium stearate 4g.
Add up to weight 205g, make 1000 altogether, every heavy 205mg contains styrax 20mg, Borneolum Syntheticum 10mg.
Preparation method: present embodiment adopts the direct powder compression preparation.
The first step correctly takes by weighing each former, adjuvant according to the component dosage that prescription requires;
Second step crossed 100 mesh sieves with borneol and grinding; Respectively at 45 ℃ of oven dry, it is standby that pulverizing is crossed 100 mesh sieves for mannitol, partially pregelatinized starch (kind reaching);
The 3rd step dried sodium bicarbonate, citric acid down respectively at 45 ℃, pulverizing, and it is standby to cross 100 mesh sieves;
The 4th step absorbed the back with the Borneolum Syntheticum ground and mixed with mannitol with styrax, respectively with adjuvants such as lactose, partially pregelatinized starch, sodium bicarbonate, citric acid, crospolyvinylpyrrolidone, Fructus Citri Limoniae essence, aspartame with the equivalent method mix homogeneously that progressively increases;
The 5th step added magnesium stearate and micropowder silica gel, and mix homogeneously adopts THP flower basket type tablet machine and diameter 8mm punch die direct compression to form.
Embodiment three
Prescription:
Raw material---styrax 20g, Borneolum Syntheticum 10g;
Diluent---mannitol 100g, crospolyvinylpyrrolidone 10g, lactose 100g;
Disintegrating agent---partially pregelatinized starch (kind reaching) 8.5g;
Effervescent---sodium bicarbonate 20g, fumaric acid 16g;
Fluidizer---micropowder silica gel 10g;
Correctives---Fructus Citri Limoniae essence 5g; Aspartame 1.5g;
Lubricant---magnesium stearate 4g.
Add up to weight 305g, make 1000 altogether, every heavy 305mg contains styrax 20mg, Borneolum Syntheticum 10mg.
Preparation method: present embodiment adopts the direct powder compression preparation.
The first step correctly takes by weighing each former, adjuvant according to the component dosage that prescription requires;
Second step crossed 100 mesh sieves with borneol and grinding; Respectively at 45 ℃ of oven dry, it is standby that pulverizing is crossed 100 mesh sieves for mannitol, partially pregelatinized starch (kind reaching);
The 3rd step dried sodium bicarbonate, fumaric acid down respectively at 45 ℃, pulverizing, and it is standby to cross 100 mesh sieves;
The 4th step absorbed the back with the Borneolum Syntheticum ground and mixed with mannitol with styrax, respectively with adjuvants such as lactose, partially pregelatinized starch, sodium bicarbonate, fumaric acid, crospolyvinylpyrrolidone, Fructus Citri Limoniae essence, aspartame with the equivalent method mix homogeneously that progressively increases;
The 5th step added magnesium stearate and micropowder silica gel, and mix homogeneously adopts THP flower basket type tablet machine and diameter 8mm punch die direct compression to form.
Embodiment four
Prescription:
Raw material---styrax 20g, Borneolum Syntheticum 10g;
Diluent---mannitol 100g, crospolyvinylpyrrolidone 10g, lactose 100g;
Disintegrating agent---partially pregelatinized starch (kind reaching) 8.5g;
Effervescent---sodium bicarbonate 20g, vitamin C 16g;
Fluidizer---micropowder silica gel 10g;
Correctives---Fructus Citri Limoniae essence 5g; Aspartame 1.5g;
Lubricant---magnesium stearate 4g.
Add up to weight 305g, make 1000 altogether, every heavy 305mg contains styrax 20mg, Borneolum Syntheticum 10mg.Preparation method: present embodiment adopts the direct powder compression preparation.
The first step correctly takes by weighing each former, adjuvant according to the component dosage that prescription requires;
Second step crossed 100 mesh sieves with borneol and grinding; Respectively at 45 ℃ of oven dry, it is standby that pulverizing is crossed 100 mesh sieves for mannitol, partially pregelatinized starch (kind reaching);
The 3rd step dried sodium bicarbonate, vitamin C down respectively at 45 ℃, pulverizing, and it is standby to cross 100 mesh sieves;
The 4th step absorbed the back with the Borneolum Syntheticum ground and mixed with mannitol with styrax, respectively with adjuvants such as lactose, partially pregelatinized starch, sodium bicarbonate, vitamin C, crospolyvinylpyrrolidone, Fructus Citri Limoniae essence, aspartame with the equivalent method mix homogeneously that progressively increases;
The 5th step added magnesium stearate and micropowder silica gel, and mix homogeneously adopts THP flower basket type tablet machine and diameter 8mm punch die direct compression to form.
Embodiment five
Prescription:
Raw material---styrax 20g, Borneolum Syntheticum 10g;
Diluent---mannitol 100g, crospolyvinylpyrrolidone 10g, lactose 100g;
Disintegrating agent---partially pregelatinized starch (kind reaching) 8.5g;
Effervescent---sodium bicarbonate 20g, citric acid 16g;
Fluidizer---micropowder silica gel 10g;
Correctives---Fructus Citri Limoniae essence 5g; Aspartame 1.5g;
Lubricant---magnesium stearate 4g.
Add up to weight 305g, make 1000 altogether, every heavy 305mg contains styrax 20mg, Borneolum Syntheticum 10mg.
Preparation method: present embodiment adopts the preparation of wet granule compression tablet method.
The first step correctly takes by weighing each former, adjuvant according to the component dosage that prescription requires;
Second step crossed 100 mesh sieves with borneol and grinding; Mannitol, partially pregelatinized starch (kind reaching), lactose are respectively at 45 ℃ of oven dry, and it is standby that pulverizing is crossed 100 mesh sieves;
The 3rd step absorbed back and adjuvants such as Borneolum Syntheticum, partially pregelatinized starch, crospolyvinylpyrrolidone, lactose, Fructus Citri Limoniae essence, aspartame, micropowder silica gel, magnesium stearate with the equivalent method mix homogeneously that progressively increases with mannitol with styrax, cross 100 mesh sieves, evenly be divided into two parts standby;
The 4th step sodium bicarbonate and citric acid is respectively at 45 ℃ of oven dry, and pulverizing is crossed 100 mesh sieves, mix with portion in above-mentioned two parts of powder respectively make even;
The 5th step was used 65～75% alcohol granulation respectively with above two parts of mixed materials, oven dry below 40 ℃, and granulate adopts THP flower basket type tablet machine and diameter 8mm punch die tabletting promptly.
Embodiment six
Prescription:
Raw material---styrax 20g, Borneolum Syntheticum 10g;
Diluent---mannitol 100g, crospolyvinylpyrrolidone 10g, lactose 50g;
Disintegrating agent---partially pregelatinized starch (kind reaching) 8.5g;
Effervescent---sodium bicarbonate 20g, fumaric acid 16g;
Fluidizer---micropowder silica gel 10g;
Correctives---Fructus Citri Limoniae essence 5g; Aspartame 1.5g;
Lubricant---magnesium stearate 4g.
Add up to weight 255g, make 1000 altogether, every heavy 255mg contains styrax 20mg, Borneolum Syntheticum 10mg.
Preparation method: present embodiment adopts the preparation of wet granule compression tablet method.
The first step correctly takes by weighing each former, adjuvant according to the component dosage that prescription requires;
Second step crossed 100 mesh sieves with borneol and grinding; Mannitol, partially pregelatinized starch (kind reaching), lactose are respectively at 45 ℃ of oven dry, and it is standby that pulverizing is crossed 100 mesh sieves;
The 3rd step absorbed back and adjuvants such as Borneolum Syntheticum, partially pregelatinized starch, crospolyvinylpyrrolidone, lactose, Fructus Citri Limoniae essence, aspartame, micropowder silica gel, magnesium stearate with the equivalent method mix homogeneously that progressively increases with mannitol with styrax, cross 100 mesh sieves, evenly be divided into two parts standby;
The 4th step sodium bicarbonate and fumaric acid is respectively at 45 ℃ of oven dry, and pulverizing is crossed 100 mesh sieves, mix with portion in above-mentioned two parts of powder respectively make even;
The 5th step was used 65～75% alcohol granulation respectively with above two parts of mixed materials, oven dry below 40 ℃, and granulate adopts THP flower basket type tablet machine and diameter 8mm punch die tabletting promptly.
Embodiment seven
Prescription:
Raw material---styrax 20g, Borneolum Syntheticum 10g;
Diluent---mannitol 100g, crospolyvinylpyrrolidone 10g, lactose 50g;
Disintegrating agent---partially pregelatinized starch (kind reaching) 8.5g;
Effervescent---sodium bicarbonate 20g, tartaric acid 16g;
Fluidizer---micropowder silica gel 10g;
Correctives---Fructus Citri Limoniae essence 5g; Aspartame 1.5g;
Lubricant---magnesium stearate 4g.
Add up to weight 255g, make 1000 altogether, every heavy 255mg contains styrax 20mg, Borneolum Syntheticum 10mg.
Preparation method: present embodiment adopts the preparation of wet granule compression tablet method.
The first step correctly takes by weighing each former, adjuvant according to the component dosage that prescription requires;
Second step crossed 100 mesh sieves with borneol and grinding; Mannitol, partially pregelatinized starch (kind reaching), lactose are respectively at 45 ℃ of oven dry, and it is standby that pulverizing is crossed 100 mesh sieves;
The 3rd step absorbed back and adjuvants such as Borneolum Syntheticum, partially pregelatinized starch, crospolyvinylpyrrolidone, lactose, Fructus Citri Limoniae essence, aspartame, micropowder silica gel, magnesium stearate with the equivalent method mix homogeneously that progressively increases with mannitol with styrax, cross 100 mesh sieves, evenly be divided into two parts standby;
The 4th step sodium bicarbonate and tartaric acid is respectively at 45 ℃ of oven dry, and pulverizing is crossed 100 mesh sieves, mix with portion in above-mentioned two parts of powder respectively make even;
The 5th step was used 65～75% alcohol granulation respectively with above two parts of mixed materials, oven dry below 40 ℃, and granulate adopts THP flower basket type tablet machine and diameter 8mm punch die tabletting promptly.
Embodiment eight
Prescription:
Raw material---styrax 20g, Borneolum Syntheticum 10g;
Diluent---mannitol 100g, crospolyvinylpyrrolidone 10g, lactose 50g;
Disintegrating agent---partially pregelatinized starch (kind reaching) 8.5g;
Effervescent---sodium bicarbonate 20g, vitamin C 16g;
Fluidizer---micropowder silica gel 10g;
Correctives---Fructus Citri Limoniae essence 5g; Aspartame 1.5g;
Lubricant---magnesium stearate 4g.
Add up to weight 255g, make 1000 altogether, every heavy 255mg contains styrax 20mg, Borneolum Syntheticum 10mg.
Preparation method: present embodiment adopts the preparation of wet granule compression tablet method.
The first step correctly takes by weighing each former, adjuvant according to the component dosage that prescription requires;
Second step crossed 100 mesh sieves with borneol and grinding; Mannitol, partially pregelatinized starch (kind reaching), lactose are respectively at 45 ℃ of oven dry, and it is standby that pulverizing is crossed 100 mesh sieves;
The 3rd step absorbed back and adjuvants such as Borneolum Syntheticum, partially pregelatinized starch, crospolyvinylpyrrolidone, lactose, Fructus Citri Limoniae essence, aspartame, micropowder silica gel, magnesium stearate with the equivalent method mix homogeneously that progressively increases with mannitol with styrax, cross 100 mesh sieves, evenly be divided into two parts standby;
The 4th step sodium bicarbonate and vitamin C is respectively at 45 ℃ of oven dry, and pulverizing is crossed 100 mesh sieves, mix with portion in above-mentioned two parts of powder respectively make even;
The 5th step was used 65～75% alcohol granulation respectively with above two parts of mixed materials, oven dry below 40 ℃, and granulate adopts THP flower basket type tablet machine and diameter 8mm punch die tabletting promptly.
Claims (2)
1. Styrax, a Borneolum Syntheticum oral cavity disintegration tablet for the treatment of cardiovascular and cerebrovascular disease is raw material with styrax, Borneolum Syntheticum, be prepared from a certain proportion of pharmaceutically acceptable auxiliaries, wherein:
(1) described pharmaceutically acceptable auxiliaries is:
Diluent: mannitol and/or crospolyvinylpyrrolidone and/or lactose
Disintegrating agent: pregelatinized Starch
Effervescent: sodium bicarbonate and tartaric acid or citric acid or fumaric acid or Vitamin C mixture
Correctives: Fructus Citri Limoniae essence and/or aspartame
Fluidizer: micropowder silica gel
Lubricant; Magnesium stearate
(2) content of above-mentioned styrax, Borneolum Syntheticum and each adjuvant is as follows:
Styrax: 10mg～60mg/ sheet
Borneolum Syntheticum: 5mg～30mg/ sheet
Diluent: 20mg～100mg/ sheet
Disintegrating agent: 2mg～40mg/ sheet
Effervescent: 5mg～50mg/ sheet
Correctives: 3mg～20mg/ sheet
Lubricant: 2mg～10mg/ sheet
Fluidizer: 5mg～10mg/ sheet.
2. Styrax as claimed in claim 1, Borneolum Syntheticum oral cavity disintegration tablet is characterized in that: also comprise starch or cellulose as adhesive in the described pharmaceutically acceptable auxiliaries.
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200410039229 CN1245168C (en) | 2004-02-09 | 2004-02-09 | Storax and baras camphor oral disintegration tablet and its preparing process |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410039229 CN1245168C (en) | 2004-02-09 | 2004-02-09 | Storax and baras camphor oral disintegration tablet and its preparing process |
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| CN1245168C true CN1245168C (en) | 2006-03-15 |
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