CN104382936B - A kind of oral solid formulation of sulfonation dehydrogenation rosin acid bismuth and preparation method thereof - Google Patents
A kind of oral solid formulation of sulfonation dehydrogenation rosin acid bismuth and preparation method thereof Download PDFInfo
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- CN104382936B CN104382936B CN201410668698.4A CN201410668698A CN104382936B CN 104382936 B CN104382936 B CN 104382936B CN 201410668698 A CN201410668698 A CN 201410668698A CN 104382936 B CN104382936 B CN 104382936B
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- Prior art keywords
- mixture
- sulfonation
- rosin acid
- acid bismuth
- powder
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
Abstract
The present invention relates to a kind of sulfonation dehydrogenation rosin acid bismuth preparation, and in particular to sulfonation dehydrogenation rosin acid bismuth oral solid formulation.The present invention presses following parts by weight：Sulfonation dehydrogenation rosin acid bismuth 5~15, disintegrant 20~30, diluent 50~70, adhesive 1~5, flocculant 1~3, flavouring 0.1~0.5, appropriate wetting agent.The present invention provides the oral solid formulation of another sulfonation dehydrogenation rosin acid bismuth, and supplementary material presses following parts by weight：Sulfonation dehydrogenation rosin acid bismuth 30~50, diluent 40~70, pH adjusting agent 1~10, flavouring 0~5, appropriate wetting agent.
Description
Technical field
The invention belongs to pharmaceutical technology field, and in particular to one kind can be used for treatment digestive tract ulcer, acute or chronic gastritis and
Pharmaceutical preparation of erosive gastritis and preparation method thereof.
Background technology
Peptic gastric ulcer be due to the digestion of hydrochloric acid in gastric juice, pepsin caused by ulcer disease, be mainly in stomach and
Duodenum, the easy recurrent exerbation of such disease, easily causes canceration.Conventional medicine has antiacid sodium acid carbonate, phosphoric acid
Aluminium, anti-gastric acid secretion drug secretin, Cimetidine, ranitidine, gastric mucosa protectant ulcerlmin, Bismuth Subnitrate Compoun, for general
Auspicious ketone, dynamics-promoting medicine Metoclopramide, domperidone, Mosapride etc..Antiacid easily causes hypochlorhydria using excessively,
So as to substantially reduce the digestion activity of pepsin, cause indigestion；Gastric mucosa protectant such as sanodin can cause oedema, blood
The symptoms such as pressure rise, and some dynamics-promoting medicines such as Metoclopramide causes the adverse reaction of maincenter larger.Treatment digestibility at present
The choice drug of ulcer is exactly anti-gastric acid secretion drug, and heart block can be caused by commonly using anti-gastric acid secretion drug Cimetidine
Deng side effect.Therefore, it is badly in need of researching and developing new anti-gastric acid secretion medicine.
The content of the invention
The present invention is intended to provide one kind directly acts on lesions position, novel enteron ulcer treatment medicine efficiently, less toxic
Thing.The solid system of the new compound-sulfonation dehydrogenation rosin acid bismuth formed the present invention relates to sulfonation dehydrogenation rosin acid and bismuth nitrate
Agent.As new digestive tract ulcer medicine, sulfonation dehydrogenation rosin acid bismuth forms diaphragm in mucosa surface, and can be effective
Suppress helicobacter pylori, and can suppresses pepsin activity, promotes ulcer healing.
Most bismuth agent (gastric juice) in acid is unstable, and part dissociation can cause systemic effect through gastrointestinal absorption.Sulfonation
Dehydrogenation rosin acid bismuth is new bismuth compound, does not neutralize hydrochloric acid in gastric juice also not gastric acid secretion inhibiting, but under the conditions of Gastric pH, bursting
Ulcer surface or ulcer granulation tissue form a kind of firm bismuth colloidal precipitation, it is difficult to be absorbed by alimentary canal, therefore solve routine
Bismuth agent can cause the problem of systemic effect.Sulfonation dehydrogenation rosin acid bismuth can also suppress helicobacter pylori by suppressing urease,
Helicobacter pylori eradication rate is improved, effectively reduces recurrence.Sulfonation dehydrogenation rosin acid bismuth may also act to gastric mucosa tissue simultaneously
In prostaglandin receptor, can increase mucous secretion, base and gastric mucosal blood flow, play endogenous neurogenesis effect, mucous membrane healing
Quality is high, also can effectively reduce recurrence.
1) solid pharmaceutical preparation of sulfonation dehydrogenation rosin acid bismuth of the invention, supplementary material press following parts by weight：
Wherein disintegrant is selected from dried starch, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, crosslinked polyethylene ratio and coughs up alkane
The one or more of ketone, Ac-Di-Sol, Crospovidone etc..
Diluent is selected from one kind or more of starch, Icing Sugar, dextrin, lactose, microcrystalline cellulose, mannitol, inorganic salts etc.
Kind.
Adhesive is selected from the one or more of Crospovidone, hydroxypropyl methylcellulose, PVP, carmethose etc..
Flocculant is selected from sodium alginate, citric acid, sodium citrate, agar, egg white, PVPP, Sodium Polyacrylate, poly-
The one or more of ethylene glycol terephthalate, gelatin, tannin, 101 fruit juice clarifiers etc..
Flavouring is selected from saccharin, Sucralose, Aspartame, acesulfame potassium, maltitol, D-sorbite, xylitol, lactose
The one or more of alcohol, mannitol etc..
Wetting agent is selected from the one or more of ethanol, propane diols, glycerine, dimethyl sulfoxide (DMSO) etc..
The solid pharmaceutical preparation preparation technology of sulfonation dehydrogenation rosin acid bismuth comprising above-mentioned supplementary material is as follows：
1. by sulfonation dehydrogenation rosin acid bismuth and diluent dispensing by a certain percentage；
2. mixing sieving：Sulfonation dehydrogenation rosin acid bismuth and diluent are sieved, collect the powder by screen cloth, mixing sieving
2 times, collect powder, the mixture A of weighing；
3. mixture A air-flow crushing：Airslide disintegrating mill admission pressure and feed pressure are adjusted, controls charging rate,
Air-flow crushing is carried out, powder diameter after Crushing with Jet Mill inspection crushes, powder is collected after reaching requirement particle diameter, is weighed, it is standby；
4. weigh recipe quantity suspending agent and flavouring to be well mixed with the sieving vibration of remainder diluent equal increments, shape
Resulting mixture B；
5. the mixture A after air-flow crushing is well mixed with disintegrant sieving vibration, then is mixed with mixture B sieving vibrations
Uniformly arrive mixture C；
6. the flocculant for weighing recipe quantity is dissolved in appropriate purified water, after stirring and dissolving is uniform, appropriate profit is added
Humectant is configured to solution D, standby after stirring；
7. the mixture A after air-flow crushing, mixture B and mixture C are placed in mixer granulator, fully mix, first
With appropriate wetting agent uniform wet, solution D granulation is added；Moist wood sieves, and dries；
8. dry particl sieve whole grain；Intermediate quality inspection, measure drug content, moisture, sedimentation volume ratio；Packaging, warp
Finished product storage after full inspection is qualified.
Further preferred method is：
1. by sulfonation dehydrogenation rosin acid bismuth and mannitol in 20: 43 ratio dispensing；
2. mixing sieving：Sulfonation dehydrogenation rosin acid bismuth and diluent mannitol are crossed into 60 mesh sieves, collect the powder by screen cloth
End, mixing sieving 2 times, collects powder, weighs to obtain mixture A；
3. mixture A air-flow crushing：Airslide disintegrating mill admission pressure and feed pressure are adjusted, controls charging rate,
Air-flow crushing, powder diameter after Crushing with Jet Mill inspection crushes are carried out, particle diameter should be less than 50 microns, and particle diameter is more than if detecting
50 microns, then air-flow crushing is once, collects powder, weighs, it is standby；
Mixed 4. weighing recipe quantity suspending agent and flavouring and crossing the vibration of 60 mesh sieves with remainder diluent equal increments
It is even, form mixture B；
5. the A after air-flow crushing crosses the vibration of 60 mesh sieves with disintegrant PVPP and is well mixed, then crosses 60 with mixture B
Mesh sieve, vibration are well mixed to obtain mixture C；
6. the flocculant for weighing recipe quantity is dissolved in appropriate purified water, after stirring and dissolving is uniform, appropriate profit is added
Humectant is configured to 40% wetting agent solution containing 8% flocculant, and solution D is obtained after stirring, standby；
7. the mixture A after air-flow crushing, mixture B and mixture C are placed in mixer granulator, fully mix, first
With appropriate wetting agent uniform wet, solution D granulation is added；
8. moist wood crosses 24 mesh sieves, 50 DEG C of dryings；
9. 24 mesh sieve whole grains of dry particl；
10. intermediate quality inspection, measure drug content, moisture, sedimentation volume ratio, packaging, finished product enters after full inspection is qualified
Storehouse.
2) present invention provides the solid pharmaceutical preparation of another sulfonation dehydrogenation rosin acid bismuth, and supplementary material presses following parts by weight
Wherein diluent is selected from one kind of starch, Icing Sugar, dextrin, lactose, microcrystalline cellulose, mannitol, inorganic salts etc.
It is or a variety of.PH adjusting agent is selected from the one or more of sodium citrate, potassium citrate, citric acid etc..
Flavouring is selected from saccharin, Sucralose, Aspartame, acesulfame potassium, maltitol, D-sorbite, xylitol, lactose
The one or more of alcohol, mannitol etc..
Wetting agent is selected from the one or more of ethanol, propane diols, glycerine, dimethyl sulfoxide (DMSO) etc..
The present invention provides the preparation technology of above-mentioned solid pharmaceutical preparation, as follows：
1. by sulfonation dehydrogenation rosin acid bismuth and diluent dispensing by a certain percentage；
2. mixing sieving：Sulfonation dehydrogenation rosin acid bismuth and diluent are sieved, collect the powder by screen cloth, mixing sieving
2 times, collect powder, the mixture A of weighing；
3. mixture A air-flow crushing：Airslide disintegrating mill admission pressure and feed pressure are adjusted, controls charging rate,
Air-flow crushing is carried out, powder diameter after Crushing with Jet Mill inspection crushes, powder is collected after reaching requirement particle diameter, is weighed, it is standby
With；
4. weighing recipe quantity pH adjusting agent and the sieving vibration of flavouring equal increments being well mixed, mixture B is formed；
5. the mixture A and mixture B after air-flow crushing is placed in mixer granulator, appropriate wetting agent granulation is added；It is wet
Material sieves, and dries；
The whole grain 6. dry particl is sieved；Intermediate quality inspection, measure drug content, moisture, sedimentation volume ratio；Packaging, warp
Finished product storage after full inspection is qualified.
Further preferred method is：
1. by sulfonation dehydrogenation rosin acid bismuth and diluent in 40: 52 ratio dispensing；
2. mixing sieving：Sulfonation dehydrogenation rosin acid bismuth and diluent are crossed into 60 mesh sieves, collect the powder by screen cloth, is mixed
Sieving 2 times, collect powder, the mixture A of weighing；
3. mixture A air-flow crushing：Airslide disintegrating mill admission pressure and feed pressure are adjusted, controls charging rate,
Air-flow crushing, powder diameter after Crushing with Jet Mill inspection crushes are carried out, particle diameter should be less than 50 microns, and particle diameter is more than if detecting
50 microns, then air-flow crushing is once, collects powder, weighs, it is standby；
4. weighing recipe quantity pH adjusting agent and flavouring equal increments being crossed the vibration of 80 mesh sieves and are well mixed, mixture B is formed；
5. the mixture A and mixture B after air-flow crushing is placed in mixer granulator, appropriate wetting agent granulation is added；It is wet
Material crosses 18 mesh sieves, 50 DEG C of dryings；
6. dry particl crosses 18 mesh sieve whole grains；
7. intermediate quality inspection, measure drug content, moisture, sedimentation volume ratio；
8. packing, finished product is put in storage after full inspection is qualified.
Embodiment：
With reference to embodiment, the present invention will be described in detail, but the invention is not limited in this.
Embodiment 1- prescriptions 1
The prescription screening of prescription 1
1. the screening of adhesive
Weigh alkali formula sulfonation dehydrogenation rosin acid bismuth+mannitol nixing sieve powder, Crospovidone, hydroxypropyl methylcellulose (HPMC) or
30 POVIDONE K 30 BP/USP 90 (PVPK90) or carmethose (CMC-Na), sedimentation volume ratio, observation sedimentation feelings are determined after well mixed
Condition.
Table 1- adhesives screen
Sedimentation situation can not still be improved by adding HPMC and PVPK90 from table 1, in prescription, and CMC-Na can be significantly improved
Sedimentation volume ratio, therefore consider to add CMC-Na in prescription.Because fine powder is more in prescription, cause mobility poor, therefore examine
Considering improves the mobility of particle by wet granulation.
2. the screening of flavouring and its dosage
Found in the quality research to preparation, obvious impurity peaks occur in the Aspartame used in prescription, influence
The relevant substance-measuring of preparation, now use are entered as flavouring and to its dosage to the glitch-free Sucralose of relevant substance-measuring
Row screening adjustment.It the results are shown in Table 2.
Table 2- flavourings dosage is screened
As shown in Table 2, the sugariness of prescription three is moderate, good in taste.It is 5mg/ bags to determine Sucralose dosage.
Its preparation method of prescription 1 is：
1. dispensing：Alkali formula sulfonation dehydrogenation rosin acid bismuth is converted according to moisture, content, by alkali formula sulfonation dehydrogenation rosin acid bismuth
(dry product meter): the ratio dispensing of mannitol (200g: 430g)；
2. mixing sieving：Vibratory sieve loads onto 60 mesh sieves, pours into alkali formula sulfonation dehydrogenation rosin acid bismuth and mannitol, unlatching are shaken
It is dynamic, the powder by screen cloth is collected, mixing sieving 2 times, powder is collected, weighs；
3. air-flow crushing：It is 0.5-0.7mpa to adjust airslide disintegrating mill admission pressure, feed pressure 0.4-0.6mpa, is shaken
Dynamic frequency electric current is 50-60mA, controls charging rate, air-flow crushing is carried out, after Crushing with Jet Mill is crushed with microexamination
Powder diameter, particle diameter should be less than 50 microns, if detecting, particle diameter is more than 50 microns, then air-flow crushing is once, collects powder, claims
Amount, it is standby；
4. weigh recipe quantity carmethose and Sucralose crosses 60 mesh with remainder mannitol equal increments
5. sieve vibration is well mixed, carmethose Sucralose mannitol mixture is formed；
6. the alkali formula sulfonation dehydrogenation rosin acid bismuth mannitol mixture after air-flow crushing is crossed 60 mesh sieves with PVPP and shaken
It is dynamic well mixed, then cross the vibration of 60 mesh sieves with said mixture and be well mixed；
7. the sodium citrate for weighing recipe quantity is dissolved in appropriate purified water, after stirring and dissolving is uniform, add appropriate
Ethanol is configured to 40% ethanol solution of 8% sodium citrate, standby after stirring；
8. above-mentioned mixed powder is placed in mixer granulator, fully mix, first with appropriate 95% ethanol uniform wet, then add
Enter the 40% ethanol solution granulation of 8% sodium citrate；
9. moist wood crosses 24 mesh sieves, 50 DEG C of dryings；
10. 24 mesh sieve whole grains of dry particl, intermediate quality inspection, measure drug content, moisture, sedimentation volume ratio；Bag
Dress, finished product is put in storage after full inspection is qualified.
The sulfonation dehydrogenation rosin acid bismuth dry suspensoid influence factor result of the test of table 3- prescriptions 1
Embodiment 2- prescriptions 2
The prescription screening (pH adjusting agent and flavouring screening) of prescription 2
During sulfonation dehydrogenation rosin acid bismuth particle formulation study, five groups of prescriptions are designed, each prescription is gone including sulfonation
Hydrogen rosin acid bismuth, sodium citrate, Sucralose and mannitol, sample total amount are 20g.After weighing, with 40% ethanol softwood, system
Grain, dry and whole grain.Mobility is observed, settling ratio is determined, takes each 1g of particulate samples after five prescription whole grains, add water 150ml,
Investigate mouthfeel and and determine pH value, Formulation and investigation the results are shown in Table 4.
Table 4- prescription screenings experimental design and result table
Study more than, investigated by index of mobility of particle, settling ratio, the pH value of the aqueous solution and mouthfeel at five groups
Side, learns that the mouthfeel sugariness of prescription three is suitable, and pH value of water solution is stable, so determining sodium citrate and Sucralose in prescription three
Dosage is both final dosages in sulfonation dehydrogenation rosin acid bismuth particle prescription.In i.e. every 1g prescription total amounts, dehydrogenation containing sulfonation
Rosin acid bismuth 400mg, sodium citrate 60mg, Sucralose 20mg, it is 1g that mannitol, which adds to total amount,.
The sulfonation dehydrogenation rosin acid bismuth dry suspensoid influence factor result of the test of table 5- prescriptions 2
Its preparation method of prescription 2 is：
1. dispensing：Alkali formula sulfonation dehydrogenation rosin acid bismuth is converted according to moisture, content, and mannitol dosage presses alkali formula sulfonation dehydrogenation
Rosin acid bismuth (dry product meter): the ratio dispensing of mannitol (400g: 520g)；
2. mixing sieving：Vibratory sieve loads onto 60 mesh sieves, pours into alkali formula sulfonation dehydrogenation rosin acid bismuth and mannitol, unlatching are shaken
It is dynamic, the powder by screen cloth is collected, mixing sieving 2 times, powder is collected, weighs；
3. air-flow crushing：Alkali formula sulfonation dehydrogenation rosin acid bismuth, after crossing 60 mesh sieves, air-flow crushing.Regulation airslide disintegrating mill enters
Atmospheric pressure is 0.5-0.7mpa, feed pressure 0.4-0.6mpa, controls charging rate, carries out air-flow crushing, air-flow crushing mistake
Powder diameter after journey is crushed with laser particle analyzer inspection, particle diameter should be less than 50 microns, if detecting, particle diameter is more than 50 microns, then gas
Stream crushes once, collects powder, weighs, standby；
4. weigh recipe quantity sodium citrate and Sucralose equal increments are crossed the vibration of 80 mesh sieves and are well mixed；
5. above-mentioned mixed powder is placed in mixer granulator, fully mix, 40% ethanol adds granulation；
6. moist wood crosses 18 mesh sieves, 50 DEG C of dryings；
7. 18 mesh sieve whole grains of dry particl；
8. intermediate quality inspection, measure drug content, moisture, sedimentation volume ratio；
9. packing, finished product is put in storage after full inspection is qualified.
The Study on Preparation of prescription 2
1. gas flow crushing process is studied
Alkali formula sulfonation dehydrogenation rosin acid bismuth is converted according to moisture, content, and mannitol dosage presses alkali formula sulfonation dehydrogenation rosin acid
Bismuth (dry product meter): the ratio dispensing of mannitol (400g: 520g), after being sufficiently mixed, regulation airslide disintegrating mill admission pressure is
0.5-0.7mpa, feed pressure 0.5mpa, charging rate is controlled, powder grain after being crushed after crushing with laser particle analyzer inspection
Footpath, particle diameter should be less than 50 microns.By research, final choice gas flow crushing process is airslide disintegrating mill admission pressure 0.5-
0.7mpa, feed pressure 0.5mpa, it is 80-120ev to control charging voltage speed.
Table 6-- gas flow crushing process investigates result table
2. softwood technical study processed
Recipe quantity sodium citrate and Sucralose equal increments are taken to cross the vibration of 80 mesh sieves and be well mixed, with sulfonation dehydrogenation rosin
Powder after sour bismuth crushes with mannitol, is placed in mixer granulator, fully mixes, three kinds of mode softwoods of selection, and screening is suitable
Softwood mode processed.It is used as wetting agent by comparing the ethanol of final choice 40% and carries out softwood processed.
Table 7-- softwoods technique investigates result table
3. granulating process is studied
Moist wood sieving granulation, former technique cross 24 mesh sieves, and new technology is pelletized using 18 mesh, compares two kinds of 18 mesh and 24 mesh sieves
Granulation mode, as a result shows, the granulation of 18 mesh sieves, particle high income, and obtained particle is close with the refreshing granular size of commercially available product lid,
Therefore 18 mesh sieves of selection are pelletized.It is as follows to investigate result.
Table 8-- granulating process investigates result table
4. wet granular drying process is studied
Wet granular is dried according to former technique, i.e. 50 DEG C of constant pressure and dries, different time sampling, measure moisture content, content and
Relevant material.As a result show, 50 DEG C of constant pressure and dry wet granular fast dryings, extend with drying time, relevant material will not rise, and examine
It is as follows to examine result.
The drying process of table 9 investigates result table
Embodiment 3- prescriptions 3
Preparation method is the same as embodiment 2
Embodiment 4- prescriptions 4
Preparation method is the same as embodiment 2.
Claims (4)
1. a kind of sulfonation dehydrogenation rosin acid bismuth dry suspensoid, it is characterised in that supplementary material presses following parts by weight：
2. a kind of preparation method of sulfonation dehydrogenation rosin acid bismuth dry suspensoid according to claim 1, its preparation method is by such as
Lower step：
1. by sulfonation dehydrogenation rosin acid bismuth and diluent dispensing by a certain percentage；
2. mixing sieving：Sulfonation dehydrogenation rosin acid bismuth and diluent to be sieved, collect the powder by screen cloth, mixing is sieved 2 times,
Collect powder, the mixture A of weighing；
3. mixture A air-flow crushing：Airslide disintegrating mill admission pressure and feed pressure are adjusted, controls charging rate, is carried out
Air-flow crushing, powder diameter after Crushing with Jet Mill inspection crushes, powder is collected after reaching requirement particle diameter, is weighed, standby；
4. weighing recipe quantity adhesive and flavouring to be well mixed with the sieving vibration of remainder diluent equal increments, formed mixed
Compound B；
5. the mixture A after air-flow crushing is well mixed with disintegrant sieving vibration, then is well mixed with mixture B sieving vibrations
To mixture C；
6. the flocculant for weighing recipe quantity is dissolved in appropriate purified water, after stirring and dissolving is uniform, appropriate wetting agent is added
Solution D is configured to, it is standby after stirring；
7. the mixture A after air-flow crushing, mixture B and mixture C are placed in mixer granulator, fully mix, first with suitable
Wetting agent uniform wet is measured, adds solution D granulation；Moist wood sieves, and dries；
8. dry particl sieve whole grain；Intermediate quality inspection, measure drug content, moisture, sedimentation volume ratio；Packaging, through full inspection
Finished product storage after qualified.
3. the preparation method of sulfonation dehydrogenation rosin acid bismuth dry suspensoid according to claim 1, it is characterised in that the preparation
Method is as follows：
1. by sulfonation dehydrogenation rosin acid bismuth and mannitol in 20: 43 ratio dispensing；
2. mixing sieving：Sulfonation dehydrogenation rosin acid bismuth and diluent mannitol are crossed into 60 mesh sieves, collect the powder by screen cloth, is mixed
Sieving 2 times is closed, powder is collected, weighs to obtain mixture A；
3. mixture A air-flow crushing：Airslide disintegrating mill admission pressure and feed pressure are adjusted, controls charging rate, is carried out
Air-flow crushing, powder diameter after Crushing with Jet Mill inspection crushes, particle diameter should be less than 50 microns, if it is micro- to detect that particle diameter is more than 50
Rice, then air-flow crushing is once, collects powder, weighs, it is standby；
It is well mixed 4. weighing recipe quantity adhesive and flavouring and crossing the vibration of 60 mesh sieves with remainder diluent equal increments, shape
Resulting mixture B；
5. the A after air-flow crushing crosses the vibration of 60 mesh sieves with disintegrant PVPP and is well mixed, then crosses 60 mesh with mixture B
Sieve, vibration are well mixed to obtain mixture C；
6. the flocculant for weighing recipe quantity is dissolved in appropriate purified water, after stirring and dissolving is uniform, appropriate wetting agent is added
40% wetting agent solution containing 8% flocculant is configured to, solution D is obtained after stirring, it is standby；
7. the mixture A after air-flow crushing, mixture B and mixture C are placed in mixer granulator, fully mix, first with suitable
Wetting agent uniform wet is measured, adds solution D granulation；
8. moist wood crosses 24 mesh sieves, 50 DEG C of dryings；
9. 24 mesh sieve whole grains of dry particl；
10. intermediate quality inspection, measure drug content, moisture, sedimentation volume ratio, packaging, finished product is put in storage after full inspection is qualified.
4. the dry mixed suspension preparation of a kind of sulfonation dehydrogenation rosin acid bismuth, it is characterised in that supplementary material presses following parts by weight：
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1396154A (en) * | 2001-07-16 | 2003-02-12 | 中国医药研究开发中心 | Sulfonated dehydroabietate and its preparing process and application |
| CN101229159A (en) * | 2007-01-26 | 2008-07-30 | 蔡忠彬 | Medicine for treating infectious diarrhea and peptic ulcer, preparing method and applications thereof |
| CN102697765A (en) * | 2012-06-29 | 2012-10-03 | 海南灵康制药有限公司 | Ranitidine hydrochloride/bismuth potassium citrate pharmaceutical composition solid lipid nanoparticles preparation |
| CN103772241A (en) * | 2014-01-07 | 2014-05-07 | 珠海亿邦制药股份有限公司 | Method for preparing sulfonated dehydroabietic acid salt |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1919170A (en) * | 2006-09-18 | 2007-02-28 | 黄本东 | Colloid pectin bismuth dry suspensoid and its preparing process |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1396154A (en) * | 2001-07-16 | 2003-02-12 | 中国医药研究开发中心 | Sulfonated dehydroabietate and its preparing process and application |
| CN101229159A (en) * | 2007-01-26 | 2008-07-30 | 蔡忠彬 | Medicine for treating infectious diarrhea and peptic ulcer, preparing method and applications thereof |
| CN102697765A (en) * | 2012-06-29 | 2012-10-03 | 海南灵康制药有限公司 | Ranitidine hydrochloride/bismuth potassium citrate pharmaceutical composition solid lipid nanoparticles preparation |
| CN103772241A (en) * | 2014-01-07 | 2014-05-07 | 珠海亿邦制药股份有限公司 | Method for preparing sulfonated dehydroabietic acid salt |
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