CN109200030A - Spiramvcin dry suspensoid agent and preparation method thereof - Google Patents
Spiramvcin dry suspensoid agent and preparation method thereof Download PDFInfo
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- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/10—Antimycotics
Abstract
The invention discloses a kind of spiramvcin dry suspensoid agents and preparation method thereof, it consists of the following compositions: spiramvcin 40-70 parts by weight, lactose 10-25 parts by weight, microcrystalline cellulose 8-15 parts by weight, adhesive 3-6 parts by weight, glidant 2-5 parts by weight, lubricant 2-5 parts by weight, Utech 10-20 parts by weight, surfactant 2-5 parts by weight, suspending agent 2-4 parts by weight and sweetener 0.5-1 parts by weight；The present invention is by selecting suitable auxiliary material and adjustment each component ratio, satisfactory spiramvcin particle is made, and it configures suitable water system coating solution to be coated, spiramvcin coated granule is made, finally adds a certain proportion of suspending agent, spiramvcin dry suspensoid agent is made in sweetener total mix.The present invention compensates for the deficiency of existing preparation, while bitterness and sand type when effective solution is taken in mouthfeel, is easy to the patient that old and child patient is especially difficult to swallow and takes.
Description
Technical field
The present invention relates to pharmaceutical technology fields, and in particular to a kind of spiramvcin dry suspensoid agent and preparation method thereof.
Background technique
Spiramvcin is macrolide antibiotics, and character is powder white or yellowish, micro- moisture absorption, taste when being dissolved in water
It is extremely bitter.Spiramvcin is the acetate of acetyl spiramycin, takes orally rear deacetylate and shows stronger antibacterial action.This product has
Powerful vivo bacteria corrosion action and antibacterial aftereffect (PAE), can enhance the phagocytosis of phagocyte, be distributed widely in body
Interior, concentration is compared with erythromycin height in histocyte, and Small side effects are in erythromycin.
In recent years, the main dosage form of spiramvcin has tablets and capsules, these preparations are special for the elderly and children
It is difficult to for the patient swallowed, great inconvenience will be brought to patient.And after dry suspensoid agent dosage form is made, existing solid system
The characteristics of agent, be convenient for carrying, transport, stability is good etc., and having the advantage of liquid preparation, conveniently take, be suitable for having swallowed it is tired
Difficult patient.Patent CN1823800A discloses a kind of Orally administered composition containing spiramvcin of cover bitter taste to solve to be applicable in people
The small problem of group's range, but its technology for covering bitter taste is only that addition corrigent or sweetener carry out taste masking, it can not be effective
Cover bitter taste.
Summary of the invention
It is an object of the invention to disclose a kind of spiramvcin dry suspensoid agent and preparation method thereof, solves existing dosage form and be applicable in
The problems such as crowd's range is small, while the effective bitter taste for covering drug when taking after mixing it with water.
According to an aspect of the present invention, a kind of spiramvcin dry suspensoid agent is provided, is consisted of the following compositions:
Spiramvcin 40-70 parts by weight, lactose 10-25 parts by weight, microcrystalline cellulose 8-15 parts by weight, adhesive 3-6 weight
Amount part, glidant 2-5 parts by weight, lubricant 2-5 parts by weight, Utech 10-20 parts by weight, surfactant 2-5 parts by weight help
Suspension 2-4 parts by weight and sweetener 0.5-1 parts by weight；
It is prepared by the following method:
(1) spiramvcin, lactose, microcrystalline cellulose and glidant are placed in wet granulator and are uniformly mixed, use 10-
The water-soluble bonding agent softwood of 20% weight concentration, softwood be placed in extrusion spheronization machine squeeze out and it is round as a ball, by particle in 50-60
It is dry at DEG C, take 60-80 mesh particle to get spiramvcin particle；
(2) step (1) spiramvcin particle is placed in fluidized bed, carries out bottom spray with the coating solution of 5-15% weight concentration
Coating, fluidized bed parameter are set as intake volume 15-18m3/ h, 45-60 DEG C of inlet air temperature, spray gun air pressure 0.04-0.06MPa,
Wriggling revolution speed 10-15rpm carries out granule coating, is dried at 45-60 DEG C after coating to get spiramvcin coating
Grain；
(3) the spiramvcin coated granule prepared in glidant, suspending agent, sweetener and step (2) is taken to be added multidirectional
Mixing 20-30min is in movement mixer to get spiramvcin dry suspensoid agent.
As a further improvement of the present invention, adhesive be povidone, ethylcellulose mixed suspension liquid, hydroxypropyl cellulose and
One of hydroxypropyl methylcellulose is a variety of.
As a further improvement of the present invention, the coating solution in step (2) is living by Utech 10-20 parts by weight, surface
The aqueous solution that property agent 2-5 parts by weight and lubricant 2-5 parts by weight are formulated.
As a further improvement of the present invention, glidant is one of colloidal silicon dioxide and silica or a variety of.
As a further improvement of the present invention, lubricant is one of hard magnesium, talcum powder and silica or more
Kind.
As a further improvement of the present invention, surfactant is one of lauryl sodium sulfate and stearic acid or more
Kind.
As a further improvement of the present invention, suspending agent be one of xanthan gum, hydroxypropyl cellulose, Arabic gum or
It is a variety of.
As a further improvement of the present invention, sweetener is one of acesulfame potassium, honey element, Sucralose and saccharin sodium
Or it is a variety of.
Wet granulator, extrusion spheronization machine, fluidized bed and Mixers with Multi-direction Movement of the present invention are all the prior arts.
Satisfactory spiramvcin particle is made by the suitable auxiliary material of selection and adjustment each component ratio in the present invention,
And it configures suitable water system coating solution to be coated, spiramvcin coated granule is made, finally adds a certain proportion of help
Spiramvcin dry suspensoid agent is made in suspension, sweetener total mix.
Compared with prior art, the invention has the benefit that
The spiramvcin coated granule of the preparation method preparation according to the present invention, is not adding any corrigent or sweet taste
Under the premise of agent, only faint bitter taste when being taken after mixing it with water with warm water, no sand type.After adding a certain proportion of suspending agent and sweetener
Spiramvcin dry suspensoid agent obtained without any bitter taste when taking after mixing it with water, and has optimal sweet taste and mouthfeel, while particle settles
It meets the requirements.
The present invention compensates for the deficiency of existing preparation, while bitterness and gravel when effective solution is taken in mouthfeel
Sense is easy to the old patient for being especially difficult to swallow with child patient and takes.
Detailed description of the invention
Fig. 1 is the spiramvcin dry suspensoid agent and spiramvcin capsule Dissolution profiles figure in water of the embodiment of the present invention 1；
Fig. 2 is the spiramvcin dry suspensoid agent and spiramvcin capsule dissolution rate in pH6.8 medium of the embodiment of the present invention 1
Curve graph；
Fig. 3 is the spiramvcin dry suspensoid agent and spiramvcin capsule dissolution rate in pH4.5 medium of the embodiment of the present invention 1
Curve graph；
Fig. 4 is the spiramvcin dry suspensoid agent and spiramvcin capsule dissolution rate in pH1.0 medium of the embodiment of the present invention 1
Curve graph.
Specific embodiment
Below with reference to each embodiment, the present invention is described in detail, but it should be stated that, these embodiments are simultaneously
Non- limitation of the present invention, those of ordinary skill in the art are according to these embodiments in made function, method or structure
Equivalent transformation or substitution, all belong to the scope of protection of the present invention within.
Embodiment 1
Present embodiment discloses a kind of preparation methods of spiramvcin dry suspensoid agent:
A kind of spiramvcin dry suspensoid agent, consists of the following compositions:
Spiramvcin 40-70 parts by weight, lactose 10-25 parts by weight, microcrystalline cellulose 8-15 parts by weight, povidone 3-6 weight
Measure part, colloidal silicon dioxide 2-5 parts by weight, hard magnesium 2-5 parts by weight, Utech 10-20 parts by weight, stearic acid 2-5 weight
Part, Arabic gum 2-4 parts by weight, acesulfame potassium 0.5-1 parts by weight.
It is prepared by the following method:
(1) spiramvcin, lactose, microcrystalline cellulose and colloidal silicon dioxide are placed in wet granulator and are uniformly mixed,
With the povidone aqueous solution softwood of 20% weight concentration, softwood, which is placed in extrusion spheronization machine, to be squeezed out and round as a ball, by particle 50
It is dry at DEG C, take 60-80 mesh particle to get spiramvcin particle；
(2) step (1) spiramvcin particle is placed in fluidized bed, carries out bottom spray packet with the coating solution of 5% weight concentration
Clothing, fluidized bed parameter are set as intake volume 15m3/ h, 45 DEG C of inlet air temperature, spray gun air pressure 0.04MPa, wriggling revolution speed
10rpm carries out granule coating, dries after coating at 45 DEG C to get spiramvcin coated granule；
(3) the spiramvcin coated granule prepared in colloidal silicon dioxide, Arabic gum, acesulfame potassium and step (2) is taken
It is added in Mixers with Multi-direction Movement and mixes 20min to get spiramvcin dry suspensoid agent.
Embodiment 2
Present embodiment discloses the preparation methods of another spiramvcin dry suspensoid agent:
A kind of spiramvcin dry suspensoid agent, consists of the following compositions:
Spiramvcin 40-70 parts by weight, lactose 10-25 parts by weight, microcrystalline cellulose 8-15 parts by weight, hydroxypropyl cellulose
3-6 parts by weight, silica 2-5 parts by weight, talcum powder 2-5 parts by weight, Utech 10-20 parts by weight, lauryl sodium sulfate
2-5 parts by weight, xanthan gum 2-4 parts by weight, saccharin sodium 0.5-1 parts by weight.
It is prepared by the following method:
(1) spiramvcin, lactose, microcrystalline cellulose and silica are placed in wet granulator and are uniformly mixed, used
The hydroxypropyl cellulose aqueous solution softwood of 10% weight concentration, softwood be placed in extrusion spheronization machine squeeze out and it is round as a ball, by particle
It is dry at 60 DEG C, take 60-80 mesh particle to get spiramvcin particle；
(2) step (1) spiramvcin particle is placed in fluidized bed, carries out bottom spray packet with the coating solution of 15% weight concentration
Clothing, fluidized bed parameter are set as intake volume 18m3/ h, 60 DEG C of inlet air temperature, spray gun air pressure 0.06MPa, wriggling revolution speed
15rpm carries out granule coating, dries after coating at 60 DEG C to get spiramvcin coated granule；
(3) the spiramvcin coated granule prepared in colloidal silicon dioxide, xanthan gum, saccharin sodium and step (2) is taken to add
Enter to mix 30min in Mixers with Multi-direction Movement to get spiramvcin dry suspensoid agent.
Embodiment 3
Present embodiment discloses the preparation methods of another spiramvcin dry suspensoid agent:
A kind of spiramvcin dry suspensoid agent, consists of the following compositions:
Spiramvcin 40-70 parts by weight, lactose 10-25 parts by weight, microcrystalline cellulose 8-15 parts by weight, ethyl cellulose are mixed
Suspension 3-6 parts by weight, colloidal silicon dioxide 2-5 parts by weight, talcum powder 2-5 parts by weight, Utech 10-20 parts by weight, dodecane
Base sodium sulphate 2-5 parts by weight, hydroxypropyl cellulose 2-4 parts by weight, honey element 0.5-1 parts by weight.
It is prepared by the following method:
(1) spiramvcin, lactose, microcrystalline cellulose and colloidal silicon dioxide are placed in wet granulator and are uniformly mixed,
With the ethylcellulose mixed suspension liquid aqueous solution softwood of 15% weight concentration, softwood, which is placed in extrusion spheronization machine, to be squeezed out and round as a ball,
Particle is dry at 55 DEG C, take 60-80 mesh particle to get spiramvcin particle；
(2) step (1) spiramvcin particle is placed in fluidized bed, carries out bottom spray packet with the coating solution of 10% weight concentration
Clothing, fluidized bed parameter are set as intake volume 17m3/ h, 50 DEG C of inlet air temperature, spray gun air pressure 0.05MPa, wriggling revolution speed
12rpm carries out granule coating, dries after coating at 50 DEG C to get spiramvcin coated granule；
(3) the spiramvcin coated granule prepared in colloidal silicon dioxide, xanthan gum, saccharin sodium and step (2) is taken to add
Enter to mix 25min in Mixers with Multi-direction Movement to get spiramvcin dry suspensoid agent.
Embodiment 4
Present embodiment discloses the preparation methods of another spiramvcin dry suspensoid agent:
A kind of spiramvcin dry suspensoid agent, consists of the following compositions:
Spiramvcin 40-70 parts by weight, lactose 10-25 parts by weight, microcrystalline cellulose 8-15 parts by weight, hydroxypropyl methylcellulose
3-6 parts by weight, colloidal silicon dioxide 2-5 parts by weight, silica 2-5 parts by weight, Utech 10-20 parts by weight, dodecyl
Sodium sulphate 2-5 parts by weight, xanthan gum 2-4 parts by weight, Sucralose 0.5-1 parts by weight.
It is prepared by the following method:
(1) spiramvcin, lactose, microcrystalline cellulose and colloidal silicon dioxide are placed in wet granulator and are uniformly mixed,
With the hydroxypropyl methylcellulose aqueous solution softwood of 10% weight concentration, softwood is placed in extrusion and round as a ball, general in extrusion spheronization machine
Grain is dry at 50 DEG C, takes 60-80 mesh particle to get spiramvcin particle；
(2) step (1) spiramvcin particle is placed in fluidized bed, carries out bottom spray packet with the coating solution of 15% weight concentration
Clothing, fluidized bed parameter are set as intake volume 16m3/ h, 55 DEG C of inlet air temperature, spray gun air pressure 0.04MPa, wriggling revolution speed
14rpm carries out granule coating, dries after coating at 55 DEG C to get spiramvcin coated granule；
(3) the spiramvcin coated granule prepared in colloidal silicon dioxide, xanthan gum, Sucralose and step (2) is taken
It is added in Mixers with Multi-direction Movement and mixes 20min to get spiramvcin dry suspensoid agent.
Embodiment 5
Present embodiment discloses the preparation methods of another spiramvcin dry suspensoid agent:
A kind of spiramvcin dry suspensoid agent, consists of the following compositions:
Spiramvcin 40-70 parts by weight, lactose 10-25 parts by weight, microcrystalline cellulose 8-15 parts by weight, povidone 3-6 weight
Measure part, colloidal silicon dioxide 2-5 parts by weight, hard magnesium 2-5 parts by weight, Utech 10-20 parts by weight, stearic acid 2-5 weight
Part, xanthan gum 2-4 parts by weight, acesulfame potassium 0.5-1 parts by weight.
It is prepared by the following method:
(1) spiramvcin, lactose, microcrystalline cellulose and colloidal silicon dioxide are placed in wet granulator and are uniformly mixed,
With the povidone aqueous solution softwood of 12% weight concentration, softwood, which is placed in extrusion spheronization machine, to be squeezed out and round as a ball, by particle 55
It is dry at DEG C, take 60-80 mesh particle to get spiramvcin particle；
(2) step (1) spiramvcin particle is placed in fluidized bed, carries out bottom spray packet with the coating solution of 12% weight concentration
Clothing, fluidized bed parameter are set as intake volume 18m3/ h, 55 DEG C of inlet air temperature, spray gun air pressure 0.05MPa, wriggling revolution speed
15rpm carries out granule coating, dries after coating at 55 DEG C to get spiramvcin coated granule；
(3) the spiramvcin coated granule prepared in colloidal silicon dioxide, xanthan gum, acesulfame potassium and step (2) is taken to add
Enter to mix 30min in Mixers with Multi-direction Movement to get spiramvcin dry suspensoid agent.
It is dissolved out being done in water according to spiramvcin dry suspensoid agent made from the preparation method of embodiment 1 with spiramvcin capsule
Degree experiment:
It is measured according to Chinese Pharmacopoeia (2015 editions) general rule 0931, wherein spiramvcin dry suspensoid agent is the second method paddle method, spiral shell
Rotation mycin capsule is the first method basket method, and medium volume 900ml, divides by 37.5 DEG C ± 0.5 DEG C, digestion instrument revolving speed 50rpm of medium temperature
Not in 5min, 10min, 15min, 30min, 45min, 60min are sampled detection, add the water of same volume after sampling simultaneously,
Sample 0.45um filtering with microporous membrane, takes subsequent filtrate 2ml into 50ml volumetric flask, adds dissolution medium to scale, with ultraviolet point
Light photometry measures absorbance in wavelength 232mm, calculates two kinds of dosage forms in different medium, the dissolution rate of different time and drafting
Dissolution profiles.
Spiramvcin dry suspensoid agent made from preparation method according to embodiment 1 and spiramvcin capsule dissolution rate in water
Data are as shown in table 1.
Table 1:
| Sample time (min) | 5 | 10 | 15 | 30 | 45 | 60 |
| Spiramvcin dry suspensoid agent | 3.46 | 5.17 | 7.40 | 10.98 | 15.65 | 18.05 |
| Spiramvcin capsule | 26.73 | 38.13 | 51.95 | 71.91 | 75.31 | 76.68 |
It dissolves out and writes music in spiramvcin dry suspensoid agent made from preparation method according to embodiment 1 and spiramvcin capsule water
Line is as shown in Figure 1.
Spiramvcin dry suspensoid agent made from preparation method according to embodiment 1 and spiramvcin capsule are in pH6.8 medium
Middle dissolution data is as shown in table 2.
Table 2:
| Sample time (min) | 5 | 10 | 15 | 30 | 45 | 60 |
| Spiramvcin dry suspensoid agent | 38.67 | 54.92 | 83.76 | 96.42 | 98.11 | 98.63 |
| Spiramvcin capsule | 44.08 | 59.50 | 85.31 | 97.04 | 98.65 | 99.27 |
Shown in spiramvcin dry suspensoid agent made from preparation method according to embodiment 1 and spiramvcin capsule 2.?
Dissolution profiles are as schemed in pH6.8 medium
Spiramvcin dry suspensoid agent made from preparation method according to embodiment 1 and spiramvcin capsule are in pH4.5 medium
Middle dissolution data is as shown in table 3.
Table 3:
| Sample time (min) | 5 | 10 | 15 | 30 | 45 | 60 |
| Spiramvcin dry suspensoid agent | 56.24 | 85.89 | 96.21 | 98.94 | 99.15 | 99.72 |
| Spiramvcin capsule | 52.61 | 84.50 | 94.45 | 97.26 | 98.41 | 98.03 |
Spiramvcin dry suspensoid agent made from preparation method according to embodiment 1 and spiramvcin capsule are in pH4.5 medium
Middle Dissolution profiles are as shown in Figure 3.
Spiramvcin dry suspensoid agent made from preparation method according to embodiment 1 and spiramvcin capsule are in pH1.0 medium
Middle dissolution data is as shown in table 4.
Table 4:
| Sample time (min) | 5 | 10 | 15 | 30 | 45 | 60 |
| Spiramvcin dry suspensoid agent | 67.28 | 89.51 | 97.37 | 98.60 | 98.83 | 99.04 |
| Spiramvcin capsule | 65.03 | 84.90 | 96.22 | 97.14 | 98.00 | 98.41 |
Spiramvcin dry suspensoid agent made from preparation method according to embodiment 1 and spiramvcin capsule are in pH1.0 medium
Middle Dissolution profiles are as shown in Figure 4.
According to Chinese Pharmacopoeia (2015 editions) require, by spiramvcin dry suspensoid agent prepared by embodiment 1 to embodiment 5 into
Row moisture, sedimentation volume ratio, taste, mouthfeel etc. measurement, measurement result are as shown in table 5:
Table 5:
| Project | Moisture | Sedimentation volume ratio | Taste | Mouthfeel |
| Standard | ≤ 2.0% | ≥0.90 | / | / |
| Embodiment 1 | 1.3% | 0.92 | Without bitter taste, sugariness is moderate | Without sand type |
| Embodiment 2 | 0.8% | 0.96 | Without bitter taste, sugariness is moderate | Without sand type |
| Embodiment 3 | 1.1% | 0.98 | Without bitter taste, sugariness is moderate | Without sand type |
| Embodiment 4 | 1.0% | 0.97 | Without bitter taste, sugariness is moderate | Without sand type |
| Embodiment 5 | 0.9% | 0.94 | Without bitter taste, sugariness is moderate | Without sand type |
By above-mentioned experimental data it is found that the spiramvcin coated granule that according to the present invention prepared by the preparation method, is adding
Add spiramvcin dry suspensoid agent obtained after a certain proportion of suspending agent and sweetener, without any bitter taste when taking after mixing it with water, and has most
Good sweet taste and mouthfeel, while particle sedimentation also complies with requirement.
The present invention compensates for the deficiency of existing preparation, while bitterness and sand type when effective solution is taken in mouthfeel
The problem of, it is easy to the old patient for being especially difficult to swallow with child patient and takes.
The series of detailed descriptions listed above only for feasible embodiment of the invention specifically
Protection scope bright, that they are not intended to limit the invention, it is all without departing from equivalent implementations made by technical spirit of the present invention
Or change should all be included in the protection scope of the present invention.
It is obvious to a person skilled in the art that invention is not limited to the details of the above exemplary embodiments, Er Qie
In the case where without departing substantially from spirit or essential attributes of the invention, the present invention can be realized in other specific forms.Therefore, no matter
From the point of view of which point, the present embodiments are to be considered as illustrative and not restrictive, and the scope of the present invention is by appended power
Benefit requires rather than above description limits, it is intended that all by what is fallen within the meaning and scope of the equivalent elements of the claims
Variation is included within the present invention.
In addition, it should be understood that although this specification is described in terms of embodiments, but not each embodiment is only wrapped
Containing an independent technical solution, this description of the specification is merely for the sake of clarity, and those skilled in the art should
It considers the specification as a whole, the technical solutions in the various embodiments may also be suitably combined, forms those skilled in the art
The other embodiments being understood that.
Claims (8)
1. spiramvcin dry suspensoid agent, which is characterized in that consist of the following compositions:
Spiramvcin 40-70 parts by weight, lactose 10-25 parts by weight, microcrystalline cellulose 8-15 parts by weight, adhesive 3-6 parts by weight,
Glidant 2-5 parts by weight, lubricant 2-5 parts by weight, Utech 10-20 parts by weight, surfactant 2-5 parts by weight, suspending agent
2-4 parts by weight and sweetener 0.5-1 parts by weight；
It is prepared by the following method:
(1) spiramvcin, lactose, microcrystalline cellulose and glidant are placed in wet granulator and are uniformly mixed, with 10-20% weight
Measure concentration water-soluble bonding agent softwood, softwood be placed in extrusion spheronization machine squeeze out and it is round as a ball, by particle at 50-60 DEG C do
It is dry, take 60-80 mesh particle to get spiramvcin particle；
(2) step (1) spiramvcin particle is placed in fluidized bed, carries out bottom spray packet with the coating solution of 5-15% weight concentration
Clothing, fluidized bed parameter are set as intake volume 15-18m3/ h, it is 45-60 DEG C of inlet air temperature, spray gun air pressure 0.04-0.06MPa, compacted
Dynamic revolution speed 10-15rpm, carries out granule coating, dries after coating at 45-60 DEG C to get spiramvcin coated granule；
(3) take the spiramvcin coated granule prepared in glidant, suspending agent, sweetener and step (2) that Multidirectional motion is added
Mixing 20-30min is in mixing machine to get spiramvcin dry suspensoid agent.
2. spiramvcin dry suspensoid agent according to claim 1, wherein described adhesive is povidone, ethyl cellulose
One of suspension, hydroxypropyl cellulose and hydroxypropyl methylcellulose are a variety of.
3. spiramvcin dry suspensoid agent according to claim 1, wherein the coating solution in the step (2) is by especially
The aqueous solution that odd 10-20 parts by weight, surfactant 2-5 parts by weight and lubricant 2-5 parts by weight are formulated.
4. spiramvcin dry suspensoid agent according to claim 1, wherein the glidant is colloidal silicon dioxide and dioxy
One of SiClx is a variety of.
5. spiramvcin dry suspensoid agent according to claim 1, wherein the lubricant be hard magnesium, talcum powder and
One of silica is a variety of.
6. spiramvcin dry suspensoid agent according to claim 1, wherein the surfactant is lauryl sodium sulfate
With one of stearic acid or a variety of.
7. spiramvcin dry suspensoid agent according to claim 1, wherein the suspending agent is xanthan gum, hydroxy propyl cellulose
One of element, Arabic gum are a variety of.
8. spiramvcin dry suspensoid agent according to claim 1, wherein the sweetener is acesulfame potassium, honey element, trichlorine
One of sucrose and saccharin sodium are a variety of.
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| Publication number | Priority date | Publication date | Assignee | Title |
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