CN105943537B - Compouneded anisodamine neostigmine sustained release tablets and preparation method thereof - Google Patents
Compouneded anisodamine neostigmine sustained release tablets and preparation method thereof Download PDFInfo
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- CN105943537B CN105943537B CN201610484439.5A CN201610484439A CN105943537B CN 105943537 B CN105943537 B CN 105943537B CN 201610484439 A CN201610484439 A CN 201610484439A CN 105943537 B CN105943537 B CN 105943537B
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
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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
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/27—Esters, e.g. nitroglycerine, selenocyanates of carbamic or thiocarbamic acids, meprobamate, carbachol, neostigmine
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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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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Abstract
The invention discloses a kind of sustained release tablets and preparation method thereof being made of anisodamine and neostigmine compound, the sustained release tablets, component including following weight fraction ratio: 10~20 parts of anisodamine, neostigmine: 0.01~1 part, 5~50 parts of sustained-release matrix material, lubricant: 0.3~5 part, 1~20 part of adhesive, diluent: 1~15 part, disintegrating agent: 1~50 part, 1~50 part of filler.Sustained release tablets release of the invention is steady; reduce administration number of times using sustained release tablets of the present invention, action time increases; improve the compliance of patient; reduce the excessively high caused side effect of Cmax; this product preparation process is simple, and cost is relatively low, easily controllable; it is appropriate to the scale of chemical production, there is biggish application value.
Description
Technical field
The invention belongs to technical field of pharmaceuticals, in particular to a kind of Compouneded anisodamine neostigmine sustained release tablets and its preparation
Method.
Background technique
Abroad in Recent Years the study found that cholinergic anti-inflammatory pathway be adjust immune system a kind of neurophysiological mechanism, resist
Scorching signal reaches the reticuloendothelial systems such as spleen, liver and gastrointestinal tract, subsequent vagus nerve release through descending vagal efferent
Acetylcholine, the alpha 7 nicotinic acetylcholine receptors (α 7nAchR) with macrophage and other cytokine secreting cell surfaces
Interaction, inhibits the synthesis and release of proinflammatory cytokine, control inflammation reaction, prevents tissue damage.We are in recent years
Clinical research and animal experiment also confirm that, use anticholinesterase (methyl-sulfuric acid neostigmine) and gallbladder simultaneously by a certain percentage
Alkali energy m receptor blocking agent (racemization Tangut Anisodus Radix) has " cholinergic anti-inflammatory pathway " of enhancing vagal mediation, activates α 7
The effect of nAchR.But the half-life period of methyl-sulfuric acid neostigmine and 654-2 in vivo is shorter, and (methyl-sulfuric acid neostigmine half-life period is
0.89~1.2 hour, 654-2 was only 40 minutes), the needs for continuing anti-inflammatory treatment in vivo are unable to satisfy, there is no both at home and abroad at present
Any research of the compound sustained-released tablet of both 654-2 and neostigmine is reported.
Summary of the invention
It is new up to 12 hours Compouneded anisodamines that technical problem to be solved by the invention is to provide a kind of slow release effects
This bright sustained release tablets and preparation method thereof.
The technical solution provided by the present invention is: a kind of Compouneded anisodamine neostigmine sustained release tablets, including following weight
The component of portion rate:
10~20 parts of anisodamine,
Neostigmine: 0.01~1 part,
5~50 parts of sustained-release matrix material,
Lubricant: 0.3~5 part,
1~20 part of adhesive,
Diluent: 1~15 part,
Disintegrating agent: 1~50 part,
Filler: 1~50 part.
The sustained-release matrix material is HPMC-K4M, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, HPMC-
It is K15M, HPMC-K100M, sodium alginate 420, ethyl cellulose M7, polyvinyl acetate/polyvinylpyrrolidone mixture, hard
One in resin acid, hydrogenated castor, the mixed matrix of HPMC and compritol 888, hydroxypropyl-β-cyclodextrin and polyethylene glycol mixed matrix
It plants or any two kinds is used in mixed way.
The lubricant is one of magnesium stearate, talcum powder, superfine silica gel powder or a variety of.
The adhesive is polyvinylpyrrolidone, starch, pregelatinized starch, sodium carboxymethylcellulose, gelatin, poly- second
One of glycol, ethyl cellulose, hydroxypropylcellulose, methylcellulose, sucrose solution, ethyl alcohol are a variety of.
The diluent is one of pregelatinized starch, sucrose, starch, dextrin, lactose or a variety of.
The filler and disintegrating agent is microcrystalline cellulose.
The anisodamine and this new mass ratio are (100~2000): 1
Above-mentioned anisodamine neostigmine compound slow-release tablet, preferred component slice prescription are as follows:
16.67 parts of anisodamine,
Neostigmine: 0.03 part,
K4M:20 parts of HPMC,
Magnesium stearate: 0.7 part,
PVP K30: 15 parts,
Pregelatinized starch: 8 parts,
Microcrystalline cellulose: 39.6 parts.
Above-mentioned anisodamine neostigmine compound slow-release tablet, another preferred component slice prescription are as follows:
16.67 parts of anisodamine,
Neostigmine: 0.03 part,
K4M:15 parts of HPMC,
Magnesium stearate: 0.7 part,
PVP K30: 15 parts,
Pregelatinized starch: 8 parts,
Microcrystalline cellulose: 44.6 parts.
The present invention also provides the preparation methods of the anisodamine neostigmine compound slow-release tablet, and this method includes following
Step:
(1) it stocks up: by anisodamine, neostigmine, sustained-release matrix material, diluent, filler and disintegrating agent mistake respectively
100 meshes are spare；
(2) it mixes: the raw material after above-mentioned sieving being mixed 30 minutes, fine drug powder is made, it is spare；
(3) wet granulation: adhesive is dissolved in distilled water, is mixed with said medicine fine powder, with 20 mesh nylon screen systems
Grain, it is rear to carry out 60 degrees Celsius of drying one hour；
(4) total mix: granulation is taken out, lubricant mixing 30 minutes is added；
(5) total mixture obtained tabletting: is subjected to tabletting to get Compouneded anisodamine neostigmine sustained release tablets.
Methyl-sulfuric acid neostigmine and anisodamine (654-2) are clinically common old medicines, and wherein 654-2 is cholinergic mind
Through blocking agent, smooth muscle can be made obviously to relax, and vasopasm can be released to improve microcirculation, clinic is mainly used for Poisoning body
Gram, release gastrointestinal smooth muscle spasmus caused by colic pain；Neostigmine is anticholinesterase, is clinically used for myasthenia gravis
With hand postoperative delayed intestinal tympanites and the retention of urine etc..The Compouneded anisodamine neostigmine sustained release tablets of this patent research mainly pass through
Enhance " cholinergic anti-inflammatory pathway " of vagal mediation to adjust the inflammatory reaction of body, it is excessive for treating body immunity
Various diseases caused by abnormal response.
The invention has the following advantages:
Compouneded anisodamine neostigmine sustained release tablets release of the invention is steady: anisodamine release limit is to release for 1 hour
Put 70% or more the release in 50~80%, 8 hours of release in 20~40%, 4 hours, 12 hours 90% or more (see Fig. 1) of release；Neostigmine
Discharge limit be 1 hour release 20~40%, 4 hours release 50~80%, 8 hours release 80% or more, 12 hours release 90% with
Upper (see Fig. 2)；Common anisodamine piece discharged completely (see Fig. 3) substantially at 4 hours.Use sustained release tablets of the invention make to
Medicine number is reduced, action time increases, and improves the compliance of patient, reduces the excessively high caused side effect of Cmax, this product system
Standby simple process, cost is relatively low, easily controllable, is appropriate to the scale of chemical production, there is biggish application value.
Detailed description of the invention
Fig. 1 is the result of anisodamine dissolution rate in Compouneded anisodamine neostigmine sustained release tablets；
Fig. 2 is the result of neostigmine dissolution rate in Compouneded anisodamine neostigmine sustained release tablets；
Fig. 3 is the dissolution results of commercially available Racanisodamine piece.
Specific embodiment
The present invention is described in further detail below with reference to examples and drawings, but embodiments of the present invention are not limited to
This.
Embodiment 1: the preparation of Compouneded anisodamine neostigmine sustained release tablets
1. the formula (based on 1000) of sustained release tablets: by weight, 16.67 parts of anisodamine, neostigmine: 0.03 part,
K4M:20 parts of HPMC, magnesium stearate: 0.7 part, PVP K30: 15 parts, pregelatinized starch: 8 parts, microcrystalline cellulose
Element: 39.6 parts.
2. the preparation method of sustained release tablets:
(1) it stocks up: anisodamine, neostigmine, HPMC K4M, pregelatinized starch, microcrystalline cellulose is crossed into 100 mesh respectively
It sieves spare；
(2) it mixes: by anisodamine, neostigmine, HPMC K4M, pregelatinized starch, the microcrystalline cellulose after above-mentioned sieving
Element mixing 30 minutes, is made fine drug powder, spare；
(3) wet granulation: PVP K30 is dissolved in distilled water, is mixed with said medicine fine powder, with 20 mesh
Nylon screen granulation, it is rear to carry out 60 degrees Celsius of drying one hour；
(4) total mix: granulation is taken out, magnesium stearate mixing 30 minutes is added；
(5) total mixture obtained tabletting: is subjected to tabletting to get Compouneded anisodamine neostigmine sustained release tablets.
Embodiment 2: the preparation of Compouneded anisodamine neostigmine sustained release tablets
1. the prescription (based on 1000) of sustained release tablets: by weight, 16.67 parts of anisodamine, neostigmine: 0.03 part,
K4M:15 parts of HPMC, magnesium stearate: 0.7 part, PVP K30: 15 parts, pregelatinized starch: 8 parts, microcrystalline cellulose
Element: 44.6 parts.
2. the preparation method of sustained release tablets:
(1) it stocks up: anisodamine, neostigmine, HPMC K4M, pregelatinized starch, microcrystalline cellulose is crossed into 100 mesh respectively
It sieves spare；
(2) it mixes: by anisodamine, neostigmine, HPMC K4M, pregelatinized starch, the microcrystalline cellulose after above-mentioned sieving
Element mixing 30 minutes, is made fine drug powder, spare；
(3) wet granulation: PVP K30 is dissolved in distilled water, is mixed with said medicine fine powder, with 20 mesh
Nylon screen granulation, it is rear to carry out 60 degrees Celsius of drying one hour；
(4) total mix: granulation is taken out, magnesium stearate mixing 30 minutes is added；
(5) total mixture obtained tabletting: is subjected to tabletting to get Compouneded anisodamine neostigmine sustained release tablets.
Embodiment 3: the research of anisodamine dissolution rate in Compouneded anisodamine neostigmine sustained release tablets
Referring to anisodamine tablet dissolution detection method (" Chinese Pharmacopoeia " version in 2015), using paddle method, with 0.1mol/L salt
Acid solution 900ml be dissolution medium, revolving speed be 50 revs/min, temperature setting be 37 DEG C, respectively measurement dissolution after 1,2,4,8,10,
12 hours dissolution rates.Method be each time point take solution 10ml, filter, and with take out solution same volume it is synthermal
0.1mol/L hydrochloric acid solution supplies dissolution medium, and precision measures subsequent filtrate 20ul, liquid chromatograph is injected, with octadecylsilane
Bonded silica gel is filler, 0.01mol/L potassium dihydrogen phosphate (contain 0.15% triethylamine, with phosphoric acid adjust Ph value to 6.5)-
Methanol (70:30) is mobile phase, and Detection wavelength 220nm records chromatogram；Racanisodamine reference substance is separately taken, precision claims
Calmly, add dissolution medium to dissolve and quantify dilution and solution of every 1ml containing 50ug is made, inject liquid chromatograph with method, record chromatography
Figure.Dissolution rate that is suitable with Racanisodamine by external standard method, transisomer peak area and calculating every.As shown in Figure 1, limit
Degree is 70% or more the release in 50~80%, 8 hours of release in 20~40%, 4 hours of release in 1 hour, 90% or more release in 12 hours.
Embodiment 4: the research of neostigmine dissolution rate in Compouneded anisodamine neostigmine sustained release tablets
With embodiment 3, using paddle method, using 0.1mol/L hydrochloric acid solution 900ml as dissolution medium, revolving speed is 50 revs/min, temperature
Degree is set as 37 DEG C, 1,2,4,8,10,12 hour dissolution rate after measurement dissolves out respectively.Method is that each time point takes solution
10ml, filtration, and dissolution medium is supplied with the 0.1mol/L hydrochloric acid solution synthermal with solution same volume is taken out, precision measures continuous
Filtrate 20ul injects liquid chromatograph, using octyl silane group silica gel as filler, 0.05mol/L potassium dihydrogen phosphate
(adjusting Ph value to 3.0 with phosphoric acid)-acetonitrile (87:13) (sodium heptanesulfonate containing 0.0015mol/L) is mobile phase, and Detection wavelength is
215nm records chromatogram；Neostigmine reference substance separately is taken, it is accurately weighed, add dissolution medium to dissolve and quantify dilution and is made often
Solution of the 1ml containing 50ug injects liquid chromatograph with method, records chromatogram.It is every with neostigmine calculated by peak area by external standard method
The dissolution rate of piece.As shown in Fig. 2, limit be 1 hour release 20~40%, 4 hours release 50~80%, 8 hours release 80% with
On, 90% or more release in 12 hours.
Embodiment 5: the research of commercially available Xiao Xuan Shan Lang henbane alkali tablet dissolution
With embodiment 3, using paddle method, using 0.1mol/L hydrochloric acid solution 900ml as dissolution medium, revolving speed is 50 revs/min, temperature
Degree is set as 37 DEG C, 1,2,4,8,10,12 hour dissolution rate after measurement dissolves out respectively.Method is that each time point takes solution
10ml, filtration, and dissolution medium is supplied with the 0.1mol/L hydrochloric acid solution synthermal with solution same volume is taken out, precision measures continuous
Filtrate 20ul injects liquid chromatograph, and using octadecylsilane chemically bonded silica as filler, 0.01mol/L potassium dihydrogen phosphate is molten
Liquid (contains 0.15% triethylamine, adjusting Ph value to 6.5)-methanol (70:30) with phosphoric acid is mobile phase, Detection wavelength 220nm, note
Record chromatogram；Racanisodamine reference substance separately is taken, it is accurately weighed, add dissolution medium to dissolve and quantify dilution every 1ml is made and contains
The solution of 50ug injects liquid chromatograph with method, records chromatogram., the transisomer suitable with Racanisodamine by external standard method
Peak area and calculating every dissolution rate.As shown in figure 3, release in 1 hour discharges 80~95%, 8 hours for 60~80%, 4 hours
92% or more release.
Above-described embodiment 3 compares with 5, embodies the persistence of Fu Fang Shan Lang henbane alkali neostigmine sustained release tablets release and steady
It is qualitative.Embodiment of the present invention are not limited by the above embodiments, other any without departing from Spirit Essence of the invention
With changes, modifications, substitutions, combinations, simplifications made under principle, equivalent substitute mode should be, be included in of the invention
Within protection scope.
Claims (5)
1. a kind of Compouneded anisodamine neostigmine sustained release tablets, it is characterised in that: in parts by mass, the sustained release tablets include following
Component:
10~20 parts of anisodamine,
Neostigmine: 0.01~1 part,
15~20 parts of sustained-release matrix material,
Lubricant: 0.3~0.7 part,
15 parts of adhesive,
Diluent: 8 parts,
Filler and disintegrating agent: 39.6~50 parts；
Wherein the sustained-release matrix material is HPMC K4M,
The lubricant is magnesium stearate,
The adhesive is polyvinylpyrrolidone,
The diluent is pregelatinized starch,
The filler and disintegrating agent is microcrystalline cellulose.
2. Compouneded anisodamine neostigmine sustained release tablets according to claim 1, it is characterised in that: anisodamine and it is new this
Bright mass ratio be 100~2000:1.
3. Compouneded anisodamine neostigmine sustained release tablets according to claim 1, it is characterised in that: the compound mountain Liang
The component formula of henbane alkali neostigmine sustained release tablets are as follows:
16.67 parts of anisodamine,
Neostigmine: 0.03 part,
K4M:20 parts of HPMC
Magnesium stearate: 0.7 part,
PVP K30: 15 parts,
Pregelatinized starch: 8 parts,
Microcrystalline cellulose: 39.6 parts.
4. Compouneded anisodamine neostigmine sustained release tablets according to claim 1, it is characterised in that: the compound mountain Liang
The component formula of henbane alkali neostigmine sustained release tablets are as follows:
16.67 parts of anisodamine,
Neostigmine: 0.03 part,
K4M:15 parts of HPMC
Magnesium stearate: 0.7 part,
PVP K30: 15 parts,
Pregelatinized starch: 8 parts,
Microcrystalline cellulose: 44.6 parts.
5. the preparation method of Compouneded anisodamine neostigmine sustained release tablets, feature described in Claims 1 to 4 any one exist
In: the following steps are included:
Stock: anisodamine, neostigmine, sustained-release matrix material, diluent, filler and disintegrating agent are sieved with 100 mesh sieve respectively
It is spare；
Mixing: the raw material after above-mentioned sieving being mixed 30 minutes, fine drug powder is made, spare；
Wet granulation: adhesive is dissolved in distilled water, is mixed with said medicine fine powder, is pelletized with 20 mesh nylon screens, laggard
60 degrees Celsius of row dry one hour；
Total mix: granulation is taken out, lubricant mixing 30 minutes is added；
Tabletting: total mixture obtained is subjected to tabletting to get Compouneded anisodamine neostigmine sustained release tablets.
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| CN102258492B (en) * | 2010-05-24 | 2012-12-26 | 重庆医科大学 | Neostigmine bromide slow release preparation and its preparation method |
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Effective date of registration: 20230224 Address after: No. 188, Meishan Meiliang Road, Binhu District, Wuxi City, Jiangsu Province, 214000 Patentee after: Wuxi round road medical science and Technology Research Institute Co.,Ltd. Address before: Tomorrow Home, No.25, Taiping Road, Haidian District, Beijing, 100853 Patentee before: Gu Wanqing |