CN104069170B - A kind of leaves of pulse plants courage method for preparing drop pills - Google Patents
A kind of leaves of pulse plants courage method for preparing drop pills Download PDFInfo
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- CN104069170B CN104069170B CN201410301910.3A CN201410301910A CN104069170B CN 104069170 B CN104069170 B CN 104069170B CN 201410301910 A CN201410301910 A CN 201410301910A CN 104069170 B CN104069170 B CN 104069170B
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Abstract
A kind of leaves of pulse plants courage method for preparing drop pills, took the pig gall acid starting material and Macrogol 6000 auxiliary material of 60 mesh respectively by recipe quantity, be put into mixer, it is sufficiently mixed, in mixed material input melting cylinder, heating fusing, finely dispersed light decoction is obtained simultaneously in fusing medium.Regulation recipe quantity patchouli oil is added under stirring, after dripping pill medicinal liquid agitating is uniform, by decoction under certain heat-retaining condition, instills in the cooling oil tubulation with certain temperature gradient to control speed, collects shaping dripping pill, centrifugation removes cooling oil, collects dripping pill.Dripping temperature of the present invention is no more than 85 DEG C, and the volatilization of effective flavour of a drug patchouli oil is wandered away and can also substantially reduced.The present invention halves material heated time compared with powder charging technology.
Description
Technical field
The present invention relates to solid dispersion drug preparation, and in particular to a kind of leaves of pulse plants courage method for preparing drop pills belongs to Chinese medicine preparation
Technical field.
Background technology
Pill is a kind of solid dispersions (Soild dispertion).So-called solid dispersions refer to material dispersed
(including various states of matters) be dispersed in solid state medium formation a kind of compounding substances, it is therein it is material dispersed can with molecule,
Ion or particulate state is disperseed.Solid dispersions are widely used as a kind of delivery system in modern pharmaceutical,
After solid or liquid medicine heat fusing mixing with matrix, instill in not miscible condensate liquid, shrink and condense and manufactured system
Agent, mainly for oral application.This drop method pelletizing process, solid dispersions are actually made to the form of dripping pill.
Dropping preparation method pill starts from vitamin A, D balls prepared by Denmark pharmaceutical factory in 1933.The country starts from 1958.In recent years, close
Application into, semi-synthetic matrix and solid dispersion technology makes pill have rapid development, particularly in new product of Chinese herbal medicine
Very big development is achieved in exploitation.《Chinese Pharmacopoeia》Version in 1977 takes the lead in recording drops, and nineteen ninety-five version records pill 9
Kind, version in 2000, versions in 2005 and version in 2010 are substantially to increase, the Chinese medicine drop of existing State Food and Drug Administration's issue
Ball authentication code has nearly 100 kinds, wherein the Chinese medicine dripping pills for cardiovascular system have more than 20 to plant.
Traditional Chinese Medicine Dropping Pill is just being increasingly subject to the attention of people, and it employs the advanced preparation means of Western medicine, is disperseed with solid
Dripping pill prepared by technology is that a kind of Chinese medicine preparation fully contacts with mucomembranous surface, and effective component of chinese medicine passes through mucous membrane upper surface cell
Absorb, directly enter people's circulatory system administering mode Chinese patent medicine preparation formulation, its protrusion the characteristics of it is straight such as without liver
Connect and be absorbed into blood circulation system, be effectively prevented from first pass effect, have curative effect it is rapid, bioavilability height, Small side effects,
The characteristics of medication facilitates sublingual administration, absorb more preferably, work faster.
Leaves of pulse plants courage dripping pill is initially by the factory of Shanghai Chinese medicine one the end of the seventies, in ancient prescription " clear liver guarantor's brain ball " (alias huodan pill) base
The novel form formed is researched and developed on plinth, it is punished by hyocholic acid and the taste medicine of patchouli oil (Pogostemon cablin) two
Composition, have heat-clearingization turbid, declare clearing the nasal passage effect, for chillization heat, caused nasal obstruction is attacked on courage fire and owes logical, nasosinusitis headache.
Existing leaves of pulse plants courage dripping pill quality standard is recorded rises the ear nose larynx in national standard part in Chinese patent drug provincial standard
In dept. of dermatology of section fascicle, its newest standard of becoming a full member is corrected to prescription flavour of a drug title, and " palchouli oil " before changing is " wide
Palchouli oil " (WS-11486 (ZD-1486) -2002-2012Z).There is binomial discriminating in standard, be that thin layer differentiates in palchouli oil respectively
Hundred autumns in hyodesoxycholic acid in alcohol and hyocholic acid；It is that the hyodesoxycholic acid in hyocholic acid is detected using thin layer chromatography scanning containing surveying
(>=2.7mg/ balls).
The preparation method of leaves of pulse plants courage dripping pill is first to dissolve by heating hyocholic acid with a small amount of ethanol, is then added to the poly- second melted
In glycol 6000 and it is sufficiently mixed, is eventually adding patchouli oil, instills in the dimethyl-silicon oil medium through cooling and be molded after mixing,
Surface oil stain is removed, is produced.
A small amount of ethanol is used in above-mentioned standard technique, but ethanol herein is not used as drug prescription composition, and be only
Acted on for hydrotropy is first played to hyocholic acid.Actual conditions are that the polyethylene glycol of fusing is added to by the hyodesoxycholic acid after hydrotropy
And 0.5-1 hours are stirred under keeping warm mode, most of ethanol can be volatilized in feed liquid, but can confirm that ethanol still can be
It is detained in dripping pill.The presence of ethanol can decline the cohesive force of dripping pill medium, cause dropping pill formulation hardness partially soft frangible, more not
Profit is dripping pill is leached duration, and this causes the leaves of pulse plants courage dripping pill under legal process conditions to be difficult to reach dropping pill formulation new standard
The technical requirements of (country in 2005 improves dropping pill formulation standard, it is specified that it can not add baffle plate when leaching time limit measure).
It is demonstrated experimentally that reducing amount of alcohol added or being not added with the method for ethanol to prepare leaves of pulse plants courage dripping pill, can solve dripping pill
It is partially soft, leach the quality problems such as duration, but this still has inconvenience and unfavorable factor in actual production operation.
By taking " less plus ethanol " as an example, hyocholic acid is first reconciled into slurry with ethanol, then in a continuous manner, slowly put into
Into the polyethylene glycol melted, to make hyocholic acid is dispersed need to often change the long period.
According to " being not added with ethanol " scheme, i.e., fed intake with hyocholic acid powder, then because the water-insoluble feature of hyocholic acid can make
This raw material floats on polyethylene glycol liquid level, so as to force the powder process that feeds intake to be added with slower speed, while in order to improve
Hyocholic acid dissolves dispersion effect, can often properly increase polyethylene glycol holding temperature, this also can the security of drug in itself bring
Potential danger, because polyethylene glycol can produce thermal-oxidative degradation more than 100 DEG C, produce formic acid compound and carboxylate, first therein
It can be generated in acidization with formaldehyde intermediate.
Obviously how to shorten hyocholic acid solution time and auxiliary material polyethylene glycol heated time under non high temperature state is this
The problem of invention to be paid close attention to.
The content of the invention
It is above-mentioned present in prior art to overcome it is an object of the present invention to provide a kind of leaves of pulse plants courage method for preparing drop pills
Shortcoming and defect.
The present invention breaks the normal procedure operation order, it is proposed that low-temperature mixed-thawing integral process.So-called low temperature " mixing-
Thawing " integration refers to that the Macrogol 6000 of pig gall acid starting material and powdery fully mixes in advance, then feeds intake, low-temperature heat is melted
Change, you can obtain dispersed pig gall acid polyethylene glycol liquid.Then adding patchouli oil just can start the preparation of dripping pill, whole work
The temperature control of skill process avoids being higher than 100 DEG C at 70-85 DEG C.
Technical problems to be solved needed for the present invention, it can be achieved through the following technical solutions：
A kind of leaves of pulse plants courage method for preparing drop pills, it is characterised in that comprise the following steps：
(1) pig gall acid starting material and polyethylene glycol auxiliary material are taken respectively, is put into mixer, is sufficiently mixed, and mixed material is made；
(2) in the mixed material input melting cylinder prepared step (1), heating fusing, divided simultaneously in fusing medium
Dissipate uniform light decoction；
(3) patchouli oil is added under stirring, dripping pill decoction is made, dripping pill medicinal liquid agitating is uniform；
(4) by dripping pill decoction under heat-retaining condition, control drop speed, instill in the cooling oil tubulation of thermograde, collect into
Type dripping pill；
(5) centrifugation removes cooling oil, collects dripping pill, i.e. finished product.
In step (1), the hyocholic acid is 60 mesh powders, and dosage is 2~3kg.The polyethylene glycol is molecular mass
Macrogol 6000 g/mol, dosage is 15~16kg.
In step (2), the temperature of the fusing is 70~85 DEG C.
In step (3), 2~3kg of amount of the patchouli oil.
In step (4), start dripping under 70~85 DEG C of heat-retaining conditions.The drop speed is per minute 30~60 drops.It is described
Cooling oil tubulation has thermograde, 30~40 DEG C of cooling oil liquid level temperature, 3~5 DEG C of bottom temp.
Further, the cooling oil tubulation is equipped with cooling oil, and the cooling oil uses dimethicone, and kinematic viscosity is
100~150 centistoke (mm2/ s).
Beneficial effects of the present invention：
The maximum feature of present invention process is that polyethylene glycol fusing and hyocholic acid mixed synchronization are carried out, and this both shortens material
Heated time, and can obtain finely dispersed stable emulsion decoction at a lower temperature, so as to avoid high temperature to polyethylene glycol
Possessed potentiality is destroyed, it is ensured that the security of medicine in itself.Because dripping temperature is no more than 85 DEG C, effective wide leaves of pulse plants of flavour of a drug
The volatilization of sesame oil is wandered away and can also substantially reduced.Compared with powder charging technology, the present invention can halve material heated time.
Dissolved for hyocholic acid under cryogenic or scattered bad " worry ", done binomial process certification experiment.
The dripping pill decoction prepared by new process is taken, 3 hours are stood first under the conditions of low-temperature insulation, as a result finds dripping pill decoction not
Appearance precipitates or lamination.The subsequent dripping pill decoction crosses 60 mesh sieves, and as a result decoction can illustrate that dripping pill decoction emulsifies by mesh screen
In order, hyocholic acid is dispersed is not a problem.
Embodiment
Below in conjunction with specific embodiment example, make progressive explanation to the present invention.It should be understood that following examples example is merely to illustrate
The present invention is not for restriction the scope of the present invention.
Leaves of pulse plants courage dripping pill quality evaluation obtained by preparation technology of the present invention is with rules of preparations in current edition Chinese Pharmacopoeia (2010)
For foundation, with reference to active ingredient in the medicine：Hyodesoxycholic acid, patchouli oil and in hundred autumns alcohol content measure make synthesis it is objective
Judge.
Hyodesoxycholic acid determines in the leaves of pulse plants courage dripping pill of embodiment 1
Determined according to high performance liquid chromatography (D of annex VI of Chinese Pharmacopoeia 2010 edition).
Chromatographic condition is filler with octadecylsilane chemically bonded silica with system suitability test；The ice vinegar of acetonitrile -0.1%
Acid (50:50) it is mobile phase；EISD.Number of theoretical plate is calculated with hyodesoxycholic acid peak should be not less than 3500.
The preparation precision of reference substance solution, which weighs, is dried under reduced pressure the hyodesoxycholic acid reference substance of 24 hours through phosphorus pentoxide
In right amount, it is accurately weighed, add methanol that solution of every 1ml containing 0.4mg is made, produce.
The preparation of need testing solution takes this product under weight differential item appropriate, finely ground, takes 0.1g, accurately weighed, puts 25ml
In measuring bottle, add methanol 20ml, be ultrasonically treated (power 300W, frequency 50kHz) 10 minutes, take out, let cool, add methanol to scale,
Shake up, considered, take subsequent filtrate, produce.
Determination method is accurate to draw the μ l of reference substance solution 10 and 20 μ l, the μ l of need testing solution 20, injects liquid chromatograph, surveys
It is fixed, calculated, produced with external standard two-point method logarithmic equation.
Patchouli oil determines in the leaves of pulse plants courage dripping pill of embodiment 2
Determined according to gas chromatography (E of Chinese Pharmacopoeia annex VI).
Chromatographic condition and capillary column (column length of the system suitability using 5% methyl-polysiloxane as stationary phase
For 30m, internal diameter 0.32mm, film thickness is 0.25 μm)；Column temperature is temperature programming：120 DEG C of initial temperature, kept for 5 minutes, with
10 DEG C per minute of speed is warming up to 170 DEG C, is kept for 4 minutes；Detector temperature is 280 DEG C, and injector temperature is 280 DEG C；Point
Flow into sample, split ratio 10:1.Number of theoretical plate is calculated by patchouli oil peak should be not less than 5000.
The preparation of reference substance solution compares product with patchouli oil raw material, takes in right amount, accurately weighed, adds ethyl acetate to be made
Per solution of the 1ml containing 2mg, produce.
The preparation of need testing solution takes this product 10, accurately weighed, puts in 25ml measuring bottles, with ethyl acetate ultrasonic dissolution simultaneously
Scale is diluted to, is shaken up, as need testing solution.
Determination method is accurate respectively to draw reference substance solution and each 1 μ l of need testing solution, injects gas chromatograph, normalization method is surveyed
It is fixed, produce.
Alcohol content determines in hundred autumns in the leaves of pulse plants courage dripping pill of embodiment 3
Determined according to gas chromatography (E of annex VI).
Chromatographic condition and capillary column (column length of the system suitability using 5% methyl-polysiloxane as stationary phase
For 30m, internal diameter 0.32mm, film thickness is 0.25 μm)；Column temperature is temperature programming：120 DEG C of initial temperature, kept for 5 minutes, with
10 DEG C per minute of speed is warming up to 170 DEG C, is kept for 4 minutes；Detector temperature is 280 DEG C, and injector temperature is 280 DEG C；Point
Flow into sample, split ratio 10:1.Number of theoretical plate is calculated by patchouli alcohol peak should be not less than 5000.
The preparation of reference substance solution takes patchouli alcohol reference substance appropriate, accurately weighed, adds ethyl acetate that every 1ml is made and contains
0.6mg solution, is produced.
The preparation of need testing solution takes this product 10, accurately weighed, puts in 25ml measuring bottles, with ethyl acetate ultrasonic dissolution simultaneously
Scale is diluted to, is shaken up, as need testing solution.
Determination method difference is accurate to draw reference substance solution and each 1 μ l of need testing solution, injects gas chromatograph, determines, i.e.,
.
Mixing-fusing integration system is for leaves of pulse plants courage dripping pill at 470 DEG C of embodiment
The pig gall acid starting material and Macrogol 6000 auxiliary material 2kg and 16kg of 60 mesh were taken respectively, were put into mixer, were filled
Divide mixing, mixed material is put into melting cylinder, heating fusing, and finely dispersed light decoction is obtained simultaneously melting medium.
2kg patchouli oils are added under stirring, after stirring, start dripping under 70 DEG C of heat-retaining conditions.With per minute 50 drop speed
It is 100 centistoke (mm that degree, which instills equipped with cooling, kinematic viscosity,2/ s) dimethicone colonnade in, cooling oil liquid level temperature
35 DEG C of degree, 3 DEG C of bottom temp.Dripping pill is collected, top layer cooling oil is removed, finished product dripping pill 19kg can be obtained, yield 95%, ball focuses on
Between 45-55mg, average ball weight 50mg, the time limit is leached 12 minutes, content every is containing hyodesoxycholic acid, patchouli oil and in hundred autumns
Alcohol is respectively 3.1mg, 4.2mg and 0.98.
Mixing-fusing integration system is for leaves of pulse plants courage dripping pill at 585 DEG C of embodiment
Remaining is the same as embodiment 1.
Mixing-fusing integration system is for leaves of pulse plants courage dripping pill at 6100 DEG C of embodiment
Remaining is the same as embodiment 1.
The contrast test of embodiment 7：Tradition prepares leaves of pulse plants courage dripping pill at 115 DEG C
Remaining is the same as embodiment 1.
The experiment that embodiment 8 contrasts：Tradition prepares leaves of pulse plants courage dripping pill at 130 DEG C
Remaining is the same as embodiment 1.
The experiment of new technology and old process ration, which is taken, consistent is not added with ethanol (or less plus ethanol) scheme, result of the test hair
Existing dripping pill has significant difference in outward appearance and total patchouli oil binomial, is specifically shown in table 1 below.
The old and new's process sample quality control assays' result of table 1.
It is partially white in new technology sample appearance, and old powder charging technology color sample is partially yellow；Contain in total patchouli oil
In amount, guarantor's oil mass of patchouli oil is apparently higher than old process sample in new technology dripping pill.
It is after January it has been observed that new by above-mentioned contrast test Samples EXAMPLE accelerated test (40 DEG C, 75% relative humidity)
Technique (70,85,100 DEG C) three sample appearance color and lusters change without conspicuousness, still in yellowish translucent, but are removed in old technique
The sample appearance color and luster prepared under the conditions of 70 DEG C becomes outside the pale of civilization without conspicuousness, and it is in yellow sample (85,100,115 that remaining 4 original
With 130 DEG C of techniques) significant changes but occur, color and luster starts to turn to white, wherein 130 DEG C of process sample whiting degree are most deep, together
When also found that dripping pill sample has " chip " to come off.Dripping pill sample in accelerated test whitens, and illustrates to have in dripping pill and volatilizees
Oil is wandered away.Volatile oil is that one group of homologue is formed, and its rule of volatilizing is that the light oil heavy oil that gets ahead is careful.And (white is solid for alcohol in hundred autumns
Body) it is " heavy oil " in patchouli oil volatile oil, comparatively volatilization is slow, and " light oil " to get ahead can cause alcohol in " heavy oil " hundred autumn
Content tends to rise, and this matches with the measurement result of accelerated test sample.In view of the stability of hyodesoxycholic acid physicochemical property,
This experiment is not carried out to it containing survey.Specific data are shown in Table 2.
The old and new's process sample accelerated test in the January result of table 2.
| Sample index | Outward appearance | Total patchouli oil | Alcohol in hundred autumns |
| 70 DEG C of new technologies | Yellow-white | 3.8mg/ grain | 1.15mg/ grain |
| 85 DEG C of new technologies | Yellow-white | 3.6 | 1.18 |
| 100 DEG C of new technologies | It is light yellow | 3.4 | 1.21 |
| 70 DEG C of old techniques | It is light yellow | 3.5 | 1.20 |
| 85 DEG C of old techniques | It is light yellow | 2.8 | 1.22 |
| 100 DEG C of old techniques | Shallow white | 2.5 | 1.25 |
| 115 DEG C of old techniques | White | 2.4 | 1.40 |
| 130 DEG C of old techniques | White | 2.3 | 1.53 |
The reason for analyzing above-mentioned new, old process sample mass change, it is believed that most basic is heated in dripping pill preparation process
Caused by temperature height and the change of heated time length.
The embodiment of the present invention is illustrated above, but the present invention is not limited thereto, without departing from
Spirit of the invention, the present invention can also have various change.
Claims (7)
1. a kind of leaves of pulse plants courage method for preparing drop pills, it is characterised in that comprise the following steps：
(1) pig gall acid starting material and polyethylene glycol auxiliary material are taken respectively, is put into mixer, is sufficiently mixed, and mixed material is made；
(2) in the mixed material input melting cylinder prepared step (1), heating fusing, obtained simultaneously in fusing medium scattered equal
Even light decoction；
(3) patchouli oil is added under stirring, dripping pill decoction is made, dripping pill medicinal liquid agitating is uniform；
(4) by dripping pill decoction under heat-retaining condition, control drop speed, instill in the cooling oil tubulation of thermograde, collect shaping drop
Ball；
(5) centrifugation removes cooling oil, collects dripping pill, i.e. finished product；
In step (2), the temperature of the fusing is 70~85 DEG C；
In step (4), start dripping under 70~85 DEG C of DEG C of heat-retaining conditions.
A kind of 2. leaves of pulse plants courage method for preparing drop pills according to claim 1, it is characterised in that：In step (1), the hyocholic acid
For 60 mesh powders, dosage is 2~3kg.
A kind of 3. leaves of pulse plants courage method for preparing drop pills according to claim 1, it is characterised in that：In step (1), the poly- second two
Alcohol is molecular mass 6000g/mol polyethylene glycol, and dosage is 15~16kg.
A kind of 4. leaves of pulse plants courage method for preparing drop pills according to claim 1, it is characterised in that：In step (3), the Pogostemon cablin
2~3kg of amount of oil.
A kind of 5. leaves of pulse plants courage method for preparing drop pills according to claim 1, it is characterised in that：In step (4), the drop speed is
30~60 drop per minute.
A kind of 6. leaves of pulse plants courage method for preparing drop pills according to claim 1, it is characterised in that：In step (4), the cooling oil
Tubulation has thermograde, 30~40 DEG C of cooling oil liquid level temperature, 3~5 DEG C of bottom temp.
A kind of 7. leaves of pulse plants courage method for preparing drop pills according to claim 6, it is characterised in that：The cooling oil tubulation is equipped with cold
Oily, the cooling oil uses dimethicone, and kinematic viscosity is 100~150 centistokes.
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| CN106539690B (en) * | 2015-09-18 | 2020-08-04 | 天士力医药集团股份有限公司 | Continuous intelligent preparation method of liquid cooling dropping pills |
| CN113218480B (en) * | 2020-04-14 | 2022-10-11 | 浙江大学 | Method for characterizing pill weight of dropping pills |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1626134A (en) * | 2003-12-11 | 2005-06-15 | 天津天士力制药股份有限公司 | Medication for treating chronic rhinitis and nasal sinuitis |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1626134A (en) * | 2003-12-11 | 2005-06-15 | 天津天士力制药股份有限公司 | Medication for treating chronic rhinitis and nasal sinuitis |
Non-Patent Citations (1)
| Title |
|---|
| 藿胆丸质量分析;高国峰;《中国医药工业杂质》;20130710;第44卷(第7期);第705-708页 * |
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