CN104840499B - A kind of XIAOAIPING PIAN and preparation method thereof - Google Patents
A kind of XIAOAIPING PIAN and preparation method thereof Download PDFInfo
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Abstract
The present invention provides a kind of preparation methods of Marsdenia tenacissima extract, it is to soak in water CAULIS MARSDENIAE TENACISSIMAE, and decompression is extracted, and extract is by Ultramicro-powder or micronization to get Marsdenia tenacissima extract；Wherein depressurize the condition of extraction are as follows: extract vacuum degree -0.08~-0.09mpa, Extracting temperature is controlled at 65 ± 5 DEG C.The present invention also provides a kind of XIAOAIPING PIANs and preparation method thereof.It avoids the advantage of the invention is that being extracted using decompression by the destruction of normal pressure Extracting temperature chemical component caused by higher, guarantee that heat-sensitive ingredients are destroyed from high temperature decoction in medicinal material, it can be reduced the precipitation of many big molecular impurities such as starch, tannic acid, lymphatic temperament etc., again convenient for the molding and stabilization of preparation；Avoiding particle obtained by other method of granulating using compression granulation is not rough surface, and large specific surface area is exactly that quality is loose, heap density is small etc. to cause tablet friability poor, difference of hardness, surface irregularity such as are not easy to be coated at the problem of of influencing drug quality and appearance.XIAOAIPING PIAN drug ingedient produced by the present invention is stablized, and resistance to water soak is good, and content is uniform, and tablet weight variation is stablized, and hardness is big, and friability is good, unilateral smooth and beautiful appearance.
Description
Technical field
The present invention relates to a kind of XIAOAIPING PIANs, belong to drug field.
Background technique
Currently, the method for granulating that herbal pharmaceutical enterprise generally uses includes wet granulation, dry granulation, spraying granulation, stream
Change bed granulation etc..Wherein wet process granule includes the various ways such as screw extrusion granulation, oscillating granulation, High Shear Mixer Granulator again.It is raw
Produce the method for granulating suitable according to the selection of the characteristic of required particle.The process pelletized as particle, can reach certain technique
Or the corresponding purpose required in terms of dosage form, almost related to the preparation of all solids preparation and quality, manufactured particle can be
Final molding product is also possible to intermediate.Such as granule, pellet, dripping pill must pass through pelletizing forming；Tablet, capsule
Deng the mobility and compressibility of particle need to be improved by granulation, in order to fill, divided dose and tabletting；And it can be using granulation
Method makes preparation generate expected quick-acting or long-acting etc..
Extraction is one of the technique of Chinese medicine production most critical.Chinese medicine general extraction methods extraction time is long, extracts under normal pressure
Temperature is higher, and if the boiling point of water is 100 DEG C, chemical component is easily destroyed, and is unfavorable for the traditional Chinese medicine extraction of the effective component containing thermal sensitivity.
Since the boiling point of solvent is reduced with the reduction of external atmosphere pressure, decompression is extracted can make solution be in boiling at a lower temperature
State and carry out Dynamic Extraction, not only can guarantee in medicinal material that heat-sensitive ingredients were decocted from high temperature in this way destroys, but also can be reduced many
The precipitation of big molecular impurity such as starch, tannic acid, lymphatic temperament etc., convenient for the molding and stabilization of preparation.Meanwhile passing through Decompression Controlling temperature
Degree extracts, and can find the Extracting temperature under the optimum fluidized state of each constituents of Chinese medicine, for improving extracting technique of Chinese medicine
Status is of great significance.
In the prior art, XIAOAIPING PIAN, State Food and Drug Administration's national drug standards, standard number:
WS3-B-3959-98-2014.Preparation method: taking CAULIS MARSDENIAE TENACISSIMAE to soak in water 12 hours, add water to cook three times, and 2 hours for the first time, second
Secondary 1.5 hours, third time 1 hour merged decoction liquor, and filtration, it is about the clear of 1.23 (70-80 DEG C) that filtrate, which is concentrated into relative density,
The right amount of auxiliary materials such as dextrin and starch are added in cream, mix, and granulation or is dried under reduced pressure (65 DEG C) addition magnesium stearates at 60 DEG C of drying, mixed
Even, tabletting is made 1000, film coating [specification (1)] or sugar coating [specification (2)], or is pressed into 500, film coating
[specification (3)] to get.Usage and dosage: oral.One time 8~10 [specification (1), specification (2)]；An or 4-5 piece [specification
(3)], 3 times a day.Specification: (1) the every slice weight 0.31g of Film coated tablets.(2) sugar coated tablet plate core weight 0.3g.(3) Film coated tablets every
Weight 0.63g.The disadvantage is that this product, using medicinal extract unstable quality made from conventional method, the poor compressibility after granulation leads to tablet
Hardness, friability, lay particular stress on the indexs such as difference and be not easy up to standard, and tablet surface made of suppressing is uneven, influences product matter
Amount.This product bitter taste is denseer, and taking dose is big, and medication time-histories is long, and tablet volume is larger, and dysphagia, patient's compliance is poor, medicine
Effect is also difficult to guarantee.
Summary of the invention
The technical solution of the present invention is to provide a kind of preparation methods of Marsdenia tenacissima extract.Another technical side of the invention
There is provided XIAOAIPING PIAN and preparation methods for case.
The present invention provides a kind of preparation methods of Marsdenia tenacissima extract, it is to soak in water CAULIS MARSDENIAE TENACISSIMAE, and decompression mentions
It takes, extract is by Ultramicro-powder or micronization to get Marsdenia tenacissima extract；Wherein depressurize the condition of extraction are as follows: extract vacuum degree-
0.08~-0.09mpa, Extracting temperature are controlled at 65 ± 5 DEG C.
The amount of water is 5-20 times of medicinal material amount, and soaking time is 6-12 hours.
It is further preferred that the average grain diameter of the ultra micro dusting is 1~9 μm.
It is further preferred that the average grain diameter of the micronization is 5 μm.
The present invention also provides the Marsdenia tenacissima extracts of preparation method preparation.
The present invention also provides a kind of XIAOAIPING PIANs, and it is active constituent that it, which is by the Marsdenia tenacissima extract, are added and divide
Powder is prepared, wherein the weight proportion of CAULIS MARSDENIAE TENACISSIMAE raw material and auxiliary material are as follows:
320 parts of CAULIS MARSDENIAE TENACISSIMAE, 10-40 parts of dispersing agent.
Wherein, the dispersing agent is dextrin, starch.
The present invention also provides a kind of methods for preparing the XIAOAIPING PIAN, it includes the following steps:
A, Marsdenia tenacissima extract is prepared by above-mentioned preparation method；
B, extract and dispersant is uniform, 12.5% water is added and continuess to mix, compression granulation；
C, by particle made from b step, tabletting is coated to get tablet.
Wherein, the granulation of compression described in b step is using twin-screw extruder granulator.
It avoids the advantage of the invention is that being extracted using decompression by normal pressure Extracting temperature chemical component caused by higher
Destroy, guarantee medicinal material in heat-sensitive ingredients from high temperature decoct destroy, and can be reduced many big molecular impurities for example starch, tannic acid,
The precipitation of lymphatic temperament etc., convenient for the molding and stabilization of preparation；It is avoided obtained by other method of granulating using compression granulation
Grain is not rough surface, and large specific surface area is exactly that quality is loose, and heap density is small etc. causes tablet friability poor, difference of hardness, surface
It is uneven, the problem of of influencing drug quality and appearance such as it is not easy to be coated.XIAOAIPING PIAN drug ingedient produced by the present invention is stablized,
Resistance to water soak is good, and content is uniform, and tablet weight variation is stablized, and hardness is big, and friability is good, unilateral smooth and beautiful appearance.
Specific embodiment
The preparation of the XIAOAIPING PIAN of the present invention of embodiment 1
CAULIS MARSDENIAE TENACISSIMAE 1500g is taken, is soaked in water after 12 hours, decompression is extracted 3 times.Vacuum degree -0.08~-0.09mpa is extracted,
Extracting temperature is controlled at 65 ± 5 DEG C, and extract is carried out ultra micro dusting, 5 μm of average grain diameter is crushed to, mixes 10 with starch 20g
Minute, a small amount of water is added and continuess to mix 5 minutes.With twin-screw extruder granulator, (Changzhou China Europe drying and granulating equipment has
Limit company: SET series twin-screw extruder pelletizer), be pressed into 1000 to get.
The preparation of the XIAOAIPING PIAN of the present invention of embodiment 2
CAULIS MARSDENIAE TENACISSIMAE 1500g is taken, is soaked in water after 12 hours, decompression is extracted 3 times.Extract vacuum degree -0.08~-0.09mpa；
Extracting temperature is controlled at 65 ± 5 DEG C, and extract is carried out ultra micro dusting, 3 μm of average grain diameter is crushed to, mixes 10 with starch 15g
Minute, a small amount of water is added and continuess to mix 5 minutes.With twin-screw extruder granulator, be pressed into 1000, sugar coating to get.
The preparation of the XIAOAIPING PIAN of the present invention of embodiment 3
CAULIS MARSDENIAE TENACISSIMAE 1500g is taken, is soaked in water after 12 hours, decompression is extracted 3 times.Extract vacuum degree -0.08~-0.09mpa；
Extracting temperature is controlled at 65 ± 5 DEG C.Extract is subjected to ultra micro dusting, ultra micro dusting is carried out, is crushed to 8 μm of average grain diameter, with
Starch 30g is mixed 10 minutes, and 12.5% water is added and continuess to mix 5 minutes.With twin-screw extruder granulator, it is pressed into
1000, film coating to get.
Beneficial effects of the present invention are further illustrated below by way of comparative test.
The XIAOAIPING PIAN of the present invention of experimental example 1 is micronized partial size selection
It is as a result as follows as described in Example 1 by different micronization partial size screening tests:
The result shows that when partial size is 5 μm, recovery rate and 30 minutes drug-eluting amount highests, and it is significantly better than other grains
Diameter.
The extracting method reduced pressure screening test of the present invention of experimental example 2
Due to vacuum degree corresponding under the boiling temperature of water
| Boiling temperature (DEG C) | 95 | 90 | 85 | 80 | 75 | 70 | 65 | 60 | 55 | 45 |
| Vacuum degree (mpa) | -0.016 | -0.031 | -0.043 | -0.054 | -0.063 | -0.070 | -0.076 | -0.081 | -0.085 | -0.092 |
In the case where water proposes state, temperature can be coordinated between 55-100 degree, and the major parameter of control is vacuum degree, vacuum degree with
Screening situation between temperature is as follows:
Conclusion: CAULIS MARSDENIAE TENACISSIMAE is -0.08~-0.09mpa in vacuum degree, and Extracting temperature is controlled at 65 ± 5 DEG C, chlorogenic acid
Extraction efficiency highest, and the opposite raising 20% or so of content is extracted compared with atmospheric pressure reflux, therefore, the decompression extraction process of CAULIS MARSDENIAE TENACISSIMAE has
It imitates, is stable, feasible.
The experiment of 2 hygroscopicity of experimental example
Each two parts of the different made starch granules of method of granulating are taken, are set in the dry weighing bottle weighed into perseverance respectively,
It is accurately weighed, it is put into 75% container of relative humidity in 25 DEG C of temperature, portion, another is put into 92% container of relative humidity and surveys
Its fixed hygroscopic capacity (the results are shown in Table 1 and table 2).
It is compared using other comparative examples:
Comparative example 1
CAULIS MARSDENIAE TENACISSIMAE 1500g is taken, is soaked in water after 12 hours, decompression is extracted 3 times.Extract vacuum degree be -0.08~-
0.09mpa；Extracting temperature is controlled at 65 ± 5 DEG C, and extract is carried out ultra micro dusting, ultra micro dusting is carried out, is crushed to average grain
It 5 μm of diameter, is mixed with microcrystalline cellulose 24g 15 minutes.With rolling granulator dry granulation, be pressed into 1000 to get.
Comparative example 2
CAULIS MARSDENIAE TENACISSIMAE 1500g is taken, is soaked in water after 12 hours, decompression is extracted 3 times.Extract vacuum degree be -0.08~-
0.09mpa；Extract is carried out ultra micro dusting at 65 ± 5 DEG C by Extracting temperature control, 25 μm of average grain diameter is crushed to, with starch
12g is mixed 5 minutes.It is added 10% starch slurry 80ml (starch-containing 8g), mixes 10 minutes.It is stainless with 16 purpose of oscillating granulator
Steel sieve granulation, be pressed into 1000 to get.
Comparative example 3
CAULIS MARSDENIAE TENACISSIMAE 1500g is taken, is soaked in water after 12 hours, decompression is extracted 3 times.Extract vacuum degree be -0.08~-
0.09mpa；Extracting temperature is controlled at 65 ± 5 DEG C, and extract is carried out ultra micro dusting, ultra micro dusting is carried out, is crushed to average grain
It 5 μm of diameter, is mixed with lactose 48g 15 minutes.With bed spray drying and granulating, the starch slurry that adhesive used is 6% is (containing shallow lake
Powder 5g).Be pressed into 1000 to get.
Comparative example 4
CAULIS MARSDENIAE TENACISSIMAE 1500g is taken, is soaked in water after 12 hours, decompression is extracted 3 times.Extraction vacuum degree is 0-0.1mpa；It extracts
Temperature is controlled at 65 ± 5 DEG C, and extract is carried out ultra micro dusting, 50 μm of average grain diameter is crushed to, mixes 10 points with dextrin 40 g
Clock is added 12.5% water and continuess to mix 5 minutes.With twin-screw extruder granulator, it is pressed into 1000, sugar coating, i.e.,
?.
1 variable grain hygroscopicity of table investigates result table (RH=75%)
2 variable grain hygroscopicity of table investigates result table (RH=92%)
By moisture absorption data it is found that the resistance to water soak of embodiment 1 is best, that is, compress method, the dispersing agent starch of granulation
And it is best using the particle hygroscopicity pulverized.
3 disintegration time limited of experimental example and assay
(1) disintegration time limited: instrument: ZB-1D disintegration tester
Method: according to 2010 editions I D of annex of Chinese Pharmacopoeia measurement to get.
(2) assay:
Instrument: LC-10A high performance liquid chromatograph；BP211D electronic balance (German Startorious)；SZ-93 type is automatic
Dual pure water distiller；Electronic thermostatic water-bath；KQ250E type ultrasonic cleaner；III type circulating water type of SHZ- is mostly used vacuum
Pump.
Method: it is measured according to high performance liquid chromatography (one the first method of annex IL of Chinese Pharmacopoeia version in 2010).
Chromatographic condition and system suitability are taken off with octadecylsilane bonded silica for filler, with -0.5% phosphorus of acetonitrile
Acid solution (8:92) is mobile phase, Detection wavelength 324nm.Theoretical cam curve is calculated by ortho acid peak should be not less than 5000.
The preparation of reference substance solution takes chlorogenic acid reference substance appropriate, and stable precision is set in brown bottle, and 50% methanol is added to be made
Solution of every 13ml containing 36ug to get.
The preparation of test solution takes this product 10, and sugar coated tablet removes coating, and stable precision is finely ground, takes about 1g accurate steady
It is fixed, it sets in stuffed conical flask, 50% methanol 25ml, close plug is added in precision, and stable weight is ultrasonically treated (power 250w, frequency
40kHz) 40 minutes, let cool, then stable weight, supply less loss weight with 50% methanol, shake up, filter, take subsequent filtrate to get.
Measuring method is accurate respectively to draw reference substance solution 5-10ul, test solution 10ul, injects liquid chromatograph, surveys
It is fixed to get.
The XIAOAIPING PIAN and commercially available XIAOAIPING PIAN prepared in the process of the present invention by above-mentioned (1), the comparison of (2) method of inspection
Disintegration time limited and assay discovery, it is flat that the commercially available cancer that disappears is significantly less than with XIAOAIPING PIAN disintegration time limited prepared by the present invention
Piece, and the amount containing chlorogenic acid of XIAOAIPING PIAN prepared by the present invention is apparently higher than commercially available XIAOAIPING PIAN, can effectively ensure that such medicine
The quick release of object finished product preparation and the finiteness safety of medication.
3 disintegration time limited of table and assay result
| Inspection project | Disintegration time limited (min) | Assay |
| Embodiment 1 | 15 | Every amount containing chlorogenic acid is 0.19mg |
| Embodiment 2 | 18 | Every amount containing chlorogenic acid is 0.16mg |
| Embodiment 3 | 20 | Every amount containing chlorogenic acid is 0.18mg |
| Commercially available XIAOAIPING PIAN | 27 | Every amount containing chlorogenic acid is 0.12mg |
4 tablet weight variation of experimental example, hardness, friability, appearance test
Instrument: CJY-300B type tablet friability somascope, YPJ-200B type tablet hardness instrument, electronic balance.
Method: friability shines two Ⅹ G of annex of Chinese Pharmacopoeia version in 2010；Appearance, tablet weight variation shine Chinese Pharmacopoeia 2010
One I D of annex of version.
4 tablet weight variation of table, hardness, friability, appearance test
Shown by above-mentioned experiment: XIAOAIPING PIAN obtained by the present invention, superior in quality stabilization and smooth in appearance beauty, greatly
The quality of product and the compliance of patient are improved greatly.
Claims (6)
1. a kind of preparation method of Marsdenia tenacissima extract, it is characterised in that: it is to soak in water CAULIS MARSDENIAE TENACISSIMAE, and decompression is extracted, and is mentioned
Take object by Ultramicro-powder or micronization to get Marsdenia tenacissima extract；Wherein the amount of water is 5-20 times of medicinal material amount, is impregnated
Time is 6-12 hours；
Depressurize the condition extracted are as follows: extract vacuum degree -0.08~-0.09mpa, Extracting temperature is controlled at 55 ± 5 DEG C；
The average grain diameter of the ultra micro dusting is 5 μm.
2. the Marsdenia tenacissima extract of claim 1 preparation method preparation.
3. a kind of XIAOAIPING PIAN, it is characterised in that: it is active constituent that it, which is by Marsdenia tenacissima extract as claimed in claim 2, is added
Enter dispersing agent to be prepared, wherein the weight proportion of CAULIS MARSDENIAE TENACISSIMAE raw material and auxiliary material are as follows:
320 parts of CAULIS MARSDENIAE TENACISSIMAE, 10-40 parts of dispersing agent.
4. XIAOAIPING PIAN according to claim 3, it is characterised in that: the dispersing agent is dextrin, starch.
5. a kind of method for preparing XIAOAIPING PIAN described in claim 3 or 4, it includes the following steps:
A, by CAULIS MARSDENIAE TENACISSIMAE, the water that 5-20 times of amount of dosing material impregnates, after impregnating 6-12 hours；Decompression extract, extract vacuum degree be-
0.08~-0.09mpa, Extracting temperature are controlled at 55 ± 5 DEG C；Extract is passed through into Ultramicro-powder or micronization, ultra micro dusting is put down
Equal partial size is 1~9 μm to get Marsdenia tenacissima extract；
B, the Marsdenia tenacissima extract for obtaining a step and dispersant are uniform, and 12.5% water is added and continuess to mix, compression system
Grain；
C, by particle made from b step, tabletting is coated to get tablet.
6. the preparation method of XIAOAIPING PIAN according to claim 5, it is characterised in that: compression described in b step, which is pelletized, is
Using twin-screw extruder granulator.
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| CN105878319A (en) * | 2016-05-08 | 2016-08-24 | 通化振霖药业有限责任公司 | Xiaoaiping tablet and preparation method thereof |
| CN108926619B (en) * | 2018-09-04 | 2021-06-08 | 湖南时代阳光药业股份有限公司 | Preparation method of infant spleen-supporting granules |
| CN115737695A (en) * | 2022-11-17 | 2023-03-07 | 乐泰药业有限公司 | Pharmaceutical preparation for treating various malignant tumors, leukemia and chronic bronchitis, and its preparation method and quality control method |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1372971A (en) * | 2002-03-21 | 2002-10-09 | 张平 | Chinese-medicinal injection for treating cancer |
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2015
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1372971A (en) * | 2002-03-21 | 2002-10-09 | 张平 | Chinese-medicinal injection for treating cancer |
Non-Patent Citations (3)
| Title |
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| 中药减压提取工艺探讨;马庆宇等;《黑龙江科技信息》;20090515(第14期);第88页正文第1栏第3段-第3栏第1段 |
| 乌骨藤及其制剂的研究进展;张文平等;《齐鲁药事》;20060528;第25卷(第05期);第293-295页 |
| 超微粉碎技术及其在中药制剂中的应用;李红菊等;《中国药剂学杂志》;20060315;第4卷(第2期);第51页第1段，1.2节，第52页1.6节 |
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