CN110007020A - A kind of preparation of white peony root dispensing granule primary standard substance and method of quality control - Google Patents
A kind of preparation of white peony root dispensing granule primary standard substance and method of quality control Download PDFInfo
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- CN110007020A CN110007020A CN201910263820.2A CN201910263820A CN110007020A CN 110007020 A CN110007020 A CN 110007020A CN 201910263820 A CN201910263820 A CN 201910263820A CN 110007020 A CN110007020 A CN 110007020A
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- Prior art keywords
- peony root
- white peony
- primary standard
- standard substance
- dispensing granule
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/04—Preparation or injection of sample to be analysed
- G01N30/06—Preparation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/37—Extraction at elevated pressure or temperature, e.g. pressurized solvent extraction [PSE], supercritical carbon dioxide extraction or subcritical water extraction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
Abstract
The invention discloses a kind of preparation of white peony root dispensing granule primary standard substance and method of quality control; using radix paeoniae alba decoction pieces as raw material; by water decoct twice, be concentrated under reduced pressure, white peony root dispensing granule primary standard substance is made in the process flows such as dry, global quality control is carried out using high performance liquid chromatography.The present invention is on the basis of motherland's Chinese Traditional Medicine decoction, in conjunction with modern times freeze-drying, diaphragm vacuum and low temperature concentration high technology equipment, pharmaceutical technology and high-efficient liquid phase chromatogram technology, and refer to Radix Paeoniae Alba chemical constitution study, the research of family's decocting process, the research of HPLC characteristic spectrum are carried out to Radix Paeoniae Alba, obtain a kind of reference substance that can be used as white peony root dispensing granule and arrange quality control.The substance can help to realize full constituents extraction, Manufacturing science, quality controllable, and Radix Paeoniae Alba Chinese medicinal granule and family that large-scale production may be implemented decoct the Appreciation gist of curative effect consistency, guarantee Chinese medicinal granule quality.The substance has preparation simply, and health is convenient for storage.
Description
Technical field
The present invention relates to the preparation of traditional Chinese medicine product technical field more particularly to a kind of white peony root dispensing granule primary standard substance and
Method of quality control.
Background technique
Radix Paeoniae Alba, it is bitter in taste, sour, slightly cold, there is the effect of nourishing blood for regulating menstruation, astringing YIN to stop sweating, soft liver analgesic, suppressing liver-YANG, use
In blood deficiency chlorosis, irregular menstruation, spontaneous perspiration, night sweat, hypochondriac pain, abdominal pain, four limbs contraction pain, headache and dizziness.
Radix Paeoniae Alba is used as medicine with medicine materical crude slice, before use the mode of decoction taken, and The Quality of Sliced Herbal Medicine is unstable can not
Control decocts quality and is difficult to ensure, takes inconvenience, be not easy to store.And Chinese medicinal granule is to meet the high-quality of concocted specification
Medicinal material (prepared slices of Chinese crude drugs) is raw material, is extracted, is concentrated using modern high technology, product system class made of granulation, guaranteed in original
The nature and flavor feature of medicine.But how to guarantee quality of the white peony root dispensing granule in the case where losing medicine materical crude slice appearance character and decocted with family
The consistency for boiling curative effect, there is presently no a reasonable controls, so the method that we imitate family's decoction, dry using freezing
The method of dry and diaphragm vacuum and low temperature concentration prepares white peony root dispensing granule primary standard substance, establishes its HPLC with high performance liquid chromatography
Characteristic spectrum arranges the reference of quality control as white peony root dispensing granule.
Summary of the invention
The object of the invention is to remedy the disadvantages of known techniques, provides a kind of system of white peony root dispensing granule primary standard substance
Standby and method of quality control.
The present invention is achieved by the following technical solutions:
A kind of preparation method of white peony root dispensing granule primary standard substance, the preparation of the white peony root dispensing granule primary standard substance, use are cold
The dry method combined with the concentration of diaphragm vacuum and low temperature is lyophilized to be made.
The preparation method of the white peony root dispensing granule primary standard substance, specifically includes the following steps:
(1) radix paeoniae alba decoction pieces are weighed, first decocts the water for adding 8-10 times of medicine materical crude slice amount to measure, and first impregnates 30min, is cooked by slow fire again after boiling
30min filters to isolate decoction liquor while hot, and the second pan-fried plus 6-8 times amount water decocts 30min, merges decoction liquor, mix, spare；
(2) step 1 gained medical fluid is taken, vacuum degree -0.090-0.099 is adjusted, is concentrated into the clear of 1.07-1.09 at 65 DEG C or less
Cream, it is spare；
(3) step 2 gained clear cream is placed in the stainless steel disc of certain specification, is placed in freeze drier, closed door-plate and open
Refrigeration waits baffle temperature to be down to target temperature, transfers the program of formula access, opens vacuum pump, temperature control and formula and opens
It closes, is freeze-dried, after freeze-drying, close vacuum pump, open vent valve, pump pressure reaches normal pressure, closes refrigeration, fast
Speed opens door-plate, collects sample, sealing.
It is kept for 4 hours in the freezing dry process prior to -45 DEG C, keeps then at -10 DEG C 2 hours, finally protected in 40 DEG C
It holds 55 hours.
The present invention also provides a kind of method of quality control of white peony root dispensing granule primary standard substance, and quality control is using efficient
Liquid chromatography establishes the HPLC characteristic spectrum of white peony root dispensing granule primary standard substance.
The method of quality control, comprising the following steps:
(1) this product powder 0.1g is taken, it is accurately weighed, it sets in 25ml measuring bottle, methanol ultrasound 30min is added；It stands, filters, respectively
It is filtered with miillpore filter, filtrate is as test sample；
(2) Paeoniflorin 0.6mg is taken, is placed in 10ml volumetric flask, scale is dissolved and be settled to methanol, as object of reference；
(3) it is tested using high performance liquid chromatography, it is accurate respectively to draw test solution, contrast solution 5-10 μ l, inject chromatography
Instrument is measured according to following chromatographic condition:
Using octadecylsilane chemically bonded silica as filler；Mobile phase presses following mobile phase binary gradient elutes:
| Time (min) | A acetonitrile (%) | B water [being 3.0 with phosphoric acid tune pH] (%) |
| 0 | 10 | 90 |
| 5 | 15 | 85 |
| 25 | 18 | 82 |
| 27 | 30 | 70 |
| 38 | 35 | 65 |
| 40 | 40 | 60 |
| 50 | 40 | 60 |
Flow velocity: 1.0ml/min；Column temperature: 25 DEG C；Detection wavelength: 230nm；Number of theoretical plate should be not less than by the calculating of Paeoniflorin peak
2000；
(4) by step 3 measurement result, analysis comparison is carried out, establishes the HPLC characteristic spectrum of white peony root dispensing granule primary standard substance.
The aperture of miillpore filter is 0.45 μm in the method for quality control step 1.
The invention has the advantages that
High-tech is concentrated on the basis of motherland's Chinese Traditional Medicine decoction, in conjunction with modern times freeze-drying, diaphragm vacuum and low temperature in the present invention
Skill equipment, pharmaceutical technology and high-efficient liquid phase chromatogram technology, and Radix Paeoniae Alba chemical constitution study is referred to, family is carried out to Radix Paeoniae Alba and decocts work
Skill research, the research of HPLC characteristic spectrum obtain a kind of reference substance that can be used as white peony root dispensing granule and arrange quality control.It should
Substance can help to realize full constituents extraction, Manufacturing science, quality controllable, and the Radix Paeoniae Alba Chinese medicine preparation of large-scale production may be implemented
Particle and family decoct the Appreciation gist of curative effect consistency, guarantee Chinese medicinal granule quality.The substance has preparation simple, defends
Storage is convenient in life.
Detailed description of the invention
Fig. 1 show white Peony Root, medicine materical crude slice and standard decoction HPLC characteristic spectrum.
Specific embodiment
Below in conjunction with specific example, technical scheme is described further:
Embodiment 1
The preparation of Radix Paeoniae Alba primary standard substance granule:
(1) raw material is weighed: radix paeoniae alba decoction pieces 6666g；
(2) radix paeoniae alba decoction pieces are put into cooking pot for herbs, decocted twice, added 9 times of medicine materical crude slice amount of water for the first time, impregnate 30 minutes, decoct 30
Minute, second plus 7 times of water of medicine materical crude slice amount decoct 30 minutes, and medical fluid filtration, filtrate merges, and is pumped into concentration tank, and (vacuum is concentrated
Spend -0.090~-0.099MPa), be concentrated into relative density be 1.07-1.09(65 DEG C) clear cream, it is spare；
(3) step 2 gained clear cream is taken, gained clear cream is placed in the stainless steel disc of certain specification, is placed in freeze drier, closes
Door-plate opens refrigeration, and baffle temperature is waited to be down to target temperature, transfers the program of formula access, opens vacuum pump, temperature control
It switchs, is freeze-dried, concrete operations are shown in Table 1 with formula:
The design of 1 lyophilisation condition of table
| Segment number | Target temperature DEG C | Hour | Minute | Control |
| 1 | -45 | 4 | 0 | 0 |
| 2 | -10 | 2 | 0 | 30 |
| 3 | 40 | 55 | 0 | 10 |
Freeze-drying terminates, and closes vacuum pump, opens vent valve, and pump pressure reaches normal pressure, closes refrigeration, opens door-plate rapidly, receives
Collect sample, sealing；
(4) step 3 gained dried cream powder is crushed, crosses 80 meshes；It is first packed with 10 grams of polyethylene, then packed with 50 grams of full aluminium bags
(50g/ bags of loading amount) is to get finished product.
Embodiment 2
The method of quality control of white peony root dispensing granule primary standard substance HPLC characteristic spectrum:
(1) this product powder 0.1g is taken, it is accurately weighed, it sets in 25ml measuring bottle, methanol ultrasound 30min is added；It stands, filters, respectively
It is filtered with miillpore filter (0.45 μm of aperture), filtrate is as test sample.
(2) Paeoniflorin 0.6mg is taken, is placed in 10ml volumetric flask, scale is dissolved and be settled to methanol, as object of reference；
(3) accurate respectively to draw for examination referring to four 0512 high performance liquid chromatography of the general rule tests of " Chinese Pharmacopoeia " version in 2015
Product solution, contrast solution 5-10 μ l, injecting chromatograph are measured according to following chromatographic condition；
Using octadecylsilane chemically bonded silica as filler；Mobile phase presses mobile phase binary gradient elutes (such as table 2)；Flow velocity:
1.0ml/min；Column temperature: 25 DEG C；Detection wavelength: 230nm；Number of theoretical plate is calculated by Paeoniflorin peak should be not less than 2000；
2 mobile phase elution requirement of table
| Time (min) | A acetonitrile (%) | B water [being 3.0 with phosphoric acid tune pH] (%) |
| 0 | 10 | 90 |
| 5 | 15 | 85 |
| 25 | 18 | 82 |
| 27 | 30 | 70 |
| 38 | 35 | 65 |
| 40 | 40 | 60 |
| 50 | 40 | 60 |
(4) by step 3 measurement result, analysis comparison is carried out, is carried out with the HPLC characteristic spectrum of white peony root dispensing granule primary standard substance
Control.
As shown in Figure 1, showing to contain Radix Paeoniae Alba ingredient in test sample.
Embodiment 3
Moisture, extract and assay measurement in white peony root dispensing granule primary standard substance:
To moisture, extract and assay in the white peony root dispensing granule primary standard substance of 3 batches prepared in aforementioned manners into
Row detection.Moisture is detected according to a conventional method.Determination of extractives is according to the hot dipping under ethanol soluble extractives measuring method item
(four general rules 2201 of " Chinese Pharmacopoeia " version in 2015) measurement, uses ethanol as solvent.Assay is according to (" Chinese Pharmacopoeia " 2015
Year version one) the lower measuring method of Radix Paeoniae Alba.Every inspection result is as shown in table 3, shows that indices comply with standard.
The every testing result of table 3
| Lot number | Moisture | Extract | Paeoniflorin content (%) |
| 1 | 4.8 | 54.05 | 11.45 |
| 2 | 4.2 | 49.63 | 8.85 |
| 3 | 4.3 | 39.37 | 12.35 |
Claims (6)
1. a kind of preparation method of white peony root dispensing granule primary standard substance, which is characterized in that the white peony root dispensing granule primary standard substance
Preparation, it is obtained with the method that combines of diaphragm vacuum and low temperature concentration using freeze-drying.
2. the preparation method of white peony root dispensing granule primary standard substance according to claim 1, which is characterized in that specifically include with
Lower step:
(1) radix paeoniae alba decoction pieces are weighed, first decocts the water for adding 8-10 times of medicine materical crude slice amount to measure, and first impregnates 30min, is cooked by slow fire again after boiling
30min filters to isolate decoction liquor while hot, and the second pan-fried plus 6-8 times amount water decocts 30min, merges decoction liquor, mix, spare；
(2) step 1 gained medical fluid is taken, vacuum degree -0.090-0.099 is adjusted, is concentrated into the clear of 1.07-1.09 at 65 DEG C or less
Cream, it is spare；
(3) step 2 gained clear cream is placed in the stainless steel disc of certain specification, is placed in freeze drier, closed door-plate and open
Refrigeration waits baffle temperature to be down to target temperature, transfers the program of formula access, opens vacuum pump, temperature control and formula and opens
It closes, is freeze-dried, after freeze-drying, close vacuum pump, open vent valve, pump pressure reaches normal pressure, closes refrigeration, fast
Speed opens door-plate, collects sample, sealing.
3. according to claim 1 or the preparation method of 2 described in any item white peony root dispensing granule primary standard substances, which is characterized in that
It is kept for 4 hours in the freezing dry process prior to -45 DEG C, keeps then at -10 DEG C 2 hours, finally kept for 55 hours in 40 DEG C.
4. a kind of method of quality control of white peony root dispensing granule primary standard substance, which is characterized in that quality control uses efficient liquid phase
Chromatography establishes the HPLC characteristic spectrum of white peony root dispensing granule primary standard substance.
5. method of quality control according to claim 4, which comprises the following steps:
(1) this product powder 0.1g is taken, it is accurately weighed, it sets in 25ml measuring bottle, methanol ultrasound 30min is added；It stands, filters, respectively
It is filtered with miillpore filter, filtrate is as test sample；
(2) Paeoniflorin 0.6mg is taken, is placed in 10ml volumetric flask, scale is dissolved and be settled to methanol, as object of reference；
(3) it is tested using high performance liquid chromatography, it is accurate respectively to draw test solution, contrast solution 5-10 μ l, inject chromatography
Instrument is measured according to following chromatographic condition:
Using octadecylsilane chemically bonded silica as filler；Mobile phase presses following mobile phase binary gradient elutes:
Flow velocity: 1.0ml/min；Column temperature: 25 DEG C；Detection wavelength: 230nm；Number of theoretical plate should be not less than by the calculating of Paeoniflorin peak
2000；
(4) by step 3 measurement result, analysis comparison is carried out, establishes the HPLC characteristic spectrum of white peony root dispensing granule primary standard substance.
6. method of quality control according to claim 5, which is characterized in that the aperture of miillpore filter is in the step 1
0.45µm。
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|---|---|---|---|
| CN201910263820.2A CN110007020A (en) | 2019-04-03 | 2019-04-03 | A kind of preparation of white peony root dispensing granule primary standard substance and method of quality control |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101474263A (en) * | 2007-12-18 | 2009-07-08 | 北京康仁堂药业有限公司 | White peony root dispensing granule as well as preparation method and quality control method thereof |
| CN102138985A (en) * | 2011-03-22 | 2011-08-03 | 宁波立华制药有限公司 | Quality control method of total glycosides single preparation of white paeony roots |
| CN103405489A (en) * | 2013-07-09 | 2013-11-27 | 安徽济人药业有限公司 | Balloonflower formula granules, and preparation method and quality control method thereof |
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| CN108553519A (en) * | 2018-07-06 | 2018-09-21 | 芜湖天成普阳中药科技有限公司 | Radix Paeoniae Alba is fresh to carry freeze-drying granule pieces |
-
2019
- 2019-04-03 CN CN201910263820.2A patent/CN110007020A/en active Pending
Patent Citations (5)
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|---|---|---|---|---|
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| CN102138985A (en) * | 2011-03-22 | 2011-08-03 | 宁波立华制药有限公司 | Quality control method of total glycosides single preparation of white paeony roots |
| CN103405489A (en) * | 2013-07-09 | 2013-11-27 | 安徽济人药业有限公司 | Balloonflower formula granules, and preparation method and quality control method thereof |
| CN105866296A (en) * | 2016-06-15 | 2016-08-17 | 华润三九医药股份有限公司 | Method for building fingerprint spectrum for radix paeoniae alba pharmaceutic preparation |
| CN108553519A (en) * | 2018-07-06 | 2018-09-21 | 芜湖天成普阳中药科技有限公司 | Radix Paeoniae Alba is fresh to carry freeze-drying granule pieces |
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| 唐晓章 等: "经典名方芍药甘草汤的物质基准量值传递分析", 《中国实验方剂学杂志》 * |
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