CN109700772A - "Xingpi Yanger Granule" and preparation method thereof and method of quality control - Google Patents
"Xingpi Yanger Granule" and preparation method thereof and method of quality control Download PDFInfo
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- CN109700772A CN109700772A CN201910165531.9A CN201910165531A CN109700772A CN 109700772 A CN109700772 A CN 109700772A CN 201910165531 A CN201910165531 A CN 201910165531A CN 109700772 A CN109700772 A CN 109700772A
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Abstract
The present invention relates to a kind of "Xingpi Yanger Granule" and preparation method thereof and method of quality control, the "Xingpi Yanger Granule" is prepared as follows: taking tassel flower, pilose gerbera herb, pittosporum illicioides and the jatamans valeriana rhizome of recipe quantity, 40~60 DEG C of warm water is added to impregnate 0.5h, it decocts 2 times, collecting decoction, filtering are concentrated into the clear cream that relative density is 1.15~1.18 (80 DEG C), auxiliary material is added to pelletize to obtain the final product, this method can be sufficiently reserved effective component；The invention also discloses the method for quality control of "Xingpi Yanger Granule", can preferably control product quality.
Description
Technical field
The invention belongs to pharmaceutical fields, are related to the preparation method of "Xingpi Yanger Granule", further relate to the matter of "Xingpi Yanger Granule"
Amount control method.
Background technique
Cause people's anorexia since Spleen-Qi Deficiency is stagnant, cause diarrhea loose stool, is that people is thin powerless, the hidrosis enuresis；In this case
Need appetizing of being amusing, QI invigorating qi-restoratives, intestine-stabling and anti-diarrheal；There is the drug in terms of improving appetite and invigorating spleen in existing drug, can play certain
Effect, still, therapeutic effect is not especially desirable.Publication No. CN1415325A discloses a kind of appetizing of being amusing QI invigorating benefit
Empty Chinese materia medica preparation, but the preparation method of "Xingpi Yanger Granule" is not disclosed, and without "Xingpi Yanger Granule" Quality Identification yet
Standard.
Therefore, to obtain quality and the stable "Xingpi Yanger Granule" of curative effect, it is necessary to suggest a kind of system of "Xingpi Yanger Granule"
Preparation Method, and the method for establishing the control of "Xingpi Yanger Granule" quality.
Summary of the invention
In view of this, one of the objects of the present invention is to provide a kind of "Xingpi Yanger Granule"s；The second object of the present invention exists
In providing a kind of method for preparing "Xingpi Yanger Granule"；The third object of the present invention is to provide the matter of the "Xingpi Yanger Granule"
Amount control method.
For achieving the above object, the invention provides the following technical scheme:
A kind of "Xingpi Yanger Granule", prepares using the following method: taking tassel flower, pilose gerbera herb, pittosporum illicioides and the spider of recipe quantity
Spider is fragrant, adds 40~60 DEG C of warm water to impregnate 0.5h, decocts 2 times, collecting decoction, filtering, be concentrated into relative density be 1.15~
The clear cream of 1.18 (80 DEG C), adds cane sugar powder appropriate, mixes, is made particle, it is dry to get.
Preferably, the soaking time is 30min.
Preferably, described to decoct 2 times specially for the first time 2 hours, second 1.5 hours.
A kind of preparation method of "Xingpi Yanger Granule" includes the following steps: to take the tassel flower of recipe quantity, pilose gerbera herb, mountain
Cape jasmine tea and jatamans valeriana rhizome add 40~60 DEG C of warm water to impregnate 0.5h, decoct 2 times, collecting decoction, and filtering, being concentrated into relative density is
The clear cream of 1.15~1.18 (80 DEG C), adds cane sugar powder appropriate, mixes, is made particle, it is dry to get.Preferably, tassel flower
360g, pilose gerbera herb 326g, pittosporum illicioides 210g and jatamans valeriana rhizome 72g.
Preferably, the soaking time is 30min.
Preferably, described to decoct 2 times specially for the first time 2 hours, second 1.5 hours.
The method of quality control of the "Xingpi Yanger Granule", including tassel flower identification and pilose gerbera herb identification；
The tassel flower identification specifically: take the clear cream in "Xingpi Yanger Granule" preparation process, adding volume fraction is 25%
~28% strong ammonia solution, then plus chloroform, be ultrasonically treated, filtering, filtrate is evaporated, and residue adds methanol to dissolve, as examination
Product solution；Tassel flower control medicinal material separately is taken, adds water, is heated to reflux, is filtered, filtrate concentration adds ethyl alcohol, filters, and filtrate is steamed to nothing
Alcohol taste is shaken with ethyl acetate and is extracted, combined ethyl acetate liquid, is that 4% sodium bicarbonate solution washs, then uses water with mass fraction
Washing, discards water lotion, acetic acid ethyl fluid is evaporated, and residue adds methanol to dissolve, as reference substance solution.Draw test solution and
Control medicinal material solution is put respectively on same silica gel g thin-layer plate, using toluene-acetone-ethyl alcohol-strong ammonia solution as solvent, is opened up
It opens, takes out, dry, spray with alchlor test solution, set and inspected under ultraviolet lamp；In sample chromatogram, with reference medicine chromatography
On corresponding position, the fluorescence spot of same color is shown；
Pilose gerbera herb identification specifically: take the clear cream in "Xingpi Yanger Granule" preparation process, add methanol, at ultrasound
Reason, filtering, filtrate are evaporated, and residue adds methanol to dissolve, as test solution；Pilose gerbera herb control medicinal material separately is taken, adds methanol, is surpassed
Sonication, filtering, filtrate are evaporated, and residue adds methanol to dissolve, and control medicinal material solution is made；Test solution and control medicinal material is molten
Liquid is put respectively on same silica gel g thin-layer plate, using chloroform-methanol-water as solvent, sets the expansion of solvent presaturation 15 minutes
In cylinder, it is unfolded, takes out, dry, set and inspected under ultraviolet lamp；In sample chromatogram, in position corresponding with reference medicine chromatography
On, show the fluorescence spot of same color.
Preferably, the tassel flower identification is specially the clear cream taken in "Xingpi Yanger Granule" preparation process, is added by every 3g
Strong ammonia solution 2 drips, then adds chloroform 20ml by every 3g, is ultrasonically treated 20 minutes, and filtering, filtrate is evaporated, and residue adds methanol 1ml
Make to dissolve, as test solution；Tassel flower control medicinal material 5g separately is taken, adds water 100ml, is heated to reflux 1 hour, lets cool, is filtered,
Filtrate is concentrated into about 30ml, adds ethyl alcohol 30ml, stirs evenly, and filtering, filtrate is steamed to no alcohol taste, with ethyl acetate shaking extraction 2 times, often
Secondary 30ml, combined ethyl acetate liquid are washed with 4% sodium bicarbonate solution 20ml, then are washed with water 10ml, discard water lotion, second
Acetoacetic ester liquid is evaporated, and residue adds methanol 1ml to make to dissolve, as reference substance solution.Test solution and control medicinal material solution are drawn,
It is put respectively on same silica gel g thin-layer plate, is 20:20:3:1 as solvent using toluene-acetone-ethyl alcohol-strong ammonia solution volume ratio,
Expansion is taken out, is dried, and sprays with alchlor test solution, sets and inspect under ultraviolet lamp (365nm)；In sample chromatogram, with compare
On the corresponding position of medicinal material chromatography, the fluorescence spot of same color is shown.
Preferably, the pilose gerbera herb identification specifically: the clear cream in "Xingpi Yanger Granule" preparation process is taken, by mass body
Product is ultrasonically treated 20 minutes, filtering, filtrate is evaporated, and residue presses "Xingpi Yanger Granule" and methanol quality than being that methanol is added in 1:10
Volume ratio is that methanol dissolution is added in 2:1, as test solution；Pilose gerbera herb control medicinal material separately is taken, is 1 by mass volume ratio:
10 are added methanol, are ultrasonically treated 20 minutes, and filtering, filtrate is evaporated, and residue is by "Xingpi Yanger Granule" and methanol quality volume ratio
Methanol dissolution is added in 2:1, is made in the same way of control medicinal material solution, draws test solution and control medicinal material solution, puts respectively in same
It is 30:10:0.4 as solvent using chloroform-methanol-water volume ratio on one silica gel g thin-layer plate, is unfolded, takes out, dry, set ultraviolet
It is inspected under light lamp；In sample chromatogram, on position corresponding with reference medicine chromatography, the fluorescence spot of same color is shown.
The beneficial effects of the present invention are: the invention discloses the preparation method of "Xingpi Yanger Granule" and its quality controlling parties
Method, preparation process impregnate the bulk pharmaceutical chemicals warm water of recipe quantity, decoct 2 times, collecting decoction, filtering, be concentrated into 80 DEG C it is relatively close
The clear cream that degree is 1.15~1.18, this method extracting method is simple, does not use organic solvent, can be sufficiently reserved each effective component；
And medicinal extract solid content and product extract content are high, the invention also discloses the method for quality control of "Xingpi Yanger Granule", can be more
Good control product quality, processing and quality control to "Xingpi Yanger Granule" are of great significance.
Detailed description of the invention
Fig. 1 is tassel flower thin-layer chromatography qualification result (1, tassel flower control medicinal material；2, tassel flower sample is lacked；3, sample 1；
4, sample 2；5, sample 3；6, sample 4；7, sample 5).
Fig. 2 is pilose gerbera herb thin-layer chromatography qualification result (1, pilose gerbera herb control medicinal material；2, pilose gerbera herb sample is lacked；3,
Sample 1；4, sample 2；5, sample 3；6, sample T4；7, sample 5).
Specific embodiment
Below by a preferred embodiment of the present invention will be described in detail.
Embodiment 1, the preparation method of "Xingpi Yanger Granule"
The preparation method of "Xingpi Yanger Granule" includes the following steps: to take tassel flower 360g, pilose gerbera herb 326g, pittosporum illicioides
210g and jatamans valeriana rhizome 72g adds 40~60 DEG C of warm water to impregnate 30 minutes, decocts 2 times, and 2 hours for the first time, second 1.5 hours,
Collecting decoction, filtering, filtrate are concentrated into the clear cream that relative density is 1.15~1.18 (80 DEG C), add cane sugar powder appropriate, mixes, system
It is dry at particle, be made 1000g to get.
Control group: using Publication No. CN1415325A prepare "Xingpi Yanger Granule", then measure the method for the present invention and
Control group medicinal extract solid yield and product yield of extraction, the results are shown in Table 1.
Table 1, "Xingpi Yanger Granule" medicinal extract solid content and product yield of extraction
| Serial number | Technique | Medicinal extract solid content | Product extract |
| 1 | Control group | 32% | 2.5% |
| 2 | Present invention process | 45% | 4.2% |
As can be seen from Table 1, it is significantly increased using present invention process medicinal extract solid content and product extract.
The method of quality control of embodiment 2, "Xingpi Yanger Granule"
(1) tassel flower is identified: taking the clear cream 3g in 5 parts of embodiments, 1 "Xingpi Yanger Granule" preparation process, enriching ammonia solution 2
Drop adds chloroform 20ml, is ultrasonically treated 20 minutes, and filtering, filtrate is evaporated, and residue adds methanol 1ml to make to dissolve, as test sample
Solution；Tassel flower control medicinal material (lot number: the source 121359-200703: Nat'l Pharmaceutical & Biological Products Control Institute) 5g separately is taken, adds water
100ml is heated to reflux 1 hour, lets cool, and filtering, filtrate is concentrated into about 30ml, adds ethyl alcohol 30ml, stir evenly, and filters, filtrate steam to
It without alcohol taste, is extracted 2 times, each 30ml with ethyl acetate shaking, combined ethyl acetate liquid, is 4% sodium bicarbonate with mass fraction
Solution 20ml washing, then washed with water 10ml, water lotion is discarded, acetic acid ethyl fluid is evaporated, and residue adds methanol 1ml to make to dissolve, and is made
For reference substance solution.Test solution and control medicinal material solution are drawn, is put respectively on same silica gel g thin-layer plate, with toluene-the third
Ketone-ethyl alcohol-strong ammonia solution volume ratio is that 20:20:3:1 is solvent, is unfolded, and takes out, dries, and sprays with alchlor test solution, sets
It is inspected under ultraviolet lamp (365nm)；In sample chromatogram, on position corresponding with reference medicine chromatography, same color is shown
Fluorescence spot, negative noiseless (Fig. 1).
(2) pilose gerbera herb is identified: being taken the clear cream 2g in 5 parts of embodiments, 1 "Xingpi Yanger Granule" preparation process, is added methanol
20ml is ultrasonically treated 20 minutes, and filtering, filtrate is evaporated, and residue adds methanol 1ml to make to dissolve, as test solution；Separately take hair big
Fourth grass control medicinal material 1g, is made in the same way of control medicinal material solution.According to thin-layered chromatography (one annex VI of " Chinese Pharmacopoeia " version in 2010
B it) tests, draws above-mentioned each 5~10 μ l of two solution, put respectively on same silica gel g thin-layer plate, with chloroform-Methanol-water (body
Product is than 30:10:0.4) for solvent, in the expansion cylinder for setting solvent presaturation 15 minutes, it is unfolded, takes out, dry, set ultraviolet light
It is inspected under lamp (365nm), in sample chromatogram, on position corresponding with reference medicine chromatography, shows the fluorescent spot of same color
Point, negative noiseless (Fig. 2).
Embodiment 3, the verifying of "Xingpi Yanger Granule" drug effect
For the drug effect for proving "Xingpi Yanger Granule", experiment specific method is carried out in terms of improving immunity to "Xingpi Yanger Granule"
It is as follows:
Take health red mouse 180, be randomly divided into 3 groups, respectively blank group (blank group), test group (take be amusing it is feeding
Youngster's particle) and control group (take Publication No. CN1415325A and preparation is made), each 150mg, 3 times a day, the 2 Monday courses for the treatment of；
Control group takes the physiological saline of equivalent, and the index of immunity carried out before taking to mouse detects, and detection is exempted from again after 15 days
Epidemic disease index, the results are shown in Table 2.
The influence of table 2, "Xingpi Yanger Granule" to mouse immune index
As can be seen from Table 2, index and spleen index and the equal no significant difference of thymus index, medication cross-reference group before three groups of medications
Though index and spleen index and thymus index are without significant difference compared with blank group, index and spleen index and thymus gland refer to experimental group before and after treatment
Number significant difference, and experimental group effect is better than control group.
Finally, it is stated that preferred embodiment above is only used to illustrate the technical scheme of the present invention and not to limit it, although logical
It crosses above preferred embodiment the present invention is described in detail, however, those skilled in the art should understand that, can be
Various changes are made to it in form and in details, without departing from claims of the present invention limited range.
Claims (9)
1. a kind of "Xingpi Yanger Granule", which is characterized in that prepare using the following method: taking the tassel flower, pilose gerbera herb, mountain of recipe quantity
Cape jasmine tea and jatamans valeriana rhizome add 40~60 DEG C of warm water to impregnate 0.5h, decoct 2 times, collecting decoction, and filtering, being concentrated into relative density is
The clear cream of 1.15~1.18 (80 DEG C), adds cane sugar powder appropriate, mixes, is made particle, it is dry to get.
2. "Xingpi Yanger Granule" according to claim 1, it is characterised in that: the soaking time is 30min.
3. "Xingpi Yanger Granule" according to claim 1, it is characterised in that: it is described to decoct 2 times specially for the first time 2 hours,
Second 1.5 hours.
4. a kind of preparation method of "Xingpi Yanger Granule", which comprises the steps of: take tassel flower, the hair of recipe quantity
Gerbera, pittosporum illicioides and jatamans valeriana rhizome, add 40~60 DEG C of warm water to impregnate 0.5h, decoct 2 times, collecting decoction, and filtering is concentrated into phase
Be the clear cream of 1.15~1.18 (80 DEG C) to density, add cane sugar powder appropriate, mix, be made particle, it is dry to get.
5. the preparation method of "Xingpi Yanger Granule" according to claim 4, it is characterised in that: the soaking time is 30min.
6. the preparation method of "Xingpi Yanger Granule" according to claim 4, it is characterised in that: described to decoct 2 times be specially the
One time 2 hours, second 1.5 hours.
7. the method for quality control of "Xingpi Yanger Granule" described in any one of claim 1-3, it is characterised in that: including tassel flower
Identification and pilose gerbera herb identification；
Tassel flower identification specifically: take the clear cream in "Xingpi Yanger Granule" preparation process, add volume fraction be 25%~
28% strong ammonia solution, then plus chloroform, be ultrasonically treated, filtering, filtrate is evaporated, and residue adds methanol to dissolve, as test sample
Solution；Tassel flower control medicinal material separately is taken, adds water, is heated to reflux, is filtered, filtrate concentration adds ethyl alcohol, filters, and filtrate is steamed to no alcohol
Taste is shaken with ethyl acetate and is extracted, and combined ethyl acetate liquid is washed with the sodium bicarbonate solution that mass fraction is 4%, then uses water
Washing, discards water lotion, acetic acid ethyl fluid is evaporated, and residue adds methanol to dissolve, as reference substance solution；Draw test solution and
Control medicinal material solution is put respectively on same silica gel g thin-layer plate, using toluene-acetone-ethyl alcohol-strong ammonia solution as solvent, is opened up
It opens, takes out, dry, spray with alchlor test solution, set and inspected under ultraviolet lamp；In sample chromatogram, with reference medicine chromatography
On corresponding position, the fluorescence spot of same color is shown；
The pilose gerbera herb identification specifically: take the clear cream in "Xingpi Yanger Granule" preparation process, add methanol, be ultrasonically treated, mistake
Filter, filtrate are evaporated, and residue adds methanol to dissolve, as test solution；Pilose gerbera herb control medicinal material separately is taken, adds methanol, at ultrasound
Reason, filtering, filtrate are evaporated, and residue adds methanol to dissolve, and control medicinal material solution is made；By test solution and control medicinal material solution point
Other point, using chloroform-methanol-water as solvent, sets the expansion cylinder of solvent presaturation 15 minutes on same silica gel g thin-layer plate
It is interior, it is unfolded, takes out, dry, set and inspected under ultraviolet lamp；In sample chromatogram, on position corresponding with reference medicine chromatography,
The fluorescence spot of aobvious same color.
8. the method for quality control of "Xingpi Yanger Granule" according to claim 7, it is characterised in that: the tassel flower identification tool
Body is the clear cream taken in "Xingpi Yanger Granule" preparation process, and strong ammonia solution 2 is added by every 3g and drips, then adds chloroform by every 3g
20ml is ultrasonically treated 20 minutes, and filtering, filtrate is evaporated, and residue adds methanol 1ml to make to dissolve, as test solution；Separately take a bit
Red control medicinal material 5g, adds water 100ml, is heated to reflux 1 hour, lets cool, and filtering, filtrate is concentrated into about 30ml, adds ethyl alcohol 30ml, stir
Even, filtering, filtrate is steamed to no alcohol taste, is extracted 2 times, each 30ml with ethyl acetate shaking, combined ethyl acetate liquid, with quality point
Number washs for 4% sodium bicarbonate solution 20ml, then is washed with water 10ml, discards water lotion, acetic acid ethyl fluid is evaporated, and residue adds
Methanol 1ml makes to dissolve, as reference substance solution；Test solution and control medicinal material solution are drawn, is put respectively thin in same silica G
Be 20:20:3:1 as solvent using toluene-acetone-ethyl alcohol-strong ammonia solution volume ratio on laminate, be unfolded, take out, dry, spray with
Alchlor test solution is set and is inspected under 365nm ultraviolet lamp；In sample chromatogram, on position corresponding with reference medicine chromatography,
The fluorescence spot of aobvious same color.
9. the method for quality control of "Xingpi Yanger Granule" according to claim 7, it is characterised in that: the pilose gerbera herb identification
Specifically:
The clear cream in "Xingpi Yanger Granule" preparation process is taken, is that methanol is added in 1:10 by mass volume ratio, is ultrasonically treated 20 minutes,
Filtering, filtrate are evaporated, and residue is that methanol dissolution is added in 2:1 by "Xingpi Yanger Granule" and methanol quality volume ratio, as test sample
Solution；Pilose gerbera herb control medicinal material separately is taken, is that methanol is added in 1:10 by mass volume ratio, is ultrasonically treated 20 minutes, filtering, filtrate
It is evaporated, residue is that methanol dissolution is added in 2:1 by "Xingpi Yanger Granule" and methanol quality volume ratio, and it is molten to be made in the same way of control medicinal material
Liquid draws test solution and control medicinal material solution, is put respectively on same silica gel g thin-layer plate, with chloroform-methanol-water volume
Than being solvent for 30:10:0.4, it is unfolded, takes out, dry, set and inspected under ultraviolet lamp；In sample chromatogram, with comparison medicine
Wood color is composed on corresponding position, and the fluorescence spot of same color is shown.
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| CN201910165531.9A CN109700772B (en) | 2019-03-05 | 2019-03-05 | Spleen-enlivening and infant-nourishing granules, preparation method and quality control method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113552278A (en) * | 2021-07-13 | 2021-10-26 | 贵州健兴药业有限公司 | Method for detecting spleen-enlivening capsules |
| CN114681536A (en) * | 2020-12-28 | 2022-07-01 | 贵州健兴药业有限公司 | Improved preparation method of spleen-enlivening pharmaceutical composition |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104225016A (en) * | 2014-10-13 | 2014-12-24 | 陈红 | Drug composition for treating spleen and stomach deficiency type chronic atrophic gastritis |
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2019
- 2019-03-05 CN CN201910165531.9A patent/CN109700772B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104225016A (en) * | 2014-10-13 | 2014-12-24 | 陈红 | Drug composition for treating spleen and stomach deficiency type chronic atrophic gastritis |
Non-Patent Citations (1)
| Title |
|---|
| 中华人民共和国卫生部药典委员会编: "《国家药品中药标准》", 31 December 2002 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114681536A (en) * | 2020-12-28 | 2022-07-01 | 贵州健兴药业有限公司 | Improved preparation method of spleen-enlivening pharmaceutical composition |
| CN114681536B (en) * | 2020-12-28 | 2023-05-09 | 贵州健兴药业有限公司 | Improved preparation method of spleen-enlivening pharmaceutical composition |
| CN113552278A (en) * | 2021-07-13 | 2021-10-26 | 贵州健兴药业有限公司 | Method for detecting spleen-enlivening capsules |
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| CN109700772B (en) | 2020-05-26 |
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Denomination of invention: Xingpi Yanger granule and its preparation and quality control Effective date of registration: 20210527 Granted publication date: 20200526 Pledgee: Bank of Communications Co.,Ltd. Guizhou Branch Pledgor: GUIZHOU JIANXING PHARMACEUTICAL Co.,Ltd. Registration number: Y2021520000006 |
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Denomination of invention: Xingpi Yanger Granules and Its Preparation and Quality Control Methods Effective date of registration: 20221017 Granted publication date: 20200526 Pledgee: Guiyang Branch of Shanghai Pudong Development Bank Co.,Ltd. Pledgor: Guizhou Jianxing Pharmaceutical Co.,Ltd. Registration number: Y2022520000041 |