CN115177657A - Application of selfheal in improving safety of medicine containing radix stephaniae tetrandrae - Google Patents

Application of selfheal in improving safety of medicine containing radix stephaniae tetrandrae Download PDF

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Publication number
CN115177657A
CN115177657A CN202210979687.2A CN202210979687A CN115177657A CN 115177657 A CN115177657 A CN 115177657A CN 202210979687 A CN202210979687 A CN 202210979687A CN 115177657 A CN115177657 A CN 115177657A
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stephaniae tetrandrae
radix stephaniae
selfheal
medicine
tetrandrine
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CN115177657B (en
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林徐剑
刘雳
吴俊�
施晓萍
徐棋萍
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CHIATAI QINGCHUNBAO PHARMACEUTICAL CO LTD
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CHIATAI QINGCHUNBAO PHARMACEUTICAL CO LTD
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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)
    • A61K36/59—Menispermaceae (Moonseed family), e.g. hyperbaena or coralbead
    • 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)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/536—Prunella or Brunella (selfheal)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The invention belongs to the field of traditional Chinese medicines, and particularly relates to application of selfheal in improving the safety of a medicine containing radix stephaniae tetrandrae. The tetrandra root medicine is a single medicine of tetrandra root or a traditional Chinese medicine compound preparation containing the raw material of the tetrandra root, and the mass ratio of the tetrandra root to the prunella vulgaris is 1. The invention finds that the selfheal is added into the formula containing the tetrandra root, so that the transfer rate of fangchinoline and tetrandrine in the tetrandra root can be greatly reduced, the medication safety of the tetrandra root is improved, and the tetrandrine has a larger attenuation effect on the tetrandra root.

Description

Application of selfheal in improving safety of medicine containing radix stephaniae tetrandrae
Technical Field
The invention belongs to the field of traditional Chinese medicines, and particularly relates to application of selfheal in improving the safety of a medicine containing radix stephaniae tetrandrae.
Background
The origin of the tetrandra root is the tetrandra root which is a plant in the family of the Menispermaceae specified in the Chinese pharmacopoeia, and the tetrandra root which is a plant in the family of the Aristolochiaceae is also used as the tetrandra root in the past, but the plant in the family of the Aristolochiaceae has relatively definite renal toxicity, and the medicinal standard of the tetrandra root is cancelled due to the safety consideration of clinical medication. The currently allowed tetrandra root is tetrandra root.
In recent years, with the continuous and intensive research on tetrandra root, research findings and literature reports exist, tetrandra root also has obvious hepatotoxicity and renal toxicity, and even if the tetrandra root is administrated in pharmacopoeia dosage, certain hepatorenal function changes can be caused for a long time. The hepatorenal toxicity of tetrandra root is mainly related to alkaloid components, wherein the highest content of tetrandrine and tetrandrine has the drug effects of analgesia and anti-inflammation, but certain toxicity exists.
The preparation of the compound Chinese medicine preparation generally adopts the traditional water extraction and decoction process, the traditional Chinese medicine decoction may generate the functions of synergy and attenuation, and generally compared with the single decoction of a certain medicine, the content of some effective components after the decoction is obviously increased or the content of some components with toxic and side effects is obviously reduced. Although more experts in the industry currently approve the way of decocting the traditional Chinese medicines together, the research is less, and the traditional Chinese medicines have no commonality, and not all the components have the functions of synergism and toxicity reduction after being decocted together.
The safety of the medication of the tetrandrine is always a more important research, particularly the tetrandrine and the tetrandrine component. In the research, the transfer rates of fangchinoline and tetrandrine after the fangchinoline is decocted with water independently are both 25-30%; the composition is combined with other medicines to form a prescription, for example, the composition is combined with astragalus, bighead atractylodes rhizome and liquorice to form fangji astragalus decoction (from golden lack of health), the transfer rate of fangji norolin and tetrandrine is about 25% after the fangji astragalus decoction is mixed with water, and the transfer rate is not obviously changed with that of single decoction.
Disclosure of Invention
Aiming at the defects in the prior art, the invention provides a compatible composition for improving the safety of the drug containing the tetrandra root. Can greatly reduce the transfer rate of fangchinoline and tetrandrine in the stephania tetrandra and improve the medication safety of the stephania tetrandra.
In order to realize the purpose of the invention, the technical scheme is as follows:
application of Prunellae Spica in improving safety of radix Stephaniae Tetrandrae containing medicine is provided.
Preferably, the tetrandra root medicine is a single medicine of tetrandra root or a traditional Chinese medicine compound preparation containing the raw material of the tetrandra root.
Preferably, the mass ratio of the tetrandra root to the prunella vulgaris is 1.
Preferably, the mass ratio of the tetrandra root to the selfheal is 1.5-3.
Preferably, the selfheal can reduce the content of fangchinoline and/or tetrandrine in the tetrandrine medicine or the water extraction transfer rate.
The invention also aims to provide a compatible composition, which comprises the medicines containing the radix stephaniae tetrandrae and the selfheal, wherein the mass ratio of the radix stephaniae tetrandrae to the selfheal is 1.
Preferably, the mass ratio of the tetrandra root to the selfheal is 1.5-3.
Preferably, the compatible composition also comprises a pharmaceutical adjuvant; the medicinal auxiliary materials are selected from one or more of dextrin, starch, calcium sulfate, calcium bicarbonate, crospovidone, croscarmellose sodium, silicon dioxide, magnesium stearate and talcum powder.
The invention also aims to provide a preparation method of the compatible composition, which comprises the steps of mixing the selfheal with the drug containing the tetrandra root, adding water for extraction, filtering, concentrating and drying to obtain the compound.
Preferably, the mass of the water: the total mass of the selfheal and the medicine containing the radix stephaniae tetrandrae is 6-12, the extraction temperature is 90-100 ℃, the extraction frequency is 1-3 times, and the extraction time is 1-2 hours.
Compared with the prior art, the invention has the beneficial effects that:
(1) The transfer rates of fangchinoline and tetrandrine are both 25% -30% after the fangchinoline is decocted alone or is decocted with other medicinal compositions, and the transfer rates of fangchinoline and tetrandrine after the fangchinoline and the tetrandrine are decocted with the selfheal can be reduced to be within 1% at most, so that the effect is very obvious.
(2) The toxicity test of zebra fish further shows that MNLC (maximum non-lethal concentration) and LC of the radix stephaniae tetrandrae and the selfheal after being decocted by adding water 10 (10% lethal concentration) in comparison with Fangji root aloneThe water decoction is greatly improved; radix Stephaniae Tetrandrae and radix astragali Shang Chufang (radix Stephaniae Tetrandrae, radix astragali, atractylodis rhizoma, glycyrrhrizae radix) and MNLC (maximum non-lethal concentration) and LC of Prunellae Spica 10 The (10% lethal concentration) is greatly improved compared with the prescription of the tetrandra and astragalus decoction, which shows that the administration safety of the tetrandra medicine can be greatly improved after the prunella vulgaris is added.
Drawings
FIG. 1 is a chromatogram of a control solution of fangchinoline and tetrandrine, wherein peak a is fangchinoline and peak b is tetrandrine.
FIG. 2 is a chromatogram obtained by superposing the content measurement of fangchinoline and tetrandrine in dry paste obtained by decocting radix Stephaniae Tetrandrae and Prunellae Spica in different mass ratios in examples 1-4, wherein peak a is fangchinoline and peak b is tetrandrine. The chromatograms from top to bottom are example 4, example 3, example 2, example 1 and Menispermaceae single decoction.
FIG. 3 is the chromatogram for measuring the contents of fangchinoline and tetrandrine in example 5, wherein peak a is fangchinoline and peak b is tetrandrine.
FIG. 4 is a chromatogram for measuring the content of fangchinoline and tetrandrine in dry paste obtained by single decoction of radix Stephaniae Tetrandrae in comparative example 1, wherein peak a is fangchinoline and peak b is tetrandrine.
FIG. 5 is the chromatogram for measuring the content of fangchinoline and tetrandrine in dry paste of comparative example 2, radix Stephaniae Tetrandrae and radix astragali Shang Chufang, wherein peak a is fangchinoline and peak b is tetrandrine.
Note: the unclear horizontal and vertical coordinates do not influence the disclosure and understanding of the technical scheme of the invention.
Detailed Description
The present invention will be further described with reference to the following embodiments.
Examples 1-5 the raw material amounts of the compatible compositions are shown in table 1.
Table 1 formula table
Examples Stephania tetrandra (parts by weight) Prunellae Spica (parts by weight)
Example 1 1 0.2
Example 2 1 0.5
Example 3 1 1
Example 4 1 2
The preparation method of the compatible composition of the radix stephaniae tetrandrae and the selfheal in the embodiments 1-4 is as follows:
decocting radix Stephaniae Tetrandrae decoction pieces and Prunellae Spica decoction pieces in water for 2 times, decocting with 8 times of water for 1.5 hr and 6 times of water for 1 hr, filtering, concentrating at 60 deg.C under reduced pressure to dry, and vacuum drying at 60 deg.C under reduced pressure to obtain dry extract. The contents of fangchinoline and tetrandrine in the dry paste are measured and the transfer rate is calculated, and the results are shown in table 2.
Example 5
Taking 2 parts of radix stephaniae tetrandrae decoction pieces, 2.5 parts of radix astragali decoction pieces, 1.5 parts of rhizoma atractylodis macrocephalae decoction pieces and 1 part of liquorice decoction pieces, namely radix stephaniae tetrandrae and radix astragali Shang Chufang (from golden Kui-Yao), adding 4 parts of selfheal decoction pieces, adding water for decocting for 3 times, adding 8 times of water for decocting for 1 hour for the first time, adding 6 times of water for decocting for 1 hour for the second time, adding 6 times of water for decocting for 1 hour for the third time, filtering water decoction, concentrating under reduced pressure at 60 ℃ until the water decoction is dried, and spraying and drying to obtain dry paste.
Comparative example 1
Decocting radix Stephaniae Tetrandrae decoction pieces in water for 2 times, decocting with 8 times of water for 1.5 hr for the first time, decocting with 6 times of water for 1 hr for the second time, filtering the decoction, concentrating under reduced pressure at 60 deg.C to dry, and vacuum drying at 60 deg.C to obtain dry extract.
Comparative example 2
Taking 2 parts of radix stephaniae tetrandrae decoction pieces, 2.5 parts of radix astragali decoction pieces, 1.5 parts of rhizoma atractylodis macrocephalae decoction pieces and 1 part of liquorice decoction pieces, namely the radix stephaniae tetrandrae and radix astragali Shang Chufang (from golden Kui-Yao L.), adding water for decocting for 2 times, adding 8 times of water for decocting for 1.5 hours for the first time, adding 6 times of water for decocting for 1 hour for the second time, filtering a water decoction, concentrating under reduced pressure at 60 ℃ to dryness, and drying under reduced pressure and vacuum at 60 ℃ to obtain dry paste.
Test 1
The contents of fangchinoline and tetrandrine in the dry extract powders of examples 1 to 5 and comparative examples 1 to 2 were determined by HPLC.
The method for determining the content of fangchinoline and tetrandrine by high performance liquid chromatography comprises the following steps:
high performance liquid chromatography conditions:
the name of the instrument: agilent 1260 high performance liquid chromatograph
A chromatographic column: ZORBAX Eclipse Plus C18 (column length 150mm, inner diameter 4.6mm, particle size 5 μm)
Flow rate: 1.0ml/min
Column temperature: 25 deg.C
Detection wavelength: 237nm
Mobile phase: a mixture of acetonitrile-methanol-water-glacial acetic acid (40
Preparation of control solutions: a proper amount of fangchinoline reference substances (China food and drug testing institute, 110793-201807, content is calculated by 98.3%) and fangchinoline reference substances (China food and drug testing institute, batch number: 110711-201810, content is calculated by 99.6%) are precisely weighed, and methanol solution is added to prepare mixed reference substance solution containing fangchinoline 51.07 mug and tetrandrine 103.70 mug in each 1 ml.
Preparation of a test solution: taking a proper amount of dry paste obtained after drying the extract obtained by decocting the single medicinal materials of the stephania tetrandra, the selfheal and the like, adding 25ml of 50% ethanol, weighing, carrying out ultrasonic treatment (power of 200W and frequency of 40 kHz) for 30 minutes, taking out, cooling, weighing again, complementing the loss weight by using 50% ethanol, centrifuging (8000 revolutions per minute) for 10 minutes, and taking supernatant fluid to obtain the traditional Chinese medicine preparation.
The chromatogram of the fangchinoline and tetrandrine mixed reference solution is shown in figure 1; examples 1-4 different mass ratios of fangji and prunella vulgaris are decocted to obtain dry paste containing fangjinolin and tetrandrine, and the content determination superposition chromatogram is shown in figure 2; comparative example 1 chromatogram for measuring the content of fangchinoline and tetrandrine in dry paste obtained by decocting radix Stephaniae Tetrandrae in single decoction is shown in figure 3; chromatogram for measuring the content of fangchinoline and tetrandrine in dry extract obtained by decocting radix Stephaniae Tetrandrae and radix astragali Shang Chufang is shown in figure 4.
The contents of fangchinoline and tetrandrine in each example and comparative example were measured by the above chromatographic conditions, and the transfer rates were calculated, and the results are shown in table 2. Transfer rate% = content of ingredients in dry paste/content of ingredients in raw medicinal material × 100%.
TABLE 2
Group of Sinomenolein transfer rate (%) Tetrandrine transfer rate (%)
Example 1 13.29 15.12
Example 2 4.40 4.94
Example 3 2.61 2.67
Example 4 0.44 0.60
Example 5 1.77 2.82
Comparative example 1 27.09 26.37
Comparative example 2 22.09 23.39
Test 2
The dry pastes prepared in examples 2-5 and comparative examples 1-2 were subjected to toxicity test of zebra fish, and MNLC (maximum non-lethal concentration) and LC of each sample on zebra fish were calculated 10 (10% lethal concentration).
The test method comprises the following steps:
randomly selecting 2dbf wild-type AB strain zebra fish in a 6-well plate, treating 30 zebra fish in each well (experimental group), and setting a normal control group with the capacity of 3mL in each well. And (4) treating for 72h at 28 ℃, counting the death number of the zebra fish in each experimental group every day, removing the zebra fish in time, and counting the acute toxicity incidence rate of each experimental group after 72 h. The best concentration-mortality effect curve was plotted using Origin 8.0 statistical software and the MNLC and LC of the samples against zebrafish were calculated 10 。
MNLC (maximum non-lethal concentration) and LC 10 (10％Lethal concentration) results are shown in table 3, and concentration-mortality results are shown in table 4.
TABLE 3 MNLC (maximum non-lethal concentration) and LC 10 (10% lethal concentration) results
Group of MNLC(μg/mL) LC 10 (μg/mL)
Example 2 1452 1495
Example 3 2716 2732
Example 4 2431 2475
Example 6 2938 2982
Comparative example 1 359 367
Comparative example 2 1945 1989
Table 4 concentration-mortality results
Figure BDA0003797915450000051
Figure BDA0003797915450000061
The above detailed description is directed to one of the possible embodiments of the present invention, which is not intended to limit the scope of the invention, but rather the scope of the invention is intended to include all equivalent implementations or modifications without departing from the scope of the invention.

Claims (10)

1. Application of Prunellae Spica in improving safety of radix Stephaniae Tetrandrae containing medicine is provided.
2. The use of claim 1, wherein the radix Stephaniae Tetrandrae drug is a single drug of radix Stephaniae Tetrandrae or a compound Chinese medicinal preparation containing radix Stephaniae Tetrandrae.
3. The use as claimed in claim 1, wherein the mass ratio of radix Stephaniae Tetrandrae to Prunellae Spica is 1.
4. The use as claimed in claim 1, wherein the mass ratio of radix Stephaniae Tetrandrae to Prunellae Spica is 1.
5. The use of claim 1, wherein the Prunellae Spica can reduce the content of fangchinoline and/or tetrandrine in radix Stephaniae Tetrandrae medicine or the water extraction transfer rate.
6. A compatible composition is characterized by comprising a medicine containing radix stephaniae tetrandrae and selfheal, wherein the mass ratio of the radix stephaniae tetrandrae to the selfheal is 1:0.2-5.
7. The compatible composition of claim 6, wherein the mass ratio of the stephania tetrandra to the prunella vulgaris is 1.
8. The compatible composition of claim 6, further comprising a pharmaceutical excipient; the medicinal auxiliary materials are selected from one or more of dextrin, starch, calcium sulfate, calcium bicarbonate, crospovidone, croscarmellose sodium, silicon dioxide, magnesium stearate and talcum powder.
9. A process for preparing a compatible composition as claimed in any one of claims 6 to 8, which comprises mixing Prunellae Spica with the radix Stephaniae Tetrandrae-containing drug, extracting with water, filtering, concentrating and drying.
10. The method of claim 9, wherein the water has a mass: the total mass of the selfheal and the medicine containing the radix stephaniae tetrandrae is 6-12, the extraction temperature is 90-100 ℃, the extraction frequency is 1-3 times, and the extraction time is 1-2 hours.
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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001022934A2 (en) * 1999-09-24 2001-04-05 Yng Wong Quing Non Delivery of small doses of ingestible treatments
US20060216251A1 (en) * 2005-03-24 2006-09-28 Tracie Martyn International, Llc Topical formulations and methods of use
CN102285994A (en) * 2011-08-30 2011-12-21 聊城大学 Method for separating and purifying fangchinoline and tetrandrine from stephania tetrandra
CN104422737A (en) * 2013-08-25 2015-03-18 上海中医药大学附属龙华医院 Method for rapidly detecting index composition in Chinese herbal medicine compound preparation
CN109856280A (en) * 2019-02-25 2019-06-07 广西中医药大学 Method that is a kind of while measuring tetrandrine and fangchinoline content in root of fangji medicinal material

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001022934A2 (en) * 1999-09-24 2001-04-05 Yng Wong Quing Non Delivery of small doses of ingestible treatments
US20060216251A1 (en) * 2005-03-24 2006-09-28 Tracie Martyn International, Llc Topical formulations and methods of use
CN102285994A (en) * 2011-08-30 2011-12-21 聊城大学 Method for separating and purifying fangchinoline and tetrandrine from stephania tetrandra
CN104422737A (en) * 2013-08-25 2015-03-18 上海中医药大学附属龙华医院 Method for rapidly detecting index composition in Chinese herbal medicine compound preparation
CN109856280A (en) * 2019-02-25 2019-06-07 广西中医药大学 Method that is a kind of while measuring tetrandrine and fangchinoline content in root of fangji medicinal material

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