CN116808119A - Mountain chrysanthemum antihypertensive capsule and preparation method thereof - Google Patents
Mountain chrysanthemum antihypertensive capsule and preparation method thereof Download PDFInfo
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- CN116808119A CN116808119A CN202310319659.2A CN202310319659A CN116808119A CN 116808119 A CN116808119 A CN 116808119A CN 202310319659 A CN202310319659 A CN 202310319659A CN 116808119 A CN116808119 A CN 116808119A
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- capsule
- antihypertensive
- chrysanthemum
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- 244000189548 Chrysanthemum x morifolium Species 0.000 title claims abstract description 78
- 230000003276 anti-hypertensive effect Effects 0.000 title claims abstract description 61
- 235000007516 Chrysanthemum Nutrition 0.000 title claims abstract description 59
- 238000002360 preparation method Methods 0.000 title claims abstract description 18
- 239000003814 drug Substances 0.000 claims abstract description 39
- 239000002220 antihypertensive agent Substances 0.000 claims abstract description 33
- 229940127088 antihypertensive drug Drugs 0.000 claims abstract description 33
- 239000000463 material Substances 0.000 claims abstract description 28
- LQGUBLBATBMXHT-UHFFFAOYSA-N chrysophanol Chemical compound C1=CC=C2C(=O)C3=CC(C)=CC(O)=C3C(=O)C2=C1O LQGUBLBATBMXHT-UHFFFAOYSA-N 0.000 claims abstract description 24
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- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims description 5
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Classifications
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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)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/734—Crataegus (hawthorn)
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- A—HUMAN NECESSITIES
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- 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)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/287—Chrysanthemum, e.g. daisy
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/482—Cassia, e.g. golden shower tree
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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)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/536—Prunella or Brunella (selfheal)
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- A61K36/88—Liliopsida (monocotyledons)
- A61K36/884—Alismataceae (Water-plantain family)
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
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- A61K9/485—Inorganic compounds
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- A—HUMAN NECESSITIES
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
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- 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
- A61K2236/10—Preparation or pretreatment of starting material
- A61K2236/19—Preparation or pretreatment of starting material involving fermentation using yeast, bacteria or both; enzymatic treatment
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- 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
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- Health & Medical Sciences (AREA)
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- Chemical & Material Sciences (AREA)
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- Bioinformatics & Cheminformatics (AREA)
- Inorganic Chemistry (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The application discloses a chrysanthemum morifolium ramat antihypertensive capsule and a preparation method thereof, and relates to the technical field of traditional Chinese medicines. The chrysanthemum morifolium ramat antihypertensive capsule comprises a capsule shell and contents, wherein the weight of the contents in the capsule shell is 0.15-0.3g, the total length of the capsule shell is 13.6-19.3mm, the outer diameter of the capsule shell is 5.3-6.85mm, the contents comprise chrysanthemum morifolium ramat antihypertensive medicines and auxiliary materials in a weight ratio of 1 (0.8-1.1), and the chrysanthemum morifolium ramat antihypertensive medicines comprise the following components in parts by weight: 1400-1500 parts of hawthorn, 170-190 parts of selfheal, 230-250 parts of chrysanthemum, 230-250 parts of herba cepbalanoplosis segeti, 170-190 parts of salted alismatis, and 230-250 parts of stir-fried semen cassiae, wherein the mass percentage of ursolic acid in the chrysanthemum morifolium antihypertensive drug is more than 3.68mg/g, and the mass percentage of chrysophanol in the chrysanthemum morifolium antihypertensive drug is more than 1.62mg/g. The aster antihypertensive capsule has the advantages of smaller size and good drug effect, and is convenient for patients to swallow.
Description
Technical Field
The application relates to the technical field of traditional Chinese medicines, in particular to a chrysanthemum antihypertensive capsule and a preparation method thereof.
Background
Hypertension is the most common chronic disease and is also the most important risk factor for cardiovascular and cerebrovascular diseases. Hyperlipidemia is a disease in which the levels of cholesterol, triglycerides, and low density lipoproteins in plasma are elevated and the high density lipoproteins are too low due to various causes. Patients suffer from hypertension and hyperlipidemia simultaneously, and the symptoms of hypertension complicated with hyperlipidemia, such as excessive liver fire, headache, dizziness, tinnitus, eye distention, flushed face, wiry pulse, etc.
In the related art, a chrysanthemum antihypertensive capsule is disclosed, which comprises hawthorn, selfheal, chrysanthemum, herba cepbalanoplosis segeti, salted rhizoma alismatis and fried semen cassiae. Reflux-extracting fructus crataegi, prunellae Spica, salted Alismatis rhizoma and parched semen Cassiae with 50% ethanol as water twice to obtain ethanol extractive solution. Decocting flos Chrysanthemi and herba Cephalanoploris in water twice, mixing decoctions, filtering, concentrating, mixing with ethanol extract, concentrating to obtain fluid extract, adding appropriate amount of starch, drying under reduced pressure, pulverizing, and making into capsule with weight of 0.5 g.
Generally, 0.5g of the medicine needs to be 0# capsule or 00# capsule with the total length of more than 21mm and the external diameter of more than 7.5mm, so that the produced aster antihypertensive capsule has a large size and can cause a part of patients to be difficult to swallow.
Disclosure of Invention
In order to facilitate swallowing by patients, the application provides a aster antihypertensive capsule and a preparation method thereof.
In a first aspect, the application provides a chrysanthemum antihypertensive capsule, which adopts the following technical scheme:
the aster antihypertensive capsule comprises a capsule shell and contents, wherein the weight of the contents in the capsule shell is 0.15-0.3g, the total length of the capsule shell is 13.6-19.3mm, the outer diameter of the capsule shell is 5.3-6.85mm, the contents comprise aster antihypertensive medicaments and auxiliary materials in a weight ratio of 1 (0.8-1.1), and the aster antihypertensive medicaments comprise the following components in parts by weight: 1400-1500 parts of hawthorn, 170-190 parts of selfheal, 230-250 parts of chrysanthemum, 230-250 parts of herba cepbalanoplosis segeti, 170-190 parts of salted alismatis, and 230-250 parts of stir-fried semen cassiae, wherein the mass percentage of ursolic acid in the chrysanthemum morifolium antihypertensive drug is more than 3.68mg/g, and the mass percentage of chrysophanol in the chrysanthemum morifolium antihypertensive drug is more than 1.62mg/g.
By adopting the technical scheme, the hawthorn can promote digestion and remove stasis; flos Chrysanthemi, prunellae Spica, semen Cassiae, and semen Cassiae for removing liver fire and invigorating yang; salted alisma rhizome, rhizoma alismatis, has the effect of purging the deficiency fire of kidney channel; herba Cephalanoploris has effects of cooling blood and removing blood stasis; the medicines are combined to have the effects of calming liver, reducing pathogenic fire, promoting diuresis and removing blood stasis. As the mass percentage of the ursolic acid in the chrysanthemum morifolium ramat antihypertensive drug is more than 3.68mg/g and the mass percentage of the chrysophanol is more than 1.62mg/g, the content of the chrysophanol in each capsule shell is more than 0.25mg and the chrysophanol is more than 0.11mg. This shows that, although the mountain chrysanthemum antihypertensive capsule adopts the capsule shell with smaller total length and outer diameter, the weight of the content in the capsule shell is also smaller, but the capsule still has higher mass percent of effective medicine components in each capsule, and the prepared capsule has good medicine effect. Therefore, the aster antihypertensive capsule has the advantages of smaller size and good drug effect, and is convenient for patients to swallow.
In a specific embodiment, the aster antihypertensive drug comprises the following components in parts by weight: 1440 parts of hawthorn, 180 parts of selfheal, 240 parts of chrysanthemum, 240 parts of herba Cephalanoploris, 180 parts of salted alismatis and 240 parts of stir-fried semen cassiae.
In a specific embodiment, the adjuvant is any one of xylitol, mannitol, calcium sulfate dihydrate or calcium hydrogen phosphate.
By adopting the technical scheme, xylitol, mannitol, calcium sulfate dihydrate or calcium hydrophosphate have no hygroscopicity, can reduce the hygroscopicity of the medicine, has stable property, good compressibility and good disintegration, is convenient to prepare granular contents after being mixed with the chrysanthemum antihypertensive medicine, and is beneficial to keeping good medicine effect in the capsule shell. In human body, the four auxiliary materials are helpful for the disintegration of the content and the absorption of the effective medicine components by human body. In addition, compared with starch, the mass of xylitol, mannitol, calcium sulfate dihydrate or calcium hydrophosphate is smaller than that of starch with the same volume, so that the mass percentage of auxiliary materials in the content is reduced by adopting the four auxiliary materials, the mass of the content contained in each capsule shell is reduced, and the effect of reducing the size of the capsule is realized.
In a specific embodiment, the capsule shell is a # 1 capsule, a # 2 capsule, a # 3 capsule, or a # 4 capsule.
By adopting the technical scheme, the total length of the 1# capsule, the 2# capsule, the 3# capsule or the 4# capsule is between 13.6 and 19.3mm, the outer diameter is between 5.3 and 6.85mm, and the size of the capsule is smaller than that of the 0# capsule, so that 0.15 to 0.3g of medicine can be filled into the capsule shell. The 1# capsule, the 2# capsule, the 3# capsule or the 4# capsule are all easy to obtain raw materials, and are beneficial to reducing the production cost.
In a second aspect, the application provides a preparation method of a chrysanthemum antihypertensive capsule, which adopts the following technical scheme:
a preparation method of a chrysanthemum antihypertensive capsule comprises the following steps:
weighing: weighing hawthorn, selfheal, chrysanthemum, herba Cephalanoploris, salted alismatis and stir-fried semen cassiae according to the proportion;
alcohol extraction: mixing four ingredients of hawthorn, selfheal, salted alisma and fried cassia seed, crushing to obtain mixed powder A, mixing the mixed powder A, complex enzyme and water, carrying out enzymolysis, adding ethanol for reflux extraction, filtering the extracting solution to obtain filtrate A, and carrying out reduced pressure recovery of ethanol on the filtrate A to obtain an ethanol extracting solution;
decocting: mixing flos Chrysanthemi and herba Cephalanoploris, pulverizing to obtain mixed powder B, mixing the mixed powder B, complex enzyme and water, performing enzymolysis, decocting with water, and filtering decoction to obtain decoction;
pulverizing: mixing the ethanol extract with the decoction, adding flocculant, mixing, filtering to obtain filtrate B, and spray drying to obtain flos Chrysanthemi antihypertensive drug;
preparing capsules: mixing flos Chrysanthemi antihypertensive drug and adjuvants according to proportion, adding ethanol, mixing well, drying under reduced pressure to remove ethanol, and pulverizing to obtain content; each capsule shell is filled with 0.15-0.3g of content, and the pressure-reducing capsule of the chrysanthemum is obtained.
Through adopting the technical scheme, before reflux extraction and decoction, cellulose, pectin and the like in the cell walls of medicinal materials are subjected to enzymolysis by adopting compound enzyme, so that the cell walls of the medicinal materials are damaged, effective medicinal components in the medicinal materials are conveniently extracted, an alcohol extract and a decoction are combined, and then a flocculating agent is added and filtered, so that impurities and byproducts in the combined liquid can be removed, the mass percent of the effective medicinal components in the mountain chrysanthemum antihypertensive medicament is improved, and the side reaction of the mountain chrysanthemum antihypertensive medicament in a human body is reduced. The mass percentage of the ursolic acid in the chrysanthemum antihypertensive drug is more than 3.68mg/g, and the mass percentage of the chrysophanol is more than 1.62mg/g.
In a specific embodiment, the complex enzyme comprises a cellulase, a protease and a pectinase.
By adopting the technical scheme, because the adopted medicinal materials are plant traditional Chinese medicines, cellulose in medicinal material cells can be decomposed by adopting cellulase, plant protein in medicinal material cells can be decomposed by adopting protease, pectin in medicinal material cells can be decomposed by pectinase, the changes of local loosening, swelling, collapse and the like of cell walls and interstitial structures are caused, and the mass transfer resistance of mass transfer barriers such as cell walls and interstitial structures to the diffusion of active ingredients from the inside of cells to an extraction medium is reduced, so that the effect of conveniently extracting the active medicinal ingredients in the medicinal materials is achieved. In addition, as the pectase carries out enzymolysis on pectin, the viscosity of the extracting solution and the decoction is reduced, and the filterability of the extracting solution and the decoction is improved, thereby being beneficial to reducing the loss of effective medicinal components caused by filtration and improving the yield of the chrysanthemum morifolium antihypertensive medicament.
In a specific embodiment, the flocculant is chitin or gelatin.
By adopting the technical scheme, the chitin or the gelatin has good flocculation effect on plant cells, enzyme, cellulose, pectin and other impurities in the liquid medicine, is safe and nontoxic, and does not destroy effective medicinal components in the liquid medicine.
In a specific embodiment, the milling step is as follows: mixing the ethanol extract with the decoction, adding flocculant, mixing, performing solid-liquid separation, collecting the liquid after solid-liquid separation, passing through a column filled with macroporous resin, eluting the Chinese medicinal components on the macroporous resin with 60% ethanol to obtain filtrate B, and spray drying the filtrate B to obtain the flos Chrysanthemi Indici antihypertensive drug.
By adopting the technical scheme, centrifugal separation is firstly carried out, so that the impurities and byproducts with large particle diameters in the liquid medicine are removed, macroporous resin is used for eluting with ethanol, the effective medicine components in the liquid medicine are further purified, and the mass percentage of the effective medicine components in the chrysanthemum morifolium antihypertensive medicine can be further improved.
In a specific embodiment, the enzymatic hydrolysis is performed at 45-55deg.C and pH 3.0-4.5 for 100-180min in the ethanol extraction step and the decoction step.
By adopting the technical scheme, under the conditions of the temperature and the pH, the activity of the complex enzyme is improved, and the enzymolysis is facilitated.
In a specific implementation manner, in the alcohol extraction step, ethanol is added for reflux extraction twice, each reflux extraction is carried out for 0.5h, and the two extracts are combined and filtered to obtain filtrate A; in the decoction step, the decoction is carried out twice for 0.5h each time, and the two decoctions are combined and filtered to obtain decoction.
By adopting the technical scheme, as enzymolysis is carried out before reflux extraction and decoction, the time of reflux extraction and decoction time can be greatly shortened, and the effective medicinal components in the medicinal materials can be effectively extracted, so that the efficiency is improved.
In summary, the present application includes at least one of the following beneficial technical effects:
1. the aster antihypertensive capsule has the advantages of smaller size and good drug effect, and is convenient for patients to swallow;
2. the preparation method disclosed by the application is beneficial to damaging the cell walls of medicinal materials, is convenient for extracting effective medicinal components in the medicinal materials, and can also remove impurities and byproducts in the combined liquid, so that the mass percent of the effective medicinal components in the chrysanthemum morifolium antihypertensive medicament is improved, and the side reaction of the chrysanthemum morifolium antihypertensive medicament in a human body is reduced;
3. the preparation method of the application can improve the filterability of the extracting solution and the decoction, thereby being beneficial to reducing the loss of effective medicine components caused by filtration and improving the yield of the aster ageratoides antihypertensive medicine.
Detailed Description
The present application will be described in further detail with reference to examples and comparative examples.
Examples
Example 1
The embodiment provides a chrysanthemum antihypertensive drug which is prepared from the following components in parts by weight: 1440g of hawthorn, 180g of selfheal, 240g of chrysanthemum, 240g of common cephalanoplos herb, 180g of salted alismatis and 240g of stir-fried cassia seed.
The embodiment provides a compound enzyme, which comprises cellulase, protease and pectase in a weight ratio of 1:1:1, wherein the cellulase is Xia Cheng FDG-2225 food-grade acid cellulase, and the weight ratio of the cellulase to the pectase is 1.1 mu/g; the protease is Xia Cheng FDG-3203 food-grade acid protease, 10 ten thousand u/g; the pectase is Futai food-grade acid pectase, 3 ten thousand u/g.
The embodiment provides a chrysanthemum morifolium ramat antihypertensive capsule which comprises capsule shells and contents filled in the capsule shells, wherein the weight of the contents in each capsule shell is 0.3g, and the contents comprise chrysanthemum morifolium ramat antihypertensive drugs and mannitol in a weight ratio of 1:1. The capsule shell is a No. 1 capsule, the total length of the capsule shell after the cap and the body of the capsule shell are locked is 19.0 plus or minus 0.3mm, and the maximum outer diameter of the capsule shell is 6.82 plus or minus 0.03mm.
The embodiment also provides a preparation method of the chrysanthemum morifolium ramat antihypertensive capsule, which comprises the following steps:
firstly, weighing: weighing fructus crataegi, prunellae Spica, flos Chrysanthemi, herba Cephalanoploris, alismatis rhizoma with Sal and parched semen Cassiae according to the above ratio.
Then, extracting part of the medicinal materials with alcohol, wherein the steps are as follows: mixing four ingredients of hawthorn, selfheal, salted alisma and fried cassia seed, crushing in a 200-mesh superfine crusher to obtain mixed powder A, uniformly mixing the mixed powder A, compound enzyme and water according to the weight ratio of 1:0.2:5, regulating the pH value to be 4, standing for 120min at 50 ℃, obtaining an enzymolysis mixture A, adding analytically pure ethanol into the enzymolysis mixture A, carrying out reflux extraction on the mixture A and ethanol for 0.5h, carrying out suction filtration on the extract to obtain filtrate A, carrying out decompression on the filtrate A to recover ethanol, wherein the pressure is-0.08 MPa, and concentrating to the relative density of 1.15 (60 ℃) to obtain an ethanol extract.
And decocting the other part of medicines, wherein the steps are as follows: mixing chrysanthemum and herba Cephalanoploris, crushing in a 200-mesh superfine crusher to obtain mixed powder B, uniformly mixing the mixed powder B, complex enzyme and water according to the weight ratio of 1:0.2:5, regulating the pH value to be 4, standing for 120min at 50 ℃, and performing enzymolysis to obtain an enzymolysis mixture B, adding water into the enzymolysis mixture B, wherein the weight ratio of the enzymolysis mixture B to the water is 1:8, decocting for 0.5h, and performing suction filtration on the decoction to obtain the decoction.
Then the ethanol extract and the decoction are adopted for pulverizing, and the steps are as follows: mixing the ethanol extract with the decoction to obtain a mixed solution, adding food-grade gelatin into the mixed solution, mixing the food-grade gelatin and the mixed solution uniformly in a weight ratio of 1:20, standing for 10min, performing suction filtration to obtain filtrate B, and spray-drying the filtrate B to obtain the chrysanthemum antihypertensive drug.
Then the chrysanthemum antihypertensive medicine is prepared into capsules, and the steps are as follows: mixing the antihypertensive drug of the chrysanthemum and the auxiliary materials according to the proportion, adding the analytically pure ethanol, stirring the mixture into paste after uniform mixing, decompressing and drying the paste to remove the ethanol, wherein the pressure is-0.08 MPa, and then crushing the paste into particles to obtain the content; and filling the contents into each capsule shell to obtain the chrysanthemum antihypertensive capsules.
Example 2
The present example differs from example 1 only in that the antihypertensive drug of mountain chrysanthemum is prepared by adopting the following components by weight: 1400g of hawthorn, 170g of selfheal, 230g of chrysanthemum, 230g of herba Cephalanoploris, 170g of salted alismatis and 230g of stir-fried semen cassiae.
Example 3
The present example differs from example 1 only in that the antihypertensive drug of mountain chrysanthemum is prepared by adopting the following components by weight: 1500g of hawthorn, 190g of selfheal, 250g of chrysanthemum, 250g of herba Cephalanoploris, 190g of salted alismatis and 250g of stir-fried semen cassiae.
Example 4
This example differs from example 1 only in that the mountain chrysanthemum antihypertensive capsule comprises a capsule shell and contents contained in the capsule shell, the weight of the contents in each capsule shell is 0.25g, and the contents comprise mountain chrysanthemum antihypertensive drug and mannitol in a weight ratio of 1:0.9. The capsule shell is a No. 2 capsule, the total length of the capsule shell after the cap and the body of the capsule shell are locked is 17.5 plus or minus 0.3mm, and the maximum outer diameter of the capsule shell is 6.35 plus or minus 0.03mm.
Example 5
This example differs from example 1 only in that the mountain chrysanthemum antihypertensive capsule comprises a capsule shell and contents contained in the capsule shell, the weight of the contents in each capsule shell is 0.2g, and the contents comprise mountain chrysanthemum antihypertensive drug and mannitol in a weight ratio of 1:0.8. The capsule shell is a 3# capsule, the total length of the capsule shell after the cap and the body of the capsule shell are locked is 15.5+/-0.3 mm, and the maximum outer diameter of the capsule shell is 5.86+/-0.03 mm.
Example 6
This example differs from example 1 only in that the mountain chrysanthemum antihypertensive capsule comprises a capsule shell and contents contained in the capsule shell, the weight of the contents in each capsule shell is 0.15g, and the contents comprise mountain chrysanthemum antihypertensive drug and mannitol in a weight ratio of 1:1.1. The capsule shell is a 3# capsule, the total length of the capsule shell after the cap and the body of the capsule shell are locked is 13.9 plus or minus 0.3mm, and the maximum outer diameter of the capsule shell is 5.33 plus or minus 0.03mm.
Example 7
This example differs from example 1 only in that mannitol is replaced with an equal amount of xylitol.
Example 8
This example differs from example 1 only in that mannitol is replaced with an equivalent amount of calcium sulfate dihydrate.
Example 9
This example differs from example 1 only in that mannitol is replaced with an equivalent amount of dibasic calcium phosphate.
Example 10
This example differs from example 1 only in that the food grade gelatin is replaced with an equivalent amount of food grade chitin.
Example 11
The difference between this example and example 1 is that when extracting part of the medicinal materials with alcohol, the pH is adjusted to 3.0, the temperature is 45 ℃, and the mixture is left for 100min to complete enzymolysis, thus obtaining an enzymolysis mixture A; and (3) when the other part of medicinal materials are decocted, the pH is regulated to 3.0, the temperature is 45 ℃, and the mixture is stood for 100min, so that enzymolysis is finished, and the enzymolysis mixture B is obtained.
Example 12
The difference between this example and example 1 is that when extracting part of the medicinal materials with alcohol, the pH is adjusted to 4.5, the temperature is 55 ℃, and the mixture is left for 180min to complete enzymolysis, thus obtaining an enzymolysis mixture A; and (3) when the other part of medicinal materials are decocted, the pH is regulated to 4.5, the temperature is 55 ℃, and the mixture is stood for 180 minutes, so that enzymolysis is finished, and the enzymolysis mixture B is obtained.
Example 13
The present example differs from example 1 only in that the steps of pulverizing by using the alcohol extract and the decoction are as follows: mixing the ethanol extract with the decoction to obtain a mixed solution, adding food-grade gelatin into the mixed solution, mixing the food-grade gelatin and the mixed solution uniformly in a weight ratio of 1:20, standing for 10min, performing suction filtration, collecting the liquid after suction filtration, passing through a column filled with macroporous resin, eluting the traditional Chinese medicine components on the macroporous resin with 60% ethanol by mass concentration to obtain filtrate B, and performing spray drying on the filtrate B to obtain the chrysanthemum morifolium antihypertensive drug.
Example 14
The difference between the embodiment and the embodiment 1 is that when the alcohol extraction is carried out on part of medicinal materials, the analytically pure ethanol is added into the A enzymolysis mixture, the weight ratio of the A enzymolysis mixture to the ethanol is 1:3, 2 reflux extraction is carried out, each reflux extraction is carried out for 0.5h, and the 2 times of extracting solutions are combined and then are subjected to suction filtration, so that A filtrate is obtained; when the other part of medicinal materials are decocted, water is added into the enzymolysis mixture B, the weight ratio of the enzymolysis mixture B to the water is 1:8, 2 times of decoction are carried out, each time of decoction is 0.5h, and the 2 times of decoction are combined and then are subjected to suction filtration, so as to obtain decoction.
Comparative example
Comparative example 1
This comparative example differs from example 1 only in that the weight of the contents in each capsule shell is 0.12g.
Comparative example 2
The comparative example differs from example 1 only in that the preparation method of the mountain chrysanthemum antihypertensive capsule comprises the following steps:
firstly, weighing: weighing fructus crataegi, prunellae Spica, flos Chrysanthemi, herba Cephalanoploris, salted Alismatis rhizoma and parched semen Cassiae according to the proportion.
Then, extracting part of the medicinal materials with alcohol, wherein the steps are as follows: mixing four ingredients of hawthorn, selfheal, salted alisma and fried cassia seed, crushing in a 200-mesh superfine crusher to obtain mixed powder A, adding analytically pure ethanol into the mixed powder A, carrying out reflux extraction for 2 times, carrying out reflux extraction for 2 hours for the first time and 1.5 hours for the second time, combining the 2 times of extracting solutions, carrying out suction filtration to obtain filtrate A, carrying out reduced pressure recovery of ethanol on the filtrate A, wherein the pressure is-0.08 MPa, and concentrating the filtrate A until the relative density is 1.15 (60 ℃), thus obtaining an alcohol extract.
And decocting the other part of medicines, wherein the steps are as follows: mixing flos Chrysanthemi and herba Cephalanoploris, pulverizing in 200 mesh superfine pulverizer to obtain mixed powder B, adding water into the mixed powder B, decocting for 2 times (each for 2 hr) with the weight ratio of mixed powder B to water being 1:8, mixing 2 decoctions, and suction filtering to obtain decoction.
Then the ethanol extract and the decoction are adopted for pulverizing, and the steps are as follows: mixing the ethanol extract with the decoction to obtain a mixed solution, performing suction filtration on the mixed solution to obtain filtrate B, and performing spray drying on the filtrate B to obtain the chrysanthemum antihypertensive drug.
Then the chrysanthemum antihypertensive medicine is prepared into capsules, and the steps are as follows: mixing the antihypertensive drug of the chrysanthemum and the auxiliary materials according to the proportion, adding the analytically pure ethanol, uniformly mixing, stirring to form a paste, drying the paste under reduced pressure to remove the ethanol under the pressure of-0.08 MPa, and then crushing into particles to obtain the content; and filling the contents into each capsule shell to obtain the chrysanthemum antihypertensive capsules.
Performance test
For each example and comparative example, the following performance tests were performed:
1. determination of effective drug ingredients: according to the detection method of the aster antihypertensive capsules in WS-452 (Z-052) -2001-2001Z, the mass percentages of ursolic acid and chrysophanol in the aster antihypertensive drugs are respectively measured, and the mass of the ursolic acid and chrysophanol in the contents are calculated. Wherein the mass of ursolic acid in the content = mass percentage of ursolic acid in the aster antihypertensive drug x the mass of aster antihypertensive drug in the content = mass percentage of chrysophanol in the aster antihypertensive drug x the mass of aster antihypertensive drug in the content. The test results are shown in Table 1.
2. Acute toxicity test of animals
Test drug: examples 1-14 and comparative examples 1-2 mountain chrysanthemum antihypertensive capsule contents;
test animals: kunming mice, weighing 18-22g, were supplied by Jiangsu province pharmaceutical research institute.
The test method comprises the following steps: healthy Kunming mice, male and female were each half, and 20 total mice. The administration was fasted for 12 hours without water. The contents of the mountain chrysanthemum antihypertensive capsules of examples 1-14 and comparative examples 1-2 were prepared into medicaments with the mass concentration of 80% by distilled water, respectively, and each mouse was subjected to one-time gastric lavage with a weight of 0.8ml/20 g. Animal response was observed and animal death was recorded for 7 consecutive days following dosing. The test results are shown in Table 2.
3. Animal long-term toxicity test
Test drug: examples 1-14 and comparative examples 1-2 mountain chrysanthemum antihypertensive capsule contents;
test animals: 90 SD rats, male and female, were 5-6 weeks old and were supplied from the animal room of Jiangsu province pharmaceutical institute.
The test method comprises the following steps: the test is divided into three groups; high dose group (46.4 g/kg), low dose group (23.2 g/kg) and blank group (distilled water), 30 rats per group, male and female halves. Dosing was 6 days per week, 8 am each day: 30-9:30 times of gastric lavage administration are carried out for 6 months, and each administration volume is 1.3ml/100g of body weight. Each group was vaccinated with a portion of animals 24 hours after the last dose of months 3 and 6, and each index was measured. Part of the animals left after 6 months stopped for 2 weeks and were then biopsied. The test results are shown in Table 3.
4. Clinical trial
For 180 cases of syndrome differentiation of traditional Chinese medicine, which belong to excessive liver fire and excessive liver yang, and the blood pressure reaches the definite diagnosis of the hypertension level, the clinical symptoms of heart failure, brain failure and complications are equally divided into 18 groups for treatment. The treatment method comprises the following steps: the preparation is administered twice a day, two granules each time. One month is a treatment course, and the total treatment is 2 treatment courses. The results of the treatment are shown in Table 4.
TABLE 1 data sheet for measuring effective pharmaceutical ingredient
TABLE 2 animal acute toxicity test data sheet
| Group of | Number of animal deaths | Group of | Number of animal deaths |
| Example 1 | 0 | Example 9 | 0 |
| Example 2 | 0 | Example 10 | 0 |
| Example 3 | 0 | Example 11 | 0 |
| Example 4 | 0 | Example 12 | 0 |
| Example 5 | 0 | Example 13 | 0 |
| Example 6 | 0 | Example 14 | 0 |
| Example 7 | 0 | Comparative example 1 | 0 |
| Example 8 | 0 | Comparative example 2 | 0 |
TABLE 3 data sheet for animal long-term toxicity test
Table 4 clinical trial data sheet
It can be seen from the combination of example 1 and comparative examples 1-2 and tables 1-4 that the mass percentage of ursolic acid and the mass percentage of chrysophanol in comparative examples 1-2 are significantly smaller than those in the mountain chrysanthemum antihypertensive capsule of example 1, and that the mass percentage of ursolic acid in the contents of comparative examples 1-2 is less than 0.25mg and the mass percentage of chrysophanol is less than 0.11mg. Although the acute toxicity test and the long-term toxicity test of animals of the mountain chrysanthemum antihypertensive capsules of the comparative examples 1-2 do not cause death of animals or remarkable abnormality of viscera, the clinic significant number and the effective number of the mountain chrysanthemum antihypertensive capsules of the comparative examples 1-2 are obviously smaller. This shows that the preparation of the mountain chrysanthemum antihypertensive capsule with good drug effect is facilitated by adopting the raw material proportion and the preparation process of the embodiment 1. Moreover, the aster antihypertensive capsule of example 1 is smaller in size and more convenient for the patient to swallow than the 0# capsule.
As can be seen by combining examples 1-14 and tables 1-4, the aster antihypertensive capsules of examples 1-14 are smaller than the 0# capsules in size and have good safety and efficacy, which shows that the aster antihypertensive capsules with good efficacy and convenient swallowing by patients can be prepared by adopting the raw material proportions and the process conditions in the range of examples 1-14.
The present embodiment is only for explanation of the present application and is not to be construed as limiting the present application, and modifications to the present embodiment, which may not creatively contribute to the present application as required by those skilled in the art after reading the present specification, are all protected by patent laws within the scope of claims of the present application.
Claims (10)
1. A chrysanthemum antihypertensive capsule is characterized in that: the capsule comprises a capsule shell and contents, wherein the weight of the contents in the capsule shell is 0.15-0.3g, the total length of the capsule shell is 13.6-19.3mm, the outer diameter of the capsule shell is 5.3-6.85mm, the contents comprise a aster antihypertensive medicament and auxiliary materials in a weight ratio of 1 (0.8-1.1), and the aster antihypertensive medicament comprises the following components in parts by weight: 1400-1500 parts of hawthorn, 170-190 parts of selfheal, 230-250 parts of chrysanthemum, 230-250 parts of herba cepbalanoplosis segeti, 170-190 parts of salted alismatis, and 230-250 parts of stir-fried semen cassiae, wherein the mass percentage of ursolic acid in the chrysanthemum morifolium antihypertensive drug is more than 3.68mg/g, and the mass percentage of chrysophanol in the chrysanthemum morifolium antihypertensive drug is more than 1.62mg/g.
2. The chrysanthemum antihypertensive capsule of claim 1, wherein the chrysanthemum antihypertensive drug comprises the following components in parts by weight: 1440 parts of hawthorn, 180 parts of selfheal, 240 parts of chrysanthemum, 240 parts of herba Cephalanoploris, 180 parts of salted alismatis and 240 parts of stir-fried semen cassiae.
3. The aster antihypertensive capsule of claim 1, wherein the auxiliary material is any one of xylitol, mannitol, calcium sulfate dihydrate or calcium hydrophosphate.
4. The aster antihypertensive capsule of claim 1, wherein the capsule shell is a # 1 capsule, a # 2 capsule, a # 3 capsule or a # 4 capsule.
5. A method for preparing a antihypertensive capsule of aster according to any one of claims 1-4, comprising the steps of:
weighing: weighing hawthorn, selfheal, chrysanthemum, herba Cephalanoploris, salted alismatis and stir-fried semen cassiae according to the proportion;
alcohol extraction: mixing four ingredients of hawthorn, selfheal, salted alisma and fried cassia seed, crushing to obtain mixed powder A, mixing the mixed powder A, complex enzyme and water, carrying out enzymolysis, adding ethanol for reflux extraction, filtering the extracting solution to obtain filtrate A, and carrying out reduced pressure recovery of ethanol on the filtrate A to obtain an ethanol extracting solution;
decocting: mixing flos Chrysanthemi and herba Cephalanoploris, pulverizing to obtain mixed powder B, mixing the mixed powder B, complex enzyme and water, performing enzymolysis, decocting with water, and filtering decoction to obtain decoction;
pulverizing: mixing the ethanol extract with the decoction, adding flocculant, mixing, filtering to obtain filtrate B, and spray drying to obtain flos Chrysanthemi antihypertensive drug;
preparing capsules: mixing flos Chrysanthemi antihypertensive drug and adjuvants according to proportion, adding ethanol, mixing well, drying under reduced pressure to remove ethanol, and pulverizing to obtain content; each capsule shell is filled with 0.15-0.3g of content, and the pressure-reducing capsule of the chrysanthemum is obtained.
6. The preparation method of the chrysanthemum antihypertensive capsule according to claim 5, which is characterized in that: the complex enzyme comprises cellulase, protease and pectase.
7. The preparation method of the chrysanthemum antihypertensive capsule according to claim 5, which is characterized in that: the flocculant is chitin or gelatin.
8. The method for preparing the mountain chrysanthemum antihypertensive capsule according to claim 5, wherein the step of pulverizing is as follows: mixing the ethanol extract with the decoction, adding flocculant, mixing, performing solid-liquid separation, collecting the liquid after solid-liquid separation, passing through a column filled with macroporous resin, eluting the Chinese medicinal components on the macroporous resin with 60% ethanol to obtain filtrate B, and spray drying the filtrate B to obtain the flos Chrysanthemi Indici antihypertensive drug.
9. The preparation method of the mountain chrysanthemum antihypertensive capsule according to claim 5, wherein in the alcohol extraction step and the decoction step, enzymolysis is carried out at 45-55 ℃ in an environment with a pH of 3.0-4.5, and the enzymolysis time is 100-180min.
10. The preparation method of the mountain chrysanthemum antihypertensive capsule according to claim 5, wherein in the alcohol extraction step, ethanol is added for reflux extraction twice, each reflux extraction is carried out for 0.5h, and the two extraction solutions are combined and filtered to obtain filtrate A; in the decoction step, the decoction is carried out twice for 0.5h each time, and the two decoctions are combined and filtered to obtain decoction.
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| CN202310319659.2A CN116808119A (en) | 2023-03-29 | 2023-03-29 | Mountain chrysanthemum antihypertensive capsule and preparation method thereof |
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