CN107890479B - A Chinese medicinal capsule for treating coronary heart disease, and its preparation method - Google Patents
A Chinese medicinal capsule for treating coronary heart disease, and its preparation method Download PDFInfo
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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)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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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)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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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)
- A61K36/29—Berberidaceae (Barberry family), e.g. barberry, cohosh or mayapple
- A61K36/296—Epimedium
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
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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
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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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
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Abstract
The invention discloses a traditional Chinese medicine capsule for treating coronary heart disease and a preparation method thereof, wherein the traditional Chinese medicine capsule for treating coronary heart disease comprises the following raw materials in parts by weight: 10 parts of white paeony root, 1-1.5 parts of red ginseng, 4-5 parts of epimedium herb, 2-3 parts of hawthorn, 0.1-5 parts of polyethylene glycol 6000, and a proper amount of pH regulator and/or a proper amount of corn starch. According to the scheme of the invention, the auxiliary material polyethylene glycol 6000 is added on the basis of the traditional Chinese medicine water extraction process, so that the extraction transfer rate of active ingredients can be effectively improved, the moisture absorption of the capsule can be effectively prevented, the stability of the capsule is increased, the product quality is prolonged, and the method has the characteristics of simple process operation and easiness in industrialization.
Description
Technical Field
The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine capsule for treating coronary heart disease and a preparation method thereof.
Background
Coronary atherosclerotic heart disease is a heart disease caused by myocardial ischemia, hypoxia or necrosis due to stenosis or obstruction of a blood vessel cavity caused by atherosclerotic lesions generated in coronary vessels, and is often referred to as "coronary heart disease". Coronary heart disease may be more widespread, but also includes inflammation, embolism and the like resulting in stenosis or occlusion of the lumen. The world health organization classifies coronary heart disease into 5 major categories: asymptomatic myocardial ischemia (occult coronary heart disease), angina pectoris, myocardial infarction, ischemic heart failure (ischemic heart disease) and sudden death 5 clinical types. Clinically, stable coronary heart disease and acute coronary syndrome are often classified.
The Xintongkang capsule is prepared from red ginseng powder and Chinese medicinal extracts of peony, epimedium, hawthorn, etc., wherein the peony is a monarch drug in the formula, and the effective component of the peony is paeoniflorin. The Xintongkang capsule has the functions of benefiting qi, activating blood circulation, warming yang, nourishing yin, eliminating stagnation and relieving pain, is mainly used for treating chest stabbing pain or stuffiness pain, fixed pain, palpitation and short breath or spontaneous perspiration due to mental fatigue, dry throat and vexation, coronary heart disease, angina and the like caused by qi stagnation and blood stasis, can obviously increase coronary flow, reduce oxygen consumption of cardiac muscle, inhibit platelet aggregation, enhance the hypoxia tolerance of cardiac muscle and obviously enhance the cardiac function. Is the variety collected in the fourth volume of the drug Standard of the Ministry of health (new drug Change), the national Chinese medicine protection variety and the national basic medicine.
The extraction process of the traditional Chinese medicine extract of the Xintongkang capsule in the prior art is a water extraction and alcohol precipitation method, but the extraction and transfer rate of effective components in a thick extract is low, data show that the extract yield of the thick extract is only 10-20%, the average extraction and transfer rate of the effective components is not more than 70% calculated by paeoniflorin in a monarch drug of radix paeoniae alba, the effective components in medicinal materials are not completely extracted, so that the waste of medicinal material resources is serious, the process cost is high, and the treatment effect of the Xintongkang capsule is seriously influenced due to the low extraction and transfer rate of the paeoniflorin, so that the preparation process of the Xintongkang.
In addition, in the process of filling the Xintongkang capsules, the problems that the dry powder of the medicinal extract has strong hygroscopicity, is easy to agglomerate and thicken, causes great weight difference of filled capsules, content reduction, disintegration time limit extension and the like and seriously affects the quality of the capsules are found, the moisture absorption and weight gain rate of the dry powder of the extract is reduced only by controlling the environmental humidity in the filling process, but the process control stability is poor and the risk is high.
In the development process, the auxiliary material polyethylene glycol 6000 is added into the extract by controlling the pH value of the extract in the water extraction process of the Xintongkang traditional Chinese medicine capsule extract, so that the extraction transfer rate of effective components can be effectively improved, and the stability of the capsule can be obviously improved. According to the preparation method, the average extraction transfer rate of the active ingredient paeoniflorin in the extract extraction is not lower than 90%, the prepared capsule is stored for 24 hours under 75% relative humidity, the moisture absorption and weight gain are not obvious, the disintegration time limit is not obviously prolonged, the moisture absorption of the capsule is effectively prevented, the stability of the capsule is increased, and the problems of low extraction transfer rate of the active ingredient and strong moisture absorption of the dry powder of the traditional Chinese medicine extract in the production of the Xintongkang capsule are solved.
Polyethylene glycol 6000(PEG6000) is a high molecular polymer prepared by condensing ethylene oxide and water, and has a molecular formula of HO (CH)2CH2O) nH, wherein n represents the average number of oxyethylene groups, is non-toxic, non-irritating and widely used in various pharmaceutical formulations, generally as a base for emulsions, suppositories, as a plasticizer and as a sustained release material.
Disclosure of Invention
The invention aims to provide a preparation method of a traditional Chinese medicine capsule for treating coronary heart disease, aiming at the problems of low transfer rate of effective components extracted from the traditional Chinese medicine and unstable quality of traditional Chinese medicine products due to strong hygroscopicity.
The purpose of the invention can be realized by the following technical scheme:
a traditional Chinese medicine capsule for treating coronary heart disease comprises the following raw materials in parts by weight: 10 parts of white paeony root, 1-1.5 parts of red ginseng, 4-5 parts of epimedium herb, 2-3 parts of hawthorn, 0.1-5 parts of polyethylene glycol 6000, and a proper amount of pH regulator and/or a proper amount of corn starch.
The traditional Chinese medicine capsule for treating coronary heart disease preferably comprises the following raw materials in parts by weight: 10 parts of white paeony root, 1-1.5 parts of red ginseng, 4-5 parts of epimedium herb, 2-3 parts of hawthorn, 0.5-2 parts of polyethylene glycol 6000, and a proper amount of pH regulator and/or a proper amount of corn starch.
Wherein, the pH regulator is preferably one or more of organic acids, and is further preferably one or more of fumaric acid, citric acid, malic acid and tartaric acid; citric acid is particularly preferred.
The traditional Chinese medicine capsule for treating coronary heart disease is preferably prepared by the following method:
1) adding water into the white paeony root, the epimedium herb and the hawthorn in formula amount, adjusting the pH of the solution to 2-6 by using a pH regulator, and adding polyethylene glycol 6000 in formula amount; wherein the amount of water added is 10-12 times of the total weight of radix Paeoniae alba, herba Epimedii and fructus crataegi Pinnatifidae;
2) leaching at 30-50 deg.C for 2-8 hr, filtering, and concentrating the filtrate to viscous state;
3) adding alcohol, precipitating with ethanol, standing for 24-36 hr, filtering, and concentrating the filtrate under reduced pressure to obtain soft extract;
4) weighing red ginseng powder with a formula amount, mixing the red ginseng powder with the thick extract obtained in the step 3), drying, crushing, sieving by a 60-mesh sieve to obtain extract dry powder, and filling capsules, wherein the filling amount of the extract dry powder is less than 0.3g of each capsule and is complemented by corn starch.
The preparation method of the traditional Chinese medicine capsule comprises the following steps:
1) adding water into the white paeony root, the epimedium herb and the hawthorn in formula amount, adjusting the pH of the solution to 2-6 by using a pH regulator, and adding polyethylene glycol 6000 in formula amount; wherein the amount of water added is 10-12 times of the total weight of radix Paeoniae alba, herba Epimedii and fructus crataegi Pinnatifidae;
2) leaching at 30-50 deg.C for 2-8 hr, filtering, and concentrating the filtrate to viscous state;
3) adding alcohol, precipitating with ethanol, standing for 24-36 hr, filtering, and concentrating the filtrate under reduced pressure to obtain soft extract;
4) weighing red ginseng powder with a formula amount, mixing the red ginseng powder with the thick extract obtained in the step 3), drying, crushing, sieving by a 60-mesh sieve to obtain extract dry powder, and filling capsules, wherein the filling amount of the extract dry powder is less than 0.3g of each capsule and is complemented by corn starch.
The pH regulator in the step 1) is preferably one or more of organic acids, and further preferably fumaric acid, citric acid, malic acid and tartaric acid.
In step 1), the pH of the solution is preferably adjusted to 2-4 by using a pH regulator.
In the step 1), citric acid is further preferably used as the pH regulator, and the pH of the solution is regulated to 2-4.
In step 3), the alcohol is preferably added so that the alcohol content reaches 65 to 70%.
The drying mode in the step 4) is preferably reduced pressure drying, spray drying or freeze drying.
Has the advantages that: the invention is based on the problem that the transfer rate of effective components in the extraction of the Xintongkang capsule traditional Chinese medicine extract is low, the prepared traditional Chinese medicine preparation is easy to absorb moisture, and the disintegration time limit of the capsule can be prolonged after long-term storage. The invention unexpectedly discovers that the auxiliary material polyethylene glycol 6000 is added on the basis of the traditional extract water extraction process, so that the extraction transfer rate of effective components can be effectively improved, and the stability of the capsule can be obviously improved. According to the preparation method, the average extraction transfer rate of the active ingredient paeoniflorin in extract extraction is not lower than 90%, the prepared capsule is stored for 24 hours under 75% relative humidity, the moisture absorption and weight gain are not obvious, the disintegration time limit is not obviously prolonged, the moisture absorption of the capsule is effectively prevented, the stability of the capsule is increased, the product quality is prolonged, and the preparation method has the characteristics of simple process operation and easiness in realization of industrialization.
Detailed Description
The extraction transfer rate in the following examples was calculated as follows:
the extraction transfer rate is equal to the total mass of the target components in the thick paste/the total mass of the target components in the medicinal materials multiplied by 100 percent.
Example 1
Capsules were prepared according to the following formulation and process, and the data are presented in table 1 below.
Weighing radix paeoniae alba (paeoniflorin content is 4.4%), herba epimedii and fructus crataegi in a formula amount, adding into an extraction tank, sealing, adding 10 times of the total amount of medicinal materials, adjusting the pH value of the solution to about 4 by using a pH regulator, adding auxiliary materials in the formula amount, soaking and extracting for 2 hours at 50 ℃, filtering, concentrating the filtrate under reduced pressure to form viscous liquid, adding 95% ethanol until the alcohol content is 65%, standing for 24 hours, filtering, concentrating the filtrate under reduced pressure to obtain thick paste, mixing with red ginseng powder in the formula amount, drying together, crushing into fine powder, sieving by a 60-mesh sieve to obtain dry powder of Chinese medicinal extract, directly filling into capsules, and supplementing a proper amount of starch to 0.3g of each capsule to obtain the Xintongkang capsules.
Measuring penoniflorin content in the intermediate soft extract, calculating extraction transfer rate, storing the Xintongkang capsule at 75% relative humidity for 24 hr, and sampling to determine moisture absorption weight gain rate and disintegration time limit.
TABLE 1
Researches show that in an experimental group without PEG-6000 or other auxiliary materials, the extraction transfer rate and the disintegration time limit of paeoniflorin are prolonged under a high humidity condition, the extraction transfer rate is improved after Tween-80 and RH40 are added, but the disintegration time limit is not improved, and the problem of the prolongation of the disintegration time limit also exists, and only the PEG-6000 is added, so that the extraction transfer rate can be increased by more than 90%, the disintegration time limit of the capsule can be kept basically unchanged, and the stability of the capsule is improved.
Example 2
Capsules were prepared according to the following formulation and process, and the data are presented in table 2 below.
Weighing radix paeoniae alba (paeoniflorin content is 4.4%), herba epimedii and fructus crataegi in a formula amount, adding into an extraction tank, sealing, adding 12 times of the total amount of medicinal materials, adjusting the pH value of the solution to about 4 by using a pH regulator, adding auxiliary materials in the formula amount, soaking and extracting at 30 ℃ for 8 hours, filtering, concentrating the filtrate under reduced pressure to obtain viscous liquid, adding 95% ethanol until the alcohol content is 70%, standing for 24 hours, filtering, concentrating the filtrate under reduced pressure to obtain thick paste, mixing with red ginseng powder in the formula amount, drying together, crushing into fine powder, sieving by a 60-mesh sieve to obtain dry powder of Chinese medicinal extract, directly filling into capsules, and supplementing a proper amount of starch to 0.3g of each capsule to obtain the Xintongkang capsules.
Measuring penoniflorin content in the intermediate soft extract, calculating extraction transfer rate, storing the Xintongkang capsule at 75% relative humidity for 24 hr, and sampling to determine moisture absorption weight gain rate and disintegration time limit.
TABLE 2
Researches show that the problem of low extraction and transfer rate of effective components can be solved by adding 1-50% of PEG-6000 into radix Paeoniae alba even if the dosage of the prescription is changed, and the capsule is prevented from absorbing moisture, so that the disintegration time limit is ensured, and the product quality is improved.
Example 3
Capsules were prepared according to the following formulation and process and the data are given in table 3 below.
Weighing radix paeoniae alba (paeoniflorin content is 4.4%), herba epimedii and fructus crataegi in a formula amount, adding into an extraction tank, sealing, adding 10 times of the total amount of medicinal materials, adjusting the pH value of the solution to about 4 by using a pH regulator, adding auxiliary materials in the formula amount, soaking and extracting at 40 ℃ for 5 hours, filtering, concentrating the filtrate under reduced pressure to obtain viscous liquid, adding 95% ethanol until the alcohol content is 70%, standing for 24 hours, filtering, concentrating the filtrate under reduced pressure to obtain thick paste, mixing with red ginseng powder in the formula amount, drying together, crushing into fine powder, sieving by a 60-mesh sieve to obtain dry powder of traditional Chinese medicine extract, directly filling into capsules, and supplementing a proper amount of starch to 0.3g of each capsule to obtain the Xintongkang capsules.
Measuring penoniflorin content in the intermediate soft extract, calculating extraction transfer rate, storing the Xintongkang capsule at 75% relative humidity for 24 hr, and sampling to determine moisture absorption weight gain rate and disintegration time limit.
TABLE 3
Researches show that on the basis of the scheme of the invention, the pH value of the extracting solution is adjusted by adopting an organic acid reagent, the paeoniflorin extraction transfer rate is higher, the moisture absorption weight gain rate is superior to that of an inorganic acid pH adjusting agent, and the disintegration time limit is not obviously prolonged.
Claims (8)
1. A traditional Chinese medicine capsule for treating coronary heart disease is characterized by comprising the following raw materials in parts by weight: 10 parts of white paeony root, 1-1.5 parts of red ginseng, 4-5 parts of epimedium herb, 2-3 parts of hawthorn, 0.1-5 parts of polyethylene glycol 6000, a proper amount of pH regulator and/or a proper amount of corn starch;
the traditional Chinese medicine capsule for treating coronary heart disease is prepared by the following method:
1) adding water into the white paeony root, the epimedium herb and the hawthorn in formula amount, adjusting the pH of the solution to 2-6 by using a pH regulator, and adding polyethylene glycol 6000 in formula amount; wherein the amount of water added is 10-12 times of the total weight of radix Paeoniae alba, herba Epimedii and fructus crataegi Pinnatifidae;
2) leaching at 30-50 deg.C for 2-8 hr, filtering, and concentrating the filtrate to viscous state;
3) adding alcohol, precipitating with ethanol, standing for 24-36 hr, filtering, and concentrating the filtrate under reduced pressure to obtain soft extract;
4) weighing red ginseng powder with a formula amount, mixing the red ginseng powder with the thick extract obtained in the step 3), drying, crushing, sieving by a 60-mesh sieve to obtain extract dry powder, and filling capsules, wherein the filling amount of the extract dry powder is less than 0.3g of each capsule and is complemented by corn starch.
2. The traditional Chinese medicine capsule for treating coronary heart disease according to claim 1, comprising the following raw materials in parts by weight: 10 parts of white paeony root, 1-1.5 parts of red ginseng, 4-5 parts of epimedium herb, 2-3 parts of hawthorn, 0.5-2 parts of polyethylene glycol 6000, and a proper amount of pH regulator and/or a proper amount of corn starch.
3. The traditional Chinese medicine capsule for treating coronary heart disease according to claim 1, wherein the pH regulator is one or more of fumaric acid, citric acid, malic acid and tartaric acid.
4. The method for preparing a Chinese medicinal capsule as claimed in any one of claims 1-3, comprising the steps of:
1) adding water into the white paeony root, the epimedium herb and the hawthorn in formula amount, adjusting the pH of the solution to 2-6 by using a pH regulator, and adding polyethylene glycol 6000 in formula amount; wherein the amount of water added is 10-12 times of the total weight of radix Paeoniae alba, herba Epimedii and fructus crataegi Pinnatifidae;
2) leaching at 30-50 deg.C for 2-8 hr, filtering, and concentrating the filtrate to viscous state;
3) adding alcohol, precipitating with ethanol, standing for 24-36 hr, filtering, and concentrating the filtrate under reduced pressure to obtain soft extract;
4) weighing red ginseng powder with a formula amount, mixing the red ginseng powder with the thick extract obtained in the step 3), drying, crushing, sieving by a 60-mesh sieve to obtain extract dry powder, and filling capsules, wherein the filling amount of the extract dry powder is less than 0.3g of each capsule and is complemented by corn starch.
5. The method for preparing a Chinese medicinal capsule according to claim 4, wherein the pH of the solution in step 1) is adjusted to 2-4 with a pH adjusting agent.
6. The method for preparing a Chinese medicinal capsule according to claim 5, wherein the pH regulator in step 1) is citric acid, and the pH of the solution is adjusted to 2-4.
7. The method for preparing a Chinese medicinal capsule according to claim 4, wherein the alcohol is added in step 3) to make the alcohol content reach 65-70%.
8. The method for preparing a Chinese medicinal capsule according to claim 4, wherein the drying in step 4) is drying under reduced pressure, spray drying or freeze drying.
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