WO2018090380A1 - 一种胶囊及其制备工艺 - Google Patents

一种胶囊及其制备工艺 Download PDF

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WO2018090380A1
WO2018090380A1 PCT/CN2016/106659 CN2016106659W WO2018090380A1 WO 2018090380 A1 WO2018090380 A1 WO 2018090380A1 CN 2016106659 W CN2016106659 W CN 2016106659W WO 2018090380 A1 WO2018090380 A1 WO 2018090380A1
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parts
capsule
hours
sandalwood
extract
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PCT/CN2016/106659
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English (en)
French (fr)
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佘宜寰
韩风雨
于秀玲
李洪泽
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内蒙古天奇中蒙制药股份有限公司
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Priority to PCT/CN2016/106659 priority Critical patent/WO2018090380A1/zh
Priority to CN201611195339.7A priority patent/CN108079235A/zh
Publication of WO2018090380A1 publication Critical patent/WO2018090380A1/zh

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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)
    • 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)
    • A61K36/22—Anacardiaceae (Sumac family), e.g. smoketree, sumac or poison oak
    • 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)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • 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
    • A61K36/537—Salvia (sage)
    • 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)
    • A61K36/67—Piperaceae (Pepper family), e.g. Jamaican pepper or kava
    • 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)
    • A61K36/83—Thymelaeaceae (Mezereum family), e.g. leatherwood or false ohelo
    • A61K36/835—Aquilaria
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9064—Amomum, e.g. round cardamom
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—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
    • 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

Definitions

  • the invention belongs to the technical field of medicine, and particularly relates to a coronary heart activating blood capsule and a preparation process thereof.
  • the invention provides a capsule and a preparation process thereof, which are mainly used for treating coronary heart disease, and the dosage form of the product is a capsule, which is more favorable for the retention of the active ingredient of the medicine than the traditional soup, and is convenient for taking, storing and transporting;
  • the invention also provides a preparation process of the capsule, which can fully and effectively extract the active substance of the medicinal material, thereby solving the key problem of the preparation of the capsule.
  • the present invention provides a capsule comprising the following components, the parts by weight of which are expressed as follows:
  • the invention further includes an auxiliary material, the auxiliary material is one or more of a filler, a binder, and a lubricant;
  • the filler is starch, powdered sugar, lactose, dextrin, compressible starch, microcrystalline fiber
  • the lubricant is one of magnesium stearate, micronized silica gel, talc, hydrogenated vegetable oil, polyethylene glycol, and magnesium lauryl sulfate or Several.
  • the filler is dextrin or microcrystalline cellulose; the lubricant is micronized silica gel and magnesium stearate.
  • the invention also provides a preparation process of the capsule, comprising the following steps:
  • 1S A predetermined proportion of sandalwood, scented, red sandalwood, nutmeg, soaked in 7-9 times water for 2 hours, reflux extraction for 8 hours, to obtain volatile oil, dregs, steam distillate and water extract, spare Adding a saturated aqueous solution of ⁇ -cyclodextrin to the volatile oil, and encapsulating at 55-65 ° C for 2-2.5 hours to obtain a volatile oil clathrate for use;
  • 2S take a predetermined proportion of Salvia miltiorrhiza, add 8-10 times the amount of 80-90% ethanol heated reflux extraction, Danshen medicine residue reserve; extract the filtrate, concentrate the filtrate to clear paste, spare;
  • 3S Adding 8-7 times of 55-65% ethanol of Danshen dregs and a predetermined proportion of jujube, seabuckthorn, agarwood, safflower and sorghum, heating and refluxing, extracting the filtrate, and concentrating the filtrate to a clear paste. ;
  • step 2S reflux extraction is performed 2-3 times, each time 1-2 hours; in step 3S, reflux extraction is performed 2-3 times, each time is 1.5-2.5 hours; in step 4S, boiling 1-2 Times, 2-3 hours each time.
  • step 2S is carried out by refluxing 3 times for 1.5 hours each time; in the step 3S, the reflux is extracted twice for 2 hours each time; in the step 4S, the boiling is performed 2 times for 2 hours each time.
  • a saturated aqueous solution containing 3.5-4.5 g of ⁇ -cyclodextrin is added per ml of the volatile oil.
  • the relative density of the clear paste prepared in the steps 2S, 3S, and 4S is 1.03-1.09.
  • the capsule provided by the invention comprises 420-450 parts of Salvia miltiorrhiza, and Danshen contains tanshinone and salvianolic acid B, which can antagonize angiotensin II, enhance cardiac function, expand blood vessels, inhibit platelet aggregation, lower blood viscosity and improve blood flow. And so on.
  • the volatile oil contained in the fragrance and its aromatic water can effectively inhibit the experimental thrombosis in rats by 250mg/kg; it can significantly increase the level of platelet cAMP in rabbits, and the rabbit plasma plasmin Activity has a significant effect, suggesting an antithrombotic effect.
  • 135-150 parts of nutmeg the volatile oil contained in nutmeg has a protective effect on myocardial ischemia-reperfusion injury in rats, can treat arrhythmia, and has a therapeutic effect on cardiovascular diseases.
  • the capsule also includes 135-148 parts of jujube, 140-150 parts of seabuckthorn, 210-225 parts of agarwood, 125-138 parts of alfalfa, and 68-75 parts of samurai.
  • the prescriptions are jujube, seabuckthorn, agarwood, alfalfa and mountain.
  • the active ingredient is a flavonoid compound, and the flavonoid compound has the effects of calming the nerves, relieving angina, improving heart rhythm, and resisting cardiovascular diseases. It can significantly inhibit platelet aggregation and reduce blood rheology indicators, anti-oxidation, and protective effect on myocardial ischemia.
  • the capsule further comprises 43-48 parts of sandalwood and 43-48 parts of red sandalwood; preferably, 48 parts of sandalwood and 48 parts of red sandalwood; and 0.91g/kg of sandal tea decoction has an inhibitory effect on gastrointestinal function.
  • the sandalwood ether extract 0.91g/kg has a promoting effect on gastrointestinal function.
  • the volatile oil of sandalwood 0.91g/kg can increase cAMP and cAMP/cGMP values, and promote the metabolism of substances.
  • the capsules used in the capsules of the invention have the obvious curative effect on the treatment of coronary heart disease angina pectoris under the weight ratio of the invention; and the sandalwood incense and sandalwood It has the functions of qi and stomach, can be used to relieve gastrointestinal discomfort, and promote the absorption of other active ingredients.
  • the above weight fraction can achieve better results.
  • the capsule of the present invention further comprises an auxiliary material, which is one or more of a filler, a binder and a lubricant;
  • the filler is starch, powdered sugar, lactose, dextrin, compressible starch, microcrystalline cellulose, nectar One or more of an alcohol and an inorganic salt;
  • the lubricant is one or more of magnesium stearate, micronized silica gel, talc, hydrogenated vegetable oil, polyethylene glycol, and magnesium lauryl sulfate.
  • the filler is dextrin or microcrystalline cellulose, which accounts for 10% of the contents of the capsule.
  • the filler of the ratio of the kind can be used to make the capsule have good fluidity and hygroscopicity, and can ensure the smooth filling of the capsule. Carry out and the accuracy of the capsule loading.
  • the lubricant is micro-powder silica gel and magnesium stearate, each of which accounts for 1%, which can further improve the fluidity of the mixed powder and increase the pellet forming rate.
  • the invention also provides a preparation process of the capsule, comprising the following steps:
  • Salvia miltiorrhiza Take a predetermined proportion of Salvia miltiorrhiza, add 8-10 times the amount of 80-90% ethanol and heat reflux to extract 2-3 times, each time 1-2 hours, preferably, reflux extraction 3 times, each time 1.5 hours, Danshen medicine The slag is reserved; the extract is filtered, and the filtrate is concentrated to a clearing paste for use.
  • Salvia miltiorrhiza contains tanshinone, which is an alcohol-soluble component. The above experimental conditions can be used to fully extract the tanshinone from Salvia miltiorrhiza.
  • 3S Adding 8-10 times of 55-65% ethanol with a predetermined proportion of dried jujube, seabuckthorn, agarwood, safflower and sorghum, and heating and refluxing for 2-3 times, each time 1.5-2.5 hours, preferably The extract was refluxed twice for 2 hours each time, the extract was filtered, and the filtrate was concentrated to a clear paste for use.
  • the total flavonoids content of wolf chrome ketone was used as the index, and the extraction process of total flavonoids was systematically studied. Experiments show that under the above experimental conditions, the total flavonoids extracted are the highest.
  • 4S combine the above medicine medicinal slag with 8 times the amount of water to cook 1-2 times, each time 2-3 hours, preferably, decoct 2 times, each time 2 hours, decoction filtered, filtrate and step 1S
  • the steam distillate and the water extract are combined and concentrated to a clear paste to extract the water-soluble active ingredient salvianolic acid B and polysaccharide in Salvia miltiorrhiza; 60-70% ethanol is added, and the mixture is allowed to stand for 24 hours to precipitate, and the supernatant is taken. Concentrate to clear paste and set aside.
  • the content of salvianolic acid B decreases with the increase of alcohol concentration, and 60-70% ethanol has good alcohol precipitation effect and hardly affects the content of salvianolic acid B.
  • the clear paste prepared in the steps 2S, 3S, and 4S was measured at 40 ° C and the relative density was 1.03-1.09. Through the detection, the preparation process is used for extraction and purification, and the average amount of the immersion cream of the capsule is 22.0 to 24.0%.
  • the present invention provides a capsule for treating coronary heart disease, which is more advantageous for the retention of active ingredients than traditional soups, and ensures the smooth operation of capsule filling capsules by screening the types and amounts of excipients. And the accuracy of the capsule loading; through the screening and optimization of the experimental conditions of the preparation process of the capsule, the effective pharmaceutical ingredients in the medicine material are fully and effectively extracted, and the retention of the active ingredient is ensured. At the same time, it is made into a capsule preparation for easy taking, storage and transportation.
  • Figure 1 shows a step diagram of a process for preparing a capsule according to the present invention.
  • the capsule of the invention mainly comprises 420-450 parts of Salvia miltiorrhiza, 43-48 parts of sandalwood, 90-100 parts of fragrant incense, 43-48 parts of rosewood incense, 135-150 parts of nutmeg, 135-148 parts of jujube, seabuckthorn 140 -150 parts, 210-225 parts of agarwood, 125-138 parts of sputum, 68-75 parts of safflower; preferably, the weight fraction of sandalwood and red sandalwood is 48 parts of sandalwood and 48 parts of red sandalwood.
  • the capsule further comprises an auxiliary material.
  • the filler is dextrin or microcrystalline cellulose
  • the lubricant is micro-powder silica gel and magnesium stearate.
  • Preparation process a predetermined proportion of sandalwood, fragrant, rosewood, nutmeg, 7-9 times water soak for 2 hours, reflux extraction for 8 hours, to obtain volatile oil, dregs, steam distillate and water extract, Standby; add a saturated aqueous solution containing 3.5-4.5 g of ⁇ -cyclodextrin per ml of volatile oil, and cover it at 55-65 ° C for 2-2.5 hours to obtain a volatile oil inclusion compound for use; take a predetermined proportion of salvia miltiorrhiza, add 8-10 The amount of 80-90% ethanol is heated and refluxed for 2-3 times, each time for 1-2 hours, the Danshen medicinal slag is reserved; the extract is filtered, and the filtrate is concentrated to a clear density of 1.03-1.09, ready for use; The dregs and the predetermined proportion of jujube, sea buckthorn, agarwood, safflower, sorghum and 8-10 times the amount of 55-65% ethanol, heated
  • the liquid and the aqueous extract are combined and concentrated to a clear paste having a relative density of 1.03-1.09; 60-70% ethanol is added, and the precipitate is allowed to stand.
  • the supernatant is concentrated to a clear paste having a relative density of 1.03-1.09, and used; the obtained clear paste is combined, spray-dried to obtain an extract powder of the extract; the auxiliary material and the volatile oil clathrate are added, mixed, and filled into capsules. .
  • Lactose, dextrin, starch and microcrystalline cellulose were used as filling agents respectively.
  • the fluidity of the mixed powder and the hygroscopic rate of 24h were used as indicators to investigate the variety and dosage of the auxiliary materials.
  • the results are shown in Table 1.
  • the amount of excipient refers to the percentage of excipients in the contents of the capsule (including the extract powder and excipients of the extract).
  • micronized silica gel can increase the pellet forming rate and has very good fluidity.
  • No. 4 was selected: 1.0% micronized silica gel and 1.0% magnesium stearate as a lubricant.
  • the capsules of the present invention ensure the smooth progress of capsule filling capsules and the accuracy of capsule loading by screening the types and amounts of excipients; screening of various experimental conditions by the preparation process of the capsules Optimization, so that the effective pharmaceutical ingredients in the medicinal materials are fully and effectively extracted, and the retention of the active ingredients is ensured compared with the traditional decoction. At the same time, it is made into a capsule preparation for easy taking, storage and transportation.
  • the capsule of the invention is more favorable for the retention of the active ingredient of the medicine, and is convenient for taking, storing and transporting; at the same time, the screening of the type and amount of the auxiliary material ensures the smooth filling of the capsule capsule. Accuracy of performing and capsule loading; screening and optimization of the experimental conditions of the preparation process of the capsule, the effective pharmaceutical ingredients in the medicinal material are fully and effectively extracted, and the active ingredients are ensured compared with the traditional decoction Reservation. At the same time, it is made into a capsule preparation for easy taking, storage and transportation.

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Abstract

一种胶囊及其制备工艺，该胶囊包括丹参420-450份、檀香43-48份、降香90-100份、紫檀香43-48份、肉豆蔻135-150份、广枣135-148份、沙棘140-150份、沉香210-225份、荜茇125-138份、山奈68-75份。与传统汤剂相比，更有利于有效成分的保留，通过对辅料的种类和用量的筛选，保证了胶囊灌装的顺利进行和胶囊装量的准确性；通过对该胶囊的制备工艺各实验条件的筛选与优化，使药材中的有效药物成分得到了充分、有效地提取，保证了有效成分的保留。同时，制成胶囊制剂，便于服用和储藏运输。

Description

一种胶囊及其制备工艺 技术领域
本发明属于医药技术领域，具体涉及一种冠心活血胶囊及其制备工艺。
背景技术
冠心病在中老年人中的发病率越来越高，而且呈现出发病群体逐渐年轻化的发展趋势。冠心病患者通常会伴随心悸、心绞痛、心供血不足等状况，不能从事体力劳动，严重的生活不能自理，甚至死亡。目前治疗冠心病常用西药，价格昂贵，毒副作用也非常大，而应用中药治疗或辅助治疗只能减轻患者痛苦，不能根治，且疗效也不能令人满意。
因此临床上急需对冠心病疗效显著、安全性好、使用方便的中药制剂。
发明内容
本发明提供一种胶囊及其制备工艺，主要用于治疗冠心病，本品剂型为胶囊剂，和传统汤剂相比，更有利于药物有效成份的保留，且便于服用和储藏运输；同时，本发明还提供了该胶囊的制备工艺，使用本工艺能够将药材活性物质充分、有效地提取，解决了该胶囊制备的关键问题。
本发明提供一种胶囊，包括以下组分，所述各组分的重量份表示如下：
Figure PCTCN2016106659-appb-000001
其中，还包括以下组分，所述各组分的重量份表示如下：
檀香    43-48份；
紫檀香    43-48份；
其中，还包括以下组分，所述各组分的重量份表示如下：
檀香      48份；
紫檀香    48份；
其中，还包括辅料，所述辅料为填充剂、粘合剂、润滑剂中的一种或几种；所述填充剂为淀粉、糖粉、乳糖、糊精、可压性淀粉、微晶纤维素、甘露醇、无机盐类中的一种或几种；所述润滑剂为硬脂酸镁、微粉硅胶、滑石粉、氢化植物油、聚乙二醇类和月桂醇硫酸镁中的一种或几种。
其中，所述填充剂为糊精或微晶纤维素；所述润滑剂为微粉硅胶和硬脂酸镁。
本发明还提供了该胶囊的制备工艺，包括以下步骤：
1S：将预定比例的檀香、降香、紫檀香、肉豆蔻，加7-9倍量水浸泡2小时、回流提取8小时，得挥发油、药渣、水蒸汽蒸馏液及水提液，备用；向挥发油中加入β-环糊精的饱和水溶液，在55-65℃条件下包合2-2.5小时，得挥发油包合物备用；
2S：取预定比例的丹参，加8-10倍量的80-90％乙醇加热回流提取，丹参药渣备用；提取液过滤，将滤液浓缩至清膏，备用；
3S：将丹参药渣与预定比例的广枣、沙棘、沉香、山奈、荜茇加8-10倍量的55-65％乙醇，加热回流提取，提取液过滤，将滤液浓缩至清膏，备用；
4S：将以上药材的药渣合并加8倍量水煎煮，煎液过滤，滤液与步骤1S所得水蒸汽蒸馏液及水提液合并，浓缩至清膏；加入60-70％的乙醇，静置沉淀，取上清液，浓缩至清膏，备用；
5S：将步骤2S、3S、4S所得的清膏合并，喷雾干燥，得提取物的浸膏粉；加入辅料以及步骤1S所得的挥发油包合物，混匀、装入胶囊。
其中，所述步骤2S中回流提取2-3次，每次1-2小时；所述步骤3S中回流提取2-3次，每次1.5-2.5小时；所述步骤4S中煎煮1-2次，每次2-3小时。
其中，所述步骤2S中回流提取3次，每次1.5小时；所述步骤3S中回流提取2次，每次2小时；所述步骤4S中煎煮2次，每次2小时。
其中，所述步骤1S中，每毫升挥发油加入含3.5-4.5gβ-环糊精的饱和水溶液。
其中，所述步骤2S、3S、4S中制备的清膏的相对密度为1.03-1.09。
本发明提供的胶囊，包括丹参420-450份，丹参中含有丹参酮和丹酚酸B，能拮抗血管紧张素Ⅱ，具有增强心功能、扩血管、抑制血小板聚集，降低血黏度及改善血流变性等作用。
降香90-100份，降香中所包含的挥发油及其芳香水以250mg/kg灌胃可以明显抑制大鼠实验性血栓形成；可明显提高孵育兔血小板cAMP的水平，对兔血浆纤溶酶活性有显著促进作用，提示有抗血栓作用。肉豆蔻135-150份，肉豆蔻所包含的挥发油对大鼠心肌缺血再灌注损伤具有保护作用，可以治疗心律不齐，对心血管疾病有治疗作用。
本胶囊还包括广枣135-148份、沙棘140-150份、沉香210-225份、荜茇125-138份、山奈68-75份，处方中广枣﹑沙棘﹑沉香﹑荜茇、山奈的活性成分为黄酮类化合物，黄酮类化合物具有安神，缓解心绞痛，改善心律，抗心血管疾病等作用。可明显的抑制血小板聚集和降低血液流变学各项指标、抗氧化、对心肌缺血有保护作用。
此外，该胶囊还包括檀香43-48份、紫檀香43-48份；优选的，檀香48份、紫檀香48份；檀香水煎液0.91g/kg对胃肠道功能有抑制作用，檀香乙醚萃取物0.91g/kg对胃肠功能有促进作用。檀香挥发油0.91g/kg能升高cAMP和cAMP/cGMP值，且对物质代谢有促进作用。
本发明的胶囊采用的丹参、降香、肉豆蔻、广枣、沙棘、沉香、荜茇、山奈在本发明的重量份配比下对治疗冠心病心绞痛具有明显的疗效；而紫檀香和檀香有理气、和胃的作用，可用于缓解胃肠道不适，对其它有效成分的吸收具有促进作用，采用以上重量份范围可达到比较好的效果。
本发明的胶囊还包括辅料，为填充剂、粘合剂、润滑剂中的一种或几种；填充剂为淀粉、糖粉、乳糖、糊精、可压性淀粉、微晶纤维素、甘露醇、无机盐类中的一种或几种；润滑剂为硬脂酸镁、微粉硅胶、滑石粉、氢化植物油、聚乙二醇类和月桂醇硫酸镁中的一种或几种。优选的，填充剂为糊精或微晶纤维素，占胶囊内容物的10％，选用该种类该比例的填充剂，可以使胶囊具有良好的流动性以及吸湿性，可以保证灌装胶囊的顺利进行和胶囊装量的准确性。润滑剂为微粉硅胶和硬脂酸镁，所占比例各为1％，可以进一步改善混合粉的流动性，提高颗粒成型率。
本发明还提供了该胶囊的制备工艺，包括以下步骤：
1S：将预定比例的檀香、降香、紫檀香、肉豆蔻，加7-9倍量水浸泡2小时、回流提取8小时，得挥发油、药渣、水蒸汽蒸馏液及水提液，备用，在该实验条件下，挥发油的收集量最多。为减少挥发油在贮存期的挥发，每毫升挥发油加入含3.5-4.5gβ-环糊精的饱和水溶液，在55-65℃条件下包合2-2.5小时，所得包合物收得率最高。
2S：取预定比例的丹参，加8-10倍量的80-90％乙醇加热回流提取2-3次，每次1-2小时，优选的，回流提取3次，每次1.5小时，丹参药渣备用；提取液过滤，将滤液浓缩至清膏，备用。丹参中含有丹参酮，属醇溶性成分，采用以上实验条件参数，可以充分地将丹参中的丹参酮提取出来。
3S：将丹参药渣与预定比例的广枣、沙棘、沉香、山奈、荜茇加8-10倍量的55-65％乙醇，加热回流提取2-3次，每次1.5-2.5小时，优选的，回流提取2次，每次2小时，提取液过滤，将滤液浓缩至清膏，备用。为了有效提取山奈﹑广枣﹑沙棘﹑沉香﹑荜茇中的活性成分——黄酮类化合物，以狼毒色原酮为标准品总黄酮含量为考察指标，对总黄酮提取工艺进行了系统研究，实验表明，在以上实验条件下，所提取的总黄酮含量最高。
4S：将以上药材的药渣合并加8倍量水煎煮1-2次，每次2-3小时，优选的，煎煮2次，每次2小时，煎液过滤，滤液与步骤1S所得水蒸汽蒸馏液及水提液合并，浓缩至清膏，可以提取丹参中的水溶性有效成分丹酚酸B及多糖；加入60-70％的乙醇，静置24小时使沉淀，取上清液，浓缩至清膏，备用。丹酚酸B的含量随着醇浓度的增加而降低，采用60-70％乙醇，既具有良好的醇沉效果，且几乎不影响丹酚酸B的含量。
5S：将步骤2S、3S、4S所得的清膏合并，喷雾干燥，得提取物的浸膏粉；加入辅料以及步骤1S所得的挥发油包合物，混匀、装入胶囊。
步骤2S、3S、4S中制备的清膏在40℃测相对密度为1.03-1.09。通过检测，使用该制备工艺提取精制，胶囊的平均浸提出膏量为22.0～24.0％。
以上，本发明提供了一种胶囊，用于治疗冠心病，与传统汤剂相比，更有利于有效成分的保留，通过对辅料的种类和用量的筛选，保证了胶囊灌装胶囊的顺利进行和胶囊装量的准确性；通过对该胶囊的制备工艺各实验条件的筛选与优化，使药材中的有效药物成分得到了充分、有效地提取，保证了有效成分的保留。同时，制成胶囊制剂，便于服用和储藏运输。
附图说明
并入到说明书中并且构成说明书的一部分的附图示出了本发明的实施例，并且与描述一起用于解释本发明的原理，在这些附图中，类似的附图标记用于表示类似的要素，下面描述中的附图是本发明的一些实施例，而不是全部实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，可以根据这些附图获得其他的附图。
图1示出了根据本发明的胶囊的制备工艺的步骤图。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚，下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。需要说明的是，在不冲突的情况下，本申请中的实施例及实施例中的特征可以相互任意组合。
本发明的胶囊，主要包括丹参420-450份、檀香43-48份、降香90-100份、紫檀香43-48份、肉豆蔻135-150份、广枣135-148份、沙棘140-150份、沉香210-225份、荜茇125-138份、山奈68-75份；优选的，檀香和紫檀香的重量份为檀香48份、紫檀香48份。
本胶囊还包括辅料，具体的，填充剂为糊精或微晶纤维素，润滑剂为微粉硅胶和硬脂酸镁。
制备工艺：将预定比例的檀香、降香、紫檀香、肉豆蔻，加7-9倍量水浸泡2小时、回流提取8小时，得挥发油、药渣、水蒸汽蒸馏液及水提液，备用；每毫升挥发油加入含3.5-4.5gβ-环糊精的饱和水溶液，在55-65℃条件下包合2-2.5小时，得挥发油包合物备用；取预定比例的丹参，加8-10倍量的80-90％乙醇加热回流提取2-3次，每次1-2小时，丹参药渣备用；提取液过滤，将滤液浓缩至相对密度为1.03-1.09的清膏，备用；将丹参药渣与预定比例的广枣、沙棘、沉香、山奈、荜茇加8-10倍量的55-65％乙醇，加热回流提取2-3次，每次1.5-2.5小时，提取液过滤，将滤液浓缩至相对密度为1.03-1.09的清膏，备用；将以上药材的药渣合并加8倍量水煎煮1-2次，每次2-3小时，煎液过滤，滤液与水蒸汽蒸馏液及水提液合并，浓缩至相对密度为1.03-1.09的清膏；加入60-70％的乙醇，静置沉淀，取上清液，浓缩至相对密度为1.03-1.09的清膏，备用；将所得的清膏合并，喷雾干燥，得提取物的浸膏粉；加入辅料以及挥发油包合物，混匀、装入胶囊。
下面给出胶囊及其制备工艺的具体实施例：
实施例一
1.处方：
丹参425份    檀香45份   降香92份   紫檀香43份
肉豆蔻148份  广枣135份  沙棘140份  沉香212份
荜茇137份    山奈68份
2.制备工艺：
将预定比例的檀香、降香、紫檀香、肉豆蔻，加7倍量水浸泡2小时、回流提取8小时，得挥发油、药渣、水蒸汽蒸馏液及水提液，备用；每毫升挥发油加入含4.5gβ-环糊精的饱和水溶液，在65℃条件下包合2小时，得挥发油包合物备用；取预定比例的丹参，加9倍量的90％乙醇加热回流提取3次，每次1.5小时，丹参药渣备用；提取液过滤，将滤液浓缩至相对密度为1.04的清膏，备用；将丹参药渣与预定比例的广枣、沙棘、沉香、山奈、荜茇加8倍量的65％乙醇，加热回流提取3次，每次1.5小时，提取液过滤，将滤液浓缩至相对密度为1.05的清膏，备用；将以上药材的药渣合并加8倍量水煎煮2次，每次3小时，煎液过滤，滤液与水蒸汽蒸馏液及水提液合并，浓缩至相对密度为1.09的清膏；加入70％的乙醇，静置沉淀，取上清液，浓缩至相对密度为1.05的清膏，备用；将所得的清膏合并，喷雾干燥，得提取物的浸膏粉；加入10％的微晶纤维素，1％硬酯酸镁，1％微粉硅胶及挥发油包合物，混匀，装入胶囊，即得。
实施例二
1.处方：
丹参440份      檀香48份     降香98份     紫檀香48份
肉豆蔻145份    广枣145份    沙棘145份    沉香220份
荜茇134份      山奈73份
2.制备工艺：
将预定比例的檀香、降香、紫檀香、肉豆蔻，加8倍量水浸泡2小时、回流提取8小时，得挥发油、药渣、水蒸汽蒸馏液及水提液，备用；每毫升挥发油加入含4gβ-环糊精的饱和水溶液，在60℃条件下包合2小时，得挥发油包合物备用；取预定比例的丹参，加10倍量的90％乙醇加热回流提取3次，每次1.5小时，丹参药渣备用；提取液过滤，将滤液浓缩至相对密度为1.05的清膏，备用；将丹参药渣与预定比例的广枣、沙棘、沉香、山奈、荜茇加10倍量的60％乙醇，加热回流提取2次，每次2小时，提取液过滤，将滤液浓缩至相对密度为1.05的清膏，备用；将以上药材的药渣合并加8倍量水煎煮2次，每次2小时，煎液过滤，滤液与水蒸汽蒸馏液及水提液合并，浓缩至相对密度为1.05的清膏；加入60％的乙醇，静置沉淀，取上清液，浓缩至相对密度为1.05的清膏，备用；将所得的清膏合并，喷雾干燥，得提取物的浸膏粉；加入10％的糊精，1％硬酯酸镁，1％微粉硅胶及挥发油包合物，混匀，装入胶囊，即得。
实施例三
1.处方：
丹参438份      檀香48份     降香95份     紫檀香48份
肉豆蔻135份    广枣147份    沙棘148份    沉香224份
荜茇126份      山奈68份
2.制备工艺：
将预定比例的檀香、降香、紫檀香、肉豆蔻，加9倍量水浸泡2小时、回流提取8小时，得挥发油、药渣、水蒸汽蒸馏液及水提液，备用；每毫升挥发油加入含3.5gβ-环糊精的饱和水溶液，在50℃条件下包合2.5小时，得挥发油包合物备用；取预定比例的丹参，加10倍量的80％乙醇加热回流提取3次，每次1小时，丹参药渣备用；提取液过滤，将滤液浓缩至相对密度为1.05的清膏，备用；将丹参药渣与预定比例的广枣、沙棘、沉香、山奈、荜茇加10倍量的60％乙醇，加热回流提取2次，每次2.5小时，提取液过滤，将滤液浓缩至相对密度为1.07的清膏，备用；将以上药材的药渣合并加8倍量水煎煮2次，每次2小时，煎液过滤，滤液与水蒸汽蒸馏液及水提液合并，浓缩至相对密度为1.05的清膏；加入60％的乙醇，静置沉淀，取上清液，浓缩至相对密度为1.04的清膏，备用；将所得的清膏合并，喷雾干燥，得提取物的浸膏粉；加入10％的微晶纤维素，1％硬酯酸镁，1％微粉硅胶及挥发油包合物，混匀，装入胶囊，即得。
实验测试例
一、辅料种类与用量的选择
1.填充剂的种类与用量
分别选用乳糖、糊精、淀粉、微晶纤维素为充填剂，以混合后药粉的流动性、24h吸湿率为指标，对辅料品种和用量进行考察。结果见表1。其中，辅料的用量指的是辅料占胶囊内容物(包括提取物的浸膏粉和辅料)的百分比。
表1不同辅料种类与用量比较
Figure PCTCN2016106659-appb-000002
Figure PCTCN2016106659-appb-000003
从表1可知，使用淀粉(4-6号)和糊精(7-9号)作填充剂流动性较好；流动性随着辅料用量的增加而提高，采用乳糖(1-3号)和微晶纤维素吸湿率良好，吸湿率随着辅料用量的增加而减少，达到10％以后再增加辅料其变化不大，故辅料加入量达到10％即可。可以选择10％的糊精或10％的微晶纤维素作为填充剂，可以保证灌装胶囊的顺利进行和胶囊装量的准确性。
2.润滑剂品种与用量的选择
为了防止干压制粒时产生粘辊现象、进一步改善混合粉的流动性，对润滑剂品种与用量进行了筛选。方法：取胶囊提取物的浸膏粉适量，按处方比例加入填充剂，分别加入不同润滑剂，混匀后干压制粒，计算颗粒成型率、测定休止角。结果见表2。
表2润滑剂品种与用量的选择
Figure PCTCN2016106659-appb-000004
由表2可见，加入微粉硅胶可以提高颗粒成型率，且具有非常好的流动性，综合考虑，
选择4号：1.0％微粉硅胶和1.0％硬脂酸镁作为润滑剂。
3.临界相对湿度的测定(CRH值)
精密称取胶囊内容物5份，每份约10.00g，置于不同相对湿度的恒湿容器中，放置7天，测定各样品平衡吸湿量，结果见表3。
表3平衡吸湿一览表
Figure PCTCN2016106659-appb-000005
Figure PCTCN2016106659-appb-000006
结果表明；胶囊内容物的CRH值约为50％，所以分剂量时生产环境的相对湿度应控制在50％以下较为合理。
综上，本发明所涉及的胶囊，通过对辅料的种类和用量的筛选，保证了胶囊灌装胶囊的顺利进行和胶囊装量的准确性；通过对该胶囊的制备工艺各实验条件的筛选与优化，使药材中的有效药物成分得到了充分、有效地提取，与传统汤剂相比，保证了有效成分的保留。同时，制成胶囊制剂，便于服用和储藏运输。
最后应说明的是：在本文中，术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含，从而使得包含一系列要素的过程、方法、物品或者设备不仅包括那些要素，而且还包括没有明确列出的其他要素，或者是还包括为这种过程、方法、物品或者设备所固有的要素。在没有更多限制的情况下，由语句“包括一个…”限定的要素，并不排除在包括所述要素的过程、方法、物品或者设备中还存在另外的相同要素。
以上实施例仅用以说明本发明的技术方案，而非对其限制。尽管参照前述实施例对本发明进行了详细的说明，本领域的普通技术人员应当理解：其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本发明各实施例技术方案的精神和范围。
工业实用性
本发明所涉及的胶囊，和传统汤剂相比，更有利于药物有效成份的保留，且便于服用和储藏运输；同时，通过对辅料的种类和用量的筛选，保证了胶囊灌装胶囊的顺利进行和胶囊装量的准确性；通过对该胶囊的制备工艺各实验条件的筛选与优化，使药材中的有效药物成分得到了充分、有效地提取，与传统汤剂相比，保证了有效成分的保留。同时，制成胶囊制剂，便于服用和储藏运输。

Claims (10)

  1. 一种胶囊，其特征在于，包括以下组分，所述各组分的重量份表示如下：
    Figure PCTCN2016106659-appb-100001
  2. 如权利要求1所述的胶囊，其特征在于，还包括以下组分，所述各组分的重量份表示如下：
    檀香    43-48份；
    紫檀香  43-48份；
  3. 如权利要求2所述的胶囊，其特征在于，还包括以下组分，所述各组分的重量份表示如下：
    檀香    48份；
    紫檀香  48份；
  4. 如权利要求3所述的胶囊，其特征在于，还包括辅料，所述辅料为填充剂、粘合剂、润滑剂中的一种或几种；所述填充剂为淀粉、糖粉、乳糖、糊精、可压性淀粉、微晶纤维素、甘露醇、无机盐类中的一种或几种；所述润滑剂为硬脂酸镁、微粉硅胶、滑石粉、氢化植物油、聚乙二醇类和月桂醇硫酸镁中的一种或几种。
  5. 如权利要求4所述的胶囊，其特征在于，所述填充剂为糊精或微晶纤维素；所述润滑剂为微粉硅胶和硬脂酸镁。
  6. 一种如权利要求2-5任一项所述的胶囊的制备工艺，其特征在于，包括以下步骤：
    1S：将预定比例的檀香、降香、紫檀香、肉豆蔻，加7-9倍量水浸泡2小时、回流提取8小时，得挥发油、药渣、水蒸汽蒸馏液及水提液，备用；向挥发油中加入β-环糊精的饱和水溶液，在55-65℃条件下包合2-2.5小时，得挥发油包合物备用；
    2S：取预定比例的丹参，加8-10倍量的80-90％乙醇加热回流提取，丹参药渣备用；提取液过滤，将滤液浓缩至清膏，备用；
    3S：将丹参药渣与预定比例的广枣、沙棘、沉香、山奈、荜茇加8-10倍量的55-65％乙醇，加热回流提取，提取液过滤，将滤液浓缩至清膏，备用；
    4S：将以上药材的药渣合并加8倍量水煎煮，煎液过滤，滤液与步骤1S所得水蒸汽蒸馏液及水提液合并，浓缩至清膏；加入60-70％的乙醇，静置沉淀，取上清液，浓缩至清膏，备用；
    5S：将步骤2S、3S、4S所得的清膏合并，喷雾干燥，得提取物的浸膏粉；加入辅料以及步骤1S所得的挥发油包合物，混匀、装入胶囊。
  7. 如权利要求6所述的制备工艺，其特征在于，所述步骤2S中回流提取2-3次，每次1-2小时；所述步骤3S中回流提取2-3次，每次1.5-2.5小时；所述步骤4S中煎煮1-2次，每次2-3小时。
  8. 如权利要求7所述的制备工艺，其特征在于，所述步骤2S中回流提取3次，每次1.5小时；所述步骤3S中回流提取2次，每次2小时；所述步骤4S中煎煮2次，每次2小时。
  9. 如权利要求6所述的制备工艺，其特征在于，所述步骤1S中，每毫升挥发油加入含3.5-4.5gβ-环糊精的饱和水溶液。
  10. 如权利要求6所述的制备工艺，其特征在于，所述步骤2S、3S、4S中制备的清膏的相对密度为1.03-1.09。
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