JP6725955B1 - Zhuang pharmaceutical composition for blood supplementation and method for preparing the same - Google Patents
Zhuang pharmaceutical composition for blood supplementation and method for preparing the same Download PDFInfo
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- JP6725955B1 JP6725955B1 JP2020006138A JP2020006138A JP6725955B1 JP 6725955 B1 JP6725955 B1 JP 6725955B1 JP 2020006138 A JP2020006138 A JP 2020006138A JP 2020006138 A JP2020006138 A JP 2020006138A JP 6725955 B1 JP6725955 B1 JP 6725955B1
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- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
【課題】 補血養精用チワン族医薬品組成物及びその調製方法を提供することを課題とする。【解決手段】 本発明は、補血養精用チワン族医薬品組成物を開示し、該組成物は、コシモウトウ20〜60重量部、フホウトウ10〜50重量部、センキンバツ10〜60重量部、ドニンジン10〜50重量部、キバン10〜30重量部、リュウガン10〜50重量部、デンシチ10〜40重量部、オウセイ10〜25重量部、センボウ10〜30重量部の原料を用いて調製され、その調製方法も提供する。本発明の有利な効果は、以下のとおりである。本発明によるチワン族医薬品組成物は、血を補い、精を補充し、正気を扶助し、邪気を除き、三気の流れを良くして整えるという効能を有し、顔色が青白く、カスミ目で物がはっきり見えず、動悸がして眠れず、爪が白いという症状をより良く改善し、治療効果が確実であり、効き目が早く、安定しており、副作用がなく、その調製方法も提供し、調製方法は、操作しやすく、生薬の効能を十分に発揮することができる。【選択図】なしPROBLEM TO BE SOLVED: To provide a Zhuang pharmaceutical composition for blood supplementation and purification and a method for preparing the same. The present invention discloses a Zhuang family pharmaceutical composition for blood supplementation, which composition comprises 20 to 60 parts by weight of Koshinomoto, 10 to 50 parts by weight of Futoto, 10 to 60 parts by weight of Scutellaria baicalensis, and 10 to 100 parts of carrot. 50 parts by weight, kiban 10 to 30 parts by weight, longan 10 to 50 parts by weight, density 10 to 40 parts by weight, seisei 10 to 25 parts by weight, senbou 10 to 30 parts by weight, and a preparation method thereof are also used. provide. Advantageous effects of the present invention are as follows. The Zhuang pharmaceutical composition according to the present invention has the effects of supplementing blood, supplementing sperm, assisting sanity, removing innocence, and improving the flow of three spirits, and makes the complexion pale and blemishes. It improves the symptoms of inability to see clearly, palpitation, sleeplessness, white nails, has a positive therapeutic effect, is fast-acting, stable, has no side effects, and provides a method for its preparation. The preparation method is easy to operate, and the efficacy of the crude drug can be sufficiently exerted. [Selection diagram] None
Description
本発明は、民族医薬品の分野に属し、具体的には、補血養精用チワン族医薬品組成物及びその調製方法に関する。 TECHNICAL FIELD The present invention belongs to the field of ethnic medicine, and specifically relates to a Zhuang pharmaceutical composition for blood supplementation and purification, and a method for preparing the same.
民族医薬品の重要な部分であるチワン族医薬品は、チワン族が古くから疾患を予防し治療するための有効な手段であり、チワン族の身体的健康や生存発展に重要な役割を果たしてきた。チワン族医学によれば、人体は有機的な全体であり、その各構成部分は密接に関連しており分割できないものである。人体の「巧」(天部)、「廊」(人部)、「胴」(地部)の三部、三道(谷道、気道、水道)、両路(龍路、火路)、内臓、及び「奪」(骨)、「諾」(肉)「嘘」(気)、「勒」(血)などは、いずれも互いに関連し、相互作用し、自然界と同期して機能し、制約及び化生を行い、生死を繰り返し移り変わる。人体に正気が不十分である場合、
瘴、蠱、毒などの毒邪が龍路、火路を介して侵入し、水道、谷道、気道の流れが悪くなり、臓腑骨肉ではバランスが崩れたり、又は栄養を充分に取られなかったりし、天人地という三気がともに壊れていると、さまざまな疾患に罹患しやすくなる。疾患の治療には、チワン族医学は、病因を究明することを強調し、疾患の診断を主とし、適切な処方及び適切な生薬を適用する場合が多く、これは、チワン族医学による治療法の主な特徴の1つである。チワン族医学は、疾患の治療について豊富な経験を蓄積し、チワン族医学に特有のいくつかの方法、チワン族医薬品の処方は、臨床的に良い結果を達成している。
Zhuang medicine, which is an important part of ethnic medicine, has been an effective means for the prevention and treatment of diseases in Zhuang since ancient times, and has played an important role in the physical health and development of survival of Zhuang people. According to Zhuang medicine, the human body is an organic whole, whose constituent parts are closely related and indivisible. Human body "Takumi" (top), "Corridor" (human part), "Torso" (ground), three parts, three ways (valley, airway, water supply), both roads (long road, fire road), internal organs , And “deprivation” (bone), “acceptance” (flesh) “lie” (ki), “bule” (blood), etc. are all related to each other, interact with each other, function in synchronization with the natural world, and are constrained. It also undergoes metaplasia, and changes life and death repeatedly. If your body isn't sane enough,
Poisons, scorpions, poisons, and other toxic invades through the dragon's way and fire's way, causing poor flow in the water supply, valleys, and respiratory tracts, imbalance in visceral bone and flesh, or insufficient nutrition. , If the three spirits of the heavenly land are broken together, various diseases are more likely to occur. For the treatment of diseases, Zhuang medicine emphasizes investigating the etiology, mainly focuses on diagnosis of diseases, and often applies appropriate prescriptions and appropriate herbal medicines. Is one of the main features of. Zhuang medicine has accumulated a wealth of experience in treating diseases, and some methods unique to Zhuang medicine, the prescription of Zhuang medicine, have achieved clinically good results.
チワン族医学によれば、「勒」(血)は全身の骨肉臓腑、四肢百骸に栄養素を与える非常に重要な物質であり、天地の気から生まれ、生まれつきの体質が悪かったり、生まれてから脾胃虚弱が続いたり、邪毒に抵抗したり、不適な食事をしたりするなどにより「勒内」(血虚)を引き起こし、「勒内」(血虚)は、顔色が青白く、カスミ目で物がはっきり見えず、動悸がして眠れず、爪が白いなどの症状として現れ、従って、血を補い、精を補充し、正気を扶助し、邪気を除き、三気の流れを良くして整える効能を有し、顔色が青白く、カスミ目で物がはっきり見えず、動悸がして眠れず、爪が白いなどの症状を明らかに改善する補血養精用チワン族医薬品組成物を開発することは、非常に重要である。 According to Zhuang medicine, "bule" (blood) is a very important substance that provides nutrients to the bones and organs of the whole body and the 100 limbs, and it is born from the spirit of heaven and earth Continued splenic stomach weakness, resistance to venom, and inadequate meals cause "Burenai" (blood deficiency), and "Bureuchi" (blood deficiency) has a pale complexion I can't see things clearly, my heart palpitates, I can't sleep, my nails appear white, and so on.Therefore, I supplement my blood, supplement my spirits, help my sanity, get rid of nausea, and improve the flow of three spirits. To develop a Zhuang pharmaceutical composition for blood-feeding and sperm injection, which has the effect of straightening, has a pale complexion, cannot clearly see things with dark eyes, has palpitation, cannot sleep, and has white nails. Is very important.
本発明が解决しようとする技術的課題は、血を補い、精を補充し、正気を扶助し、邪気を除き、三気の流れを良くして整える効能を有し、顔色が青白く、カスミ目で物がはっきり見えず、動悸がして眠れず、爪が白いなどの症状をより良く改善する補血養精用チワン族医薬品組成物及びその調製方法を提供することである。 The technical problem to be solved by the present invention is to supplement blood, replenish spirit, assist sanity, remove innocence, improve the flow of three spirits, prepare a complexion, have a pale complexion, and have chasm eyes. It is an object of the present invention to provide a Zhuang family pharmaceutical composition for blood supplementation and fertilization, which improves symptoms such as inability to see clearly, palpitation, sleeplessness, and white nails, and a method for preparing the same.
本発明は、以下の技術案により上記技術的課題を解决する。 The present invention solves the above technical problems by the following technical solutions.
補血養精用チワン族医薬品組成物であって、該組成物は、コシモウトウ20〜60重量部、フホウトウ10〜50重量部、センキンバツ10〜60重量部、ドニンジン10〜50重量部、キバン10〜30重量部、リュウガン10〜50重量部、デンシチ10〜40重量部、オウセイ10〜25重量部、センボウ10〜30重量部の原料を用いて調製される。 It is a Zhuang family pharmaceutical composition for blood supplementation and fertilization, wherein the composition is 20 to 60 parts by weight of Koshimato, 10 to 50 parts by weight, 10 to 60 parts by weight of kelp nut, 10 to 50 parts by weight of ginseng, and kiban 10 to 30. It is prepared using 10 parts by weight of longan, 10 to 50 parts by weight of longan, 10 to 40 parts by weight of density, 10 to 25 parts by weight of seisei, and 10 to 30 parts by weight of senbou.
さらに、上記補血養精用チワン族医薬品組成物において、該組成物は、コシモウトウ50重量部、フホウトウ40重量部、センキンバツ20重量部、ドニンジン30重量部、キバン30重量部、リュウガン20重量部、デンシチ20重量部、オウセイ20重量部、センボウ20重量部の原料を用いて調製される。 Further, in the above-mentioned pharmaceutical composition for blood purification and fertilization, the composition comprises 50 parts by weight of Koshimato, 40 parts by weight of swordfish, 20 parts by weight of radix, 30 parts by weight of ginseng, 30 parts by weight of longan, 20 parts by weight of longan, denshichi It is prepared by using 20 parts by weight, 20 parts by weight of seisei, and 20 parts by weight of senbou.
上記補血養精用チワン族医薬品組成物の調製方法であって、重量部で秤取される原料をそれぞれ洗浄して選別した後、混合して水を加えて0.5〜1時間浸すステップと、薬液が沸騰するまで強火で煎じた後、弱火に切り替えて20〜25分間煎じ、薬汁を濾取する一次煎じステップと、生薬の平面から0.5〜1センチメートル上に常温の水を再度加え、薬液が沸騰するまで強火で煎じた後、弱火に切り替えて15〜20分間煎じ、薬汁を濾取する二次煎じステップと、一次煎じと二次煎じで得られた薬汁を合わせるステップと、を含む。さらに、上記補血養精用チワン族医薬品組成物の調製方法において、前記チワン族医薬品組成物の剤形は、煎剤である。 A method for preparing the above-mentioned blood purification/fertilizing Zhuang family pharmaceutical composition, which comprises washing and selecting raw materials to be weighed in parts by weight, mixing, adding water, and soaking for 0.5 to 1 hour. , After decocting on high heat until the liquid medicine boils, switch to low heat and decoct for 20 to 25 minutes, and then carry out the primary decoction step to filter the medicinal juice and water at room temperature 0.5-1 cm above the plane of the crude drug. Add it again, decoct on high heat until the chemical solution boils, switch to low heat and decoct for 15 to 20 minutes, combine the secondary decoction step of filtering the chemical juice with the chemical juice obtained from the primary and secondary decoctions. And steps. Further, in the above method for preparing a Zhuang pharmaceutical composition for blood supplementation and purification, the dosage form of the Zhuang pharmaceutical composition is a decoction.
本発明の第2の目的は、上記補血養精用チワン族医薬品組成物の調製方法を提供することであり、重量部で秤取される原料をそれぞれ洗浄して選別した後、生薬に水を8倍加え、1回当たり1時間に3回煎じ、濾過して濃縮し、80℃で減圧乾燥し、粉砕して100メッシュのふるいにかけ、乾燥ペースト粉末にスクロースを加え、均一に混合し、75%エタノールを用いて軟質材料とし(エタノール使用量8%)、15min撹拌し、12メッシュのふるいにかけて造粒し、75℃で4h乾燥し、12メッシュのふるいにかけて整粒し、混合機で均一に混合し、梱包して包装する。 A second object of the present invention is to provide a method for preparing the above-mentioned Zhuang family pharmaceutical composition for blood supplementation and fertilization, wherein each raw material to be weighed in parts by weight is washed and selected, and then the crude drug is treated with water. Add 8 times and decoct 3 times per hour, filter and concentrate, dry under reduced pressure at 80°C, pulverize and sieve through a 100 mesh screen, add sucrose to dry paste powder, mix evenly, 75 % Ethanol to make a soft material (ethanol usage 8%), stir for 15 min, granulate with a 12 mesh sieve, dry at 75°C for 4 h, sieving with a 12 mesh sieve and homogenize with a mixer Mix, pack and package.
本発明に係るチワン族医薬品及び漢方薬組成物に含まれる原料の特徴は、以下のとおりである。 The characteristics of the raw materials contained in the Zhuang medicine and the Chinese medicine composition according to the present invention are as follows.
コシモウトウ:チワン族医薬名はGocijcwzであり、クワ科植物ジャワゴムFicus hirta Vahlの乾燥根に由来する。性味:甘、平。効能:脾の働きを高めて肺を丈夫にし、気の流れをよくして湿気を追い出し、水道を順調にする。主治:脾虚浮腫、食欲不振や無力、肺結核による咳嗽、盗汗、帯下、産後無乳、月経不順、風湿痺痛、水腫などである。 Koshimoto: The drug name of the Zhuang family is Gocijcwz, which is derived from the dried roots of the mulberry plant Java gum Ficus hirta Vahl. Taste: sweet, flat. Efficacy: Increases the function of the spleen, strengthens the lungs, improves the flow of air, expels moisture, and smoothes the water supply. Main cure: Splenic edema, anorexia and incompetence, cough due to pulmonary tuberculosis, night sweats, swallowing, postpartum milklessness, irregular menstruation, wind eczema, edema, etc.
フホウトウ:チワン族医薬名はGaeundauxであり、ニシキギ科植物ツルマサキEuonymus fortuei(Turcz.)Hand.−Mazz.の葉付き茎枝に由来する。性味:苦、甘、微辛、熱。効能:龍路、火路を整えて、湿毒を取り除く。主治:腰筋労損、風湿骨痛、咯血、膣出血、月経不順、骨折、創傷出血などである。 Futoto: The name of the Zhuang family medicine is Gaeundaux, and Euonymus fortuei (Turcz.) Hand. -Mazz. Derived from the stalk with leaves. Taste: Bitter, sweet, slightly spicy, fever. Efficacy: Ryuji, arranging fire route to remove the poison. Main cure: Lumbago labor, wind and wet bone pain, blood loss, vaginal bleeding, irregular menstruation, fracture, wound bleeding, etc.
センキンバツ:チワン族医薬名はGoragdinghであり、クワ科植物コヒマワリFemingia Philippinensisの根に由来する。性味:甘、渋、平。効能:火路を整えて、風毒や湿毒を取り除き、筋骨を丈夫にする。主治:風湿骨痛、腰痛、手足の弱さ、打撲傷、咽頭痛などである。 Chinese herb: The Zhuang family medicine name is Goragdingh, which is derived from the roots of the mulberry plant, the sunflower Femingia Philippinensis. Taste: sweet, astringent, flat. Efficacy: Organizes fire routes to eliminate wind and moisture poisons and strengthens muscles and bones. Curative: Wind and bone pain, low back pain, weak limbs, bruise, sore throat.
ドニンジン:チワン族医薬名はGocaenghnaenghであり、スベリヒユ科植物ハゼランTalinum paniculatum(Jacq.)Gaertnの根に由来する。性味:甘、平。効能:気道、谷道の流れをよくして、気を補充して虚の状態を改善する。主治:気虚、泄瀉、眩暈、咳嗽、自汗、盗汗、月経不順、帯下などである。 Ginseng: The drug name of Zhuang family is Gocaengnaengh, which is derived from the root of the plant of the purslane family Talinum paniculatum (Jacq.) Gaertn. Taste: sweet, flat. Efficacy: Improves the condition of the void by improving the flow of airways and valleys and replenishing the air. Chief: qi, dysphoria, dizziness, cough, self-sweat, night sweats, irregular menstruation, obishita, etc.
キバン:チワン族医薬名はBajbyaj.であり、カメ科動物クサガメChinernys reevesii(Gray)の甲羅に由来する。性味:咸、甘、寒。効能:龍路の流れをよくして、虚の状態を改善して骨を丈夫にする。主治:自汗、盗汗、眩暈、手足の弱さ、健忘などである。 Kiban: The Zhuang medicine name is Bajbyaj. And is derived from the shell of the turtle family Turtle Chainernys reevesii (Gray). Taste: Ham, sweet, cold. Efficacy: Improve the flow of Ryuji, improve the state of imagination and strengthen bones. Chief: Self-sweat, night sweats, dizziness, weak limbs, amnesia.
リュウガンは、チワン族医薬名はNohmaknganxであり、ムクロジ科植物リュウガンDimocarpus longan Lourの仮種皮に由来する。性味は、甘、熱である。効能は、火路保養、心神安定である。主治は、眩暈、失眠、血虚、崩漏、月経不順などである。 Longan has a Zhuang medicine name, Nohmaknganx, and is derived from the pseudoseed of the plant of the sectaceae Longan Dimocarpus longan Lour. The taste is sweet and heat. Efficacy is a fire tract remedy, a god of stability. The main cures are dizziness, sleeplessness, blood loss, collapse, and irregular menstruation.
デンシチ:チワン族医薬名はGodienzcaetであり、ウコギ科植物サンシチニンジンPanax notoginseng(Burk)F.H.Chen ex C.Chowの根に由来する。性味:甘、熱。効能:龍路、火路調整、補血、止血、うっ血解消及び止痛。主治:産後血虚、咯血、吐血、衄血、便血、崩漏、胸痛、胃痛、打撲傷、生理痛、産後腹痛などである。 Density: The name of the Zhuang family medicine is Godienzcaet, and it is Panax notoginseng (Burk) F. H. Chen ex C.I. Derived from the roots of Chow. Taste: sweet, heat. Efficacy: Ryuji, fire regulation, blood supply, hemostasis, decongestion and pain relief. Curative: Postpartum blood loss, blood loss, bloodshed, blood loss, fecal blood, cramps, chest pain, stomach pain, bruise, menstrual pain, postpartum abdominal pain.
オウセイ:チワン族医薬名はGinghswであり、ユリ科植物多花黄精Polygonatum cyrtonema Huaの根茎に由来する。性味:甘、平。効能:風毒を取り除き、谷道を整えて、脾の働きを改善して気をよくする。主治:咳嗽、脾虚疲労、食欲不振や口腔乾燥、消渇、手足の弱さ、陽萎遺精、耳鳴目暗、髭髪早白、体虚羸痩、癬などである。 Sei: The name of the Zhuang medicine is Ginghsw, which is derived from the rhizome of Polygonatum cyrtonema Hua, which is a flowering plant of the lily family. Taste: sweet, flat. Efficacy: Remove wind poison, improve the valley, improve the function of the spleen and make you feel better. Chief: Cough, splenic fatigue, loss of appetite, dry mouth, dryness, weakness of limbs, dysphorus, tinnitus darkness, whitening of beard hair, thinning body, and scabies.
センボウ:チワン族医薬名はGohazsienであり、センボウ科植物キンバイザサCurculigo orchioides Gaertnの根茎に由来する。性味:辛、熱、有毒。効能:水道を整えて、湿熱毒を追い出す。主治:陽萎、小便失禁、胃痛、腰痛、筋痛などである。 Ambassador: The Zhuang medicine name is Gohazsien, which is derived from the rhizome of the moss family plant Curcumigo orchioides Gaertn. Taste: Spicy, fever, toxic. Efficacy: Clean the water supply and eliminate the heat and heat poison. Main cure: Yang wilt, urinary incontinence, stomach pain, low back pain, myalgia.
処方におけるコシモウトウ、フホウトウ、センキンバツは、主薬であり、ドニンジン、キバンは、副薬であり、リュウガン、デンシチ、オウセイは公薬であり、センボウは母薬であり、処方全体は、主副公母を組み合わせて使用し、血を補い、精を補充し、正気を扶助し、邪気を除き、三気の流れを良くして整える効能を果たす。 In the prescription, Koshimotou, Futotou, Sengokuto are the main drugs, Donnin and Kiban are the side drugs, Ryugan, Densichi, and Oisei are the public drugs, Senboku is the mother drug, and the whole prescription is the main and sub-parents. Used in combination, it supplements blood, replenishes spirits, assists sanity, removes nausea, and improves the flow of three spirits.
本発明は、以下の顕著な効果を有する。 The present invention has the following remarkable effects.
本発明は、血を補い、精を補充し、正気を扶助し、邪気を除き、三気の流れを良くして整えるという明確な効能を有し、顔色が青白く、カスミ目で物がはっきり見えず、動悸がして眠れず、爪が白いなどの症状をより良く改善する補血養精用チワン族医薬品組成物であり、その調製方法を提供し、調製方法は操作しやすく、生薬の効能を十分に発揮することができる。 INDUSTRIAL APPLICABILITY The present invention has clear effects of supplementing blood, replenishing spirit, assisting sanity, removing evil, and improving the flow of three spirits, pale complexion, clearly visible things with dark eyes It is a Zhuang pharmaceutical composition for blood supplementation and fertilization that improves symptoms such as palpitation, sleeplessness, and white nails, and provides a preparation method thereof, which is easy to operate and has the efficacy of a crude drug. It can be fully demonstrated.
以下、実施例により本発明をさらに説明するが、本発明の保護範囲を限定するものではない。 Hereinafter, the present invention will be further described with reference to examples, but the scope of protection of the present invention is not limited thereto.
一、補血養精用チワン族医薬品組成物の調製プロセス
(一)生産プロセスの設計
本処方は、臨床的経験に基づく処方であり、剤形として一般的に煎剤を使用し、製造方法が簡単であり、機器の条件により制限されないような利点を有する。しかし、煎剤は、ほとんど単剤として煎じたものであり、品質の統一及び量産が難しく、保存しにくく、携帯や輸送が不便であり、使用も不便である。上記欠点を解決し、大多数の患者により受け取られやすくするために、一般的な投与経路及び方法に適している剤形である顆粒剤を、本製品の調製剤形とする。伝統的な漢方薬の煎剤は、水を抽出溶媒とすることが多く、水による抽出は、コストが低く、薬効が確実であるため、水を抽出溶媒とする予定である。このため、生産プロセスの方法は、水で煎じて、乾燥ペーストを得た後、賦形剤を加え、造粒することである。
1.Preparation process of Zhuang pharmaceutical composition for blood supplementation (1) Design of production process This formulation is based on clinical experience, and generally uses decoction as the dosage form, and the manufacturing method is simple. Yes, it has the advantage that it is not limited by the conditions of the device. However, most of the decoctions are brewed as a single agent, and it is difficult to unify the quality and mass-produce them, difficult to store, inconvenient to carry and transport, and inconvenient to use. In order to solve the above-mentioned drawbacks and make it easier to be received by the majority of patients, granules, which is a dosage form suitable for general administration routes and methods, is used as a preparation dosage form of the product. Water is often used as the extraction solvent for traditional Chinese herbal decoctions, and water extraction is planned to be water because the cost is low and the drug effect is certain. For this reason, the method of the production process is to decoct with water to obtain a dry paste, then add excipients and granulate.
(二)水抽出プロセス条件のスクリーニング
1、直交試験の設計
水抽出効果に影響を及ぼす要因は、(1)煎じ回数、(2)煎じ時間、(3)水添加量、(4)破砕度、である。3水準で、これらの要因について、直交試験の最適化を実行し、L9(34)直交表を用いて直交試験を実行した(詳細は表1、表2を参照)。
(2) Screening of water extraction process conditions 1. Design of orthogonal test The factors that influence the water extraction effect are (1) number of decoctions, (2) decoction time, (3) water addition amount, (4) crushing degree, Is. In three levels, (see details in Table 1, Table 2) for these factors, and performing an optimization of the orthogonal test, L 9 (3 4) was performed orthogonal test using an orthogonal table.
2、最適化指標及び総合スコアリング方法
本製品の処方には、抽出する必要がある生薬は合計6つであり、そのうち、君薬は、コシモウトウであり、フラボノイド成分を主に含有し、その代表的な成分はソラレンであり、ソラレンの含有量のレベルは本製品の有効性と密に関連し、本製品のプロセス条件の最適化指標とすることができ、ソラレンの最高含有量を60点として、各サンプルの相対スコアを計算し、総固形分は、抽出効率を全体的に反映することができ、本製品のプロセス条件の第2の最適化指標とし、最高の総固形分を40点として、各サンプルの相対スコアを計算し、2つのスコアを加算すると、各サンプルの総合スコアとなった。
2. Optimization index and total scoring method There are a total of six herbal medicines that need to be extracted in the formulation of this product, and among them, Kimi-koto is a citrus cortex, which mainly contains flavonoid components, and its representative The main ingredient is psoralen, and the psoralen content level is closely related to the effectiveness of this product and can be an index for optimizing the process conditions of this product. The maximum psoralen content is 60 points. Calculate the relative score of each sample, the total solid content can reflect the extraction efficiency as a whole, as the second optimization index of the process condition of this product, the maximum total solid content as 40 points The relative score of each sample was calculated, and the two scores were added to give the total score of each sample.
3、最適化方法
3.1直交試験
表2に示される直交設計試験表に従って試験を設定し、各群の試験では、処方量の生薬を準備し、各試験番号の煎剤をそれぞれ合わせ、均一に混合し、濾過し、濾液を濃縮した後、1000mlに定容し、試験液とした。
3. Optimization method 3.1 Orthogonal test The test is set according to the orthogonal design test table shown in Table 2, and in the test of each group, the prescribed amount of crude drug is prepared, and the decoctions of the respective test numbers are respectively combined and uniformly. After mixing, filtering, and concentrating the filtrate, the volume was adjusted to 1000 ml to obtain a test solution.
3.2測定方法
総固形分の測定
試験液100mlを精密に量り、105℃で一定重量まで乾燥した蒸発皿に入れ、水浴で蒸乾し、80℃で一定重量まで減圧乾燥し、重量を秤量して、乾燥ペーストの量を算出した。
3.2 Measurement method Measurement of total solid content 100 ml of the test solution is precisely weighed, placed in an evaporation dish that has been dried to a certain weight at 105°C, steam-dried in a water bath, and dried under reduced pressure to a certain weight at 80°C, and then weighed. Then, the amount of dry paste was calculated.
ソラレン含有量の測定
ソラレン5.09mgを精密に量り、メタノールを加え、10mlメスフラスコにおいて溶解させて、標準品溶液を得た。サンプル10mlを精密に吸い取り、栓付き三角フラスコに入れ、さらに、75%エタノール25mlを精密に吸い取った。重量を秤量した後、75%エタノールで減少重量を補充し、均一に振り、濾過して、濾液10mlを精密に量り、水浴鍋に入れて、蒸乾した。乾燥渣をメタノールで分別溶解し、10mlメスフラスコに順次移し、所定の目盛りまでメタノールを加え、均一に振り、試験品溶液を得た。クロマトグラフィーカラム:Phenomenex Gemini C18 (250mm×4.6mm、5μm)、流動相:アセトニトリル−0.1%リン酸水(勾配溶出)、流動相:アセトニトリル−0.2%リン酸溶液(35:65)、検出波長:245nm、流速:1.0ml/min、カラム温度:、40℃であった。試料注入量を10uLとし、標準品及び試験品におけるソラレンの含有量をそれぞれ測定した。
Measurement of Psoralen Content 5.09 mg of psoralen was precisely weighed, methanol was added and dissolved in a 10 ml volumetric flask to obtain a standard solution. 10 ml of the sample was precisely sucked, placed in an Erlenmeyer flask with a stopper, and further 25 ml of 75% ethanol was precisely sucked. After weighing the weight, the reduced weight was replenished with 75% ethanol, shaken uniformly, filtered, 10 ml of the filtrate was accurately weighed, put in a water bath pan, and dried by steam. The dried residue was fractionally dissolved with methanol, transferred to a 10 ml volumetric flask one by one, methanol was added to a predetermined scale and shaken uniformly to obtain a test product solution. Chromatography column: Phenomenex Gemini C18 (250 mm×4.6 mm, 5 μm), mobile phase: acetonitrile-0.1% phosphoric acid water (gradient elution), mobile phase: acetonitrile-0.2% phosphoric acid solution (35:65). ), detection wavelength: 245 nm, flow rate: 1.0 ml/min, column temperature: 40°C. The sample injection amount was 10 uL, and the psoralen contents in the standard product and the test product were measured.
4、直交試験最適化の結果及び分析
直交試験の結果(詳細は表2を参照)を分析したところ、抽出効率に対する各要因の影響は、煎じ回数>水添加量>破砕度>煎じ時間であり、抽出プロセスの最適なレベルの組み合わせは、A3B1C3D2であることが明らかになった。表3−1の分散分析の結果から、抽出に対しては、煎じ回数と水添加量の影響が著しく、煎じ時間と破砕度の影響には、有意性がないことがわかった。従って、作業効率の向上の観点から、水抽出プロセスでは、生薬に水を8倍加え、1回当たり1時間に3回煎じるようにした。
4. Orthogonal test optimization result and analysis When the orthogonal test result (see Table 2 for details) was analyzed, the influence of each factor on the extraction efficiency was the number of decoctions> the amount of water added> the degree of crushing> the decoction time. , The optimum level combination of the extraction process was found to be A 3 B 1 C 3 D 2 . From the results of the analysis of variance in Table 3-1, it was found that the extraction was significantly influenced by the number of times of decoction and the amount of water added, and the effects of the decoction time and the crushing degree were not significant. Therefore, from the viewpoint of improving work efficiency, in the water extraction process, water was added to the crude drug 8 times and decocted 3 times per hour.
表1 補血養精用チワン族医薬品組成物の水煎じプロセス条件の直交試験の要因及びレベルの表
注: 1.煎じ時間:毎回の時間
2.水添加量:処方生薬の総重量(g)の倍数
Table 1 Factors and Levels of Orthogonal Test of Water Decoction Process Conditions of Zhuwan Family Pharmaceutical Composition for Blood Supplementation
Note: 1. Decoction time: each time 2. Amount of water added: multiple of the total weight (g) of prescription crude drug
表2 補血養精用チワン族医薬品組成物の水煎じプロセス条件の直交試験L9(34)及びその最適化結果の表
Table Table 2 Hoketsu YoTadashi for Zhuang water decoction process conditions orthogonal test L 9 (3 4) of the pharmaceutical composition and its optimization results
表3−1 水煎じプロセス条件の直交試験の分散分析の表
F0.01(2,2)=99.0、F0.05(2,2)=19.0
Table 3-1 Table of analysis of variance for orthogonal test of water decoction process conditions
F 0.01 (2,2)=99.0, F 0.05 (2,2)=19.0
5、直交試験最適化結果の確認試験
上記プロセスに従って3回煎じた煎じ滓に8倍の水を加え、1時間煎じ、煎剤を濾取し、1000mlまで濃縮し、50mlを精密に量り、上記ソラレン含有量の測定方法に従って測定した結果、ソラレンのHPLCピークが小さく、乾燥ペーストが1.5%得られ、それは、生薬を3回煎じると、有効成分が基本的に抽出されることを示した。
5. Orthogonal test Optimization test confirmation test Add 8 times water to the decoction decocted three times according to the above process, decoct for 1 hour, filter the decoction, concentrate to 1000 ml, measure 50 ml precisely, and poralen above As a result of measuring according to the content measuring method, the HPLC peak of psoralen was small and 1.5% of dry paste was obtained, which showed that when the crude drug was decocted 3 times, the active ingredient was basically extracted.
(三)濃厚ペーストの乾燥プロセスの最適化
最適化した水抽出プロセスで本製品を濃縮した濃厚ペーストを、70℃、80℃、90℃で一定重量まで減圧乾燥し、乾燥ペーストを約1g、精密に秤量し、上記ソラレン測定方法に従ってサンプルソラレンの含有量を測定し、結果を表3−2に示した。実験結果から、乾燥温度は、本製品のソラレンの含有量に影響を及ぼし、80℃での減圧乾燥が最適であり、ソラレン含有量を低下させることなく作業効率を向上できることを示し、これにより、濃厚ペーストの乾燥温度条件として、80℃で減圧乾燥することとした。
(3) Optimization of the drying process of concentrated paste The concentrated paste obtained by concentrating this product by the optimized water extraction process is dried under reduced pressure at 70°C, 80°C, and 90°C to a constant weight, and about 1 g of dried paste The sample psoralen content was measured according to the above psoralen measurement method, and the results are shown in Table 3-2. The experimental results show that the drying temperature affects the psoralen content of this product, vacuum drying at 80°C is optimal, and the working efficiency can be improved without lowering the psoralen content. As the drying temperature condition of the thick paste, it was decided to perform vacuum drying at 80°C.
表3−2、濃厚ペーストの乾燥温度試験
Table 3-2, Drying temperature test of thick paste
(四)造粒成形プロセスの最適化についての検討
最適な抽出プロセスに従って得られた薬液を濃縮乾燥し、エキス粉末を得て、賦形剤をエキス粉末と均一に混合して顆粒に製造したときの収率、溶解度及び口当たりに応じて適切な賦形剤を選択した。結果を表4−1に示した。
(4) Study on optimization of granulation molding process When the drug solution obtained according to the optimum extraction process is concentrated and dried to obtain an extract powder, and an excipient is uniformly mixed with the extract powder to produce granules. Appropriate excipients were selected depending on the yield, solubility and mouthfeel of the. The results are shown in Table 4-1.
顆粒収率の測定:調製された顆粒を秤量した。顆粒収率=合格顆粒の重量g/(エキス粉末の重量g+賦形剤の重量g)×100%
溶解度の測定:一定重量まで乾燥した5mL遠心分離管に精密に秤量した顆粒を加え、沸騰水5mLを精密に加え、5分間撹拌して振とうし、3000r/分で15分間遠心分離し、上清液を捨て、80℃で残渣を一定重量まで乾燥し、精密に秤量し、溶解率を算出した。溶解率=溶解顆粒の質量/顆粒の質量×100%
口当たり等級:重苦味、微苦味を伴う甘味。
Measurement of granule yield: The prepared granules were weighed. Granule yield=weight g of accepted granules/(weight g of extract powder+weight g of excipient)×100%
Solubility measurement: Add precisely weighed granules to a 5 mL centrifuge tube dried to a certain weight, add 5 mL of boiling water precisely, stir for 5 minutes, shake, centrifuge at 3000 r/min for 15 minutes, The clean liquid was discarded, the residue was dried to a constant weight at 80° C., weighed precisely, and the dissolution rate was calculated. Dissolution rate = mass of dissolved granules / mass of granules x 100%
Mouthfeel grade: Sweetness with heavy bitterness and slight bitterness.
表4−1 賦形剤のスクリーニング結果
賦形剤のスクリーニング実験結果より、賦形剤をスクロースとした。
Table 4-1 Excipient screening results
Based on the results of the excipient screening experiment, the excipient was sucrose.
成形プロセスについての検討:
成形プロセスに影響を及ぼす多くの要因のうち、エタノールの濃度、エタノールの使用量及び撹拌時間を考慮して要因レベル及びL9(34)直交試験表を設計し、表2−2、表2−3として示した。成形性を評価指標とした。
Consideration of molding process:
Of the many factors affecting the molding process, the concentration of ethanol, the amount and factor levels in consideration of the stirring time and L 9 ethanol (3 4) Design the orthogonal test table, Table 2-2, Table 2 -3. The moldability was used as an evaluation index.
表4−2 要因レベル表
Table 4-2 Factor level table
表4−3 L9(34)直交試験表
Table 4-3 L 9 (3 4 ) orthogonal test table
表4−4 分散分析結果
注:F0.05(2.2)=19.00
分散分析結果から、顆粒収率に対する3つの要因の影響の度合いは、A>B>Cであり、要因A、Bには有意であることがわかった。視覚分析の結果により、最適なプロセスはA2B2C3であることを確認し、最適なプロセス条件A2B2C3試験を繰り返したところ、顆粒収率が直交表の試験結果とほぼ一致した。表4−5を参照されたい。従って、成形プロセスを、エタノール濃度75%、エタノール使用量8%、15min撹拌とした。
Table 4-4 ANOVA results
Note: F 0.05 (2.2)=19.00
From the analysis of variance analysis, it was found that the degree of influence of the three factors on the yield of granules was A>B>C, and the factors A and B were significant. From the results of visual analysis, it was confirmed that the optimum process was A 2 B 2 C 3 , and when the optimum process condition A 2 B 2 C 3 test was repeated, the granule yield was almost the same as the test result in the orthogonal table. Matched See Tables 4-5. Therefore, the molding process was carried out with an ethanol concentration of 75%, an amount of ethanol used of 8%, and stirring for 15 minutes.
表4−5 検証実験結果リスト(n=3)
Table 4-5 List of verification experiment results (n=3)
(五)パイロットテストについての検討
スクリーニングされた処方プロセスに従って、100倍拡大し、3つのパイロットテストを実行し、そのバッチ番号を、それぞれ20160401、20160402、20160403とした。各バッチには、100000gの比率で原料を秤取した。8倍量の水を加え、1回当たり60minに、3回抽出し、濾過して濃縮し、真空乾燥し、粉砕して100メッシュのふるいにかけ、乾燥ペースト粉末に、100000gまでスクロースを加え、均一に混合し、75%エタノールを用いて軟質材料とし、12メッシュのふるいにかけて造粒し、75℃で4h乾燥し、12メッシュのふるいにかけて整粒し、混合機で均一に混合し、梱包して包装し、得られた顆粒サンプルの顆粒収率、粒度及び溶解度をそれぞれ統計し、得られた結果を表に示した。
(5) Examination on pilot test According to the screened prescription process, 100 times expansion was performed and three pilot tests were performed, and the batch numbers were set to 201604401, 201640402, and 201660403, respectively. In each batch, raw materials were weighed at a rate of 100,000 g. Add 8 times amount of water, extract 3 times for 60 min each time, filter, concentrate, vacuum dry, pulverize and sieve to 100 mesh sieve, add sucrose up to 100000g to dry paste powder, homogenize To 75% ethanol to make a soft material, granulate through a 12-mesh sieve, dry at 75°C for 4 h, sieving through a 12-mesh sieve, uniformly mix with a mixer, and package. The granule yield, particle size and solubility of each of the obtained granule samples after packaging were statistically analyzed, and the obtained results are shown in the table.
表5 3バッチのパイロットテスト結果
Table 5 Results of 3 batch pilot test
(六)安定性調査試験
本製品の包装、貯蔵、輸送中の安定性を検討し、製剤の有効期限を設定する基礎を提供するために、『漢方薬、天然薬物安定性研究の技術指導原則』に記載の要件に従って、顆粒剤安定性試験の関連規定及び本製品の品質基準のドラフトにより、龍鑽通痺顆粒の3つのサンプルについて、加速安定性試験及び長期安定性試験を実行した。本製品について12ヶ月の長期常温調査及び6ヶ月の加速安定性調査を行った結果、3つのサンプルの性状、同定、検査、含有量測定及び微生物限界検査は、いずれも規定を満たした。この結果から、本製品の有効期間は、暫定的に2年に設定できることを示し、貯蔵条件は30℃±2℃であり、相対湿度は65%±5%であり、低密度ポリエチレン医薬品包装用複合フィルムを包装材料とした。
(6) Stability investigation test In order to provide a basis for studying the stability of this product during packaging, storage and transportation, and for setting the expiration date of the drug product, "Technical Guiding Principles of Kampo Medicine and Natural Drug Stability Research" According to the requirements described in 1 above, the accelerated stability test and the long-term stability test were carried out on three samples of Ryurantsugran granule according to the relevant regulations of the granule stability test and the draft of the quality standard of this product. As a result of conducting a long-term room temperature investigation for 12 months and an accelerated stability investigation for 6 months for this product, the properties, identification, inspection, content measurement, and microbial limit inspection of all three samples satisfied the regulations. From this result, it is shown that the shelf life of this product can be provisionally set to 2 years, the storage condition is 30°C ± 2°C, the relative humidity is 65% ± 5%, and it is for packaging low-density polyethylene pharmaceutical products. The composite film was used as the packaging material.
(七)結論
補血養精用チワン族医薬品組成物の最適な調製プロセスは、生薬に水を8倍加え、1回当たり1時間に3回煎じ、濾過して濃縮し、80℃で減圧乾燥し、粉砕して100メッシュのふるいにかけ、乾燥ペースト粉末にスクロースを加え、均一に混合し、75%エタノールを用いて軟質材料とし(エタノール使用量8%)、15min撹拌し、12メッシュのふるいにかけて造粒し、75℃で4h乾燥し、12メッシュのふるいにかけて整粒し、混合機で均一に混合し、梱包して包装することである。
(7) Conclusion The optimal process for preparing a Zhuang family pharmaceutical composition for blood supplementation is to add 8 times water to crude drug, decoct 3 times per hour, filter, concentrate, and dry under reduced pressure at 80°C. , Crush and sieve with 100 mesh, add sucrose to dry paste powder, mix evenly, make a soft material with 75% ethanol (8% of ethanol used), stir for 15 min, and make with 12 mesh sieve. Granules are dried at 75° C. for 4 hours, sieved with a 12-mesh sieve, sized, uniformly mixed with a mixer, and packed and packaged.
二、臨床実施例
実施例1
1.チワン族医薬品組成物は、重量部で、コシモウトウ60g、フホウトウ50g、センキンバツ60g、ドニンジン50g、キバン30g、リュウガン50g、デンシチ40g、オウセイ25g、センボウ30gの原料を含む。
Second, clinical example Example 1
1. The Zhuang family pharmaceutical composition contains, by weight, 60 g of Kotomotou, 50 g of Futotou, 60 g of Scutellaria baicalensis, 50 g of ginseng, 30 g of kiban, 50 g of longan, 40 g of denshichi, 25 g of seisei, and 30 g of senbou.
2.チワン族医薬品組成物の調製方法:
何氏、女性、32歳、河池市人、血虚精虧3年、上記投薬方法に従って、このチワン族医薬品組成物を服用した後、症状が好転した。
2. Method for preparing Zhuang pharmaceutical composition:
He, female, 32 years old, Kawahito, 3 years old, after taking this Zhuang pharmaceutical composition according to the above-mentioned administration method, the symptoms improved.
金氏、女性、27歳、玉林市人、血虚精虧3年、上記投薬方法に従って、このチワン族医薬品組成物を服用した後、症状が好転した。 Kim, female, 27 years old, Tamabayashi, 3 years old, after 3 years of vomiting, after taking this Zhuang pharmaceutical composition according to the above-mentioned administration method, the symptoms improved.
実施例2
1.チワン族医薬品組成物は、重量部で、コシモウトウ50部、フホウトウ40部、センキンバツ20部、ドニンジン30部、キバン30部、リュウガン20部、デンシチ20部、オウセイ20部、センボウ20部の原料を含む。比率は、5:4:2:3:3:2:2:2:2であった。
Example 2
1. The Zhuang family pharmaceutical composition contains, by weight, 50 parts of Koshimotou, 40 parts of Futoto, 20 parts of Senbutsu, 30 parts of carrots, 30 parts of kiban, 20 parts of longan, 20 parts of denshi, 20 parts of seisei, and 20 parts of senbou. .. The ratio was 5:4:2:3:3:2:2:2:2.
2.チワン族医薬品組成物の調製方法:
重量部で秤取された原料をそれぞれ洗浄して選別した後、生薬に水を8倍加え、1回当たり1時間に3回煎じ、濾過して濃縮し、80℃で減圧乾燥し、粉砕して100メッシュのふるいにかけ、乾燥ペースト粉末にスクロースを加え、均一に混合し、75%エタノールを用いて軟質材料とし(エタノール使用量8%)、15min撹拌し、12メッシュのふるいにかけて造粒し、75℃で4h乾燥し、12メッシュのふるいにかけて整粒し、混合機で均一に混合し、梱包して包装し、1パックあたり30gとした。
2. Method for preparing Zhuang pharmaceutical composition:
After washing and selecting each of the raw materials weighed out in parts by weight, water is added to the crude drug 8 times, decocted 3 times per hour, filtered, concentrated, dried under reduced pressure at 80° C., and crushed. Sucrose to dry paste powder, mix evenly, make a soft material with 75% ethanol (ethanol usage 8%), stir for 15 min, granulate with 12 mesh sieve, It was dried at 75° C. for 4 hours, sized with a 12-mesh sieve, uniformly mixed with a mixer, packed and packaged to give 30 g per pack.
3.投薬方法:上記顆粒剤を、1パック/回、朝晩1回ずつ経口投与し、14日間を1クールとし、2クール連続して治療した。 3. Dosing method: The above granules were orally administered once per pack, once in the morning and once in the morning, and treated for 14 consecutive days, 2 courses in succession.
4.本発明の薬物を使用した患者についての臨床的な統計資料:
4.1基本資料
診断基準:(1)現代医学診断基準(『亜健康漢方医臨床ガイド』の診断基準に従って策定)を参照し、被験者の主訴により、顔色が青白く、カスミ目で物がはっきり見えず、動悸がして眠れず、爪が白いなどの不快感は、3ヶ月以上繰り返し発作し、重要な器質的疾患や精神疾患はなく、投薬を必要とせず、関連する実験室及び身体検査では陽性結果はない。(2)漢方医証候診断基準(2002版『新しい漢方薬の臨床研究指導原則』)を参照し、血虚の主症は、顔色が青白く、眩暈、心悸、次症は、手足麻木、爪が白く、不眠、脈が細くて又は虚大であるが無力であり、舌が淡く苔が白く、2つの主症+1つの次症を持っている人は血虚であると判定された。亜健康診断基準及び漢方医血虚証基準を満たした患者は、男性53例、女性67例、合計120例であり、年齢28〜48歳、病状2〜9年であった。
4. Clinical statistical data on patients who have used the drug of the present invention:
4.1 Basic data Diagnostic criteria: (1) Refer to the modern medical diagnostic criteria (developed according to the diagnostic criteria of the “Ahealth Chinese Medicine Clinical Guide”), and the subject's chief complaint makes the complexion pale and the object clearly visible with dark eyes. Discomfort, including palpitation, sleeplessness, and white nails, repeated bouts of more than 3 months, no significant organic or mental illness, no medication required, and related laboratory and physical examinations There are no positive results. (2) Refer to the Kampo medicine diagnostic criteria (2002 edition “Principles of New Chinese Medicine Clinical Research Guidance”), the main symptom of blood loss is pale complexion, dizziness, heart palpitations, and secondary symptoms are limb, asahi and nails. A person with white, insomnia, thin veins or voids, helplessness, pale tongue, white moss, two main symptoms and one secondary symptom was determined to be bloodless. The number of patients who met the sub-health examination criteria and the Kampo medicine blood deficiency criteria was 53 males and 67 females, for a total of 120 cases, and the age was 28 to 48 years and the medical condition was 2 to 9 years.
4.2実験の群分け
患者を、観察群と、対照群の2群にランダムに分け、各群を60人とした。
4.2 Grouping of Experiments Patients were randomly divided into two groups, an observation group and a control group, and each group had 60 patients.
4.3治療計画
観察群:上記顆粒剤を、1パック/回、朝晩1回ずつ経口投与し、14日間を1クールとし、2クール連続治療する。
4.3 Treatment plan Observation group: The above-mentioned granules are orally administered once per pack and once in the morning and evening, and one course is given for 14 days, and two courses are continuously treated.
対照群:多糖鉄複合物カプセル0.15g、ビタミンC 50mgを1日1回経口投与し、2週間の連続治療を1クールとした。対照群及び観察群については、3クール投薬後に、病状の変化を観察した。 Control group: Polysaccharide iron complex capsules 0.15 g and vitamin C 50 mg were orally administered once a day, and continuous treatment for 2 weeks was 1 course. Regarding the control group and the observation group, changes in the medical condition were observed after 3 courses of medication.
5.治療効果の判定
『漢方医証候の治療効果判定基準』に記載の血虚型亜健康の治療効果判定基準を参照する。短時間治癒:漢方医により診断された症状が消えるか、ほぼ消える。著効:漢方医により診断された症状が大幅に改善される。有効:漢方医により診断された症状がいずれも改善されたが、有意ではない。無効:漢方医により診断された症状が有意に改善されず、さらに悪化する。
5. Judgment of therapeutic effect Refer to the therapeutic effect judgment standard for blood-subtype subhealth described in "Criteria for therapeutic effect evaluation of Kampo medicine signs". Short-term healing: The symptoms diagnosed by a Chinese medicine doctor disappear or almost disappear. Remarkable effect: The symptoms diagnosed by Chinese medicine doctors are significantly improved. Effective: All the symptoms diagnosed by the Kampo doctor were improved but not significant. Ineffective: Symptoms diagnosed by a Kampo doctor are not significantly improved and are exacerbated.
6.統計学的処理
SPSS20.0統計ソフトウェアを用いて分析し、計数資料に対してカイ二乗検定を行い、計量資料に対してt検定を行った。P<0.05の場合は、差には統計的に有意であるとした。
6. Statistical processing The analysis was performed using SPSS20.0 statistical software, the chi-square test was performed on the count data, and the t-test was performed on the measurement data. Differences were considered statistically significant if P<0.05.
7.実験結果
観察群の総有効率は91.67%であり、対照群の総有効率は80.00%であった。観察群は、対照群と比較すると、差が統計的に有意であった。観察群の臨床的治療効果は、対照群よりも優れていた。
7. Experimental Results The total effective rate of the observation group was 91.67%, and the total effective rate of the control group was 80.00%. The difference in the observation group was statistically significant when compared with the control group. The clinical treatment effect of the observation group was superior to that of the control group.
表6 対照群と観察群の臨床的治療効果の比較
注、対照群と比較すると、P<0.05。
Table 6 Comparison of clinical treatment effect between control group and observation group
Note, P<0.05 when compared with the control group.
8.典型的な病例
譚氏、女性、36歳、南寧市人、血虚精虧3年、上記投薬方法に従って、このチワン族医薬品組成物を服用した後、症状が好転した。
程氏、女性、26歳、市人、血虚精虧3年、上記投薬方法に従って、このチワン族医薬品組成物を服用した後、症状が好転した。
8. Typical illness Mr. Tan, female, 36 years old, Nanning city, 3 years old, after taking this Zhuang pharmaceutical composition according to the above administration method, the symptoms improved.
After receiving this Zhuang pharmaceutical composition according to the above administration method, the symptoms improved.
Claims (4)
ことを特徴とする、補血用チワン族医薬品組成物。 20 to 60 parts by weight of Koshimato, 10 to 50 parts by weight of sardine, 10 to 60 parts by weight of sardine, 10 to 50 parts by weight of carrot, 10 to 30 parts by weight of kiban, 10 to 50 parts by weight of longan, 10 to 40 parts by weight of denshi, seisei Prepared using 10 to 25 parts by weight and 10 to 30 parts by weight of senbou,
A Zhuang pharmaceutical composition for blood supplementation, which is characterized in that:
ことを特徴とする請求項1に記載の補血用チワン族医薬品組成物。 Using 50 parts by weight of Koshimoto, 40 parts by weight of futou, 20 parts by weight of sardines, 30 parts by weight of carrot, 30 parts by weight of longan, 20 parts by weight of longan, 20 parts by weight of denshi, 20 parts by weight of senbou, and 20 parts by weight of senbou Prepared,
The Zhuang family pharmaceutical composition for blood supplementation according to claim 1, wherein
ことを特徴とする請求項1又は2に記載の補血用チワン族医薬品組成物の調製方法。 After washing each of the raw materials weighed in the above-mentioned parts by weight, water was added to the crude drug 8 times and decocted for 1 hour each time, decocted 3 times, filtered, concentrated, and dried under reduced pressure at 80°C. , Crushed and sieved with 100 mesh, add sucrose to dry paste powder, mix evenly, prepare soft material with ethanol with purity of 75% (ethanol dose is 8%), stir for 15 minutes , and mix with 12 mesh Sieving, granulating, drying at 75° C. for 4 hours , sieving with a 12 mesh sieve, uniform mixing with a mixer, packing and packaging,
The method for preparing a Zhuang family pharmaceutical composition for blood supplementation according to claim 1 or 2, characterized in that.
ことを特徴とする請求項3に記載の補血用チワン族医薬品組成物の調製方法。 The dosage form of the Zhuang pharmaceutical composition is a decoction or a granule,
The method for preparing a Zhuang family pharmaceutical composition for blood supplementation according to claim 3, wherein.
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