CN101810806A - Medicament for treating hyperprolactinemia and preparation method thereof - Google Patents
Medicament for treating hyperprolactinemia and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a Chinese medicament for treating hyperprolactinemia and a preparation method thereof. The medicament is prepared from ten Chinese medicinal materials, namely radix bupleuri, white peony roots, angelica, nutgrass galingale rhizome, cortex moutan radicis, gardenia, roses, malt, herba ecliptae and glossy privet fruits. The medicament has the efficacy in soothing liver, relieving upset, nourishing Yin and blood, clearing heat and relieving restlessness, and is used for premenstrual tension syndrome, infertility accompanied by serum prolactin increase, as well as people with liver depression, heat transformation, deficiency of yin-fluid and blood. Symptoms include irregular menstruation, amenorrhea, no impregnation long after marriage, painful chest and hypochondrium or mammary swelling pain, light headedness, vexation, irascibility, agrypnia, dreaminess, mouth-throat dryness, waist-knee lassitude, red tongue with thin yellow fur or thin white dry fur and string-like rapid pulse. Clinical verification results show that the medicament is safe, effective and free from toxic or side effects on human bodies.
Description
Affiliated technical field
The invention belongs to the preparing technical field of pharmaceuticals, relating to a kind of is the medicine that is used for the treatment of hyperprolactinemia of feedstock production and the preparation method of this medicine with the Chinese herbal medicine.
Background technology
Owing to the development of radioimmunoassay detection technology, be diagnosed as patient's quantity showed increased of hyperprolactinemia (HPRL), in gynaecopathia, often raise with PRL as galactorrhea, cyclomastopathy etc., find also that simultaneously taking contraceptive for a long time can cause PRL to increase.The positive rate that had the report early cervical carcinoma HPRL to occur in recent years again is 65.8%.HPRL has caused very big misery for numerous women, influences their work and health.At present, the unique effective Western medicine that is used for the treatment of hyperprolactinemia both at home and abroad adopts the import bromocriptine, and this medicine costs an arm and a leg, and side effect is big, and the patient is difficult to accept, and causes some drug withdrawal midway to influence therapeutic effect; Other anti-lactotropin Western medicine comprise: levodopa, octahydro benzoquinoline, vitamin B
6Deng, but effect is all than bromocriptine only; Have the Chinese medicine of producing code and then do not treat the medicine of primary disease.Chinese medicine is the rarity of motherland, has passed through the accumulation of more than one thousand years, has formed the experience of many treatment primary disease, and on traditional Chinese medical science ancient books, hyperprolactinemia belongs to the category of " milk is from excessive, menoxenia, amenorrhea, infertile ".Its morbidity is many does not relax because of feelings will, depression of liver-QI, and catharsis is not normal, or depressed rage impairing the liver, or cloudy blood consumption is hindered puerperal when producing, due to the deficiency of the liver and kindey.Method of treatment is then with " must separate four strongly fragrant to open the door of born of the same parents' tire through it ".These all provide the theoretical foundation of the side's of legislation medicine for diseases such as the premenstrualtension syndrome due to the modern Chinese medicine treatment hyperprolactinemia, infertile, menoxenia.Therefore, it is very necessary to develop a kind of little, cheap Chinese patent medicine preparation of HPRL good effect, side effect for the treatment of, and has become important research project in the current gynecological field.
Summary of the invention
The objective of the invention is to solve and remedy existing premenstrualtension syndrome, infertility clinically and increase with serum prolactin, disease belongs in short supply the reaching of Chinese medicine medicine of depressed liver and heat transmission deficiency of YIN-blood and has only the operable problem of Western medicine bromocriptine medicine clinically.Providing a kind of is the taking of feedstock production, easy to carry with the Chinese herbal medicine, absorbs fast and determined curative effect, and preparation method is simple, the Chinese medicine medicine that is used for the treatment of the serum hyperprolactinemia with low cost and the preparation method of this medicine.
The objective of the invention is at the problem that does not also have Chinese medicine Drug therapy premenstrual syndrome, infertility with the high lactotropin of serum clinically, and the preparation scheme of medicine of the present invention is that the designer obtains by summing up development according to clinical practice for many years and on the modern pharmacology experiment basis.In view of hyperprolactinemia pathogenic factor difference, complexity more than the cause of disease, and usually be compound disease, as milk from overflow, menoxenia, amenorrhea, infertile etc., so the designer is according to depressed liver and heat transmission, the mechanism characteristics of deficiency of YIN-blood, the plan method according to " element is asked. the most pure virginity will be discussed greatly " principle of " soothing the stagnant liver ", " be knotted loose it ", " deficiency syndrome should be treated by tonifying method ", " easypro its vim and vigour, make its accent reach and make peace flat ", " hot person looses it ", thirty years of age soothing the liver heat clearing away, nourishing YIN and benefiting blood, the method for clearing heat and relieving fidgetness is to control it.Therefore, designer of the present invention is according to clinical practice for many years, the adopted marrow main idea in side with JIAWEI XIAOYAO SAN and ERZHI WAN two sides, extract, the raw material of Chinese medicine that selected human body is easy to absorb combines Chinese medicine preparation, and this medicine is made up of Radix Bupleuri, the Radix Paeoniae Alba, Radix Angelicae Sinensis, Rhizoma Cyperi, Cortex Moutan, Fructus Gardeniae, Flos Rosae Rugosae, Fructus Hordei Germinatus, Herba Ecliptae, Fructus Ligustri Lucidi ten flavor Chinese crude drugs, full side has dispersing the stagnated live-QI to relieve the stagnation of QI, nourishing YIN and benefiting blood, the effect of clearing heat and relieving fidgetness is having significant curative effect aspect the clinical treatment hyperprolactinemia.
Another purpose of the present invention is to provide the preparation method of above-mentioned Chinese medicine medicine.
The weight proportion that constitutes each component raw material of medicine of the present invention is:
Radix Bupleuri 1～7 Radix Paeoniae Alba 2～10 Radix Angelicae Sinensis 1～7 Rhizoma Cyperi 1～7 Cortex Moutan 1～6 Fructus Gardeniae 1～6 Flos Rosae Rugosae 1～6
Fructus Hordei Germinatus 5～40 Herba Ecliptaes 1～7 Fructus Ligustri Lucidi 1～7
Medicine of the present invention is a kind ofly to increase with serum prolactin at clinical premenstrualtension syndrome, infertility, and disease belongs to the depressed liver and heat transmission deficiency of YIN-blood.Its etiology and pathogenesis is that premenstrual syndrome belongs to traditional Chinese medical science menopathy category, and infertility conforms to the infertile of the traditional Chinese medical science.Thereby developed effective Chinese medicine preparation, its composition, function and indication meet theory of Chinese medical science.According to Radix Bupleuri toil in the pathogeny side, cold nature is gone into the liver and gall warp." the southern regions of the Yunnan Province book on Chinese herbal medicine " carries it, and " gas of the contrary knot of row Liver Channel ends left side side of body irritability pain, controls married woman's heat in blood and burns warp, can transfer menstruation." the kind accent of this product reaches irritability and perpendicular pent-up, is to treat depression of liver-QI, distending pain over the hypochondrium, menoxenia, breast is made bloated good merchantable brand, so be monarch drug.Blood stored in the liver, main catharsis, body is cloudy and with positive, so with the Radix Paeoniae Alba, Chinese Angelica blood replonishing easing the affected liver.Radix Paeoniae Alba sour in the mouth bitterness is slightly cold, and goes into the liver spleen channel, and " Mingyi Bielu " carries: " live clear and coherent blood vessels, in delaying, dispelling malignant blood, main crafty blood." " the southern regions of the Yunnan Province book on Chinese herbal medicine " call it and " receive the adverse flow of liver-QI pain, take good care of conscience spleen channel blood, relax through sending down the abnormal ascending QI, end the irritability pain." essentials of Matea Medica says: " enrich blood, have loose bowels, strengthening the spleen is held back liver-yin." this product is longer than nourishing blood for regulating menstruation, the yin fluid astringing easing the affected liver.Radix Angelicae Sinensis sweet in the mouth suffering is warm in nature, goes into liver heart spleen channel, can enrich blood and invigorate blood circulation, and kind again pain relieving is the key medicine of gynecological's regulating menstruation.Two medicine mutual reinforcements between are usefulness, for controlling menoxenia, amenorrhea, dysmenorrhea, reaching blood-deficiency leading to hyperactivity of the liver, the good merchantable brand of pain in chest and hypochondrium.The little bitterness of Rhizoma Cyperi acrid-sweet flavor is flat, goes into Liver Channel, the function resolving depression of regulating the flow of vital energy, menstruction regulating and pain relieving." the southern regions of the Yunnan Province book on Chinese herbal medicine " called it and " transferred the gas in the blood, dissipating depression of QI gas." " medical center bun want the property of medicine " be referred to as that " tonifying liver, broken strongly fragrant, a surname reaches QI and blood, all medicines of liver man." " herbal Confucian classics " say: " and lid blood not voluntarily, capable with gas, QI rising in reverse order is not and strongly fragrant, and then blood is also puckery with fixed attention, gas along blood then also from and and freely, this woman's bleeding not during menses, menses are uncomfortable, so the ear of salty need." three medicines share, the tonifying liver body helps liver usefulness, and QI and blood is taken into account, principal drug assistance dispersing the stagnated live-QI to relieve the stagnation of QI altogether, the merit of transferring smooth menses.
The hot cold nature of Cortex Moutan bitter in the mouth is gone into the conscience kidney channel, and " herbal outline " claims it: " with blood, hemopoietic, removing heat from blood, control the blood fire second of the three ten-day periods of the hot season, heat clearing away and restlessness relieving." this product is apt to into blood system, can clearing away heat from blood, the blood stasis that can loose again has removing heat from blood and the blood that do not stagnate, and blood and not absurd row loose.The Fructus Gardeniae bitter in the mouth is cold in nature, goes into liver cardiopulmonary stomach tri-jiao channel, function clearing away heat-fire, removing heat from blood relieving restlessness." medicine class on the analogy of natural things " carries: " control vexed annoyed insomnia." " property of medicine is wanted in the medical center bun ": " let out heart-fire, tranquilizing mind is held back mutually fiery absurd row." two medicines share the heat extraction with the stagnated fire of clear eliminating pathogen in the liver warp.More than five medicines be ministerial drug altogether.
The Flos Rosae Rugosae sweet and slightly bitter taste is warm in nature, goes into the liver spleen channel, and the energy of supplementary Amplifications of the Compendium of Materia Medica meaning " regulate the flow of vital energy by regulating and activating blood circulation." " book on Chinese herbal medicine is new again " speech: " the strongly fragrant gas of soothing liver-QI gallbladder, spleen invigorating pathogenic fire reducing." this product fragrance unclogs and readjusts, the property of medicine is gentle, and easing the affected liver is amusing, and smooth gas is invigorated blood circulation.Can the depressed liver-energy dispersing and QI regulating resolving depression, again can with the regulating menstruation of blood dissipating blood stasis.The Fructus Hordei Germinatus sweet in the mouth is flat, and merit is apt to dispersing the stagnated live-QI to relieve the stagnation of QI, happy QI and blood.Kidney storing essence, blood stored in the liver, The liver and the kidney have a common source, so with the cloudy blood of Fructus Ligustri Lucidi, Herba Ecliptae liver and kidney tonifying.Promptly help the Radix Paeoniae Alba, Radix Angelicae Sinensis to take a tonic or nourishing food to build up one's health liver blood, anti-again liver-fire consumption impairment of YIN blood.Four medicines are adjuvant drug altogether.
The Radix Bupleuri priming is gone into liver, holds concurrently to be messenger drug, and is said as " book on Chinese herbal medicine justice ": the liver network disease of not relaxing, be side of body costalgia last, and infra is a umbilicus abdominal distention, is that all yang-energy is not declared, and due to the wood imbalance reaches, in answering medication, goes into Radix Bupleuri less, thinks that assistant makes guide, very victory proves effective.
All medicines share, and the tonifying liver body helps liver usefulness, and QI and blood is taken into account, and Liver and kidney is accent also, grow and have both clearly, and suffering is loose soothing the liver and do not consumed the gas clearing up internal heat by using drugs of bitter in taste and cold in nature and not cool holding back, and the moon softens nourishing and do not stop up stagnant.Prosperous in order to do the multiple blood of the moon, Liver and kidney must be supported, and stagnated fire gets clearly, and irritability is orderly and clearly, and all diseases can be separated.Really for treatment pre-menstrual period nercousness, infertility increase with serum prolactin, card belongs to depressed liver and heat transmission, deficiency of YIN-blood person's good recipe.
The above-mentioned medicine that is used for dispersing the stagnated live-QI to relieve the stagnation of QI, nourishing YIN and benefiting blood, clearing heat and relieving fidgetness can be made the multiple dosage form of medicine, as granule, capsule, tablet etc.The preparation method of granule of making or capsule or tablet is as described below:
1. ten flavor medical materials in the prescription are got Rhizoma Cyperi, Radix Angelicae Sinensis extraction volatile oil, and Cortex Moutan extracts paeonol, and aqueous solution after the distillation and medicinal residues device are in addition collected;
2. the volatile oil of said extracted, paeonol merge, and use cyclic dextrin clathrate;
3. remain seven flavors such as Radix Bupleuri in the prescription, decoct with water secondary, decocted 2 hours for the first time; Add for the second time above-mentioned medicinal residues and decocted 1 hour, collecting decoction filters.Filtrate and above-mentioned aqueous solution merge, and are concentrated into clear paste;
4. step 3. the clear paste of carrying be dried to dry extract;
5. step 2. gained cyclodextrin inclusion complex, step 3. the gained extract powder add the dextrin mixing, make granule, drying is made granule or is incapsulated and makes capsule or tabletting is made tablet, promptly gets granule or the capsule or the tablet of medicine of the present invention.
Prescription of the present invention is formed science, meets traditional Chinese medical science principle-method-recipe-medicines principle, and preparation method rationally also is fit to big production, has good social benefit and economic benefit.
The specific embodiment:
Embodiment 1
Chinese medicine medicine provided by the invention is made up of the following weight proportion raw material:
Radix Bupleuri 200g Radix Paeoniae Alba 500g Radix Angelicae Sinensis 200g Rhizoma Cyperi 200g Cortex Moutan 300g Fructus Gardeniae 300g
Flos Rosae Rugosae 300g Fructus Hordei Germinatus 2000g Herba Ecliptae 200g Fructus Ligustri Lucidi 200g
Described dosage form is a granule, and the processing step of preparation method is as follows:
Ten flavor medical materials in the prescription are got Rhizoma Cyperi, Radix Angelicae Sinensis extraction volatile oil, and Cortex Moutan extracts paeonol, and aqueous solution after the distillation and medicinal residues device are in addition collected; The volatile oil of said extracted, paeonol merge, and use the alpha-cyclodextrin inclusion; Seven flavors such as Radix Bupleuri decoct with water secondary, add 14 times of amounts of water for the first time, decoct 2 hours; After for the second time adding above-mentioned medicinal residues, add 12 times of amounts of water, decocted 1 hour, collecting decoction filters.Filtrate and above-mentioned aqueous solution merge, and are concentrated into relative density 1.08～1.20 (60 ℃) clear paste; 80 ℃ are dried to dry extract; Get dry extract and add dextrin, alpha-cyclodextrin inclusion complex etc., mixing, wet method is made granule, and drying is made granule.
Embodiment 2
Radix Bupleuri 200g Radix Paeoniae Alba 500g Radix Angelicae Sinensis 200g Rhizoma Cyperi 200g Cortex Moutan 300g Fructus Gardeniae 300g
Flos Rosae Rugosae 300g Fructus Hordei Germinatus 2000g Herba Ecliptae 200g Fructus Ligustri Lucidi 200g
Described dosage form is a granule, and the processing step of preparation method is as follows:
Ten flavor medical materials in the prescription are got Rhizoma Cyperi, Radix Angelicae Sinensis extraction volatile oil, and Cortex Moutan extracts paeonol, and aqueous solution after the distillation and medicinal residues device are in addition collected; The volatile oil of said extracted, paeonol merge, and use the beta-schardinger dextrin-inclusion; Seven flavors such as Radix Bupleuri decoct with water secondary, add 14 times of amounts of water for the first time, decoct 2 hours; After for the second time adding above-mentioned medicinal residues, add 12 times of amounts of water, decocted 1 hour, collecting decoction filters.Filtrate and above-mentioned aqueous solution merge, and are concentrated into relative density 1.08～1.20 (60 ℃) clear paste; 60 ℃ of vacuum dryings become dry extract; Get dry extract and add dextrin, beta-cyclo dextrin included compound etc., mixing, wet method is made granule, and drying is made granule.
Embodiment 3
Radix Bupleuri 400g Radix Paeoniae Alba 500g Radix Angelicae Sinensis 400g Rhizoma Cyperi 400g Cortex Moutan 300g Fructus Gardeniae 300g
Flos Rosae Rugosae 300g Fructus Hordei Germinatus 2000g Herba Ecliptae 400g Fructus Ligustri Lucidi 400g
Described dosage form is a granule, and the processing step of preparation method is as follows:
Ten flavor medical materials in the prescription are got Rhizoma Cyperi, Radix Angelicae Sinensis extraction volatile oil, and Cortex Moutan extracts paeonol, and aqueous solution after the distillation and medicinal residues device are in addition collected; The volatile oil of said extracted, paeonol merge, and use the alpha-cyclodextrin inclusion; Seven flavors such as Radix Bupleuri decoct with water secondary, add 14 times of amounts of water for the first time, decoct 2 hours; After for the second time adding above-mentioned medicinal residues, add 14 times of amounts of water, decocted 1 hour, collecting decoction filters.Filtrate and above-mentioned aqueous solution merge, and are concentrated into relative density 1.10～1.14 (60 ℃) clear paste; Be spray dried to dry extract; Get dry extract alpha-cyclodextrin inclusion complex etc., mixing, dry method is made granule, and drying is made granule.
Embodiment 4
Radix Bupleuri 400g Radix Paeoniae Alba 500g Radix Angelicae Sinensis 400g Rhizoma Cyperi 400g Cortex Moutan 300g Fructus Gardeniae 300g
Flos Rosae Rugosae 300g Fructus Hordei Germinatus 2000g Herba Ecliptae 400g Fructus Ligustri Lucidi 400g
Described dosage form is a granule, and the processing step of preparation method is as follows:
Ten flavor medical materials in the prescription are got Rhizoma Cyperi, Radix Angelicae Sinensis extraction volatile oil, and Cortex Moutan extracts paeonol, and aqueous solution after the distillation and medicinal residues device are in addition collected; The volatile oil of said extracted, paeonol merge, and use the beta-schardinger dextrin-inclusion; Seven flavors such as Radix Bupleuri decoct with water secondary, add 14 times of amounts of water for the first time, decoct 2 hours; After for the second time adding above-mentioned medicinal residues, add 14 times of amounts of water, decocted 1 hour, collecting decoction filters.Filtrate and above-mentioned aqueous solution merge, and are concentrated into relative density 1.12～1.14 (60 ℃) clear paste; Be spray dried to dry extract; Get dry extract and add dextrin, beta-cyclo dextrin included compound etc., mixing, dry method is made granule, and drying is made granule.
Embodiment 5
Radix Bupleuri 100g Radix Paeoniae Alba 200g Radix Angelicae Sinensis 100g Rhizoma Cyperi 100g Cortex Moutan 150g Fructus Gardeniae 150g
Flos Rosae Rugosae 150g Fructus Hordei Germinatus 1000g Herba Ecliptae 100g Fructus Ligustri Lucidi 100g
Described dosage form is a granule, and the processing step of preparation method is as follows:
Ten flavor medical materials in the prescription are got Rhizoma Cyperi, Radix Angelicae Sinensis extraction volatile oil, and Cortex Moutan extracts paeonol, and aqueous solution after the distillation and medicinal residues device are in addition collected; The volatile oil of said extracted, paeonol merge, and use the alpha-cyclodextrin inclusion; Seven flavors such as Radix Bupleuri decoct with water secondary, add 12 times of amounts of water for the first time, decoct 2 hours; After for the second time adding above-mentioned medicinal residues, add 12 times of amounts of water, decocted 1 hour, collecting decoction filters.Filtrate and above-mentioned aqueous solution merge, and are concentrated into relative density 1.10～1.18 (60 ℃) clear paste; 80 ℃ are dried to dry extract; Get dry extract and add dextrin, alpha-cyclodextrin inclusion complex etc., mixing, wet method is made granule, and drying is made granule.
Embodiment 6
Radix Bupleuri 100g Radix Paeoniae Alba 200g Radix Angelicae Sinensis 100g Rhizoma Cyperi 100g Cortex Moutan 150g Fructus Gardeniae 150g
Flos Rosae Rugosae 150g Fructus Hordei Germinatus 1000g Herba Ecliptae 100g Fructus Ligustri Lucidi 100g
Described dosage form is a granule, and the processing step of preparation method is as follows:
Ten flavor medical materials in the prescription are got Rhizoma Cyperi, Radix Angelicae Sinensis extraction volatile oil, and Cortex Moutan extracts paeonol, and aqueous solution after the distillation and medicinal residues device are in addition collected; The volatile oil of said extracted, paeonol merge, and use the beta-schardinger dextrin-inclusion; Seven flavors such as Radix Bupleuri decoct with water secondary, add 12 times of amounts of water for the first time, decoct 2 hours; After for the second time adding above-mentioned medicinal residues, add 12 times of amounts of water, decocted 1 hour, collecting decoction filters.Filtrate and above-mentioned aqueous solution merge, and are concentrated into relative density 1.10～1.18 (60 ℃) clear paste; Vacuum drying becomes dry extract; Get dry extract and add dextrin, beta-cyclo dextrin included compound etc., mixing, dry method is made granule, and drying is made granule.
Embodiment 7
Radix Bupleuri 100g Radix Paeoniae Alba 200g Radix Angelicae Sinensis 100g Rhizoma Cyperi 100g Cortex Moutan 150g Fructus Gardeniae 150g
Flos Rosae Rugosae 150g Fructus Hordei Germinatus 1000g Herba Ecliptae 100g Fructus Ligustri Lucidi 100g
Described dosage form is a granule, and the processing step of preparation method is as follows:
Ten flavor medical materials in the prescription are got Rhizoma Cyperi, Radix Angelicae Sinensis extraction volatile oil, and Cortex Moutan extracts paeonol, and aqueous solution after the distillation and medicinal residues device are in addition collected; The volatile oil of said extracted, paeonol merge, and use the beta-schardinger dextrin-inclusion; Seven flavors such as Radix Bupleuri decoct with water secondary, add 12 times of amounts of water for the first time, decoct 2 hours; After for the second time adding above-mentioned medicinal residues, add 12 times of amounts of water, decocted 1 hour, collecting decoction filters.Filtrate and above-mentioned aqueous solution merge, and are concentrated into relative density 1.10～1.18 (60 ℃) clear paste; Be spray dried to dry extract; Get dry extract and add dextrin, beta-cyclo dextrin included compound etc., mixing, dry method is made granule, and drying is made granule.
Embodiment 8
Radix Bupleuri 500g Radix Paeoniae Alba 400g Radix Angelicae Sinensis 500g Rhizoma Cyperi 500g Cortex Moutan 600g Fructus Gardeniae 600g
Flos Rosae Rugosae 600g Fructus Hordei Germinatus 3000g Herba Ecliptae 500g Fructus Ligustri Lucidi 500g
Described dosage form is a granule, and the processing step of preparation method is as follows:
Ten flavor medical materials in the prescription are got Rhizoma Cyperi, Radix Angelicae Sinensis extraction volatile oil, and Cortex Moutan extracts paeonol, and aqueous solution after the distillation and medicinal residues device are in addition collected; The volatile oil of said extracted, paeonol merge, and use the hydroxypropyl cyclodextrin inclusion; Seven flavors such as Radix Bupleuri decoct with water secondary, add 12 times of amounts of water for the first time, decoct 2 hours; After for the second time adding above-mentioned medicinal residues, add 10 times of amounts of water, decocted 1 hour, collecting decoction filters.Filtrate and above-mentioned aqueous solution merge, and are concentrated into relative density 1.12～1.20 (60 ℃) clear paste; Vacuum drying becomes dry extract; Get dry extract and add dextrin, hydroxypropyl cyclodextrin inclusion complex etc., mixing, wet method is made granule, and drying is made granule.
Embodiment 9
Radix Bupleuri 500g Radix Paeoniae Alba 400g Radix Angelicae Sinensis 500g Rhizoma Cyperi 500g Cortex Moutan 600g Fructus Gardeniae 600g
Flos Rosae Rugosae 600g Fructus Hordei Germinatus 3000g Herba Ecliptae 500g Fructus Ligustri Lucidi 500g
Described dosage form is a granule, and the processing step of preparation method is as follows:
Ten flavor medical materials in the prescription are got Rhizoma Cyperi, Radix Angelicae Sinensis extraction volatile oil, and Cortex Moutan extracts paeonol, and aqueous solution after the distillation and medicinal residues device are in addition collected; The volatile oil of said extracted, paeonol merge, and use the hydroxypropyl cyclodextrin inclusion; Seven flavors such as Radix Bupleuri decoct with water secondary, add 12 times of amounts of water for the first time, decoct 2 hours; After for the second time adding above-mentioned medicinal residues, add 10 times of amounts of water, decocted 1 hour, collecting decoction filters.Filtrate and above-mentioned aqueous solution merge, and are concentrated into relative density 1.12～1.16 (60 ℃) clear paste; Be spray dried to dry extract; Get dry extract and add dextrin, hydroxypropyl cyclodextrin inclusion complex etc., mixing, dry method is made granule, and drying is made granule.
Embodiment 10
Radix Bupleuri 500g Radix Paeoniae Alba 400g Radix Angelicae Sinensis 500g Rhizoma Cyperi 500g Cortex Moutan 600g Fructus Gardeniae 600g
Flos Rosae Rugosae 600g Fructus Hordei Germinatus 3000g Herba Ecliptae 500g Fructus Ligustri Lucidi 500g
Described dosage form is a granule, and the processing step of preparation method is as follows:
Ten flavor medical materials in the prescription are got Rhizoma Cyperi, Radix Angelicae Sinensis extraction volatile oil, and Cortex Moutan extracts paeonol, and aqueous solution after the distillation and medicinal residues device are in addition collected; The volatile oil of said extracted, paeonol merge, and use the beta-schardinger dextrin-inclusion; Seven flavors such as Radix Bupleuri decoct with water secondary, add 12 times of amounts of water for the first time, decoct 2 hours; After for the second time adding above-mentioned medicinal residues, add 10 times of amounts of water, decocted 1 hour, collecting decoction filters.Filtrate and above-mentioned aqueous solution merge, and are concentrated into relative density 1.12～1.14 (60 ℃) clear paste; Be spray dried to dry extract; Get dry extract and add dextrin, beta-cyclo dextrin included compound etc., mixing, dry method is made granule, and drying is made granule.
The present invention is therapeutic effect and the safety that proves this medicine in development process, pharmacodynamics, toxicology and the clinicing aspect of this medicinal granule carried out experimentation, and its result of study is as follows:
Pharmacodynamic study
Through granule of the present invention is carried out pharmacodynamics test, method and result are as follows:
1. granule is to the effect of hyperprolactinemia rat model
Get 40 female rats, give sulpiride 20mg/kg ip, continuous 21 days, cause the hyperprolactinemia model, other gets female rats as normal group, gives isometric(al) aseptic parenteral solution water.Modeling success back animal is cut tail and gets blood RIA fever survey levels of serum PRL level, the modeling animal is divided into five groups immediately by the levels of serum PRL level, be basic, normal, high group of model group, granule, bromocriptine group, give solvent respectively, granule 1.5,3.0,6.0g/kg, bromocriptine 1.0mg/kg, administration volume 20ml/kg, successive administration 18 days.After the last administration 24 hours, each treated animal of Jiang was got blood RIA method and is surveyed levels of serum PRL, E
2, the P level.Get ovary, uterus, accurately weighing, the record organ weights, and calculate organ coefficient.The long approximately 2cm in clip rats with left uterus puts into the culture dish that contains low calcium Rockwell liquid immediately in addition, removes residual connective tissue and fat.The ligation of vagina end also is fixed on the little hook of L shaped breather that fills low calcium Rockwell liquid sulculus, and the other end links to each other with the muscular tension transducer, and water bath with thermostatic control maintains the temperature at 37 ℃ ± 0.5 ℃, and constantly feeds O in nutritional solution
2(60 bubble per minutes).Adjust specimen and make it vertical hanging in bath, specimen gives the load of 2.0g, balance 30min.Lead physiograph with muscular tension transducer input four, through A/D transition card, contraction situation when showing in real time that with LLS-2 type physiological signal acquisition system writes down 10,20,30,45,60 minutes of specimen, frequency acquisition is 10HZ then, and calibration voltage is 1v/g.The result shows that rat gives sulpiride 20mg/kg ip after continuous 21 days, and the serum prolactin level obviously raises, and each group more all has significant difference (P＜0.01) with normal group, confirms hyperprolactinemia model modeling success.Administration is all obviously reductions of each administration group levels of serum PRL after 18 days, compare P＜0.05 or P＜0.05 with model group; The safe granule 3.0 of woman, 6.0g/kg combination bromocriptine group are to serum E
2With P obvious effect is arranged also, significant difference is arranged with model group.
In addition, relatively organ weights (ovary+uterus), organ coefficient (ovary+uterus) all obviously descend for model group and normal group; Each administration group and model group comparison organ weights, organ coefficient all have the trend of increasing, and wherein granule 6.0g/kg organizes organ weights, and granule group 3.0,6.0g/kg group and bromocriptine group organ coefficient have significant difference (P＜0.05 or 0.01).
Compare with normal group, model group uterine smooth muscle shrinkage amplitude, frequency and contractility all reduce.Compare with model group, granule 3.0,6.0g/kg group and bromocriptine group can make rat model uterine smooth muscle shrinkage amplitude, contractility improve (P＜0.05), but the granule group does not have obvious influence (P＞0.05) to rat model uterine smooth muscle contraction frequency
2. to the effect of liver depression mice due to the carbon tetrachloride
Get 90 of mices, body weight 25-30g filters out 70 of the qualified mices in analgesic test, is divided into normal group, model group, the basic, normal, high dosage group of granule, stable group, aspirin group at random, 10 every group.Except that the normal group animal, each treated animal gives carbon tetrachloride-twice of Oleum Arachidis hypogaeae semen emulsion 1000mg/kg subcutaneous injection (the 1st, 6 day respectively once) respectively
[3]Liver depression marquis such as the visible movable increase of animal pattern, weight loss, threshold of pain reduction, irritability after the modeling.Each administration group gives the safe granule 2.5,5.0 of woman, 10g/kg, stable 1mg/kg, aspirin 200mg/kg respectively after the modeling, administration volume 30ml/kg, and be administered once every day, and observe the analgesic activity of medicine with hot plate method.The result shows that model group mice weight increase delays, and granule group 2.5-10g/kg has the improvement effect to this.
The normal spontaneous activity in mice showed increased of carbon tetrachloride liver depression mice, threshold of pain level obviously descends.Above-mentioned symptoms such as each dosage group of granule have obvious therapeutic action, compare with model group, and granule 10,5.0g/kg organize the spontaneous activity in mice number of times, all there were significant differences to the mice pain reaction time for the 2.5-10g/kg group.
Conclusion
1. female rats gives sulpiride 20mg/kg ip and can cause the plain mass formed by blood stasis model of highly dense breast after continuous 21 days.The modeling medicine of selective dopamine receptor blocking agent sulpiride as the hyperprolactinemia animal model adopted in this test, makes animal blood PRL raise E
2, P descends.
2. granule 1.5-6.0g/kg ig after 18 days hyperprolactinemia rat blood serum PRL obviously reduce, granule 3.06.0g/kg is to serum E
2, indexs such as P and (ovary+uterus) organ coefficient, organ weights also have obvious effect.
3. granule 6.0g/kg ig can improve hyperprolactinemia rat uterus shrinkage amplitude, contractility in 18 days.
4. granule 2.5-10g/kg ig 18 days increases the effects of having clear improvement such as number of times, the threshold of pain descend, body weight gain is slow to the activity of carbon tetrachloride liver gloomy mice.
Acute toxicity test
Through granule acute toxicity test of the present invention is shown, get 40 of Kunming mouses, be divided into 2 groups at random by body weight: granule group (0.37g/ml) and matched group (distilled water), 0.4ml/10g body weight gastric infusion is pressed in fasting after 12 hours, three times on the one, observed 14 days behind the medicine, none death of mice, the main organs no abnormality seen, the maximum tolerated dose that shows this product mice gastric infusion on the one is 44.4g/kg, and the clinical plan dosage of this product is 30g/ day, in body weight for humans 60kg, average dosage is 0.5g/kg, calculates that thus this medicine mouse stomach administration maximum tolerated dose is 88.8 times of clinical people's consumption per day.
Conclusion: spontaneous activity had both appearred in mice behind the granule group gastric infusion slightly increases, the basic recovery normally behind the 0.5h, and administration visible brown soft stool on the same day recovered in second day.Observe the 14d animal continuously and do not see that other is obviously unusual, execution in the 14th day is also cutd open inspection part mice, perusal main organs no abnormality seen.Therefore, the maximum tolerated dose of granule group filling stomach mice is 44.4g/kg (being calculated as 240g/kg with crude drug).
The rat long term toxicity test
Show through long term toxicity test the continuous i.g.13 of granule of the present invention week rat, get 80 of Healthy female Wistar rats, be divided into matched group at random by body weight, granule group low (3.7g/kg/d), in (7.4g/kg/d), high (14.8g/kg/d) dosage group, continuous 13 weeks of i.g. administration, every day 8:00,16:00 difference administration 1 time, administration 7d weekly, outward appearance and the general behavior of observing animal every day change, and in 13 weeks of administration and each treated animal routine urinalysis of drug withdrawal 2 week detection, routine blood test and serum biochemistry index are surveyed in the ventral aorta blood sampling, at last animal are cutd open inspection and taking internal organ and are carried out histopathological examination.
Conclusion: 1. granule group 3.7,7.4g/kg/d, continuously i.g.13 week, every indexs such as animal general behavior, body weight gain, routine urianlysis, hematology, serum biochemistry and histopathologic examination are all no abnormal.2. granule group 14.8g/kg, i.g.13 week continuously, after the animal drugs 4 weeks only visible hair dimness, recover normal after the drug withdrawal, every indexs such as general behavior, body weight gain, routine urianlysis, hematology, serum biochemistry, histopathologic examination are all no abnormal.3. this is tested high, medium and low dosage and is respectively clinical anthropomorphic 29.6,14.8,7.4 times of using dosage, and the clinical practice of prompting this product is safe.
The clinical verification test
Randomized, double-blind is adopted in granule clinical trial of the present invention, placebo, the optimal efficiency EXPERIMENTAL DESIGN, result of the test shows, its traditional Chinese medical science disease clinical trial group cure rate 9.65%, obvious effective rate 34.21%, recovery from illness and obvious effective rate 43.86%, matched group cure rate 0.%, obvious effective rate 8.33%, recovery from illness and obvious effective rate 8.33%, test group recovery from illness and obvious effective rate are apparently higher than matched group, prolactin level before test group and the treatment of control group, through the t check, group difference not statistically significant (P＞0.05) is after treatment, difference before prolactin antagonist is treated the back and treated, test group is 12.115 ± 22.853, and matched group is 8.471 ± 15.808, shows that medication the 8th all test group prolactin antagonist falls are greater than matched group.
The result shows, main clinic symptoms such as granule of the present invention obviously improves distending pain in the chest and hypochondrium, susceptible to lose temper due to restlessness, galactorrhea that hyperprolactinemia causes, have a dizzy spell, and can reduce the prolactin antagonist index, no serious adverse events takes place in the process of the test, is worth clinical expansion to use.
Claims (9)
1. Chinese medicine medicine that is used for the treatment of hyperprolactinemia is characterized in that it is made up of Radix Bupleuri, the Radix Paeoniae Alba, Radix Angelicae Sinensis, Rhizoma Cyperi, Cortex Moutan, Fructus Gardeniae, Flos Rosae Rugosae, Fructus Hordei Germinatus, Herba Ecliptae, Fructus Ligustri Lucidi 10 flavor raw materials.
2. Chinese medicine medicine according to claim 1 is characterized by described pharmaceutical forms of administration and is in capsule, tablet, the granule any one.
3. according to claim 1 and 2 described a kind of medicines that are used for the treatment of hyperprolactinemia, it is characterized in that it is the medicine of dosage form under the pharmaceutics of being made by the following weight proportion raw material:
Radix Bupleuri 1～7 Radix Paeoniae Alba 2～10 Radix Angelicae Sinensis 1～7 Rhizoma Cyperi 1～7 Cortex Moutan 1～6 Fructus Gardeniae 1～6 Flos Rosae Rugosae 1～6 Fructus Hordei Germinatus 5～40 Herba Ecliptaes 1～7 Fructus Ligustri Lucidi 1～7.
4. prepare claim 1 or 2 or the method for described medicinal granule or capsule or tablet or pill according to a kind of being exclusively used in, it is characterized in that having following processing step:
1. Rhizoma Cyperi, Radix Angelicae Sinensis extract volatile oil in the side of getting, and Cortex Moutan extracts paeonol, and aqueous solution after the distillation and medicinal residues device are in addition collected;
2. volatile oil, paeonol merge, and use cyclic dextrin clathrate;
3. seven flavors such as Radix Bupleuri decoct with water secondary, decoct 2 hours for the first time; Add for the second time above-mentioned medicinal residues and decocted 1 hour, collecting decoction filters.Filtrate and above-mentioned aqueous solution merge, and are concentrated into clear paste;
4. step 3. the clear paste of carrying be dried to dry extract;
5. step 2. gained cyclodextrin inclusion complex, step 3. the gained extract powder add the dextrin mixing, make granule, drying is made granule or capsule or tablet.
5. according to the method for the described medicinal granule of claim 5 or capsule or tablet or pill, it is characterized in that the used cyclodextrin of inclusion is alpha-cyclodextrin or beta-schardinger dextrin-or hydroxypropyl cyclodextrin.
6. according to the method for the described medicinal granule of claim 5 or capsule or tablet or pill, amount of water is 6～20 times when it is characterized in that extracting at every turn.
7. according to the method for the described medicinal granule of claim 5 or capsule or tablet or pill, it is characterized in that extracting the clear paste relative density that latter incorporated aqueous solution is condensed into is 1.05～1.50.
8. according to the method for the described medicinal granule of claim 5 or capsule or tablet or pill, it is characterized in that the clear paste drying means of carrying is normal temperature drying, drying under reduced pressure, spray drying, microwave drying.
9. according to the method for the described medicinal granule of claim 5 or capsule or tablet or pill, the particulate method of the system that it is characterized in that is wet granulation, dry granulation.
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Cited By (7)
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| CN103877502A (en) * | 2014-03-22 | 2014-06-25 | 李双双 | Traditional Chinese medicine composition for treating hyperpro-lactinemia |
| CN104547579A (en) * | 2015-01-05 | 2015-04-29 | 赵秀芬 | Medicine composition for treating hyperprolactinemia infertility and application of medicine composition |
| CN105232890A (en) * | 2015-10-13 | 2016-01-13 | 林庆华 | Traditional Chinese medicine preparation for treating hyperprolactinemia and nursing method |
| CN105709125A (en) * | 2016-04-22 | 2016-06-29 | 刘英晓 | Traditional Chinese medicine decoction for auxiliary treatment of hyperprolactinemia |
| CN109420088A (en) * | 2017-08-25 | 2019-03-05 | 王停 | A kind of Chinese medicinal formulae for hyperprolactinemia conditioning |
| CN112717084A (en) * | 2021-02-25 | 2021-04-30 | 江西中医药大学 | Traditional Chinese medicine composition for treating hyperprolactinemia, preparation method and application |
| WO2023005130A1 (en) * | 2021-07-26 | 2023-02-02 | 安徽医科大学 | Traditional chinese medicine composition for treating infertility, and preparation method therefor and application thereof |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103877502A (en) * | 2014-03-22 | 2014-06-25 | 李双双 | Traditional Chinese medicine composition for treating hyperpro-lactinemia |
| CN104547579A (en) * | 2015-01-05 | 2015-04-29 | 赵秀芬 | Medicine composition for treating hyperprolactinemia infertility and application of medicine composition |
| CN105232890A (en) * | 2015-10-13 | 2016-01-13 | 林庆华 | Traditional Chinese medicine preparation for treating hyperprolactinemia and nursing method |
| CN105709125A (en) * | 2016-04-22 | 2016-06-29 | 刘英晓 | Traditional Chinese medicine decoction for auxiliary treatment of hyperprolactinemia |
| CN109420088A (en) * | 2017-08-25 | 2019-03-05 | 王停 | A kind of Chinese medicinal formulae for hyperprolactinemia conditioning |
| CN112717084A (en) * | 2021-02-25 | 2021-04-30 | 江西中医药大学 | Traditional Chinese medicine composition for treating hyperprolactinemia, preparation method and application |
| WO2023005130A1 (en) * | 2021-07-26 | 2023-02-02 | 安徽医科大学 | Traditional chinese medicine composition for treating infertility, and preparation method therefor and application thereof |
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