CN101972368B - Process for preparing chrysanthemum pressure-reducing granules - Google Patents
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Abstract
The invention discloses a process for preparing chrysanthemum pressure-reducing granules. The granules comprise 500 grams of hawthorn, 83.3 grams of chrysanthemum, 62.5 grams of oriental waterplantain rhizome (salted), 62.5 grams of self-heal, 83.3 grams of common cephalanoplos herb and 83.3 grams of cassia seed (sauted). The process comprises the following steps of: crushing oriental waterplantain rhizome into fine powder, and decocting the rest five gouts such as the hawthorn and the like twice by adding water, wherein 10 times of water is added every time, the first decocting time is 3 hours and the second decocting time is 2 hours; and combining and filtering the decoction, concentrating the filtrate with reduced pressure to obtain thick paste with relative density of 1.30 to 1.40 (50DEG C), adding the oriental waterplantain rhizome fine powder into the thick paste, blending the thick paste and the fine powder uniformly, drying the mixture in vacuum, crushing the mixture, screening the crushed mixture, adding a proper amount of dextrin and cane sugar to prepare granules, and drying the granules to obtain 1,000 grams of granules; or adding a proper amount of dextrin to prepare granules, and drying the granules to obtain 600 grams of granules /(cane sugar is not added). The chrysanthemum pressure-reducing granules are used for treating high blood pressure.
Description
Technical field the present invention relates to the particulate preparation technology of a kind of mountain chrysanthemum blood pressure lowering.
The prevalence of background technology hypertension and sickness rate have difference between different countries, area or race, industrialized country is high than developing country; The sickness rate of hypertension and blood pressure level raise with the age increase, and hypertension is more common at elderly population.The traditional Chinese medical herbal treatment hypertension is bringing high blood pressure down, relief of symptoms, is preventing and treating unique effect is arranged aspect the complication.
Summary of the invention the objective of the invention is: provide a kind of mountain chrysanthemum blood pressure lowering particulate preparation technology.
Technical scheme of the present invention is following:
1. these article prescription as follows: Fructus Crataegi 500g Flos Chrysanthemi 83.3g Rhizoma Alismatis (processed with salt) 62.5g Spica Prunellae 62.5g Herba Cirsii 83.3g Semen Cassiae (stir-fry) 83.3g
2. method for making: above Six-element, Rhizoma Alismatis powder is broken into fine powder, and five tastes decocte with water secondaries such as all the other Fructus Crataegis add 10 times of water gagings at every turn, 3 hours for the first time; 2 hours for the second time, collecting decoction filtered, and filtrate decompression is concentrated into the thick paste that relative density is 1.30～1.40 (50 ℃), adds the Rhizoma Alismatis fine powder; Mixing, vacuum drying is pulverized, and sieves; Add an amount of dextrin and sucrose, process granule, drying is processed 1000g; Or add an amount of dextrin, and process granule, drying is processed 600g (not adding cane sugar type), promptly gets.
3. these article specification is every packed 5g (containing cane sugar type); Every packed 3g (not adding cane sugar type).
These article by Fructus Crataegi, Flos Chrysanthemi, Rhizoma Alismatis (processed with salt), Spica Prunellae, Herba Cirsii, Semen Cassiae (stir-fry) through extract, pulverize, sterilization, dry, granulate, always mix, operation is refining forms for packing etc.The existing elaboration as follows:
4.1 pre-treating technology
Concentrate 4.1.1 extract: take by weighing medical material by times expansions such as recipe quantities, add 10 times of water gagings and soaked 2 hours, extract 2 times, 3 hours for the first time, 2 hours for the second time, medicinal liquid separated employing industrial filter cloth (200 order) with medicinal residues, the normal pressure filtration.Adopt concentrating under reduced pressure, pressure be-0.08Mpa, the temperature when concentrated is by being controlled at 60～70 ℃, and it is 1.3～1.4 (50 ± 1 ℃) that thick paste is concentrated into relative density.
4.1.2 pulverize: adopt the ZZKF-3-400 automatic control to pulverize unit and pulverize, the pulverizer sieve number is 120 orders, and the medicated powder fineness is 100 orders, moisture≤5.0%; Medicated powder receipts degree>=90.0%.
4.1.3 mix the cream drying: drying was carried out in the bed board decompression after these article thick paste and Rhizoma Alismatis fine powder adopted and mix cream; Investigate through different-thickness, different temperatures being carried out drying, find that the best bed board thickness of these article is 2cm, adopt to be lower than the extraction temperature; Baking temperature is 70～80 ℃, and pressure is-0.06～0.08Mpa.
4.1.4 sterilization: the dried cream powder to after pulverizing adopts the Co60 irradiation sterilization, and irradiation intensity meets the provisions of the relevant regulations issued by the State.
4.1.5 total mixing: the granule behind the granulate is placed in the three-dimensional motion mixer, and mixing rotating speed is 4～6 rev/mins, and incorporation time is 30 minutes.The granule place that takes a sample to check sees, measures moisture content and yield.
4.2 granule preparing process
4.2.1 the supplementary material ratio is following
Add cane sugar type: dried cream: sucrose: dextrin is 1: 1.3: 1.3
Do not add cane sugar type: dried cream: dextrin is 1: 1.1
4.2.2 the preparation of soft material: get extract powder and dextrin, cane sugar powder are put in the homogenizer and mixed by prescription, add 60% ethanol, stir and processed soft material in 5 minutes
4.2.3 preparation of granules: the soft material of processing is transferred in the 14 order nylon screen granulator processes granule; Wet granular is placed in the GFG-120 type HighefficientFluidbeddrier, and baking temperature is controlled at 80 ℃～100 ℃, dry 10 minutes; Moisture content is controlled at 4%～7%; Remove coarse grain through 12 mesh sieves again, after 16 mesh sieves remove the fine powder granulate, promptly get.
4.2.4 be distributed into bag: use B.DZ.F-30A granule racking machine to carry out packing, separate-loading packaging according to specified specification: 30～50 bags/minute, plastic packaging temperature: 150 ℃.
4.2.5 finished product: the packing that branch installs is packed large, carry out outer package by every box-packed 10 bags standard.
4.3 the formulation of quality standard: for controlling this quality better; Formulated these article end product quality standard; This substandard increases than tablet; On original basis, having increased is the thin layer discrimination method of the Spica Prunellae of reference substance with the ursolic acid, is that reference substance, Herba Cirsii are the thin layer discrimination method of the Herba Cirsii of control medicinal material with the rutin.With reference to the tablet standard set up the Rhizoma Alismatis medical material microscopical identification master method, to have set up with emodin, chrysophanol be the thin layer discrimination method of the Semen Cassiae of reference substance; Adopt HPLC to formulate the assay method that contains of these article; These article contain Semen Cassiae in chrysophanol for every bag, must not be lower than 0.20mg.
4.4 investigate through long-term and accelerated stability, this quality is controlled, stable, safety.
Beneficial effect of the present invention: be tablet on the chrysanthemum blood pressure lowering market, mountain, these article are developed successfully, and granule reduces processing step, shortens the production cycle, increased new dosage form, are convenient to the many-sided selection of patient medication.These article are divided into and contain cane sugar type and do not add two kinds of specifications of cane sugar type, and it is sweet to add the cane sugar type flavor, liked by the patient, do not add the cane sugar type dose and reduce, and greatly facilitate the patient and provide convenience for the crowd of diabetics and impaired glucose tolerance.
Motherland's medical science " Linzheng Zhinan Yi, dizzy door, Hua Xiuyun by " is said: " fall string through all wind of cloud, all belong to liver, head is that ear, order, mouth, nose all are the key that empties at first of the sun, suffer from dizzy person, non-external heresy ... ".Hypertension is pressed the dizzy category of the many genus of Chinese medical discrimination, and modal clinically syndrome is a syndrome of upper hyperactivity of liver yang.Hypertension, particularly essential hypertension, its morbidity is no doubt relevant with natural endowment, but posteriori living habit, living environment and environmental stimuli etc., to primary disease bring out with the state of an illness increase the weight of to have contact closely.The pathogenesis key of primary disease is the cloudy potential deficiency of plain body Liver and kidney, and long-term in addition seven emotions are crossed usefulness, overaction of the five emotions, and consumption is hindered healthy energy, and infringement is unit very.Irritability stasis with the passing of time, the kidney failing to nourish the liver that is bound to, the YIN pathogen fire of fainting is in unison and is risen, on disturb key clearly, the mistakes degree that goes up and down, headache, dizzy, tinnitus, fidgety, cardiopalmus, insomnia are grown thickly at disease.Or chronic deficiency of kidney-YIN, can not nourishing the liver, so that deficiecny of liver-YIN, excessive rising of liver-YANG is dizzy.These article suppressing the hyperactive liver and subsiding YANG can improve symptom rapidly, bring high blood pressure down, and curative effect is sure.Hawthorn digesting spleen invigorating in the side, circulation of qi promoting dissipating blood stasis; The heat clearing away of chrysanthemum powder forimproving wind, suppressing the hyperactive liver make eye bright.Be used to have a headache dizzy, conjunctival congestion and swelling pain, eyes is dim-sighted; Rhizoma Alismatis (processed with salt) diuresis, clearing away damp-heat.Be used for dysuria, edema overflow, dizziness due to fluid-retention hyperlipidemia; Spica Prunellae relieves inflammation or internal heat, makes eye bright, is used to have a headache dizzy; Herba Cirsii cooling blood for hemostasis, eliminating phlegm for diminishing swelling are used to treat hypertension; Semen Cassiae (stir-fry) clearing away heat to improve acuity of vision is used for conjunctival congestion, puckery pain, dizzy, the poor vision of headache.More than all flavors share, the effect of common suppressing the hyperactive liver and subsiding YANG is used for that headache due to the hyperactivity of YANG due to deficiency of YIN is dizzy, tinnitus is forgetful, waist knee joint epidemic disease is soft, dysphoria with feverish sensation in the chest palms and soles, palpitation and insomnia; Hypertension is seen above-mentioned patient.
These article are evident in efficacy for treatment liver-Yang sthenia type hypertension, disease such as dizzy, existing clinical data summed up as follows:
1. treatment essential hypertension: 70 routine primary hypertension patients are divided into observation group and matched group at random in 1: 1 ratio, take mountain chrysanthemum blood pressure lowering granule and Bezoar pill for lowering blood pressure treatment 28d respectively.Result: observation group's blood pressure lowering produce effects 20 examples, effective 11 examples; Total effective rate 88.56%; Be superior to matched group (produce effects 6 examples, effective 17 examples, total effective 65.72%, P＜0.05); And can improve symptom, blood fat reducing, improve blood viscosity and ischemic electrocardiogram, and safe and reliable, no obvious adverse reaction.It is thus clear that treatment essential hypertension curative effect is obvious.
2. treatment cervical vertigo: use these article and cooperate cervical vertebrae traction liver-Yang sthenia type cervical vertigo, the 45 routine patients that confront treat, male 18 examples, and women 27 examples, 30～58 years old age, average 46.1 years old, the course of disease 3～12 months, the course of disease is the longest 5 years, and is the shortest 3 days.Add up after treating 2 courses of treatment, 16 examples are cured (dizzy disappearance, other transference cures or obviously alleviate); 15 routine produce effects (symptom such as dizzy obviously alleviates, little have murky sense); 11 examples are (dizzy etc. symptom alleviate to some extent) effectively; 3 examples invalid (symptom does not have change or increases the weight of), total effective rate 93.33%.
3. treat the liver-Yang sthenia type angioneurotic headache: the liver-Yang sthenia type angioneurotic headache is treated, after 1～2 course of treatment, reach 14 examples of clinical recovery, 28 examples of produce effects, effective 11 examples, invalid 9 examples.Effective percentage 85.5%.The model case Wang, the man, 63 years old, the teacher, readme headache is difficult to stand, and the clothes pain relief behind the pain medicine of dispelling influences work and study.Health check-up, blood pressure, cardio-pulmonary function is normal, no cervical vertebra medical history.The traditional Chinese medical science four diagnostic methods: headache, have sometimes dizzy, flushing conjunctival congestion, irritated irritability, bitter taste in the mouth and dry throat, white, the red tongue of tongue, stringy,thready and rapid pulse.Diagnosis: headache of the liver yang hyperactivity type.With 10 doses of mountain chrysanthemum blood pressure lowering granule clothes, the readme alleviation of pain continues to take 15 doses of recoveries from illness.Follow up a case by regular visits to and do not send out in 1 year.
4. treat the type of deficiency of YIN leading to hyper activity of YANG hypertension: 61 routine outpatients are observed, and the treatment group adopts mountain chrysanthemum blood pressure lowering granule associating Betaloc treatment type of deficiency of YIN leading to hyper activity of YANG hypertension, and the matched group list is treated with Betaloc.Result: efficacy of antihypertensive treatment: treatment group produce effects 16 examples, effective 12 examples, invalid 3 examples, total effective rate 90.32%.Matched group produce effects 11 examples, effective 10 examples, invalid 9 examples, total effective rate 70.00%.Two groups of blood pressure lowering total effective rates compare, and the treatment group is superior to matched group (P＜0.05).Improve the clinical symptoms curative effect: treatment group produce effects 15 examples, effective 14 examples, invalid 2 examples, total effective rate 93.55%.Matched group produce effects 7 examples, effective 2 examples, invalid 11 examples, total effective rate 63.33%.Two groups of clinical symptoms total effective rates compare, and the treatment group obviously is superior to matched group (P＜0.01).
5. treatment migraine: 90 routine out-patients are observed, and the treatment group adopts mountain chrysanthemum blood pressure lowering granule therapy, and matched group adopts XIBILING JIAONANG.Therapeutic outcome: treatment group 13 examples of fully recovering, 25 examples that take a turn for the better, invalid 7 examples, total effective rate 84.4%; Matched group 5 examples of fully recovering, 18 examples that take a turn for the better, invalid 22 examples, total effective rate 51.1%.The treatment group obviously is superior to matched group P＜0.05.
6. treat dizzy: adopt dizzy card 30 examples of mountain chrysanthemum blood pressure lowering granule therapy liver-Yang sthenia type, cure 12 examples, produce effects 8 examples, effective 9 examples, invalid 1 example, total effective rate 96.7%.Model case, the Wang, woman 41 years old, on August 22nd, 2008 examined, irascible temperament usually, job insecurity in recent years in addition, so the unsuccessful distending pain in the head of feelings will, very then dizzy servant accompanied tinnitus, dreaminess, is insomnia, desires, thin fur matter is red, stringy pulse.Card belongs to excessive rising of liver-YANG, controls with suppressing the hyperactive liver and subsiding YANG, and after one week, symptom obviously alleviates with mountain chrysanthemum blood pressure lowering granule, continues to use for two weeks, follows up a case by regular visits to and does not see recurrence in 3 months.
In sum, dizzy, all disease curative effect produce effects of hypertension of these article treatment.
Description of drawings Fig. 1 process chart.
The specific embodiment is the feasibility that specifies this technology; Amplifying 200 times by above recipe quantity produces; Be Fructus Crataegi 10kg, Flos Chrysanthemi 16.66kg, Rhizoma Alismatis (processed with salt) 12.5kg, Spica Prunellae 12.5kg, Herba Cirsii 16.66kg, Semen Cassiae (stir-fry) 16.66kg, produce three lot sample article respectively by above-mentioned technological requirement, its quality and preliminarily stabilised property are good; Explain that this technology advanced person is reasonable, feasible, three batches of pilot scale data see the following form
The production detail list is amplified in pilot scale
Claims (1)
1. particulate preparation technology of mountain chrysanthemum blood pressure lowering is characterized in that:
Write out a prescription as follows: the Semen Cassiae 83.3g of the Rhizoma Alismatis 62.5g Spica Prunellae 62.5g Herba Cirsii 83.3g parch of Fructus Crataegi 500g Flos Chrysanthemi 83.3g processed with salt
Method for making:
(1) pre-treating technology: above Six-element, Rhizoma Alismatis powder is broken into fine powder, and five tastes decocting and concentrating such as all the other Fructus Crataegis become cream;
Extract and concentrate: the five tastes such as Fructus Crataegi take by weighing medical material by times expansions such as recipe quantities, add 10 times of water gagings and soak 2 hours, extract 2 times, and 3 hours for the first time, 2 hours for the second time, medicinal liquid separated employing industrial filter cloth 200 orders, normal pressure filtration with medicinal residues; Adopt concentrating under reduced pressure, pressure be-0.08Mpa, the temperature when concentrated is by being controlled at 60～70 ℃, and the relative density when thick paste is concentrated into 50 ± 1 ℃ is 1.3～1.4;
Pulverize: Rhizoma Alismatis is adopted the ZZKF-3-400 automatic control to pulverize unit and pulverizes, and the pulverizer sieve number is 120 orders, and the medicated powder fineness is 100 orders, moisture≤5.0%; Medicated powder receipts degree>=90.0%;
Mix the cream drying: drying was carried out in the bed board decompression after these article thick paste and Rhizoma Alismatis fine powder adopted and mix cream, and bed board thickness is 2cm, adopts to be lower than the extraction temperature, and baking temperature is 70～80 ℃, and pressure is-0.06～0.08Mpa:;
Sterilization: the dried cream powder to after pulverizing adopts the Co60 irradiation sterilization;
Total mixing: the granule behind the granulate is placed in the three-dimensional motion mixer, and mixing rotating speed is 4～6 rev/mins, and incorporation time is 30 minutes; The granule place that takes a sample to check sees, measures moisture and yield;
(2) granule preparing process
The supplementary material ratio:
Add cane sugar type: dried cream: sucrose: dextrin is 1: 1.3: 1.3
Do not add cane sugar type: dried cream: dextrin is 1: 1.1
The preparation of soft material: get extract powder and dextrin, cane sugar powder are put in the homogenizer and mixed by prescription, add 60% ethanol, stir and processed soft material in 5 minutes;
Preparation of granules: the soft material of processing is transferred in the 14 order nylon screen granulator processes granule; Wet granular is inserted in the GFG-120 type HighefficientFluidbeddrier, and baking temperature is controlled at 80 ℃～100 ℃, dry 10 minutes; Moisture Control is 4%～7%; Remove coarse grain through 12 mesh sieves again, after 16 mesh sieves remove the fine powder granulate, promptly get;
Be distributed into bag: use B.DZ.F-30A granule racking machine to carry out packing, separate-loading packaging according to specified specification: the 30-50 bag/minute, plastic packaging temperature: 150 ℃;
Finished product: the packing that branch installs is packed large, carry out outer dress bag by every box-packed 10 bags standard.
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Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102670769A (en) * | 2011-03-18 | 2012-09-19 | 李启辉 | Tea lowering blood pressure and enabling all natural plants to serve as formula and preparation method thereof |
| CN102988635A (en) * | 2012-12-21 | 2013-03-27 | 陕西步长高新制药有限公司 | Nifedipine-containing medicinal composition |
| CN103689172A (en) * | 2013-12-21 | 2014-04-02 | 山东中大药业有限公司 | Health cassia seed tea |
| CN103908539B (en) * | 2014-05-03 | 2017-02-01 | 李全浩 | Traditional Chinese medicine composition for treating hypertension as well as preparation method and application of traditional Chinese medicine composition |
| CN104906278A (en) * | 2015-05-25 | 2015-09-16 | 重庆多普泰制药股份有限公司 | Pressure-reducing tea bag and preparing method and application thereof |
| CN108614065A (en) * | 2016-12-09 | 2018-10-02 | 内蒙古天奇中蒙制药股份有限公司 | A kind of method of quality control of mountain chrysanthemum Jiangya Granula |
| CN108967600A (en) * | 2018-10-20 | 2018-12-11 | 成都柏睿泰生物科技有限公司 | A kind of Exocarpium Citri Rubrum Iron Guanyin autumn health tea and its preparation method and application |
| CN111375013A (en) * | 2018-12-30 | 2020-07-07 | 鲁南制药集团股份有限公司 | Traditional Chinese medicine composition for treating vertigo |
| CN116808119A (en) * | 2023-03-29 | 2023-09-29 | 南京同仁堂药业有限责任公司 | Mountain chrysanthemum antihypertensive capsule and preparation method thereof |
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| CN1394635A (en) * | 2002-07-31 | 2003-02-05 | 邹洪君 | Wild chrysanthemum granules and preparation method |
| CN101816733A (en) * | 2010-05-20 | 2010-09-01 | 沈阳神龙药业有限公司 | Sugar-free hawthorn and chrysanthemum preparation and preparation method thereof |
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| CN1775253A (en) * | 2005-11-18 | 2006-05-24 | 北京阜康仁生物制药科技有限公司 | Chinese hawthorn blood-pressure-reducing preparation, and new preparing method |
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| CN1394635A (en) * | 2002-07-31 | 2003-02-05 | 邹洪君 | Wild chrysanthemum granules and preparation method |
| CN101816733A (en) * | 2010-05-20 | 2010-09-01 | 沈阳神龙药业有限公司 | Sugar-free hawthorn and chrysanthemum preparation and preparation method thereof |
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