CN108126116A - A kind of preparation process of full rhizoma gastrodiae tablet - Google Patents

A kind of preparation process of full rhizoma gastrodiae tablet Download PDF

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Publication number
CN108126116A
CN108126116A CN201611085131.XA CN201611085131A CN108126116A CN 108126116 A CN108126116 A CN 108126116A CN 201611085131 A CN201611085131 A CN 201611085131A CN 108126116 A CN108126116 A CN 108126116A
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rhizoma gastrodiae
preparation process
tablet
alcohol
powder
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CN201611085131.XA
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林凡友
聂昌盛
赵天中
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/898—Orchidaceae (Orchid family)
    • A61K36/8988—Gastrodia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/10—Preparation or pretreatment of starting material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/10—Preparation or pretreatment of starting material
    • A61K2236/15—Preparation or pretreatment of starting material involving mechanical treatment, e.g. chopping up, cutting or grinding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

Abstract

The invention belongs to drug extraction and processing technique fields, disclose a kind of preparation process of full rhizoma gastrodiae tablet, include the following steps：Step 1）Crushing and ultraviolet irradiation, step 2）Alcohol extracting and microwave, step 3）Alcohol extracting and suction filtration, step 4）Concentration and dry, step 5）Film-making.Preparation process simple possible of the present invention, the tablet good drug efficacy of preparation, reduces drug administration amount, improves bioavilability.

Description

A kind of preparation process of full rhizoma gastrodiae tablet
Technical field
The invention belongs to drug extraction and processing technique fields, and in particular to a kind of preparation process of full rhizoma gastrodiae tablet.
Background technology
Apoplexy is also cerebral apoplexy, is general designation of the traditional Chinese medicine to acute cerebrovascular diseases.It is a kind of brain blood of unexpected onset Circulation disorder.Refer to the patient in cranial vascular disease, because various risk factors cause internal artery narrow, occlusion or broken It splits, and causes acute brain blood circulation disorder, sings and symptoms of the clinical signs for transient or permanent brain disorder, It is a kind of acute illness caused by the vascular diseases of blood are conveyed to brain.Headstroke can cause cerebral tissue sudden damage It is bad, when being usually happened at the blood vessel explosion that oxygen and other nutrients are conveyed to brain or be happened at blood vessel by blood clot or When other particulate matter obstructions.If nerve cell lacks enough oxygen supplies, will be dead in a few minutes.Then, by The physical function of these nerve cells control also can be ineffective therewith.Since dead brain cell can not be replaced, brain Consequence is typically permanent caused by apoplexy.
Rhizoma Gastrodiae（Scientific name：Gastrodia elata Bl.）Also known as rhizoma gastrodiae, solely shake sesame, from it is female, close and superintended and directed from grass, god grass, ghost Postal, Mokpo, RHIZONA GASTRODIAE, wind grass, Bai Longpi etc. are orchid family Gastrodia herbaceos perennials.Root-like stock is plump, no greenery, Capsule obovate elliptic, often with stem tuber or seminal propagation.Its rhizome be used as medicine to treat apoplexy, have a dizzy spell, extremity numbness, The diseases such as child convulsion are rare Chinese medicines.Rhizoma Gastrodiae gives high evaluation in some ancient medicine documents of China.More than 2000 Before year《Sheng Nong's herbal classic》Rhizoma Gastrodiae is just classified as top grade.Modern pharmacology research show Rhizoma Gastrodiae have analgesic activity, sedation, Anticonvulsant action, improving eyesight, increases intelligence effect etc. at the effect that reduces blood pressure, clinical application indicate that Rhizoma Gastrodiae is treatment headache and dizziness, wind Effective good medicine of arthritis with fixed pain caused by dampness pain, apoplexy.Clinical practice gastrodia tuber preparation is mainly decoction and capsule at present.It is recorded in Chinese Pharmacopoeia one It has all-weather open, is made into fine powder by Rhizoma Gastrodiae is processed, medication 6 every time, the ambassador patient of dosage is difficult to connect By, and old man is difficult to swallow, in addition, gastrodia capsule, due to directly being filled using medicinal material powder, active ingredient dissolution is slow, biology profit Expenditure is low.Applicant improves drug ingedient on the basis of patent before " CN2013107102995 ", avoids taking The defects of dose is excessive, bioavailability is low.
Invention content
The defects of in order to overcome the prior art, the present invention propose a kind of preparation process of full rhizoma gastrodiae tablet, this it is simple for process can Row obtains Rhizoma Gastrodiae active ingredient to greatest extent, reduces drug administration amount, improves bioavilability.
The present invention is achieved by the following technical solution：
A kind of preparation process of full rhizoma gastrodiae tablet, includes the following steps：Step 1）Crushing and ultraviolet irradiation, step 2）Alcohol extracting and micro- Wave, step 3）Alcohol extracting and suction filtration, step 4）Concentration and dry, step 5）Film-making.
Specifically, the preparation process includes the following steps：
Step 1）Crushing and ultraviolet irradiation：Rhizoma Gastrodiae is smashed into powder, is sieved with 100 mesh sieve, is then paved into the flat bed of 5mm thickness, puts 10-15min is irradiated under ultraviolet light, then collects powder, is stirred evenly, the flat bed of 5mm thickness is then paved into again, is placed in purple 10-15min is irradiated under outside line；
Step 2）Alcohol extracting and microwave：By step 1）Gained powder adds the 70% of double weight in container（v/v）Ethyl alcohol, 300rpm stirrings are extracted, and control microwave power is 500W, extraction time 30-40min in extraction process；Collected by suction filtrate A And filter residue；
Step 3）Alcohol extracting and suction filtration：85% is added into filter residue（v/v）Ethyl alcohol, regard no filter slag as criterion, then 500rpm stir 15-30min, collected by suction liquor B；
Step 4）Concentration and drying：Filtrate A and liquor B are merged, are then concentrated under reduced pressure, is finally dried in vacuo in far infrared Under the conditions of drying to get Rhizoma Gastrodiae extract；
Step 5）Film-making：Rhizoma Gastrodiae extract 150g is taken, is ground into fine powder, is sieved with 100 mesh sieve, adds microcrystalline cellulose 20g, Icing Sugar 50g, cornstarch 200g, dextrin 150g, low-substituted hydroxypropyl cellulose 10g, mixing is dry with 70% alcohol granulation, adds in Magnesium stearate 5.8g, mixing are pressed into 1000, film coating to get.
Preferably, the uitraviolet intensity is 2000-3000uW/cm2。
According to the purposes in the above-mentioned full rhizoma gastrodiae tablet for being allowed to preparation process preparation in the treatment wind.
The advantageous effect that the present invention obtains is primarily but not limited to the following aspects：
Preparation process simple possible of the present invention, the tablet good drug efficacy of preparation, reduces drug administration amount, improves biological utilisation Degree；Rhizoma Gastrodiae extraction process of the present invention use multiple technologies, including ultraviolet, alcohol extracting, microwave and concentration and etc. obtain to greatest extent Rhizoma Gastrodiae active ingredient was obtained, is more advantageous to drug effect absorption；The ultraviolet light that the present invention passes through proper strength so that cell wall is broken It is bad, improve the dissolution rate of active ingredient；Rhizoma Gastrodiae extraction process of the present invention is extracted using Microwave-Assisted Ethanol, improves production effect Rate avoids the loss of active ingredient；Extractant of the present invention avoids the use of toxic solvent and toxic residual only with ethyl alcohol It stays, and ethyl alcohol is recycled, reduce wastage of material；The whole gastrodia tuber tablet effect that the present invention is prepared is better than this public affairs Tablet on sale is taken charge of, can effectively treat the diseases such as apoplexy, is expected to replace existing whole gastrodia tuber tablet.
Specific embodiment
In order to make those skilled in the art better understand the technical solutions in the application, have below in conjunction with the application Body embodiment more clearly and completely describes the present invention, it is clear that described embodiment is only the application one Divide embodiment, instead of all the embodiments.Based on the embodiment in the application, those of ordinary skill in the art are not making All other embodiments obtained under the premise of creative work should all belong to the scope of protection of the invention.
Embodiment 1
A kind of preparation process of full rhizoma gastrodiae tablet, includes the following steps：
Step 1）Rhizoma Gastrodiae is smashed into powder, sieves with 100 mesh sieve, is then paved into the flat bed of 5mm thickness, be placed under ultraviolet light and irradiate Then 10min collects powder, stir evenly, and is then paved into the flat bed of 5mm thickness again, is placed under ultraviolet light and irradiates 10min； The uitraviolet intensity is 3000uW/cm2；
Step 2）By step 1）Gained powder adds the 70% of double weight in container（v/v）Ethyl alcohol, 300rpm stirring carry It takes, controlled at 50 DEG C, microwave power 500W, extraction time 30min in extraction process；Collected by suction filtrate A and filter Slag；
Step 3）85% is added into filter residue（v/v）Ethyl alcohol, regard no filter slag as criterion, then 500rpm stir 15min, filter Collect liquor B；
Step 4）Filtrate A and liquor B are merged, are then concentrated under reduced pressure, is finally dried under the conditions of far infrared vacuum drying, Up to Rhizoma Gastrodiae extract；Wherein, it is about 56g that extract can be obtained per kg Rhizoma Gastrodiaes, and chromatography post detection gastrodin content is 4.2g, is received Rate is more than 90%, remaining component includes gastrodia elata polysaccharide, vitamin and amino acid etc.；
Step 5）Rhizoma Gastrodiae extract 150g is taken, is ground into fine powder, is sieved with 100 mesh sieve, adds microcrystalline cellulose 20g, Icing Sugar 50g, it is beautiful Rice starch 200g, dextrin 150g, low-substituted hydroxypropyl cellulose 10g, mixing is dry with 70% alcohol granulation, adds in stearic acid Magnesium 5.8g, mixing are pressed into 1000, film coating to get.
Application method：It takes orally one at a time, three times per day.
Embodiment 2
A kind of preparation process of full rhizoma gastrodiae tablet, includes the following steps：
Step 1）Rhizoma Gastrodiae is smashed into powder, sieves with 100 mesh sieve, is then paved into the flat bed of 5mm thickness, be placed under ultraviolet light and irradiate Then 15min collects powder, stir evenly, and is then paved into the flat bed of 5mm thickness again, is placed under ultraviolet light and irradiates 15min； The uitraviolet intensity is 2000uW/cm2；
Step 2）By step 1）Gained powder adds the 70% of double weight in container（v/v）Ethyl alcohol, 300rpm stirring carry It takes, controlled at 60 DEG C, microwave power 500W, extraction time 30-40min in extraction process；Collected by suction filtrate A and Filter residue；
Step 3）85% is added into filter residue（v/v）Ethyl alcohol, regard no filter slag as criterion, then 500rpm stir 30min, filter Collect liquor B；
Step 4）Filtrate A and liquor B are merged, are then concentrated under reduced pressure, is finally dried under the conditions of far infrared vacuum drying, Up to Rhizoma Gastrodiae extract；Wherein, it is about 63g that extract can be obtained per kg Rhizoma Gastrodiaes, and chromatography post detection gastrodin content is 4.3g, is received Rate is more than 90%, remaining component includes gastrodia elata polysaccharide, vitamin and amino acid etc.；
Step 5）Rhizoma Gastrodiae extract 150g is taken, is ground into fine powder, is sieved with 100 mesh sieve, adds microcrystalline cellulose 20g, Icing Sugar 50g, it is beautiful Rice starch 200g, dextrin 150g, low-substituted hydroxypropyl cellulose 10g, mixing is dry with 70% alcohol granulation, adds in stearic acid Magnesium 5.8g, mixing are pressed into 1000, film coating to get.
Application method：It takes orally one at a time, three times per day.
Reference examples 1
A kind of preparation process of full rhizoma gastrodiae tablet, includes the following steps：
Rhizoma Gastrodiae 500g is taken to dry, fine powder is ground into, sieves with 100 mesh sieve, adds microcrystalline cellulose 20g, Icing Sugar 50g, low-substituted hydroxypropyl Base cellulose 10g, mixing is dry with 10% alcohol granulation, adds in magnesium stearate 5.8g, and mixing is pressed into 1000, and packet is thin Film clothing to get.
Application method：It is oral one time 6, three times per day.
Embodiment 3
Experiment of Zoology
Healthy Kunming Strains of Mouse 20, half male and half female, weight are 19 ± 2.0g, and 20 mouse are randomly divided into two groups, every group Half male and half female wherein 10 as control group, is filled with ordinary water；Other 10 mouse give the gastrodia elata slice of 1 technique of embodiment preparation, For 2mg/ only, three times a day, Application mouse carries out acute toxicity testing and shows dosage：Compared with the control group, mouse is not after administration See notable difference, experiment is observed continuously two weeks, mouse systemic situation, ingest, drink water, body weight increase it is normal.Administration the same day and After administration in two weeks, animal dead is had no, prompt the medicine acute toxicity low, clinical application safety.
Embodiment 4
Comparative efficacy test
60 Patients with Stroke being hospitalized for treatment are randomly selected, meets stroke diagnosis standard, is First episode.Patient by with Machine is divided into two groups, and treatment group 30, wherein male 19, women 11, at -63 years old 48 years old age, average neurologic impairment is commented Divide 25.78 ± 3.93.Control group 30, wherein male 17, women 13, -66 years old 45 years old age, average neurologic impairment Scoring 25.15 ± 4.72.It is grouped in age of onset, gender and the upper difference of nervous function damage scoring there are no significant (P ＞ 0.05)。
Patient selected by inclusion criteria is stroke patient, and all being checked through head CT or MRI confirms, meets the 4th whole nation The stroke diagnosis standard that cerebrovascular disease meeting is formulated, and drafted with reference to State Administration of Traditional Chinese Medicine's encephalopathy acute disease scientific research cooperative groups The apoplexy diagnosis efficacy assessment standard (tentative nineteen ninety-five) of formulation.It excludes TIA, intracranial hemorrhage, exclude severe cardiac, liver, lung, kidney Dysfunction and bleeding, the patient of coagulation disorders.Exclude the patient for merging gastric ulcer or hemorrhage of digestive tract.
Therapy：Treatment group：Tablet prepared by the oral embodiment of the present invention 1,1 tablet once, and 3 times a day, 2 weeks are one The course for the treatment of；Control group：Tablet prepared by oral reference examples 1 of the present invention, 1 tablet once, and 3 times a day, 2 weeks as a treatment course；Two groups equal It gives DANHONG ZHUSHEYE 6ml to add in physiological saline 250ml, intravenous drip, one time a day；2 weeks as a treatment course.Two groups of patients As infarct size greatly if simultaneously coordinate dehydration etc. symptomatic treatments.
Curative effect determinate standard：Basis after two groups of medications, one course for the treatment of《Patients with Stroke Clinical Nerve Function Deficiency is commented Minute mark is accurate》Classification is almost recovered, marked improvement, progress, it is unchanged, deteriorate, be dead.Specifically it is shown in Table 1：
Table 1
Group It is almost recovered Marked improvement Progress It is unchanged Deteriorate It is dead Total effective rate（%）
Treatment group 9 7 10 2 1 1 87%
Control group 7 5 11 3 2 2 77%
Conclusion：The general physical examination project of 3 groups of patients, the inspection of blood urine stool routine, cardiac inspection etc. are equal before and after this clinical observation treatment Without significant change.Treatment group's effect is better than control group effect, has statistical significance.
Finally, it should also be noted that it is listed above be only the present invention several specific embodiments.Obviously, the present invention not It is limited to above example, acceptable there are many deform.Those of ordinary skill in the art can be direct from present disclosure All deformations for exporting or associating, are considered as protection scope of the present invention.

Claims (4)

1. a kind of preparation process of full rhizoma gastrodiae tablet, includes the following steps：Step 1）Crushing and ultraviolet irradiation, step 2）Alcohol extracting and Microwave, step 3）Alcohol extracting and suction filtration, step 4）Concentration and dry, step 5）Film-making.
2. preparation process according to claim 1, which is characterized in that the preparation process includes the following steps：
Step 1）Crushing and ultraviolet irradiation：Rhizoma Gastrodiae is smashed into powder, is sieved with 100 mesh sieve, is then paved into the flat bed of 5mm thickness, puts 10-15min is irradiated under ultraviolet light, then collects powder, is stirred evenly, the flat bed of 5mm thickness is then paved into again, is placed in purple 10-15min is irradiated under outside line；
Step 2）Alcohol extracting and microwave：By step 1）Gained powder adds the 70% of double weight in container（v/v）Ethyl alcohol, 300rpm stirrings are extracted, and control microwave power is 500W, extraction time 30-40min in extraction process；Collected by suction filtrate A And filter residue；
Step 3）Alcohol extracting and suction filtration：85% is added into filter residue（v/v）Ethyl alcohol, regard no filter slag as criterion, then 500rpm stir 15-30min, collected by suction liquor B；
Step 4）Concentration and drying：Filtrate A and liquor B are merged, are then concentrated under reduced pressure, is finally dried in vacuo in far infrared Under the conditions of drying to get Rhizoma Gastrodiae extract；
Step 5）Film-making：Rhizoma Gastrodiae extract 150g is taken, is ground into fine powder, is sieved with 100 mesh sieve, adds microcrystalline cellulose 20g, Icing Sugar 50g, cornstarch 200g, dextrin 150g, low-substituted hydroxypropyl cellulose 10g, mixing is dry with 10% alcohol granulation, adds in Magnesium stearate 5.8g, mixing are pressed into 1000, film coating to get.
3. preparation process according to claim 2, which is characterized in that the uitraviolet intensity is 2000-3000uW/cm2。
4. it is allowed to the full rhizoma gastrodiae tablet of the preparation process preparation purposes in wind in the treatment according to claim 1-3.
CN201611085131.XA 2016-12-01 2016-12-01 A kind of preparation process of full rhizoma gastrodiae tablet Pending CN108126116A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113171429A (en) * 2021-04-14 2021-07-27 大方县九龙天麻开发有限公司 Gastrodia elata tablets and preparation method thereof

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CN102988783A (en) * 2012-12-30 2013-03-27 贵州大方百里花食品有限公司 Production method of gastrodin
CN103638336A (en) * 2013-12-22 2014-03-19 林凡友 Full rhizoma gastrodiae tablet

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WO2007006203A1 (en) * 2005-07-07 2007-01-18 Shirong Duan A capsule formulation for treating hypertension and coronary heart disease and process for preparation thereof
CN102988783A (en) * 2012-12-30 2013-03-27 贵州大方百里花食品有限公司 Production method of gastrodin
CN103638336A (en) * 2013-12-22 2014-03-19 林凡友 Full rhizoma gastrodiae tablet

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113171429A (en) * 2021-04-14 2021-07-27 大方县九龙天麻开发有限公司 Gastrodia elata tablets and preparation method thereof

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Application publication date: 20180608