CN1548110A - Calculus-expelling Jinshi bolus and its prepn - Google Patents

Calculus-expelling Jinshi bolus and its prepn Download PDF

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Publication number
CN1548110A
CN1548110A CNA031244513A CN03124451A CN1548110A CN 1548110 A CN1548110 A CN 1548110A CN A031244513 A CNA031244513 A CN A031244513A CN 03124451 A CN03124451 A CN 03124451A CN 1548110 A CN1548110 A CN 1548110A
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drying
time
preparation
tortoise beetle
ground
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毛友昌
毛小敏
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Abstract

The present invention discloses calculus expelling Jinjia bolus and its preparation. The present invention relates to preparation form innovation on the basis of available capsule, and the medicine has the advantages of fast release speed, high bioavailability, less irritation, etc. The medicine has the functions of promoting blood circulation to disperse blood clots, relieving stranguria by diuresis, and is used in treating stranguria due to urinary stone, etc. with high curative effect.

Description

Tortoise beetle lithagogue pill and preparation method
Technical field
This invention relates to the processing technology technical field of Chinese patent medicine pill, relates in particular to tortoise beetle lithagogue pill and preparation method.
Background technology
Pill is a kind of conventional dosage forms, because quick development of modern science and technology, the pharmacy structural establishment is brought in constant renewal in and is regenerated, the extensive use of the appearance of novel pellet processing machine and new adjuvant, for this ancient dosage form of medicine pill has shone youthful vigor, it has changed people to the traditional prejudice of traditional pill " black; big; thick ", it is fast that the pill that makes it to produce has drug release rate, the bioavailability height, zest is little, divided dose is accurate, take, advantage such as easy to carry, according to the relevant drug act of China, change dosage form as a kind of new drug research, original dosage form of tortoise beetle lithagogue pill is the tortoise beetle capsule for expelling stone, has listed in national Bureau of Drugs Supervision's country's standard for traditional Chinese medicines compilation (terrestrial reference rises the GB tentative standard).The technology characteristics of former dosage form is: eight flavors such as Radix Paeoniae Rubra are ground into fine powder in the ten Six-element medicines, and eight flavors such as all the other rhizoma sparganic are made the decocting dried cream powder, mixing then, encapsulated forming.Big 5 large capsule of this capsule dose, dysphagia is especially to old person, and this pharmaceutically dosage form is single, far can not satisfy people's medication demand, its quality standard still can further improve simultaneously, based on this, we use the modern pharmaceutical technology this product technology are done necessary improvement, form new preparation, the control criterion that improves the quality simultaneously guarantees the quality monitoring of product, improve drug effect, benefit the common people.This is significant to inheriting and develop motherland's medicine legacy.
Summary of the invention
The purpose of this invention is to provide a kind of tortoise beetle lithagogue pill and preparation method, improve the quality of products and curative effect, increase the stability of product, enrich medicine variety, to satisfy and to ensure people's medication demand better.
1. tortoise beetle lithagogue pill and preparation method comprise the steps:
1.1 the prescription of tortoise beetle lithagogue pill is formed
Rhizoma sparganic (system) 110-220g Myrrha (stir-fry) 66-132g Radix Paeoniae Rubra 110-220g
Semen Persicae (system) 66-132g Spina Gleditsiae 66-132g Radix Angelicae Dahuricae 44-88g
Fructus Aurantii (parched) 66-132g Rhizoma Curcumae 110-220g Pericarpium Citri Reticulatae Viride 66-132g
Olibanum (stir-fry) 66-132g Semen Coicis 110-220g Radix Cyathulae 66-132g
Semen Plantaginis 110-220g Cortex Magnoliae Officinalis 44-88g Squama Manis (system) 22-44g
Herba Desmodii Styracifolii 220-440g right amount of auxiliary materials is made 1000g altogether.
Best prescription is: rhizoma sparganic (system) 165g Myrrha (stir-fry) 99g Radix Paeoniae Rubra 165g
Semen Persicae (system) 99g Spina Gleditsiae 99g Radix Angelicae Dahuricae 66g Fructus Aurantii (parched) 99g
Rhizoma Curcumae 165g Pericarpium Citri Reticulatae Viride 99g Olibanum (stir-fry) 99g Semen Coicis 165g
Radix Cyathulae 99g Semen Plantaginis 165g Cortex Magnoliae Officinalis 66g Squama Manis (system) 33g
Herba Desmodii Styracifolii 330g right amount of auxiliary materials is made 1000g altogether.
1.2 the preparation technology of tortoise beetle lithagogue pill
Technology one, will write out a prescription in ten Six-element medicines be up to the standards standby respectively; Radix Paeoniae Rubra, Fructus Aurantii, Cortex Magnoliae Officinalis, Pericarpium Citri Reticulatae Viride, the Radix Angelicae Dahuricae, Semen Coicis, Olibanum, Myrrha are ground into fine powder, and be standby; All the other rhizoma sparganic etc. eight flavor is ground into coarse powder/be cut into decoction pieces, decocts with water 2-3 time, and each 1-4 hour, filtration, merging filtrate, filtrate is condensed into thick paste or concentrate drying is made dried cream powder, with above-mentioned fine powder and appropriate amount of auxiliary materials mixing, makes ball, drying, promptly.
Technology two, will write out a prescription in ten Six-element medicines be up to the standards standby respectively; Olibanum, Myrrha are ground into fine powder, and be standby; Radix Paeoniae Rubra, Fructus Aurantii, Cortex Magnoliae Officinalis, Pericarpium Citri Reticulatae Viride, the Radix Angelicae Dahuricae are ground into coarse powder/be cut into decoction pieces and extract 2-3 time with the 60-95% alcohol heating reflux, and each 1-3 hour, extracting solution reclaimed ethanol, are concentrated in right amount, and be standby; Nine flavor coarse powder/decoction pieces such as all the other rhizoma sparganic decoct with water 2-3 time, each 1-4 hour, filter merging filtrate, be concentrated in right amount, merge, be condensed into thick paste or concentrate drying is made dried cream powder, with above-mentioned fine powder and appropriate amount of auxiliary materials mixing with above-mentioned alcohol extract, make ball, drying, promptly.
1.3 the ball by above-mentioned technology gained is the tortoise beetle lithagogue pill.
The ball of gained can wrap film-coat in the technology, the film-coat material adopt stomach dissolution type film-coat pre-mixing agent (Opadry), hydroxypropyl cellulose, polyvinylpyrrolidone, hydroxypropyl emthylcellulose, polyvinyl alcohol, methylcellulose a kind of/multiple mixing uses.
Used adjuvant can be that one or more mixing such as sucrose, lactose, starch, beta-schardinger dextrin-, microcrystalline Cellulose, hydroxypropyl cellulose, carboxymethylstach sodium, Aspartane, polyvinylpolypyrrolidone, 30 POVIDONE K 30 BP/USP 30 are used in the technology.
The particle diameter of the ball of gained is 0.5-6mm in the technology, and optimum grain-diameter is 1.5-4mm.
In the technology ball of gained can directly use or the capsulae vacuus of packing in use.
The ball drying can adopt vacuum drying, fluid bed drying, lyophilization etc. in the technology.
Need be ground into the medical material of fine powder in the technology, can routine be ground into 80-160 purpose fine powder or superfine powder is broken into 200-300 purpose fine powder.
Be ground into coarse powder in the technology or make decoction pieces and be generally 5-40 purpose coarse powder/decoction pieces, be preferably 10-20 order coarse powder.
The condition that decocting boils in the technology is: amount of water is that 6-15 doubly measures for the first time, and second and third time doubly measured for 4-10, decocts each 1-4 hour 2-3 time.Best amount of water is 10 times of amounts for the first time in order to decoct secondary, is 8 times of amounts for the second time, decocts 2 hours for the second time 3 hours for the first time.
The reflux condition is in the technology two: the ethanol with 60-95% is molten, and the solubilizer flow control is once doubly measured for 6-14, and second and third time doubly measured for 4-12, reflux 2-3 time, each 1-3 hour.The best thinks that the ethanol of 70-75% is solvent, and the solubilizer flow control once is 10 times of amounts, is 8 times of amounts for the second time, refluxes each 2 hours 2 times.
The relative density of thick paste is 1.15-1.45 (80 ℃) in the technology, and best relative density is 1.36-1.38 (80 ℃).
Drying can adopt vacuum drying or spray drying in the technology.The vacuum drying temperature is controlled at 50-90 ℃, and the best is 60 ℃.Spray drying is for to be condensed into the concentrated solution that relative density is 1.05-1.15 (60 ℃) with extracting solution, and spray drying, inlet temperature are 100-200 ℃, leaving air temp is 50-150 ℃, best relative density is 1.08-1.12 (60 ℃), and inlet temperature is 160-180 ℃, and leaving air temp is 80-100 ℃.Particle drying adopts vacuum drying.
Extracting solution filters and also can adopt conventional the filtration in the technology, and is centrifugal, ultrafiltration, add filter behind the clarifier, centrifugal, add the method that filters ultrafiltration again behind the clarifier.
Among the present invention the quality control standard of tortoise beetle lithagogue pill mainly aspect three of discriminatings, inspection, assay.
This product is further to improve on the basis of original tortoise beetle capsule for expelling stone, the thin layer that has kept the former dosage form Radix Angelicae Dahuricae, Cortex Magnoliae Officinalis on differentiating differentiates, the thin layer that has increased Olibanum, Myrrha is differentiated; Former dosage form does not have the limit examine of arsenic salt, heavy metal on checking, has now increased heavy metal limit and must not cross 10/1000000ths, and arsenic salt must not cross 2/1000000ths.On assay, Radix Paeoniae Rubra has been carried out quantitatively.
This invention is dosage form technological innovation on existing capsular basis, and quality standard has new raising again, to improving the quality of products significant meaning is arranged, and has enriched medicine variety, satisfies and ensured people's medication demand.
The specific embodiment
This invention optimum implementation is: ten Six-element medicines are up to the standards standby respectively in will writing out a prescription; Olibanum, Myrrha are ground into fine powder, and be standby; Radix Paeoniae Rubra, Fructus Aurantii, Cortex Magnoliae Officinalis, Pericarpium Citri Reticulatae Viride, the Radix Angelicae Dahuricae extract 2 times with 70% alcohol heating reflux, and each 2 hours, extracting solution reclaimed ethanol, and it is standby to be concentrated into relative density 1.08-1.10 (60 ℃); Nine flavors such as all the other rhizoma sparganic decoct with water 2 times, 3 hours for the first time, 2 hours for the second time, filter, merging filtrate is concentrated into relative density 1.08-1.10 (60 ℃), merges with above-mentioned alcohol extract, and spray drying is made dried cream powder, with above-mentioned fine powder and appropriate amount of auxiliary materials mixing, make ball, drying, promptly.

Claims (10)

1. tortoise beetle lithagogue pill and preparation method is characterized in that:
(1) will write out a prescription in rhizoma sparganic, Myrrha, Radix Paeoniae Rubra, Semen Persicae, Spina Gleditsiae, the Radix Angelicae Dahuricae, Fructus Aurantii, Rhizoma Curcumae, Pericarpium Citri Reticulatae Viride, Olibanum, Semen Coicis, Radix Cyathulae, Semen Plantaginis, Cortex Magnoliae Officinalis, Squama Manis, Herba Desmodii Styracifolii ten Six-element medicines be up to the standards standby respectively; Radix Paeoniae Rubra, Fructus Aurantii, Cortex Magnoliae Officinalis, Pericarpium Citri Reticulatae Viride, the Radix Angelicae Dahuricae, Semen Coicis, Olibanum, Myrrha are ground into fine powder, and be standby; All the other rhizoma sparganic etc. eight flavor is ground into coarse powder/be cut into decoction pieces, decocts with water 2-3 time, and each 1-4 hour, filtration, merging filtrate, filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, with fine powder and appropriate amount of auxiliary materials mixing, makes ball, drying, promptly.
(2) will write out a prescription in rhizoma sparganic, Myrrha, Radix Paeoniae Rubra, Semen Persicae, Spina Gleditsiae, the Radix Angelicae Dahuricae, Fructus Aurantii, Rhizoma Curcumae, Pericarpium Citri Reticulatae Viride, Olibanum, Semen Coicis, Radix Cyathulae, Semen Plantaginis, Cortex Magnoliae Officinalis, Squama Manis, Herba Desmodii Styracifolii ten Six-element medicines be up to the standards standby respectively; Olibanum, Myrrha are ground into fine powder, and be standby; Radix Paeoniae Rubra, Fructus Aurantii, Cortex Magnoliae Officinalis, Pericarpium Citri Reticulatae Viride, the Radix Angelicae Dahuricae are ground into coarse powder/be cut into decoction pieces and extract 2-3 time with the 60-95% alcohol heating reflux, and each 1-3 hour, extracting solution reclaimed ethanol, are concentrated in right amount, and be standby; Nine flavor coarse powder/decoction pieces such as all the other rhizoma sparganic decoct with water 2-3 time, and each 1-4 hour, filter, merging filtrate is concentrated in right amount, merges with alcohol extract, is condensed into thick paste/concentrate drying and makes dried cream powder, with fine powder and appropriate amount of auxiliary materials mixing, makes ball, drying, promptly.
2. tortoise beetle lithagogue pill according to claim 1 and preparation method, it is characterized in that: the ball of gained can wrap film-coat, the film-coat material adopt stomach dissolution type film-coat pre-mixing agent (Opadry), hydroxypropyl cellulose, polyvinylpyrrolidone, hydroxypropyl emthylcellulose, polyvinyl alcohol, methylcellulose a kind of/multiple mixing uses; Used adjuvant can be sucrose, lactose, starch, beta-schardinger dextrin-, microcrystalline Cellulose, hydroxypropyl cellulose, carboxymethylstach sodium, Aspartane, polyvinylpolypyrrolidone, 30 1 kinds/multiple mixing use of 30 POVIDONE K 30 BP/USP.
3. tortoise beetle lithagogue pill according to claim 1 and preparation method is characterized in that: the particle diameter of the ball of gained is 0.5-6mm, and optimum grain-diameter is 1.5-4mm; The ball drying can adopt vacuum drying, fluid bed drying, lyophilization; The ball of gained can directly use/pack in the capsulae vacuus and use.
4. tortoise beetle lithagogue pill according to claim 1 and preparation method is characterized in that: need be ground into the medical material of fine powder, can routine be ground into 80-160 purpose fine powder/superfine powder and be broken into 200-300 purpose fine powder; Be ground into coarse powder or make decoction pieces and be generally 5-40 purpose coarse powder/decoction pieces, the best was a 10-20 order coarse powder.
5. tortoise beetle lithagogue pill according to claim 1 and preparation method, it is characterized in that: the condition that decocting boils is: amount of water is that 6-15 doubly measures for the first time, second and third time doubly measured for 4-10, decoct 2-3 time, each 1-4 hour, best for decocting secondary, amount of water is 10 times of amounts for the first time, be 8 times of amounts for the second time, decocted 2 hours for the second time 3 hours for the first time.
6. tortoise beetle lithagogue pill according to claim 1 and preparation method, it is characterized in that: the reflux condition is in 1 (2): the ethanol with 60-95% is molten, the solubilizer flow control is once doubly measured for 6-14, and second and third time doubly measured for 4-12, reflux 2-3 time, each 1-3 hour, the best thinks that the ethanol of 70-75% is solvent, and the solubilizer flow control once is 10 times of amounts, is 8 times of amounts for the second time, reflux each 2 hours 2 times.
7. tortoise beetle lithagogue pill according to claim 1 and preparation method is characterized in that: the relative density of thick paste is 1.15-1.45 (80 ℃), and best relative density is 1.36-1.38 (80 ℃).
8. tortoise beetle lithagogue pill according to claim 1 and preparation method, it is characterized in that: drying can adopt vacuum drying/spray drying, the vacuum drying temperature is controlled at 50-90 ℃, the best is 60 ℃, spray drying is for to be condensed into the concentrated solution that relative density is 1.05-1.15 (60 ℃) with extracting solution, spray drying, inlet temperature is 100-200 ℃, leaving air temp is 50-150 ℃, best relative density is 1.08-1.12 (60 ℃), inlet temperature is 160-180 ℃, and leaving air temp is 80-100 ℃, and particle drying adopts vacuum drying.
9. tortoise beetle lithagogue pill according to claim 1 and preparation method is characterized in that: extracting solution filters and also can adopt conventional the filtration, and is centrifugal, ultrafiltration, add filter behind the clarifier, centrifugal, add the method that filters ultrafiltration again behind the clarifier.
10. tortoise beetle lithagogue pill according to claim 1 and preparation method is characterized in that: the quality standard control of this product has the thin layer of Olibanum, Myrrha to differentiate; Have heavy metal limit must not cross 10/1000000ths on checking, arsenic salt must not be crossed 2/1000000ths limit detection, and the quantitative of Radix Paeoniae Rubra arranged on the assay.
CNA031244513A 2003-05-24 2003-05-24 Calculus-expelling Jinshi bolus and its prepn Pending CN1548110A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105816746A (en) * 2016-05-10 2016-08-03 袁守娴 Urinary system kidney tonifying and stone removing traditional Chinese medicine preparation and preparation method
CN105999020A (en) * 2016-05-15 2016-10-12 张福兰 Facial neuritis treating pharmaceutical composition and preparation method thereof
CN107753875A (en) * 2017-11-26 2018-03-06 孙国安 It is a kind of to be used for anti-inflammatory, spasmolysis, analgesic, diuresis, the medicine and preparation method for arranging stone

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105816746A (en) * 2016-05-10 2016-08-03 袁守娴 Urinary system kidney tonifying and stone removing traditional Chinese medicine preparation and preparation method
CN105999020A (en) * 2016-05-15 2016-10-12 张福兰 Facial neuritis treating pharmaceutical composition and preparation method thereof
CN107753875A (en) * 2017-11-26 2018-03-06 孙国安 It is a kind of to be used for anti-inflammatory, spasmolysis, analgesic, diuresis, the medicine and preparation method for arranging stone

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