CN1970002A - Method for preparing minipill of 'Xue Fu Zhu Yu' - Google Patents

Abstract

The invention discloses a process for preparing blood-nourishing micro-pellets by making dressed micro-pellets through conventional pharmaceutical techniques. The invention achieves simple process for manufacturing, stabilized and controllable quality, small amount of administration, shorter disintegration time, and quicker action.

Description

The preparation method of minipill of ' Xue Fu Zhu Yu '

Technical field

The present invention is a kind of preparation method of minipill of ' Xue Fu Zhu Yu ', belongs to technical field of Chinese medicine.

Technical background:

Decoction for removing blood stasis comes from errors in Medicine Corrected one book that Qing Dynasty's well-known doctor's Wang Qingren is shown, and we are after Mr. Wang Qingren has summed up the clinical experience of many decades, the prescription of the special for treating that develops " Blood stasis ".It by Semen Persicae, Radix Angelicae Sinensis, Fructus Aurantii, Rhizoma Chuanxiong, Radix Bupleuri, Flos Carthami, Radix Achyranthis Bidentatae, Radix Paeoniae Rubra, Radix Rehmanniae, Radix Platycodonis, Radix Glycyrrhizae etc. ten simply Chinese medicine form, has good blood circulation promoting and blood stasis dispelling, the effect of promoting the circulation of QI to relieve pain, be mainly used in the congestion internal resistance, the disease that blood-stasis internal-depressions such as chest pain or headache, cardiovascular and cerebrovascular disease, climacteric syndrome, treatment biliary tract infection, insomnia, diabetes cause.Among the we, Semen Persicae, Flos Carthami blood circulation promoting and blood stasis dispelling are principal agent; Rhizoma Chuanxiong, Radix Angelicae Sinensis promoting flow of QI and blood are monarch drug: the Radix Achyranthis Bidentatae blood stasis dispelling is promoted blood circulation, conducting blood to flow downwards: assistant is opened breast, soothing the liver, resolving depression with Fructus Aurantii, Radix Paeoniae Rubra, Radix Platycodonis, Radix Bupleuri; Radix Rehmanniae clearing away heat and cooling blood; The Radix Glycyrrhizae detoxifcation, coordinating the actions of various ingredients in a prescription.All medicines are harmonious, blood-activating and qi-promoting, and stasis of blood heat-transformation disappears, and stagnation of liver-QI is dredged and is reached all disease spontaneous recovery.

Modern study is thought: 1) this side reduces thrombosis weight, whole blood contrast viscosity, fibrinogen content, suppressing ADP induces the rabbit platelet aggregation that causes and promotes the platelet depolymerisation, and the effect of antagonism thorium anhydride blocking-up hepatic clearance, and resist granulomatous formation.2) concrete experiment shows that decoction for removing blood stasis has raising PaO2, and has the circulation of the blood capillary of improvement, the effect of accelerate blood operation.3) improve the blood circulation of organ, particularly microvascular circulation has vasodilator, increasing blood flow, reduce the resistance of blood flow effect, adjust blood coagulation and anticoagulation system, prevent thrombosis, improve capillary permeability, promote the reparation of damaged tissue, suppress the metabolism of connective tissue, reduce the formation and the adhesion of abnormal pigmentary deposit on the skin trace, reduce reactivity of organism, have analgesia and blood circulation promoting and blood stasis dispelling dual regulation.

Above-mentioned modern study shows, decoction for removing blood stasis is early with the limitation of the treatment " blood stasis in the heart " that broken through original meaning, can be widely used in having the various blood system diseases of the elephant of blood stasis, take the circumstances into consideration to be applied to other diseases and have blood system disease patient concurrently, because compatibility is suitable, it is tight and perfect to write out a prescription, so be used for clinical and can see special effect with 'Xue Fu Zhu Yu ' plus-minus.

Approved production at present Xuefu ecchymosis eliminating pill (first in the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation), XUEFU ZHUYU JIAONANG (the 5th in the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation), XUEFU ZHUYU KOUFUYE (Ministry of Public Health new drug become a full member standard 13) arranged, Xuefu ecchymosis eliminating pill is to make big honeyed pills with adding condensed milk after the pulverizing medicinal materials, be conventional dosage forms, the characteristics of " black, big, thick " have been demonstrated fully, the moisture-sensitive moldy metamorphism; XUEFU ZHUYU JIAONANG increases on the basis of pill, but still has the problem of moisture-sensitive, and dosage is big, takes 4～6 at every turn; XUEFU ZHUYU KOUFUYE need add a large amount of antiseptic, undesirable dose of medicine stability.In view of such circumstances, seek the therapeutic effect ideal, the simple effectively medicine preparation of stable and controllable for quality, production operation is the thing of being badly in need of solving most.

Micropill is meant the coccoid peroral dosage form of diameter less than 2.5mm, and coating behind medicine and the adjuvant mixing pill is made.Because micropill belongs to dosage decentralized preparation, a dosage unit is composed of multiple units, compare with the single dose dosage form, have many advantages: 1, can extensively be evenly distributed in the gastrointestinal tract behind the micropill clothes, because dosage inclines and dispersion, medicine increases at gastrointestinal surface distributed area, drug bioavailability is improved, thereby reduce the generation of drug resistance and the generation of toxic and side effects to greatest extent.2, the influence of the running unable to take food thing conveying rhythm and pace of moving things of pellet in gastrointestinal tract, even when sphincter of pylorus is closed, still can pass through pylorus, so micropill absorbs the influence that generally is not subjected to gastric emptying at gastrointestinal.3, the drug release behavior of micropill is a summation of forming each micropill drug release behavior of a dosage, and error or the defective unlikely drug release behavior generation to whole preparation of indivedual micropills in preparation has a strong impact on.Therefore repeatability, concordance aspect in vivo is better than tablet and capsule.

Micropill disintegrative provided by the invention is good, the bioavailability height, moistureproof, cover, improve stability of drug, thoroughly solved the problem that original dosage form exists, and do not have adverse drug taste, abnormal smells from the patient, be particularly suitable for infant, old people and swallow tablet or the inconvenient patient of capsule take.

Summary of the invention:

The objective of the invention is to: the preparation method that a kind of minipill of ' Xue Fu Zhu Yu ' is provided; This micropill disintegrative that is provided is good, the bioavailability height, and good stability can also be covered adverse drug taste, abnormal smells from the patient, is particularly suitable for infant, old people and swallow tablet or the inconvenient patient of capsule take.

A kind of minipill of ' Xue Fu Zhu Yu ' of the present invention is: effectively medicinal ingredient calculates according to components by weight percent, and it mainly is made up of for 2 parts 8 parts in Semen Persicae, 6 parts of Radix Angelicae Sinensis, 4 parts of Fructus Aurantii, 3 parts of Rhizoma Chuanxiongs, 2 parts of Radix Bupleuri, 6 parts on Flos Carthami, 6 parts of Radix Achyranthis Bidentataes, 4 parts of Radix Paeoniae Rubra, 6 parts of Radix Rehmanniae, 3 parts of Radix Platycodoniss and Radix Glycyrrhizae.

A kind of minipill of ' Xue Fu Zhu Yu ' of the present invention is: effectively medicinal component is formed through the spissated extraction concentrated solution of water extraction or thick extractum, coating material and acceptable accessories, coating material comprise acrylic resin, cellulose and derivant thereof, polyvinyl alcohol a kind of/multiple mixing uses; Acceptable accessories be celphere, sucrose, lactose, starch, dextrin, microcrystalline Cellulose, carboxymethyl starch sodium, polyvinylpolypyrrolidone, Pulvis Talci, silicon dioxide, Polyethylene Glycol, sweeting agent, pigment a kind of/multiple mixing uses.

Preparation method of the present invention is: with Radix Angelicae Sinensis, Radix Paeoniae Rubra, Fructus Aurantii, Rhizoma Chuanxiong, Radix Bupleuri, half Semen Persicae of recipe quantity, be ground into fine powder, sieve, mixing, the five tastes such as all the other Flos Carthamis and remaining Semen Persicae decoct with water, and filter, merging filtrate, be condensed into thick paste,, get medicated powder with the powder mixing, press medicated powder: starch: micropowder silica gel/Pulvis Talci: microcrystalline Cellulose 100: 10: 2: 95, with medicated powder and starch, micropowder silica gel/Pulvis Talci, the microcrystalline Cellulose mixing that sieves adds suitable quantity of water and makes soft material, and the extruder sieve plate of via hole diameter 0.5～0.9mm is extruded into fine strip shape, put in the spheronizator round as a ball, take out micropill in 50 ℃ of dryings, coating then, promptly.

The present invention is further illustrated below in conjunction with embodiment, and following each embodiment only is used to illustrate the present invention, but to not restriction of the present invention.

Embodiment one

Prescription: Semen Persicae 132g Radix Angelicae Sinensis 132g Fructus Aurantii 88g Rhizoma Chuanxiong 66g Radix Bupleuri 44g

Flos Carthami 132g Radix Achyranthis Bidentatae 132g Radix Paeoniae Rubra 88g Radix Rehmanniae 132g Radix Platycodonis 66g

Radix Glycyrrhizae 44g

Method for making: above ten simply, gets Semen Persicae (recipe quantity 1/2), Radix Angelicae Sinensis, Radix Paeoniae Rubra, Fructus Aurantii, Rhizoma Chuanxiong, Radix Bupleuri and be ground into fine powder, sieves, mixing, 5 flavor medical materials such as all the other Flos Carthamis and Semen Persicae (recipe quantity has 1/2) decoct with water 2～4 times, filter merging filtrate, it is that 1.15～thick paste/concentrate drying is made dried cream powder that filtrate is condensed into relative density, the adjuvant that adds fine powder and pharmaceutically approval is in 1: 0.5～3 ratio mixing, pill, drying, coating, promptly.Make micropill, drying; Dried micropill is placed in the coating pan, use the hydroxypropyl emthylcellulose coating, promptly.

Embodiment two

Prescription: Semen Persicae 132g Radix Angelicae Sinensis 132g Fructus Aurantii 88g Rhizoma Chuanxiong 66g Radix Bupleuri 44g

Flos Carthami 132g Radix Achyranthis Bidentatae 132g Radix Paeoniae Rubra 88g Radix Rehmanniae 132g Radix Platycodonis 66g

Radix Glycyrrhizae 44g

Method for making: above ten simply, gets Semen Persicae (recipe quantity 1/2), Radix Angelicae Sinensis, Radix Paeoniae Rubra, Fructus Aurantii, Rhizoma Chuanxiong, Radix Bupleuri and be ground into fine powder, sieves, mixing, 5 flavor medical materials such as all the other Flos Carthamis and Semen Persicae (recipe quantity has 1/2) decoct with water 2～4 times, filter merging filtrate, it is that 1.15～thick paste/concentrate drying is made dried cream powder that filtrate is condensed into relative density, the adjuvant that adds fine powder and pharmaceutically approval is in 1: 0.5～3 ratio mixing, pill, drying, coating, promptly.Make micropill, drying; Dried micropill is placed in the coating pan, use the acrylic resin coating, promptly.

Claims (5)

1, a kind of preparation method of minipill of ' Xue Fu Zhu Yu ' is characterized in that the prescription of this micropill is:

Semen Persicae 132g Radix Angelicae Sinensis 132g Fructus Aurantii 88g Rhizoma Chuanxiong 66g Radix Bupleuri 44g Flos Carthami 132g Radix Achyranthis Bidentatae 132g Radix Paeoniae Rubra 88g Radix Rehmanniae 132g Radix Platycodonis 66g Radix Glycyrrhizae 44g totally ten simply, get Semen Persicae (recipe quantity 1/2), Radix Angelicae Sinensis, Radix Paeoniae Rubra, Fructus Aurantii, Rhizoma Chuanxiong, Radix Bupleuri is ground into fine powder, 5 flavor medical materials such as all the other Flos Carthamis and Semen Persicae (recipe quantity has 1/2) decoct with water 2～4 times, filter, merging filtrate, filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, the adjuvant that adds fine powder and pharmaceutically approval is in 1: 0.5～5 ratio mixing, pill, dry, coating, promptly.

2, the preparation method of minipill of ' Xue Fu Zhu Yu ' as claimed in claim 1 is characterized in that: the described pharmaceutically adjuvant of approval be microcrystalline Cellulose, starch, dextrin, Pulvis Talci, silicon dioxide, lactose, sucrose, polyvidone, Polyethylene Glycol, sweeting agent, pigment a kind of/multiple mixing uses.

3, the preparation method of minipill of ' Xue Fu Zhu Yu ' as claimed in claim 1 is characterized in that: described pill is that fine powder and thick paste are mixed, through pushing the round as a ball pastille micropill of making.

4, the preparation method of minipill of ' Xue Fu Zhu Yu ' as claimed in claim 1 is characterized in that: described coating is to adopt coating pan, high-efficiency coating machine or sulfuration bed coating; Material be acrylic resin, cellulose and derivant thereof, polyvinyl alcohol a kind of/multiple mixing uses;

5, the preparation method of minipill of ' Xue Fu Zhu Yu ' as claimed in claim 1 is characterized in that: the micropill diameter is at 0.5-1.5mm.