CN1429596A

CN1429596A - Manufacturing process of Rujietai preparation

Info

Publication number: CN1429596A
Application number: CN 02102626
Authority: CN
Inventors: 阙锋
Original assignee: Individual
Current assignee: Individual
Priority date: 2002-01-21
Filing date: 2002-01-21
Publication date: 2003-07-16

Abstract

A Chinese medicine "Rujietai" for treating mastoplasia is prepared from 4 Chinese medicinal materials: trichosanthes fruit, cyperus tuber, arisaema tuber and barded skullcap as main components. Its advantages are sure curative effect and low by-effect.

Description

Manufacturing process of Rujietai preparation

The invention belongs to the Chinese medicine preparation preparation technology of treatment nodules of the breast, cyclomastopathy.

Cyclomastopathy also claims the mammary gland cystic mastopathy, chronic mastopathy, capsule cyclomastopathy, mammary gland fiber sexually transmitted disease (STD) or cyst breast epithelium hypertrophy disease etc.Belong to the nodules of the breast category, be commonly encountered diseases, the frequently-occurring disease of gynecological, sickness rate height, severe patient can cause cancerating, and its canceration rate exceeds 4～18 times than the normal person, and therefore, the patient must effectively be treated.Also find no specific chemical drugs at present, domestic have long history with the Chinese medicine cyclomastopathy, and prescription is also numerous, contain the similar Chinese medicine preparation that has gone on the market, though they are to the treatment acquisition curative effect in various degree of cyclomastopathy, but it is all undesirable, particularly more undesirable to the effect of cystic mastopathy, mammary gland fiber sexually transmitted disease (STD), cyst breast epithelium hypertrophy disease.Therefore, the patient expects better new drug.

Cyclomastopathy, the pathology complexity.Motherland's medical science thinks, cyclomastopathy is because internal damage by the excessive seven emotions, disorder of emotion, and meridians block or Chong and Ren channel disorder, so that depression of liver-QI, lose in catharsis, give birth in the dysfunction of the spleen in transportation, phlegm-damp, the poly-or qi depression to blood stasis of stagnation of QI expectorant, long-pending and due to the in bulk.Therefore, answer " suiting the remedy to the case ", " treating both the principal and secondary aspects of a disease " just can obtain definite curative effect.

Fructus Trichosanthis, the master contains triterpenoid saponin, organic acid, saccharide, and aminoacid, Palmic acid, linoleic acid etc. can " be moisturized relieving accumulation of pathogens, swing hot clearing away phlegm ", and " soothing liver-QI is strongly fragrant, and the profit liver is dry, and suppressing the hyperactive liver is contrary, and slow liver is anxious ", " the knot expectorant that disappears, the carbuncle poison looses ", pharmacological research has cardiovascular system effect, anti-aging effects etc.

Rhizoma Cyperi, main glucose, fructose, the protein of containing, flavonoid glycoside, volatilization wet goods, Rhizoma Cyperi be " Directorate-General DG of disorder of QI; the chief commander of gynecological " (Compendium of Material Medica), " fragrance is walked to scurry, promoting QI circulation for relieving depression; menstruction regulating and pain relieving ", " the strongly fragrant removing blood stasis that looses, make spontaneous and hundred bodies of fresh blood with " (" Elementary Medicine book on Chinese herbal medicine ").Pharmacological research shows that Rhizoma Cyperi has effect to uterus, cardiovascular system, and estrogen action and antiinflammatory action are arranged.

Radix Paeoniae Rubra, the master contains paeoniflorin, and calmness, analgesia, antiinflammatory, refrigeration function are arranged.Radix Paeoniae Rubra is gone into Liver Channel, main broken looses, main tonneau, specially goes into liver and resemble blood system, " then cold and heat are from ending in promoting the circulation of blood, and the broken blood that stagnates, then machine hernia abdominal mass is from disappearing ".(" Bencao Jingshu ")

Rhizoma Arisaematis, the master contains triterpenoid saponin, benzoic acid, alkaloid, glycoside etc., has the effect of " broken hard long-pending, subduing inflammation ".(" Kaibao Bencao ")

Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae, the master contains volatile oil flavonoid, hesperidin, has soothing the liver dispelling the stagnated QI, functions such as eliminating stagnationization stagnates, drying dampness to eliminate phlegm.

Herba Scutellariae Barbatae, Flos Chrysanthemi Indici, the master contains compositions such as alkaloid, flavonoid, sesquiterpenoids, heat-clearing and toxic substances removing is arranged, blood circulation promoting and blood stasis dispelling, dispersing swelling and dissipating binds analgesic effect.

The present invention is according to the ingenious prescription of function of cyclomastopathy pathogenesis and above-mentioned Fructus Trichosanthis, Rhizoma Cyperi, Radix Paeoniae Rubra, Rhizoma Arisaematis, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae, Herba Scutellariae Barbatae, Flos Chrysanthemi Indici, make preparation, has depressed liver-energy dispersing and QI regulating, dissipating phlegm and resolving masses, promoting blood circulation and stopping pain effect, to depression of liver-QI, expectorant stasis of blood retardance hyperplasia of mammary glands caused disease has significant curative effect.

The objective of the invention is to seek and solve a kind ofly has definite curative effect and little, the safe and reliable ideal new Chinese medicine preparation of toxic and side effects to cyclomastopathy, promotes human health.

The present invention realizes like this, according to the traditional Chinese medical science principles of formulating prescriptions, with the Fructus Trichosanthis is monarch drug, with Rhizoma Cyperi, Radix Paeoniae Rubra, Rhizoma Arisaematis is ministerial drug, is that adjuvant drug is formed prescription with Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae, Herba Scutellariae Barbatae, Flos Chrysanthemi Indici, adopts modern scientific method, promptly extract volatile ingredient and decocting in water alcohol precipitating method extraction active ingredient with the way of distillation, vacuum concentration, drying process extract total active ingredient, are mixed with Rujietai formulation again.

Rujietai formulation of the present invention has depressed liver-energy dispersing and QI regulating, dissipating phlegm and resolving masses, blood circulation promoting and blood stasis dispelling, the reducing swelling and alleviating pain effect, various types of cyclomastopathy are reached the nipple lid liquid that therefore causes, mastalgia, comprise that through fore udder swelling pain and other mastalgia prevention breast carcinoma postoperative recurrence and postoperative scar etc. have significant curative effect.This product is through clinical prerun, and total effective rate reaches 95%, and wherein produce effects and cure rate reach 69%.The Rujietai formulation pharmacological experiments shows, extracting dried cream with this product crude drug gavages, can obviously suppress the rat mammary gland hypertrophy that estradiol brings out, obviously reduce cyclomastopathy rat rat blood serum estradiol level, reduce uterus coefficient and ovary level, prompting has the effect of the cyclomastopathy of inhibition, can obviously suppress the rat paw edema that carrageenin brings out, improve mice hot plate territory, suppress spontaneous activity in mice etc., prompting this product has antiinflammatory, analgesia, sedation (see Appendix " Rujietai formulation cures mainly relevant Pharmacodynamic test of active extract data with function ").

The Rujietai formulation toxicological study is the result show: acute toxicity test, and extract dried cream rat oral gavage administration maximum tolerated dose with this product crude drug and be equivalent to 300 gram crude drug/kg, be equivalent to clinical plan 554 times with daily dose, observe a week and do not see toxicity; Long term toxicity test by total medical material 50,25,12.5g/kg gastric infusion, is equivalent to clinical plan 92,46,23 times with daily dose, and once a day, in continuous 24 weeks, histopathologic examination finds no tangible toxicity.(see Appendix: " Rujietai formulation animal acute toxicity test data ", " Rujietai formulation long-term toxicity test for animals data ".)

Pharmacology, toxicological study result show, this product safety, effective.

The key of preparation process thereof of the present invention is preparation recipe compatibility and prescription amount proportioning and extraction, preparation technology.

The prepared Rujietai formulation of the present invention has following characteristics:

1, the prescription design is unique, and prescription composition and selected medical material are all inequality with the like product that has gone on the market;

2, preparation special effect, treating both the principal and secondary aspects of a disease, curative effect is wide, can regulate allomeric function, control agent endocrine, adjusts sex hormone level, again can depressed liver-energy dispersing and QI regulating, dissipating phlegm and resolving masses, blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain, clinically all types of cyclomastopathies, mastalgia, prevention breast carcinoma postoperative recurrence there are specially good effect, and do not have obvious toxic and side effects.

3, technical matters advanced person, mature and reliable, constant product quality.

Embodiment:＜one 〉, preparation prescription forms: Fructus Trichosanthis 2825g Rhizoma Cyperi 2825g Radix Paeoniae Rubra 2275g Rhizoma Arisaematis 825g Pericarpium Citri Reticulatae Viride 775g Pericarpium Citri Reticulatae 775g Herba Scutellariae Barbatae 1775g Flos Chrysanthemi Indici 1775g＜two, preparation technology 1, distillation extraction: it is qualified that Rhizoma Cyperi, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae are concocted respectively, be ground into coarse powder, with clean Flos Chrysanthemi Indici, put in the alembic, adding distil water is an amount of, the distillation extraction volatile component, standby.2, boil and carry: Fructus Trichosanthis, Radix Paeoniae Rubra, Rhizoma Arisaematis, Herba Scutellariae Barbatae concoct respectively qualified after, Fructus Trichosanthis, Radix Paeoniae Rubra, Rhizoma Arisaematis shave, Herba Scutellariae Barbatae cutting, merge with Rhizoma Cyperi, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae, Flos Chrysanthemi Indici medicinal residues after the distillation, place retort, add water and do not have powder, decoct twice, 2 hours for the first time, 1.5 hours for the second time, merge decoction liquor, filtering, filtrate decompression is concentrated into the clear paste that relative density is 1.10～1.14 (60 ℃), leaves standstill to room temperature.3, precipitate with ethanol: (2) clear paste is added ethanol be about 50～70% to containing the alcohol amount, stir, leave standstill more than 24 hours, the leaching supernatant reclaims ethanol, and solution for vacuum concentration becomes clear paste standby.4, formulated: (1), the safe oral solutions of breast knot: 1., the filtering of volatile oil composition, add an amount of medicinal alcohol diluted for use.2., with the dilution volatile oil join in the clear paste, stir.3., a grade cane sugar is an amount of; Use dissolved in distilled water, filter, standby.4., 2. syrup is joined in the clear paste, adding distil water is sub-packed in clean 10ml and refers to capacity

In the shape bottle, promptly.Yield rate is about 97.6%.(2), the safe granule of breast knot: 1., granulate: clear paste is continued to be condensed into thick paste (relative density is 1.25～1.40), add one-level

Cane sugar powder (80 order) stirs, and makes suitable soft material, makes granule with 14 mesh sieves.2., oven dry: granule in 60 ℃ of following vacuum dryings to moisture pact≤4%, is taken out granulate.3., mix: after volatile oil is added an amount of medicinal alcohol dilution, under agitation evenly be sprayed into 2.

In the granule, fully mix.4., packing: the granule of mix homogeneously is sub-packed in (every bag of 10g) in the aluminium foil bag, promptly.Become

The product rate is about 98.2%.(3), the safe capsule of breast knot: 1., clear paste is continued to be condensed into thick paste,, pulverize in 65 ℃ of following vacuum dryings (dried cream moisture≤5%)

Cross 80 mesh sieves, standby.2., the volatile oil filtering joins in an amount of beta-schardinger dextrin-saturated aqueous solution, fully stir, under 10 ℃

Deposit more than 24 hours, the leaching precipitate is drained, and in 40 ℃ of oven dry down, porphyrize crosses 80

Mesh sieve, standby.3., will be 1. dried cream powder and the 2. abundant mix homogeneously of volatile oil wrappage fine powder, add an amount of stearic acid again

The abundant mix homogeneously of magnesium is sub-packed in the Capsules, every heavy 0.4g, that is, and yield rate

Be about 98.6%.(4), the safe tablet of breast knot: 1., clear paste is continued to be condensed into thick paste, add appropriate amount of starch (crossing 100 mesh sieves), stir into soft material,

Make granule with 14 mesh sieves, to pellet moisture≤4%, take out, use in 65 ℃ of following vacuum dryings

12 mesh sieve granulate, standby.2., the volatile oil filtering, join in an amount of beta-schardinger dextrin-saturated aqueous solution, stir,

In depositing under 10 ℃ more than 24 hours, the leaching precipitate is drained, granulate with 60 mesh sieves,

In 40 ℃ of oven dry down,, standby with 60 mesh sieve granulate.3., will be 1. dried cream powder and the 2. abundant mix homogeneously of volatile oil wrappage granule, add an amount of magnesium stearate, abundant mix homogeneously, with the dark recessed drift punch die tabletting of 12mm, every heavy 0.38g, sugar coating, promptly.Yield rate about 98.6%.

Claims

1, a kind of Chinese medicine preparation for the treatment of cyclomastopathy is characterized in that the preparation technology of said preparation: (1), preparation prescription are formed:

3 parts of 8 parts of Rhizoma Arisaematiss of 10 parts of Radix Paeoniae Rubra of 10 portions of Rhizoma Cyperis of Fructus Trichosanthis

6 parts of 6 parts of Flos Chrysanthemi Indicis of 2.5 portions of Herba Scutellariae Barbataes of 2.5 parts of Pericarpium Citri Reticulataes of Pericarpium Citri Reticulatae Viride

(2), preparation method:

Rhizoma Cyperi, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae, Flos Chrysanthemi Indici chopping, distillating extracting oil, airtight preservation; Medicinal residues are with Fructus Trichosanthis, Radix Paeoniae Rubra, Rhizoma Arisaematis, Herba Scutellariae Barbatae decocting in water, precipitate with ethanol, are condensed into thick paste, add appropriate amount of auxiliary materials, are mixed with preparation: oral liquid, granule, capsule, tablet.

2,, it is characterized in that prescription composition and medical material amount proportioning according to claims 1 described preparation process thereof.

3,, it is characterized in that distillation, decocting in water, precipitate with ethanol extraction process according to claims 1 described preparation process thereof.