CN1233345C - Chinese patent drug for treating cholelithiasis - Google Patents

Abstract

The present invention relates to a Chinese patent drug for treating cholelithiasis, which is prepared form nitre, alum and zedoary turmeric root-tuber as the monarch drug, rhizoma sparganii, pig bile cream and longhairy antenoron herb as the minister drug, tangerine peel, frankincense and myrrh as the adjuvant drug, and rhubarb, liquorice root and gentiana macrophylla as the envoy drug. The present invention has the effects of regulating the flow of qi, relieving qi stagnation, removing blood stasis, resolving static blood, removing edema, relieving pain, dissolving calculus and removing calculus, thereby obviously reducing or eliminating the threat of cholelithiasis to human beings.

Description

A kind of Chinese patent medicine that is used for the treatment of cholelithiasis

Content of the present invention belongs to the preparing technical field of pharmaceuticals, relates to a kind of Chinese patent medicine that can be used for clinical treatment cholelithiasis.

Cholelithiasis refers in the gallbladder or the disease of calculus takes place in the inside and outside bile duct of liver, is bigger commonly encountered diseases of a kind of harm and frequently-occurring disease.According to national cholelithiasis academic conference statistics in 1988, domestic many provinces and cities findings of the survey, the sickness rate of cholelithiasis is between 2.4%～16.8%, and American-European countries it is believed that and also is higher than this.The formation of cholelithiasis is infected with metabolism disorder, cholestasis and biliary system and is caused that bile component is relevant unusually, and it can cause crisis because of merging biliary tract infection, obstruction of biliary tract, perforation of gallbladder etc. again, therefore should very big threat be arranged disease centering senior health and fitness.The treatment of cholelithiasis, past is many based on surgical operation therapy, though effect is more sure, but also have many drawbacks, can be as postoperative residue calculus case up to 10%～25%, complication rate is more than 15%, and the postoperative death rate reaches 0.3%～3% according to statistics, calculus of intrahepatic duct also is difficult to the solution of armrest art in addition, thereby Chinese scholars more becomes to paying attention in the research to non-operative treatment in recent years.Try out at present in clinical non-operative treatment and comprise that the calculus therapy is (as dialectical calculus method, acupuncture calculus method, flushing calculus method etc.), the rubble therapy is (as the mechanical lithotripsy method, ultrasonic rubble method, high frequency electric rubble method, the laser lithotripsy method, microwave rubble method, extracorporeal shock-wave lithotripsy (ESWL) method etc.) and the litholytic therapy three major types, wherein litholytic therapy is divided two kinds of direct dissolution method and oral dissolution methods again, directly dissolution method medicament commonly used has the sad monoglyceride of compound recipe, methyl tertiary butyl ether(MTBE), the d-limonene, edetic acid or dimethyl sulfoxide, cyclohexanediaminetetraacetic acid etc., the medicament that oral dissolution method Western medicine is commonly used has chenodeoxycholic acid, ursodesoxycholic acid, Hyodeoxycholic Acid etc., and the research of oral Chinese medicine lithodialysis agent also day by day comes into one's own, and kind of a Chinese patent medicine preparation is put on market surplus in the of existing ten so far.Take a broad view of all medicines in many ways of present treatment cholelithiasis, both advantageous and disadvantageous, or because of curative effect relatively poor, or because of toxic and side effects bigger, or because of the equipment and technology complexity, or because of costing an arm and a leg, all embarrass the approval fully of extensive patients institute, thereby continuation excavation exploration still has very important meaning undoubtedly to develop this respect novel medicament.

The object of the present invention is to provide a kind of is that main effect is held concurrently and can be found gallbladder calculus, the little Chinese patent medicine compound preparation of side effect with lithodialysis, in order to overcome state of the art remain weak point.

The preparation scheme of Chinese Traditional Medicines of the present invention is designers according to the present situation of the epidemiology of cholelithiasis and treatment cholelithiasis, gives full play to motherland's traditional medicine advantage and defers to the tcm treatment according to syndrome differentiation principle and develop acquisition.Cholelithiasis belongs to disease scopes such as the traditional Chinese medical science " jaundice ", " association's pain ", " stone hernia ", " gallbladder-distention ", " gallbladder disease "." gallbladder-distention person, pain over the hypochondrium, bitter in mouthful, sighing frequently " just arranged, the record of " distension related to the liver person, fullness in the hypochondrium and pain extending to the lower abdomen " in " Ling Shu Miraculous Pivot or Divine Axis expand opinion " before bimillennium; The symptom that " blocked-up chest disease " described in Han dynasty " going through cold opinion TAI YANG syndrome a piece of writing " is: pain, tenderness in the diaphragm, breathe hard, the hard distension in heart bottom, skin turning yellow etc., infect rather similar to biliary system with cholelithiasis; " the addiction Huang " of record is also close with primary disease in the Sui Dynasty Chao Yuanfang (550-630 A.D.) " General Treatise on the Cause and Symptoms of Diseases ".Say when Ming Dynasty's Li Shizhen (1518-1593 A.D.) is spoken of Calculus Bovis (Calculus Bovis) medicine in Compendium of Material Medica: " Huang of cattle, the disease of cattle also.So the cattle of Huang (cholelithiasis) is arranged, many sick all beasts all have Huang and easily dead, and people's disease is yellow as the same ", so-called " people's disease Huang " refers to promptly that the people is also the same with cattle and can suffer from gallstone disease.Comprehensive above-mentioned as seen, the appearance of primary disease is because due to the stagnation of QI, blood stasis, the rule of treatment is worked as regulating qi to disperse stagnation, heart fire-clearing upset-relieving.In view of the above, designer of the present invention chooses some drug effects and concentrates and be easy to the Chinese herb medicine material composition side of being prepared into for absorption of human body, medicine in the side is a monarch drug with Sal Nitri, Alumen, Radix Curcumae, rhizoma sparganic, Fel Sus domestica unguentum, Herba Lysimachiae are ministerial drug, assistant is with Pericarpium Citri Reticulatae, Olibanum, Myrrha, and make it to play the effect of the resolving depression of regulating the flow of vital energy, blood stasis-eliminating and stagnation-dissipating, reducing swelling and alleviating pain, calculus dissolving and excreting altogether, thereby significantly reduce or eliminate the threat of cholelithiasis health of people with Radix Et Rhizoma Rhei, Radix Glycyrrhizae.

The proportioning value that constitutes each raw material components of Chinese patent medicine of the present invention is: 10～400 unit of weights of Sal Nitri (system), 5～350 unit of weights of Alumen, 10～500 unit of weights of Radix Curcumae, 5～300 unit of weights of rhizoma sparganic, 8～300 unit of weights of Fel Sus domestica unguentum, 25～800 unit of weights of Herba Lysimachiae, 8～200 unit of weights of Pericarpium Citri Reticulatae, 5～350 unit of weights of Olibanum (system), 7～500 unit of weights of Myrrha (processed), 10～400 unit of weights of Radix Et Rhizoma Rhei, 5～100 unit of weights of Radix Glycyrrhizae.

The prescription of making according to above-mentioned raw materials has demonstrated fully the determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs principle of motherland's medical science about " treatment must aim at the pathogenesis of disease ", " radicallying reform ".Principal agent Sal Nitri, Alumen in the side, record the earliest sees Shennong's Herbal, later long-term clinical practice through ancient Chinese medicine doctor, further certainly and widened the effect that this two medicine is treated various gallbladder disease and calculus, as putting down in writing in " Records of Tradition Chinese and Western Medicine in Combination ": " Sal Nitri and Melanteritum are with using; be apt to control jaundice with internal injury, calculus in the subcutaneous ulcer that disappears, calculus in the bladder "; Radix Curcumae function and blood dissipating blood stasis, promoting QI circulation for relieving depression can be controlled cholelithiasis and jaundice; Rhizoma sparganic removing blood stasis, circulation of qi promoting, pain is particularly suitable down to trusted subordinate's pain, the side of body; Fel Sus domestica unguentum can heat clearing away, moisturize, relieving constipation, sharp jaundice; Herba Lysimachiae can " heat clearing away, diuresis, detumescence " according to " Chinese medicine voluminous dictionary " record, cures mainly jaundice, edema, diseases such as vesical calculus; Pericarpium Citri Reticulatae, Olibanum, Myrrha, or promoting the circulation of QI to relieve pain or promoting blood circulation, removing blood stasis and relieving pain; Radix Et Rhizoma Rhei heat clearing away, function of gallbladder promoting, relieving constipation; Radix Glycyrrhizae emergency, pain relieving, coordinating the actions of various ingredients in a prescription experimental results show that in recent years Radix Glycyrrhizae also has the effect of function of gallbladder promoting treating the liver inflammation.Above-mentioned 11 herbal medicines are put in the flavor side, and its effect emphasizes particularly on different fields, or lithodialysis, calculus, or heat clearing away, promoting the function of the gallbladder to alleviate jaundice, or the regulating qi to disperse stagnation pain relieving, integral body combines, imitate Bo Lihong, aspect the treatment that comprises the stagnation of QI, the stagnation of QI and various cholelithiasis such as damp and hot, have fabulous effect.

Actual product of the present invention is the various form of Chinese drug made from the conventional preparation technology of Chinese medicine that comprise capsule, coated tablet, granule etc.

Clinical observation and curative effect

In development process of the present invention, for this medicine of objective evaluation to the clinical efficacy of cholelithiasis and to the safety of human body, the applicant once defends the accurate word Z-59-1 of medicine official written reply notice according to Ministry of Public Health appointment (92) and has carried out clinical trial, be total to clinical treatment during this time and observe case 300 examples, patient age is between 19～65 years old.

One, case is selected:

1, Western medicine diagnose standard,

(1), pain under upper right abdomen or the xiphoid-process;

(2), 1. abdominal distention, 2. loss of appetite;

(3), cholelithiasis is found in ultrasound diagnosis.

Have in above-mentioned (1), (2) each and (3), just diagnosable.

2, Chinese medical discrimination standard

Qi-stagnation type: upper right distention and fullness in the abdomen dull pain or paroxysmal colic, pain are drawn the shoulder back of the body or companion's gastral cavilty portion feeling of fullness, and anorexia is greasy, and body of the tongue is light red, the white or little Huang of tongue fur, stringy and tense pulse.

3, mild symptoms weight classification

Symptom	Gently (2 minutes)	In (4 minutes)	Heavy (6 minutes)
				Right hypochondrial region	The idol that has a dull ache has outbreak	Pain is retransmitted and is done frequently	Sharp ache shows effect repeatedly
The gastral cavilty feeling of fullness	Occur occasionally after the feed	Whenever occur in the feed back	No matter whether take food all occur
				Appetite descends	Detest greasy	Anorexia	Appetite reduces
Tongue fur	In vain	HUANGBAI(sic)	Yellow
				Pulse condition	String	Stringy and tense pulse	Stringy and thready pulse

4, syndrome weight criterion

Slightly: below 11 minutes;

Moderate: 12～21 minutes;

Severe: more than 22 minutes.

Two, Therapeutic Method: oral this Chinese patent medicine tablet, each 6 (every nearly weighs 0.4g), every day 3 times, taking for 6 weeks continuously is a course of treatment.

Three, curative effect determinate standard: according to " new Chinese medicine clinical research guideline cholelithiasis "

1, clinical cure: sings and symptoms disappearance (integration drops to 0), imaging examination calculus disappearance person.

2, produce effects: sings and symptoms obviously alleviates (integration descends more than 1/2), the imaging examination calculus has obvious minimizing, reach more than 1/2, or calculus diminishes 1/2 above person.

3, effective: sings and symptoms has and alleviates (integration descends to some extent), imaging examination calculus and reduce or the person of diminishing before the treatment.

4, invalid: sings and symptoms does not have and alleviates or no change, imaging examination calculus do not have the changer.

Four, therapeutic outcome: experimental observation group 300 routine cases after taking this Chinese Traditional Medicines tablet in treatment, clinical cure 65 people, produce effects 114 people, effective 88 people, invalid 33 people, total obvious effective rate 59.7%, total effective rate 89.0%.In the therapeutic test process, do not find that this medicine has obvious adverse reaction.

Claims (1)

1, a kind of Chinese patent medicine that is used for the treatment of cholelithiasis is characterized in that the raw material that makes this effective ingredient consists of: 10～400 unit of weights of system Sal Nitri, 5～350 unit of weights of Alumen, 10～500 unit of weights of Radix Curcumae, 5～300 unit of weights of rhizoma sparganic, 8～300 unit of weights of Fel Sus domestica unguentum, 25～800 unit of weights of Herba Lysimachiae, 8～200 unit of weights of Pericarpium Citri Reticulatae, 5～350 unit of weights of Olibanum (processed), 7～500 unit of weights of Myrrha (processed), 10～400 unit of weights of Radix Et Rhizoma Rhei and 5～100 unit of weights of Radix Glycyrrhizae; Wherein Sal Nitri, Alumen and Radix Curcumae are monarch drug, and rhizoma sparganic, Fel Sus domestica unguentum and Herba Lysimachiae are ministerial drug, and Pericarpium Citri Reticulatae, Olibanum and Myrrha are adjuvant drug, and Radix Et Rhizoma Rhei and Radix Glycyrrhizae are messenger drug.