CN107485700A

CN107485700A - Qing Gan Capsule and its preparation method and application

Info

Publication number: CN107485700A
Application number: CN201610795133.1A
Authority: CN
Inventors: 单晓春
Original assignee: Individual
Current assignee: Individual
Priority date: 2016-08-31
Filing date: 2016-08-31
Publication date: 2017-12-19

Abstract

The invention belongs to pharmaceutical technology field, and in particular to a kind of Qing Gan Capsule and its preparation method and application.The Qing Gan Capsule, it is made up of the bulk drug of following weight：10 20 parts of giant knotweed, 10 20 parts of Asian puccoon, 10 20 parts of bear gall, 10 20 parts of cape jasmine, 10 20 parts of oriental wormwood, 10 20 parts of Sculellaria barbata, 15 25 parts of radix scutellariae, 10 20 parts of radix scrophulariae, 10 20 parts of dandelion, 10 20 parts of honeysuckle, 5 15 parts of the capsule of weeping forsythia, 10 20 parts of Radix Isatidis, 5 15 parts of the root of herbaceous peony, 10 20 parts of Fructus Aurantii, 15 25 parts of radish seed, 10 20 parts of dried orange peel, 10 20 parts of Poria cocos, 10 20 parts of hawthorn, 10 20 parts of malt, 10 20 parts of Divine Comedy, 10 20 parts of radix bupleuri, 10 20 parts of rheum officinale, 10 20 parts of radix glycyrrhizae.The Qing Gan Capsule has the effect of clearing liver dampness removing, removing toxic substances analgesic, can be clinically used for treating icteric hepatitis, chronic hepatitis, hepatic sclerosis, chronic cholecystitis, refractory acne disease category liver and gallbladder damp-heat person, has the effect of good.

Description

Qing Gan Capsule and its preparation method and application

Technical field

The invention belongs to pharmaceutical technology field, and in particular to a kind of Qing Gan Capsule and its preparation method and application.

Background technology

Icteric hepatitis makes liver thin because a variety of causes (virus such as first, second, hepatitis, drinking, medicine etc.) acts on liver Born of the same parents' denaturation, destruction, necrosis, liver cell and fibr tissue reconstruct, cause cholangiole to be blocked so as to cause on blood mesobilirubin The disease of liter, skin mucous membrane xanthochromia, the yellow urine such as symptom such as tea, hepatalgia, heating,

Jaundice clinic is more common in acute viral hepatitis, with virus hepatitis A type, B-mode most common, is once called as popular Huang Subcutaneous ulcer and catarrhal jaundice, Combined hepatitis A and B vaccine virus are respectively provided with addicted to liver property, and season is popular more at the beginning of last month of spring in winter and at the beginning of autumn late summer, faces Bed is mainly shown as anorexia, nausea and vomiting, fatigue and weak, and hepatomegaly is with there is jaundice, and this disease is in worldwide distribution, China It is hepatitis A district occurred frequently again, small-scale prevalence can be caused sometimes.This sick doctor trained in Western medicine there is no specific short, and clinical practice is more using heavy dose Vitamin C drip-feed, while energize mixture and Potassium Magnesium Aspartate, vitamin K1, vitamin B complex etc., to improve liver Dirty metabolism, promote toxin excretion, so as to reach therapeutic purposes.

Virus B hepatitis is the popular infectious disease of world wide, especially in countries and regions such as Asia, Africa It is occurred frequently.Global about hundred million people once infected, wherein hundred million people are changed into chronic infection, latest survey result shows China's hepatitis B surface Antigen carrying rate is 7.18%, is qualified hepatitis big country.The easy chronicity of hepatitis B, chronic hepatitis b disease Cheng Qian Prolong, liver function Chang Fanfu is abnormal, can finally cause liver fibrosis, the hepatic sclerosis even generation of liver cancer.In recent years, Lamivudine etc. The new page of chb treatment has been opened in the application of nucleosides (acid) analog, and clinical efficacy is greatly improved.But with above-mentioned Long-term, the extensive use of medicine, also expose some intractable new problems：1. can only suppressing virus replication in the regular period, nothing Method thoroughly eradicates internal hepatitis B, and long-term prescription produces single medicine resistance or multidrug resistant, so as to cause to recur；2. the course for the treatment of It is long, it is discontinued difficult；3. drug price is more expensive, the financial burden of long-term prescription is heavier, unsuitable China's national situation；4. Generative safety Property it is not high, have fertility demand person need to be discontinued, be easily caused recurrence；5. less varieties and resistance site it is overlapping or intersect, choice It is small, once resistance occurs, lack the active drug and method of replacement or successive treatment；6. nonstandard Clinical practice has resulted in resistance to The increase of medicine rate；7. some patientss are primary to such medicine unresponsive；8. pair hepatitis B patient symptom, the alleviation of sign or elimination effect Unobvious.The presence of above mentioned problem, the late result of chb is have impact on, irrelevantly using antiviral drugs, or even can band Carry out the problem of more serious.

Hepatic sclerosis is clinical common chronic progressive hepatopathy, by one or more causes of disease are long-term or repeated action formed Diffusivity hepatic lesion.It is posthepatitic cirrhosis in most of China, small part is alcoholic cirrhosis and Cirrhosis In Schistosomiasis. There are extensive necrosis of liver cells, regeneration of remaining liver cell nodules, connective tissue proliferation and fiber in Histopathology every formation, Cause lobuli hepatis structure to be destroyed to be formed with pseudolobuli, liver gradually deforms, is hardened and develops into hepatic sclerosis.Early stage is due to liver generation Repay function more by force can non-evident sympton, stage has multisystem involvement using hepatic disorder and portal hypertension as main performance, Often there are the complication such as UGB, hepatic encephalopathy, scabies secondary infection, hypersplenia, ascites, canceration in late period.Hepatic sclerosis Doctor trained in Western medicine not yet specific medicament at present.

Chronic cholecystitis (ChronicCholecystitis) is common, multiple disease of digestive system, more by chronic infection, Caused by calculus, chemical stimulation or acute cholecystitis delay, clinical manifestation is asymptomatic or recurrent exerbation upper right abdominal distention and pain or hidden Bitterly, induced more by feed greasy food, often with dry mouth with bitter taste, abdominal distension, nausea and vomiting, etc. symptom.With living standard in recent years Improve, the sick incidence of disease increasingly increases.For Western medicine based on symptomatic treatment, effect is not satisfactory at present.

The content of the invention

In order to solve above-mentioned technical problem, the invention provides a kind of Qing Gan Capsule and preparation method thereof.

A kind of Qing Gan Capsule, it is made up of the bulk drug of following weight：

Giant knotweed 10-20 parts, Asian puccoon 10-20 parts, bear gall 10-20 parts, cape jasmine 10-20 parts, oriental wormwood 10-20 parts, Sculellaria barbata 10- 20 parts, radix scutellariae 15-25 parts, radix scrophulariae 10-20 parts, dandelion 10-20 parts, honeysuckle 10-20 parts, capsule of weeping forsythia 5-15 parts, Radix Isatidis 10- 20 parts, root of herbaceous peony 5-15 parts, Fructus Aurantii 10-20 parts, radish seed 15-25 parts, dried orange peel 10-20 parts, Poria cocos 10-20 parts, hawthorn 10-20 Part, malt 10-20 parts, Divine Comedy 10-20 parts, radix bupleuri 10-20 parts, rheum officinale 10-20 parts, radix glycyrrhizae 10-20 parts.

Preferably, above-mentioned Qing Gan Capsule, it is made up of the bulk drug of following weight：

Giant knotweed 13-17 parts, Asian puccoon 13-17 parts, bear gall 13-17 parts, cape jasmine 13-17 parts, oriental wormwood 13-17 parts, Sculellaria barbata 13- 17 parts, radix scutellariae 18-22 parts, radix scrophulariae 13-17 parts, dandelion 13-17 parts, honeysuckle 13-17 parts, capsule of weeping forsythia 8-12 parts, Radix Isatidis 13- 17 parts, root of herbaceous peony 8-12 parts, Fructus Aurantii 13-17 parts, radish seed 18-22 parts, dried orange peel 13-17 parts, Poria cocos 13-17 parts, hawthorn 13-17 Part, malt 13-17 parts, Divine Comedy 13-17 parts, radix bupleuri 13-17 parts, rheum officinale 13-17 parts, radix glycyrrhizae 13-17 parts.

It is furthermore preferred that above-mentioned Qing Gan Capsule, is made up of the bulk drug of following weight：

15 parts of giant knotweed, 15 parts of Asian puccoon, 15 parts of bear gall, 15 parts of cape jasmine, 15 parts of oriental wormwood, 15 parts of Sculellaria barbata, 20 parts of radix scutellariae, radix scrophulariae 15 parts, 15 parts of dandelion, 15 parts of honeysuckle, 10 parts of the capsule of weeping forsythia, 15 parts of Radix Isatidis, 10 parts of the root of herbaceous peony, 15 parts of Fructus Aurantii, 20 parts of radish seed, 15 parts of dried orange peel, 15 parts of Poria cocos, 15 parts of hawthorn, 15 parts of malt, 15 parts of Divine Comedy, 15 parts of radix bupleuri, 15 parts of rheum officinale, 15 parts of radix glycyrrhizae.

In the composition described above of the present invention, the weight of each taste Chinese medicine is calculated with crude drug, if in grams, be such as made Preparation, then because the of different sizes of preparation can be made into 100-1000 agent.The 100-1000 agent refers to the dosage form of unit dose, Such as tablet 100-1000 pieces, capsule 100-1000 grains, granule 100-1000g, oral liquid 100-1000ml, paste 100- 1000g, pill 100-1000 balls etc..

Composition described above is by weight as proportioning, can increase or reduce according to corresponding proportion in production, such as extensive Production can be in units of kg, or with t (ton) for unit；Small-scale preparation can also be in units of g.Weight can increase or Reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.

The ratio of above weight proportion screens to obtain by science, fat such as severe or mild for especial patient Or the patient of slight of stature, the proportioning of the amount of composition can be accordingly adjusted, is increased or decreased no more than 100%, drug effect is basically unchanged.

The Qing Gan Capsule of the present invention, can add some pharmaceutically acceptable auxiliary materials, can adopt individually or as needed The pharmaceutical preparation is prepared with galenic pharmacy routine techniques.Any pharmaceutically useful peroral dosage form can be made when pharmaceutical preparation is made, These formulations are selected from：Granule, tablet, capsule, oral liquid, mouth containing agent, pill, powder, preferably capsule.

The preparation method of above-mentioned Qing Gan Capsule, is comprised the following steps：

A. giant knotweed in the side of taking, Asian puccoon, cape jasmine, oriental wormwood, Sculellaria barbata, radix scrophulariae, dandelion, honeysuckle, the capsule of weeping forsythia, Radix Isatidis, white Chinese herbaceous peony, Fructus Aurantii, radish seed, dried orange peel, Poria cocos, hawthorn, malt, Divine Comedy, radix bupleuri, radix glycyrrhizae add water to cook 3 times, add drug weight for the first time The water of 8 times of amounts, the water of 6 times of amounts of second and third time plus drug weight, is decocted 2 hours every time, is merged decoction liquor concentration thick paste, is dried, Dry powder extract powder and radix scutellariae, the taste Chinese medicine of rheum officinale 2 are mixed and be ground into fine powder, obtains medicinal powder A；

B, bear gall be crushed into 100 mesh sieves, obtain bear gall fine powder；

C, bear gall fine powder is added in medicinal powder A and stirred, sterilized, produce the active material of Qing Gan Capsule of the present invention；

D, the active material is independent or is mixed with pharmaceutically acceptable auxiliary material, is made according to galenic pharmacy conventional method.

Described pharmaceutically acceptable auxiliary material is selected from：Starch, magnesium stearate, mannitol, sorbierite, sorbic acid or sylvite, Sodium pyrosulfite, sodium hydrogensulfite, sodium thiosulfate, cysteine hydrochloride, TGA, methionine, vitamin A, vitamin C, vitamin E, vitamin D, azone, EDETATE SODIUM, Ethylenediaminetetraacetic Acid Calcium Salt, the carbonate of monovalence alkali metal, acetate, phosphate or its The aqueous solution, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acid, sodium chloride, potassium chloride, sodium lactate, xylitol, dextran, sweet ammonia Acid, lactose, mannitol, silicon derivative, cellulose and its derivates, alginates, gelatin, polyvinylpyrrolidone, glycerine, third Glycol, ethanol, polysorbate60-80, Span-80, beeswax, lanolin, atoleine, hexadecanol, gallate ester, three ethanol Amine, basic amino acid, urea, allantoin, calcium carbonate, calcium bicarbonate, surfactant, polyethylene glycol, cyclodextrin, β-ring paste Essence, phospholipid material, kaolin, talcum powder, calcium stearate etc..

Above-mentioned Qing Gan Capsule is preparing the application in treating icteric hepatitis medicine.

Above-mentioned Qing Gan Capsule is preparing the application in treating chronic hepatitis medicine.

Above-mentioned Qing Gan Capsule is preparing the application in treating hepatic sclerosis medicine.

Above-mentioned Qing Gan Capsule is preparing the application in treating chronic cholecystitis medicine.

Above-mentioned Qing Gan Capsule is preparing the application in treating refractory acne medicine.

The usage and dosage of the Qing Gan Capsule of the present invention：Orally, it is daily 2-3 times, each 5-8 grains.

The prescription of the Qing Gan Capsule of the present invention, it is the prescription of clearing liver cholagogic removing toxic substances, with giant knotweed, Asian puccoon, bear gall powder clearing liver courage Based on damp and hot, add the effect of cape jasmine, oriental wormwood, Radix Isatidis, Sculellaria barbata are to help clearing liver courage, the soft liver analgesic of the root of herbaceous peony, the moon, Poria cocos are held back in blood-nourishing Spleen-benefiting mind-tranquilizing, radish seed, dried orange peel, Fructus Aurantii gas consumption product, resolving sputum remove ruffian, and hawthorn, Divine Comedy, malt help digestion, stomach invigorating, reason that radix bupleuri is soothing the liver Gas, the effect of honeysuckle, the capsule of weeping forsythia, radix scrophulariae, radix scutellariae, public English are to help removing toxic substances, rheum officinale drop solve by stagnant heat from stool.The poison of radix glycyrrhizae solution hundred, To make coordinating the drug actions of a prescription.All medicines share, clearing liver dampness removing is played altogether, the effect of relieving pain of detoxifying.Clinic is usually used in caused by liver and gallbladder damp-heat Jaundice, hypochondriac pain (all kinds of hepatitis), liver product (hepatic sclerosis) (icteric hepatitis, acute, chronic hepatitis hepatic sclerosis).Symptoms include：Dry is bitter, the side of body Rib pain, the jaundice of body mesh, deficiency of food is indigestion and loss of appetite, yellow and greasy fur, slippery and rapid pulse etc..

Inventor has found that above-mentioned Qing Gan Capsule, clinic can also be used for treating refractory acne, effective in clinical studies Rate is up to 53.33%, and cure rate is up to 96.67%.Speculate that it is treated the mechanism of refractory acne and enhances liver for Qing Gan Capsule Dirty function of detoxification, and liver is the maximum removing toxic substances organ of human body, liver function strengthens, the enhancing of toxin metabolic capability so that toxin Solved from liver, skin of not going further, so that refractory acne is thoroughly cured.

Embodiment

The present invention is further described with reference to specific embodiment, so that those skilled in the art knows more about The present invention, but and it is not so limited the present invention.

Embodiment 1

A kind of Qing Gan Capsule, it is made up of the bulk drug of following weight proportion：

Giant knotweed 15g, Asian puccoon 15g, bear gall 15g, cape jasmine 15g, oriental wormwood 15g, Sculellaria barbata 15g, radix scutellariae 20g, radix scrophulariae 15g, Pu Public English 15g, honeysuckle 15g, capsule of weeping forsythia 10g, Radix Isatidis 15g, root of herbaceous peony 10g, Fructus Aurantii 15g, radish seed 20g, dried orange peel 15g, Poria cocos 15g, hawthorn 15g, malt 15g, Divine Comedy 15g, radix bupleuri 15g, rheum officinale 15g, radix glycyrrhizae 15g.

The preparation method of the Qing Gan Capsule：

B, bear gall be crushed into 100 mesh sieves, obtain bear gall fine powder；

D, the active material bacterium, capsule, sub-bottling are dispensed in 300,000 grades of clean areas.Capsule 800 is made altogether.

Embodiment 2

Giant knotweed 13g, Asian puccoon 17g, bear gall 13g, cape jasmine 17g, oriental wormwood 13g, Sculellaria barbata 17g, radix scutellariae 18g, radix scrophulariae 17g, Pu Public English 13g, honeysuckle 17g, capsule of weeping forsythia 8g, Radix Isatidis 17g, root of herbaceous peony 8g, Fructus Aurantii 17g, radish seed 18g, dried orange peel 17g, Poria cocos 13g, Hawthorn 17g, malt 13g, Divine Comedy 17g, radix bupleuri 13g, rheum officinale 17g, radix glycyrrhizae 13g.

The preparation method of the Qing Gan Capsule：

B, bear gall be crushed into 100 mesh sieves, obtain bear gall fine powder；

Embodiment 3

Giant knotweed 17g, Asian puccoon 13g, bear gall 17g, cape jasmine 13g, oriental wormwood 17g, Sculellaria barbata 13g, radix scutellariae 22g, radix scrophulariae 13g, Pu Public English 17g, honeysuckle 13g, capsule of weeping forsythia 12g, Radix Isatidis 13g, root of herbaceous peony 12g, Fructus Aurantii 13g, radish seed 22g, dried orange peel 13g, Poria cocos 17g, hawthorn 13g, malt 17g, Divine Comedy 13g, radix bupleuri 17g, rheum officinale 13g, radix glycyrrhizae 17g.

The preparation method of the Qing Gan Capsule：

B, bear gall be crushed into 100 mesh sieves, obtain bear gall fine powder；

Embodiment 4

Giant knotweed 10g, Asian puccoon 20g, bear gall 10g, cape jasmine 20g, oriental wormwood 10g, Sculellaria barbata 20g, radix scutellariae 15g, radix scrophulariae 20g, Pu Public English 10g, honeysuckle 20g, capsule of weeping forsythia 5g, Radix Isatidis 20g, root of herbaceous peony 5g, Fructus Aurantii 20g, radish seed 15g, dried orange peel 20g, Poria cocos 10g, Hawthorn 20g, malt 10g, Divine Comedy 20g, radix bupleuri 10g, rheum officinale 20g, radix glycyrrhizae 10g.

The preparation method of the Qing Gan Capsule：

B, bear gall be crushed into 100 mesh sieves, obtain bear gall fine powder；

C, bear gall fine powder is added in medicinal powder A and stirred, sterilized, produce the active material of Qing Gan Capsule of the present invention：

Embodiment 5

Giant knotweed 20g, Asian puccoon 10g, bear gall 20g, cape jasmine 10g, oriental wormwood 20g, Sculellaria barbata 10g, radix scutellariae 25g, radix scrophulariae 10g, Pu Public English 20g, honeysuckle 10g, capsule of weeping forsythia 15g, Radix Isatidis 10g, root of herbaceous peony 15g, Fructus Aurantii 10g, Semen Raphani 25g, dried orange peel 10g, Poria cocos 20g, hawthorn 10g, malt 20g, Divine Comedy 10g, radix bupleuri 20g, rheum officinale 10g, radix glycyrrhizae 20g.

The preparation method of the Qing Gan Capsule：

B, bear gall be crushed into 100 mesh sieves, obtain bear gall fine powder；

The Qing Gan Capsule prepared to embodiment 1 has carried out clinical test, and Details as Follows：

Qing Gan Capsule treats the clinical data of icteric hepatitis

1 data and method

1.1 general information 200 acute icteric hepatitis patients of this group, wherein man 105, female 95, age 8-62 Year, course of disease 3-55 days.All case clinical manifestations and biochemical indicator meet the Xi'an meeting revision of 2000 Nian9Yue Chinese Medical Association Virus hepatitis diagnostic criteria, through liver function, virus marker thing and B ultrasound etc. check, be diagnosed as hepatitis A 84, second Type hepatitis 97, hepatitis C 2, Hepatitis E 17.200 cases are randomly divided into treatment group and each 100 of control group, Two groups of patients are in sex, age, the state of an illness and the course of disease, ALT (glutamic-pyruvic transaminase), TBIL (total bilirubin) etc., through statistics There was no significant difference (P ＞ 0.05) for processing, has comparativity.

1.2 treatment method control group gives diammonium glycyrrhizinate and reduced glutathione drip-feed.Treatment group is compareing On the basis of group, the Qing Gan Capsule of the present invention, orally, daily 2-3 times, each 5-8 grains are added.And 2 weeks and 4 weeks points after the treatment Guan Cha not the index such as ALT, TBIL.

1.3 efficacy assessment standards revise 2002 editions with reference to National Drug Administration《New Chinese medicine clinical research is instructed Principle》Drafted standard.

It is effective：Symptom and sign disappears, and Serum ALT, TBIL are normal；Effectively：Symptom and sign is obviously improved, Serum ALT, TBIL Compared with declining more than half before treatment；It is invalid：First quarter moon above symptom and sign is treated without improvement, Serum ALT,

TBIL has no decline or lasting rising.

2 results

2.1 two groups of contrasts, in terms of TBIL reduction, Qing Gan Capsule of the invention has the effect of notable.After the treatment 2 In the observation in week and 4 weeks, compared with control group, there were significant differences (P ＜ 0.05) for the TBIL declines for the treatment of group, is shown in Table 1.

The pretherapy and post-treatment TBIL changes of 1 two groups of table are compared (μm ol/L, x ± s)

Group	n	Before treatment	Treatment 2 weeks	Treatment 4 weeks
					Treatment group	100	126.42±28.77	59.24±18.57*	18.59±5.68*
Control group	100	123.26±26.59	2.36±19.86	48.96±7.95

Note：Compared with control group, P ＜ 0.05.

2.2 two groups of contrasts, the ALT for the treatment of group before the treatment, 4 weeks after latter 2 weeks, treatment, difference there are no significant meaning (P ＞ 0.05), it is shown in Table 2.

The pretherapy and post-treatment ALT changes of 2 two groups of table are compared (U/L, x ± s)

Group	n	Before treatment	Treatment 2 weeks	Treatment 4 weeks
					Treatment group	100	838.44±168.52	528.69±152.37	59.87±8.52
Control group	100	837.55±160.23	529.16±160.58	69.53±11.29

Qing Gan Capsule treats the clinical data of chronic hepatitis

1 data and method

1.1 basic datas choose the chronic hepatitis B patient 112 for meeting inclusive criteria, take random digits table Patient is divided into treatment group and treatment group, every group each 56.Male patient 29 in treatment group, female patient 27, age 15- 77 years old, average age (35.43 ± 5.85) year, the course of disease -12 years 3 months, average course of disease (3.52 ± 1.09) year；It is male in control group Property patient 30, female patient 26, age 18-75 year, average age (37.24 ± 6.07) year, the course of disease -11 years 4 months, put down The equal course of disease (3.77 ± 1.22) year.Two groups of patient base's data compare between taking group, and difference does not have statistical significance (P ＞ 0.05)。

1.2 diagnostic criteria the past patients had hepatitis B medical history or the HBsAg positives more than 6 months, patient when entering group HBsAg and HBV-DNA is positive, patient's dysfunction of liver, and echo thickening in B ultrasound prompting liver, liver or spleen are with enlargement.In Doctor's diagnosis meets following standard：Dry is bitter, pain over the hypochondriac region, and the jaundice of body mesh, deficiency of food is indigestion and loss of appetite, yellow and greasy fur, slippery and rapid pulse etc..

1.3 exclusion standards exclude other patients with viral infections for having outside hepatitis viruse simultaneously；Except it is acute, subacute Hepatitis caused by the factor such as hepatitis or drug poisoning, alcoholism；Exclusion is associated with the infull patient of the serious heart, lung, liver；Exclude With serious disturbance of consciousness patient；Except gestation or women breast-feeding their children, except merge severe psychiatric diseases, dementia patients.

1.4 treatment method

Control group is given patient's diammonium glycyrrhizinate injection 30mL+ glucose injection 250mL drip-feeds and controlled, 1 time/d, treatment Therapeutic effect is observed after 3 months.Give the symptomatic treatment supportive treatment such as patient's Inosine tablets, B family vitamin simultaneously.Treatment group is right According to the Qing Gan Capsule that the present invention is added on the basis of group, orally, daily 2-3 times, each 5-8 grains.

1.5 efficacy determinations are cured：Patient clinical symptom is wholly absent, and liver recovers normal and tenderness disappears, and liver function is extensive Multiple normal, HBeAg, HBV-DNA all turn out cloudy, stable more than 6 months；It is effective：Patient clinical symptom is clearly better, and liver is bright Aobvious to bounce back and without tenderness, percussion pain, liver function recovery is normal, has one to turn out cloudy in HBeAg, HBV-DNA；Effectively：Patient clinical Symptom has taken a turn for the better, and hepatosplenomegaly is stable, and patient's liver tenderness or percussion pain mitigate, the more original drop by half of liver function with On, there is one to switch to weakly positive in HBeAg, HBV-DNA；It is invalid：Patient clinical symptom have no improvement or aggravate, liver function compared with Without change before treatment.Pretherapy and post-treatment third aminopherase of two groups of patients, AST, gamma-glutamyl is recorded to turn Enzyme concentration situation of change is moved, HBeAg and HBV-DNA turns out cloudy situation after record patient's treatment.

Patient's treatment is arranged by special messenger, concluded for 1.6 statistical procedures and input computer, form data Storehouse, statistical analysis is carried out using SPSS16.0 softwares, be that difference has statistical significance with P ＜ 0.05.

2 results

2.1 two groups of patient outcomes' comparison therapy groups cure 28, effective 15, effective 11, invalid 2；Control Group cures 14, and effective 18, effective 7, invalid 17, treatment group's total effective rate is significantly higher than control group (P ＜ 0.05).See Table 3.

3 two groups of patient outcomes of table compare [n (%)]

Group	Number of cases	Cure	It is effective	Effectively	It is invalid	Total effective rate (%)
							Treatment group	56	28	15	11	2	96.43
Control group	56	14	18	7	17	69.64

Note：Compared with control group, * P ＜ 0.05.

Show before ALT, AST, γ-GT are relatively treated after 2.2 two groups of patients, two groups of treatments of pretherapy and post-treatment changes of liver function situation Writing improves (P ＜ 0.05), and treatment group's curative effect is better than control group (P ＜ 0.05).It is shown in Table 4.

The pretherapy and post-treatment changes of liver function situation of 4 two groups of patients of table compares (x ± s)

Note：With this group before treatment, * P ＜ 0.05；Compared with after control group treatment, #P ＜ 0.05.

The HBeAg and HBV-DNA situation treatment group patient HBeAg that turn out cloudy turn out cloudy 29 after 2.3 two groups of patients treatment, HBV- DNA turns out cloudy 24；Control group patient HBeAg turns out cloudy 16, and HBV-DNA turns out cloudy 14, and contrast difference is statistically significant between group (P ＜ 0.05), refers to table 5.

HBeAg and the HBV-DNA situations of turning out cloudy compare [n (%)] after 5 two groups of patient's treatments of table

Note：Compared with control group, * P ＜ 0.05.

Qing Gan Capsule treats the clinical data of hepatic sclerosis

1 data and method

1.1 inclusion criteria：The virus hepatitis control prece diagnosis mark that all cases were formulated by Xi'an meeting in 2000 Standard is diagnosed as hepatitis cirrhosis, and Chlid-Pugh is classified as A levels or B levels, and exclusion is associated with cardiovascular system, kidney, hematopoiesis The primary diseases such as system and UGB.

1.2 general information：It is selected 110, each 55 for the treatment of group, control group.Wherein treatment group male 32, women 23 Example, the age between 16-72 year, average age (42.17 ± 10.58) year.Chlid-Pugh A levels 25, B groups 30.Control Group male 30, women 25, the age between 17-75 year, average age (45.89 ± 11.68) year.Chlid-Pugh A groups 26, B groups 29.Every observation index is statistically analyzed no significant difference (P ＞ before two groups of general information and treatment 0.05), there is comparativity.

1.3 method：

1.3.1 treatment method：All patients give the liver protection symptomatic treatment such as Inosine tablets, liver-protecting tablet, and treatment group adds to be sent out with this Bright Qing Gan Capsule, orally, daily 2-3 times, each 5-8 grains, the course for the treatment of 1 year.Control group is then not added with.During all patient's treatments not With other anti-hepatic fibrosis medicines.

1.3.2 observational technique：All patients project listed in before and after treatment according to observation table check and such as Real record in detail.Symptom and sign observation includes：Hypochondriac pain, abdominal distension, it is weak, receive poor, tongue picture, pulse condition etc..Iconography detection uses abdomen Portion's B ultrasound is observed hilus lienis thickness footpath, inner diameter of portal vein, right liver clino-diagonal.

Each index contrast before and after treatment, treatment group and the pretherapy and post-treatment difference of control group is carried out after the course for the treatment of terminates to contrast, And carry out statistical procedures.

1.4 statistical method：Numeric ratio is examined compared with t, the comparison χ of rate²Examine, entered using SPSS16.0 statistical softwares Row data processing.

2 results

2.1 symptoms, tongue picture, pulse condition observation result：Treatment group hypochondriac pain, abdominal distension, tongue picture, pulse condition treatment compared with control group Improvement rate difference is statistically significant afterwards.It is shown in Table 6.

The treatment group of table 6 and control group symptom and sign situation [example (%)]

Group

n

Hypochondriac pain (%)

Abdominal distension (%)

Weak (%)

Receive poor (%)

Tongue picture (%)

Pulse condition (%)

Treatment group

55

48(85.71)*

45(81.82)*

43(78.18)*

44(80.00)*

42(76.36)*

43(78.18)*

Control group

55

25(45.45)

22(40)

24(43.64)

21(38.18)

23(41.82)

23(41.81)

Note：Compared with control group, * P ＜ 0.05

2.3 B ultrasound result is shown：Pretherapy and post-treatment 55 patients have carried out ultrasound diagnosis, have spleen enlargement, door before treatment Phlebectasia.Splenomegaly diminution person 42 after treatment group's treatment, effective percentage are 75%, and pretherapy and post-treatment spleen thickness footpath difference averagely contracts Small (10 ± 9) mm, (P ＜ 0.05) statistically significant with control group comparing difference).Inner diameter of portal vein also has diminution trend, but No significant difference (is shown in Table 7).

The pretherapy and post-treatment ultrasound diagnosis result of each group of table 7 (mm, x ± s)

Note：Compared with before treatment,^#P ＜ 0.05.

Qing Gan Capsule treats the clinical data of chronic cholecystitis

Data and method

1.1 general information

Exemplified by choosing 140 chronic cholecystitis patients, GP TH is carried out, is randomly divided into control group and treatment group.Control Group 70 patients, male 37, women 33, age 15-73 year, average age (41.2 ± 10.5) year, the course of disease be 2 months to 8 Year, average course of disease is (3.5 ± 0.8) year.70 patients for the treatment of group, male 38, women 32, age 16-74 year, average year Age (43.8 ± 8.9) year, the course of disease be 1 month to 9 years, average course of disease is (3.8 ± 0.9) year.Two groups of patients show through ultrasound diagnosis It is shown as cholecystitis.The basic documents such as two groups of patient ages, sex, courses of disease are more not statistically significant (P ＞ 0.05), have comparable Property.

1.2 treatment method

The Qing Gan Capsule of the present invention, orally, daily 2-3 times, each 5-8 grains are given by treatment group.

Control group gives XIAOYAN LIDAN PIAN (Guangdong Luofushan Sinopharm Co., Ltd., Chinese medicines quasi-word Z44021422) and entered Row treatment, once takes 6,3 times a day.

2 weeks are a course for the treatment of.

1.3 curative effect determinate standard

With《New Chinese medicine treats the guideline of clinical investigations of cholecystitis》For curative effect determinate standard, it is divided into effective, effective With invalid three-level.

1.4 statistical procedures

Statistical procedures are carried out to data using SPSS16.0 softwares, enumeration data is examined using t, is to have with P ＜ 0.05 The significance difference opposite sex, is prompted statistically significant.

2 results the results are shown in Table 8.

8 two groups of Clinical efficacy comparison examples of table)

Group	n	Effective (example)	Effectively (example)	Invalid (example)	Obvious effective rate (%)	Total effective rate (%)
							Treatment group	70	38	30	2	54.28**	97.14**
Control group	70	25	18	27	35.71	61.43

Note：Compared with control group, * * P ＜ 0.01.

70 patients of control group are treated, it is effective, obvious effective rate 54.28% to share 38 patients, there are 30 patients to have Effect, it is invalid, total effective rate 97.14% to have 2 patients.And control group has 25 patients to be effective, obvious effective rate is 35.71%, it is effective to have 18 patients, and it is invalid, total effective rate 61.43% to have 27 patients.Treatment group and control group ratio Compared with P ＜ 0.01.

Qing Gan Capsule treats the clinical data of intractable acne

1.1 general information

120 patients wherein man 72, female 48, age 12-39 year, the course of disease -12 years 0.8 year.It is random divide treatment group and Two groups of control group.Wherein treatment group 60, control group 60.Diseased region：Facial area is common, is also found in chest neck, color is red, The visible pus point of atop part, acne count at most 14-30, at least 5-8.A small number of cases, which can be felt, itches and pain.

1.2 treatment method

The Qing Gan Capsule of the preparation of the embodiment of the present invention 1, daily 2-3 times, each 5-8 grains are taken by treatment group.2 weeks are 1 course for the treatment of.

Control group：Pifubing Xuedu Pill is taken, 20 tablets each time, 2 times a day, 2 weeks are 1 course for the treatment of.Knot is observed after 2 courses for the treatment of Fruit.

1.3 observation of curative effect

Treatment results criterion of therapeutical effect：According to《Chinese medical disease Standardization of diagnosis and curative effect》Acne efficacy evaluation.Skin lesion is disappeared, Subjective symptoms is disappeared, and follow-up is not recurred to cure for 3 months.Take a turn for the better for skin lesion disappear more than 30%, subjective symptoms substantially mitigates.Not More for skin lesion and symptom is unchanged or regression is less than 30% (including invalid).Treatment results see attached list 9.

9 two groups of Clinical efficacy comparisons (example) of table

Note：Compared with control group, * * P ＜ 0.01.

Compared with control group, the Chinese medicine for the treatment of refractory acne of the invention, 2 course cure rates are up to 53.33%, and Pifubing Xuedu Pill control group cure rate only has 36.67%, and both have significant difference (p ＜ 0.01)；2 course for the treatment of total effective rates Up to 96.67%, and Pifubing Xuedu Pill control group efficient only both 76.67% has significant difference (p ＜ 0.01).

Claims

1. a kind of Qing Gan Capsule, it is made up of the bulk drug of following weight：

Giant knotweed 10-20 parts, Asian puccoon 10-20 parts, bear gall 10-20 parts, cape jasmine 10-20 parts, oriental wormwood 10-20 parts, Sculellaria barbata 10-20 Part, radix scutellariae 15-25 parts, radix scrophulariae 10-20 parts, dandelion 10-20 parts, honeysuckle 10-20 parts, capsule of weeping forsythia 5-15 parts, Radix Isatidis 10-20 Part, root of herbaceous peony 5-15 parts, Fructus Aurantii 10-20 parts, radish seed 15-25 parts, dried orange peel 10-20 parts, Poria cocos 10-20 parts, hawthorn 10-20 parts, Malt 10-20 parts, Divine Comedy 10-20 parts, radix bupleuri 10-20 parts, rheum officinale 10-20 parts, radix glycyrrhizae 10-20 parts.

2. according to the Qing Gan Capsule described in claim 1, it is characterised in that be made up of the bulk drug of following weight：

Giant knotweed 13-17 parts, Asian puccoon 13-17 parts, bear gall 13-17 parts, cape jasmine 13-17 parts, oriental wormwood 13-17 parts, Sculellaria barbata 13-17 Part, radix scutellariae 18-22 parts, radix scrophulariae 13-17 parts, dandelion 13-17 parts, honeysuckle 13-17 parts, capsule of weeping forsythia 8-12 parts, Radix Isatidis 13-17 Part, root of herbaceous peony 8-12 parts, Fructus Aurantii 13-17 parts, radish seed 18-22 parts, dried orange peel 13-17 parts, Poria cocos 13-17 parts, hawthorn 13-17 parts, Malt 13-17 parts, Divine Comedy 13-17 parts, radix bupleuri 13-17 parts, rheum officinale 13-17 parts, radix glycyrrhizae 13-17 parts.

3. Qing Gan Capsule according to claim 2, it is characterised in that be made up of the bulk drug of following weight：

15 parts of giant knotweed, 15 parts of Asian puccoon, 15 parts of bear gall, 15 parts of cape jasmine, 15 parts of oriental wormwood, 15 parts of Sculellaria barbata, 20 parts of radix scutellariae, radix scrophulariae 15 It is part, 15 parts of dandelion, 15 parts of honeysuckle, 10 parts of the capsule of weeping forsythia, 15 parts of Radix Isatidis, 10 parts of the root of herbaceous peony, 15 parts of Fructus Aurantii, 20 parts of radish seed, old 15 parts of skin, 15 parts of Poria cocos, 15 parts of hawthorn, 15 parts of malt, 15 parts of Divine Comedy, 15 parts of radix bupleuri, 15 parts of rheum officinale, 15 parts of radix glycyrrhizae.

4. according to the Qing Gan Capsule described in claim 1 or 2 or 3, it is characterised in that its dosage form is oral formulations.

5. Qing Gan Capsule according to claim 4, it is characterised in that its dosage form is capsule.

6. the preparation method of the Qing Gan Capsule described in claim 1 or 2 or 3, is comprised the following steps：

A, giant knotweed, Asian puccoon, cape jasmine, oriental wormwood, Sculellaria barbata, radix scrophulariae, dandelion, honeysuckle, the capsule of weeping forsythia, Radix Isatidis, the root of herbaceous peony, trifoliate orange in the side of taking Shell, radish seed, dried orange peel, Poria cocos, hawthorn, malt, Divine Comedy, radix bupleuri, radix glycyrrhizae are added water to cook 3 times, and for the first time plus 8 times of drug weight is measured Water, the water of second and third time plus 6 times of drug weight amount, decoct 2 hours every time, merge decoction liquor concentration thick paste, dry, will be dry Powder extract powder mixes with radix scutellariae, the taste Chinese medicine of rheum officinale 2 and is ground into fine powder, obtains medicinal powder A；

B, bear gall be crushed into 100 mesh sieves, obtain bear gall fine powder；

7. the Qing Gan Capsule described in claim 1 or 2 or 3 is preparing the application in treating icteric hepatitis medicine.

8. the Qing Gan Capsule described in claim 1 or 2 or 3 is preparing the application in treating chronic hepatitis medicine.

9. the Qing Gan Capsule described in claim 1 or 2 or 3 is preparing the application in treating hepatic sclerosis medicine.

10. the Qing Gan Capsule described in claim 1 or 2 or 3 is preparing the application in treating chronic cholecystitis medicine.

11. the Qing Gan Capsule described in claim 1 or 2 or 3 is preparing the application in treating refractory acne medicine.