CN1203877C - Chinese medicine preparation for curing hemorrhoidal bleeding - Google Patents

Abstract

The present invention relates to a Chinese medicinal preparation for curing hemorrhoidal bleeding and a preparation method thereof. The present invention is characterized in that six kinds of raw medicinal materials such as sophora flower, fineleaf schizonepeta herb, tangerine peel, Chinese arborvitae twig, garden burnet root and hairyvein agrimonia herb and bud are mixed according to a certain proportion and made into granules by modern extraction, separation and refining techniques. The Chinese medicinal preparation of the present invention has the advantages of reasonable prescription, advanced technology and outstanding curative effect and provides a good medicine for patients with piles.

Description

A kind of Chinese medicine preparation for the treatment of bleeding hemorrhoids and preparation method thereof

The invention belongs to a kind of medicine for the treatment of bleeding hemorrhoids, the invention still further relates to the preparation method of this medicine.

The soft arteries and veins group that hemorrhoid are that venous plexus expansion, flexing form under the rectum end mucosa and under the anal canal skin claims hemorrhoid disease, haemorrhoids again, practises claiming hemorrhoid.Because this patient is numerous, dying has saying of " ten having nine hemorrhoid ".The lighter's symptom is very not remarkable, checks and finds through the doctor.That clinical manifestation is generally is hemorrhage, the anus hemorrhoid are deviate from, and it is main swelling and ache etc.

Cause the cause of disease, the pathogenesis multiterminal of bleeding hemorrhoids.Common person such as improper diet, raw food are richly processed, sitting, station, walking for a long time for a long time, so that the internal organs imbalance of YIN and YANG, and the corruption of intestinal mansion is not normal, accumulate temperature, long-pending heat, and it is not smooth defecate, because of the damp invasion of lower energizer anorectal, and the thermal burn yin collaterals, the mad row of heat in blood, blood is not passed through, so the hematochezia of defecating.Not smooth because of local QI-blood circulation, and cause swelling and pain of anus.Damp and hot inner product, the taste abnormal ascending-descending of QI, heat smokes in last then xerostomia, bitter taste, stomach not each, so appetite owes to shake.The intestinal mansion is damp and hot does not dispel, and internal organs gas is not smooth, and big dry stool is long-pending to be difficult to resolve, hematochezia often in the time of just.The etiology and pathogenesis of bleeding hemorrhoids, except that above-mentioned, also relevant with exopathogen such as wind, dry, wet, heat.For another women 's fertility too much, chronic diarrhea chronic dysentery, people's insufficiency of vital energy and blood in old age or other chronic disease, cause deficiency of QI in middle-JIAO, collapse of QI causes proctoptosis, haemorrhoids person, blood is appeared many, causes QI and blood deficiency person.

The object of the present invention is to provide that a kind of to have a removing summer-heat hemorrhoidal hamorrhage damp and hot, the Chinese medicine preparation of the bleeding hemorrhoids of cooling blood for hemostasis.

Another purpose of present inventor provides the preparation method of this bleeding hemorrhoids therapeutic agent.

Medicine of the present invention is because following bulk drugs (weight portion) medicament of making by weight ratio:

1～3 part of 1～3 part of Pericarpium Citri Reticulatae of 1～3 portion of Herba Schizonepetae of Flos Sophorae

1～3 part of 1～3 part of Herba Agrimoniae of 1～3 portion of Radix Sanguisorbae of Cacumen Platycladi.

The method of said medicine being made medicine of the present invention is: Flos Sophorae adopts percolation or infusion process with 0%～90% ethanol extraction, is prepared into fluid extract; Herba Schizonepetae, Pericarpium Citri Reticulatae, Cacumen Platycladi are extracted volatile oil, and volatile oil beta-schardinger dextrin-inclusion, the ratio of volatile oil and beta-schardinger dextrin-are 1: 1～20, and the aqueous solution behind extraction volatile oil device is in addition deposited; Medicinal residues and Radix Sanguisorbae, Herba Agrimoniae that Herba Schizonepetae, Pericarpium Citri Reticulatae, Cacumen Platycladi are extracted behind the volatile oil decoct with water 1～4 time, each 0.5～3.5 hour, collecting decoction, filter, aqueous solution behind filtrate and the said extracted volatile oil merges, be 1.01～1.35 to density when being concentrated into hot thermometric degree and being 20～100 ℃, cooling, add the ethanol accent and contain the alcohol amount, place more than 0 hour, get supernatant to 0%～95%, reclaim ethanol, add the Flos Sophorae fluid extract, continue to reclaim ethanol, and relative density is 1.01～1.40 clear paste when being concentrated into hot thermometric degree and being 20～100 ℃; Qinghuo reagent, the inclusion complex of adding adjuvant, volatile oil, mix homogeneously is made granule or tablet or capsule.

The advantage of medicine of the present invention is:

Flos Sophorae in the side, bitter in the mouth is cool in nature, goes into liver, large intestine channel, merit is arrogated to oneself the clearing away heat and cooling blood hemostasis, always with controlling illness such as discharging fresh blood stool, hematuria, metrorrhagia, sore.Modern age, pharmaceutical research showed, Flos Sophorae can make blood capillary keep normal resistance, reduced vascular permeability, had antiinflammatory action.Herba Schizonepetae (stir-fry) is good at hemostasis, and can dispel the wind.Control in single proved recipe of stool hematochezia, much all use medicines such as Flos Sophorae, Herba Schizonepetae, take orally with Flos Sophorae, Herba Schizonepetae two medicines " frying purple be end " as " easy folk prescription ", " through proved recipe " is that the hematochezia etc. of defecating is controlled at the end with Herba Schizonepetae stir-fry simply.Pericarpium Citri Reticulatae is the name Pericarpium Citri tangerinae also, and is hot, bitter, and during temperature, function were regulated the flow of vital energy and transferred, damp eliminating was reduced phlegm, and is the main medicine of damp eliminating in we, the turbid damp of the internal organs of dispelling, and row QI of the spleen and stomach machine wetly goes then to exempt from its strongly fragrant and heat-transformation, wetly goes also to be beneficial to heat clearing away and controls the agent of blood and play a role better.

Cacumen Platycladi hardship, puckery, cold in nature, function is cooling blood for hemostasis, wind-damp dispelling looses and swells and ache.Radix Sanguisorbae hardship, acid, cold in nature, merit is arrogated to oneself cooling blood for hemostasis, heat-clearing and toxic substances removing.Two medicines are blood disorder product commonly used, can control diseases such as haematemesis, epistaxis, hematuria, and to bleeding hemorrhoids, the discharging fresh blood stool function is also excellent.Herba Agrimoniae suffering, hardship, property is flat, and function is stopped blooding, is good for the stomach, and controls spitting of blood, haematemesis, hematuria, has blood in stool, and impairment caused by overstrain is taken off power, wound hemorrhage." BAICAO mirror " once carried this medicine energy, and " therapeutic method to keep the adverse QI flowing downwards is invigorated blood circulation, and controls discharging fresh blood stool." above three medicines, pharmaceutical research also confirmed to have and shortened blood coagulation, bleeding time modern age, made effects such as promotion blood coagulation such as vasoconstriction, and adapted has synergism to removing heat from blood, hemostasis mutually.

Full side's Six-element Chinese medicine phase 5, function removing summer-heat hemorrhoidal hamorrhage is damp and hot, cooling blood for hemostasis, it is hemorrhage to be used for hemorrhoid (comprising internal hemorrhoid, mixed hemorrhoid), discharging fresh blood stool, the scarlet person of color, respond well.By dialectical classification, cure mainly syndrome of stagnant and jamming dampness-heat, show as swelling and pain of anus, constipation with dry stool, hemorrhage after an action of the bowels, color is scarlet, and with dry mouth with bitter taste, appetite owes to shake, yellowish fur, diseases such as sliding number of pulse condition or stringy and rapid pulse.

The optimization formula of preparation medicine of the present invention is:

1.5～2.5 parts of 1.5～2.5 parts of Pericarpium Citri Reticulataes of 1.5～2.5 portions of Herba Schizonepetae of Flos Sophorae

1.5～2.5 parts of 1.5～2.5 parts of Herba Agrimoniaes of 1.5～2.5 portions of Radix Sanguisorbaes of Cacumen Platycladi.

Its preparation method is: Flos Sophorae is made solvent with 0%～95% ethanol, adopts percolation or infusion process, is prepared into fluid extract; Herba Schizonepetae, Pericarpium Citri Reticulatae, Cacumen Platycladi are extracted volatile oil, and volatile oil beta-schardinger dextrin-inclusion, the ratio of volatile oil and beta-schardinger dextrin-are 1: 1～20, and the aqueous solution behind extraction volatile oil device is in addition deposited; The medicinal residues that Herba Schizonepetae, Pericarpium Citri Reticulatae, Cacumen Platycladi are extracted behind the volatile oil decoct with water 1-4 time with Radix Sanguisorbae, Herba Agrimoniae, each 0.5～3.5 hour, collecting decoction, filter, aqueous solution behind filtrate and the said extracted volatile oil merges, relative density is 1.01～135 when being concentrated into hot thermometric degree and being 20～100 ℃, cooling, add the ethanol accent and contain the alcohol amount, place more than 0 hour, get supernatant to 0%～95%, reclaim ethanol, add the Flos Sophorae fluid extract, continue to reclaim ethanol, and relative density is 1.01～1.40 clear paste when being concentrated into hot thermometric degree and being 20～100 ℃; Qinghuo reagent, the inclusion complex of adding adjuvant, volatile oil mixes and spares all, makes granule or tablet or capsule.

Preparation 1000g medicine of the present invention takes by weighing raw material by the proportioning of 2 parts in Flos Sophorae, 2 parts of Herba Schizonepetae, 2 parts of Pericarpium Citri Reticulataes, 2 parts of Cacumen Platycladis, 2 parts of Radix Sanguisorbaes, 2 parts of Herba Agrimoniaes:

Flos Sophorae 200g Herba Schizonepetae 200g Pericarpium Citri Reticulatae 200g Cacumen Platycladi 200g Radix Sanguisorbae 200g Herba Agrimoniae 200g

Preparation method is: Flos Sophorae is made solvent with 70% ethanol, adopts percolation, is prepared into the Flos Sophorae fluid extract routinely; The conventional volatile oil that extracts Herba Schizonepetae, Pericarpium Citri Reticulatae and Cacumen Platycladi, volatile oil beta-schardinger dextrin-inclusion, the ratio of volatile oil and beta-schardinger dextrin-are 1: 8, the aqueous solution behind extraction volatile oil device is in addition deposited; Herba Schizonepetae, Pericarpium Citri Reticulatae, Cacumen Platycladi is extracted medicinal residues and the Radix Sanguisorbae behind the volatile oil, Herba Agrimoniae decocts with water 2 times, each 2 hours, collecting decoction, filter, the aqueous solution merging behind filtrate and the said extracted volatile oil, relative density is 1.25～1.30 when being concentrated into hot thermometric degree and being 50 ℃, cooling, add the ethanol accent and contain the alcohol amount, place more than 24 hours, get supernatant to 60%, reclaim ethanol, add the Flos Sophorae fluid extract, continue to reclaim ethanol, and when being concentrated into hot thermometric degree and being 50 ℃ be 1.30～1.33 clear paste density, qinghuo reagent, add adjuvant, the inclusion complex of volatile oil, mix homogeneously is made granule or tablet or capsule.

For showing the therapeutic effect of the present invention to bleeding hemorrhoids, the present invention selects 100 examples suitable with test group such as medical history, sex, age, the course of disease, sick kind, state of an illness program, complication to compare group through the clinical observation to 100 routine patient systems simultaneously.

1, method

1.1 case is selected

1.1.1 diagnostic criteria

Abide by the diagnostic criteria of " the clinical research guidelines of new Chinese medicine treatment hemorrhoid ".

1.1.1.1 Western medicine diagnose standard (with reference to the diagnostic classification standard of national first anorectal academic conference formulation in 1975)

(1) symptom:

1. podex is hemorrhage just the time, or bleeds, or penetrates blood;

2. just the time or after the fatigue, hemorrhoid are deviate from outside the anus, can be from horizontal reset, or need manual reduction;

3. podex discomfort just the time, the companion weighs down pain.

(2) inspection: anus edge hemorrhoid redness, blood stasis becomes big when increasing abdominal pressure, and part patient's internal hemorrhoid is deviate from outside the anus.

(3) anoscopy: the bossed blood stasis of distal rectal, the hemorrhoid mucous hyperemia, or the companion is rotten to the corn.

In above-mentioned 3 all meeting (1) in 2 and (2), (3) 1, promptly diagnosable.

1.1.1.2 the classification of hemorrhoid

According to position, hemorrhoid piece place difference, can be divided into following 3 classes:

1) internal hemorrhoid: occur in the cirso-agglomerate of superior rectal vein clump, be positioned at more than the tooth trace, the surface is covered by mucous membrane of rectum.Be common in right front and right back 3 places, left side.

(2) external hemorrhoid: occur in the cirso-agglomerate of inferior rectal veins clump, be positioned at below the tooth trace, the surface is covered by anal canal skin.Simple external hemorrhoid sees around the anus, often gives prominence to outside because of intravenous thrombosis.Can be divided into:

Inflammatory external hemorrhoid: anus edge skin wrinkle wall projection, have inflammatory red, hot, swollen, pain to show, often and anal sinusitis, anal fissure concurrent.

Thrombosed external hemorrhoid: from the beginning of anus edge one side nuclear shape protuberance, red heat swells and ache, and lump is pale blue black then, or diabrosis or swell and ache is disappeared or thrombus organization gradually.

The varicosis external hemorrhoid: the subcutaneous swelling of anus edge behind the defecation, the vein group of visible varicose, rectal tenesmus, hypodynia, normal and internal hemorrhoid is concurrent.

(3) mixed hemorrhoid: because the upper and lower venous plexus of rectum coincide mutually, interact, thereby the hemorrhoid piece is positioned at about the tooth trace, the surface is covered by mucous membrane of rectum and anal canal skin simultaneously.

1.1.1.3 internal hemorrhoid by stages

The I phase: to have blood in stool.Have blood in stool and being divided into stool band blood, bleeding, penetrate blood.Anoscopy: have internal hemorrhoid to form hemorrhoid mucous hyperemia or erosion.

The II phase: internal hemorrhoid is deviate from during stool, and internal hemorrhoid can be from horizontal reset, sometimes with having blood in stool after an action of the bowels.Anoscopy: internal hemorrhoid is seen right front, right back and left side more.

The III phase: internal hemorrhoid is deviate from during stool, and internal hemorrhoid can not need to return with hand rest from horizontal reset after an action of the bowels.Anoscopy: how ringwise internal hemorrhoid often becomes with hemorrhoid below the tooth trace.

The IV phase: hemorrhoid are deviate from anus outer (often occurring with mixed hemorrhoid) at ordinary times.Anoscopy: except that internal hemorrhoid in the form of a ring, the following anal canal of tooth trace, anus edge also have obvious hemorrhoid to become.

Hemorrhoid such as inflammation often are thrombosis inflammatory hemorrhoid, incarceration internal hemorrhoid.

1.1.1.4 Chinese medical discrimination

The stagnancy of wind and heat card

Archorrhagia after an action of the bowels, color is scarlet, pruritus ani, it is not smooth to defecate, and General Symptoms is not obvious.

Syndrome of stagnant and jamming dampness-heat

Swelling and pain of anus, dry mouth with bitter taste, inappetence is hard and dry or constipated, and the urine yellow skin is bled in the time of just.

1.1.2 include the case standard in

According to drug function, with dialectical stagnancy of wind and heat card or the syndrome of stagnant and jamming dampness-heat of belonging to, the hemorrhoid patients of age between 18～65 years old included the checking case in.Concrete indication is: each phase internal hemorrhoid (, two, three, the fourth phase), mixed hemorrhoid belong to stagnancy of wind and heat card (hemorrhoidal hamorrhage) or syndrome of stagnant and jamming dampness-heat person, and the case of bleeding are arranged.The person does not list identifying object in not have the bleeding during checking.

1.1.3 get rid of case standard (comprising non-indication and rejecting standard)

1.1.3.1 hemorrhoid merge anal fistula, perianal abscess person,

1.1.3.2. suffer from anus colorectal cancer, rectal polyp, anal papilla tumor person.

1.1.3.3. intestinal infection disease.

1.1.3.4. the age, the gravid woman was to this medicine allergy sufferers at under-18s or over-65s.

1.1.3.5. be associated with serious primary disease such as cardiovascular, liver, kidney and hemopoietic system.

1.1.3.6. do not meet the standard of including in, not medication in accordance with regulations can't be judged curative effect or data not umbra sound curative effect or safety judgement person.

1.2. grouping, comparison

1.2.1. 200 examples are observed in this research altogether, wherein treatment group (T group) 100 examples, matched group (C group) 100 examples.

Divide three groups to observe respectively 1.2.2. will all observe case, wherein 70 examples (each 35 example of treatment group and matched group) are respectively observed by Jiangsu TCM Hospital and Nanjing Chinese Medicine Hospital, and 60 examples (treatment group and matched group respectively are 30 examples) are observed by Changzhou institute of traditional Chinese medicine.

1.2.3. controlled observation

Use the table of random number method and carry out random packet, controlled observation.The main therapeutical effect of observing the bleeding that the hemorrhoid hemostasis granules has each phase internal hemorrhoid, mixed hemorrhoid, and with the difference of former drug form therapeutical effect, and human body had no adverse reaction etc.

1.3. medicine specification, usage

1.3.1. trial drug: the hemorrhoid hemostasis granules, provide by the Tongrentang Pharmaceutical Factory, Nanjing, every bag 5 grams contain crude drug amount 6 grams.Usage: each 1 bag (5 gram), every day 3 times, 1 week of the course of treatment.Do not take any other medicative medicine during the treatment.

1.3.2. matched group: the oral haemorrhoids hemostatic pills, produce and every bottle of 60g is provided by the Tongrentang Pharmaceutical Factory, Nanjing.Usage: each 6 grams, every day 3 times, 1 week of the course of treatment.Do not take other any medicative medicines during the treatment.

1.4. observation caliber

1.4.1 curative effect determinate standard

Clinical cure: the disappearance of having blood in stool.

Produce effects: having blood in stool, (2 levels fall in the degree of having blood in stool in significantly minimizing; Or 1 level falls in the degree of having blood in stool, but amount of bleeding reduces more than or equal to 70%).

Effectively: the minimizing of having blood in stool (1 level falls in the degree of having blood in stool, or the degree of having blood in stool do not demote, but amount of bleeding reduces more than or equal to 30%, less than 70%).

Invalid: the degree of having blood in stool or amount of bleeding all do not have change.

The stage division 1.4.2. have blood in stool

0 grade: do not have and have blood in stool;

1 grade (light disease): toilet paper band blood;

2 grades (middle disease): bleed;

3 grades (serious symptom): penetrate blood.

1.4.3. judge the course of treatment

1.4.3.1. with took medicine for 1 week (7 days) is a course of treatment, judges therapeutic outcome.

1.4.3.2. onset time be meant the recovery from illness patient begin to take medicine to the shortest time of obtaining final curative effect (produce effects, effective, invalid all by 7 days calculating).

1.5. work out the special-purpose tabular form case history of clinical observation.

1.6. each checking unit specifies the personnel that possess respective capabilities, forms the clinical observation group and carries out the clinical verification observation.

2. clinical data

2.1 physical data

This test ended in April, 1998 from January, 1998,

Case source: outpatient's 132 examples, inpatient's 68 examples, totally 200 examples, wherein 100 examples are organized in treatment, matched group 100 examples.

The sex composition of table 1 200 routine cases

Grouping	Sex		Add up to
				The man	The woman
	The treatment group	64				36	100
Matched group			56	44	100

The age structure unit of table 2 200 routine cases: year

Grouping	Age (year)						Add up to
								18～	20～	30～	40～	50～	60～65
	The treatment group	1	11	18	25	22								23	100
Matched group							0	8	22	32	21	17	100

The occupation of table 3 200 routine cases constitutes

Grouping	Occupation				Add up to	X2
							The workman	The peasant	The cadre	Other
	The treatment group	45	15	27							13	100	4.34
Matched group					58	8	22	12	100

The diagnosis of table 4 200 routine cases

Grouping	Diagnosis				Add up to	X2
							The first phase internal hemorrhoid	The second phase internal hemorrhoid	Stage	Mixed hemorrhoid
	The treatment group	11	16	4							69	100	1.02
Matched group					10	14	2	74	100

The pattern of syndrome of table 5 200 routine cases

Grouping

Pattern of syndrome

Add up to

X2

	Add up to	74	15	8	3	100
							Matched group	Heavy	13	11	4	1	29
In	46	4	5	2	57
						Gently		11	0	2	1	14
Add up to	70	15	11	4	100

Through Ridit check (U=5.991), significant difference (P＜0.05) is arranged between the state of an illness weight of treatment group and the curative effect, heavy according to the treatment group state of an illness, in, light cure rate is respectively 53.3%, 81.8%, 86.7%, total effective rate is respectively 93.3%, 98.2%, 100%, the curative effect and the state of an illness are inverse relation, and promptly state of an illness weight person is than state of an illness the lighter weak curative effect.But heavy to the state of an illness through between Ridit check treatment group and matched group, in, light curative effect there was no significant difference (the U value is respectively 2.45,0.04,0.03, and the P value is all greater than 0.05).

2.2.1.3 the relation of TCM Syndrome Type and curative effect

Relation between table 9, TCM Syndrome Type and curative effect relatively

Grouping	Pattern of syndrome	Cure	Produce effects	Effectively	Invalid	Add up to
							The treatment group	Stagnancy of wind and heat	37	19	2	3	51
Stagnation of damp-heat	37	6	6	0	49
						Matched group		Stagnancy of wind and heat	38	9	2	3	52
Stagnation of damp-heat	32	6	9	1	48

Analyze through Ridit, treatment is organized between different pattern of syndrome aspect curative effect, there was no significant difference (U=0.53, P＞0.05); Different pattern of syndrome there was no significant difference (U=1.34, P＞0.05) between curative effect of treatment group and matched group.

2.2.1.4 the relation between Western medicine diagnose and curative effect

Relation between table 10, Western medicine diagnose and curative effect relatively

Grouping	Western medicine diagnose	Cure	Produce effects	Effectively	Invalid	Add up to
							The treatment group	The internal hemorrhoid first phase	7	2	1	1	11
The internal hemorrhoid second phase	12	3	1	0	16
						Three phases of internal hemorrhoid		3	0	1	0	4
Mixed hemorrhoid	52	10	5	2	69
						Matched group		The internal hemorrhoid first phase	9	0	1	0	10
The internal hemorrhoid second phase	11	2	1	0	14
							Three phases of internal hemorrhoid	2	0	0	0	2

Mixed hemorrhoid

48

13

9

4

74

Learn by statistics and handle, the treatment group is its curative effect there was no significant difference (Ridit analyzes, U=1.29, P＞0.05) aspect different Western medicine diagnoses.

3.2.2 onset time

Table 11, two groups of recovery from illness patients' onset time

Grouping	Onset time (my god)	The example number	t	P
					The treatment group	5.04±1.38	74	0.82	＞0.05
Matched group	4.85±1.37	70

Recovery from illness patient's the shortest onset time is 2 days, and the longest is 7 days, indicates two groups of recovery from illness patients' onset time there was no significant difference (U=0.82 through the t check, P＞0.05), because to take medicine 7 days is a course of treatment, observe the curative effect is so be 7 days non-recovery from illness patient's the course of treatment.

3.2.3 therapeutic effect to the blood stasis sign

Table 12, to the therapeutic outcome of blood stasis sign

Sign	Grouping	Disappear (%)	Improve (%)	No change (%)	Add up to
						Congested	The treatment group	80(80.0％)	16(16.0％)	4(4.0％)	100
Matched group	69(69.0％)	16(16.0％)	15(15.0％)	100
					Edema		The treatment group	45(95.7％)	1(2.1％)	1(2.1％)	47
Matched group	33(86.8％)	1(2.6％)	4(10.5％)	38
						Rotten to the corn	The treatment group	11(91.7％)	0	1(8.3％)	12
Matched group	9(90.0％)	0	1(10.0％)	10
					Ulcer		The treatment group	2(66.7％)	0	1(33.3％)	3
Matched group	2(100％)	0	0	2

Two groups of curative effects are learned processing (Ridit check) by statistics, to the effect (the U value is respectively 1.807,0.513,0.043,0.33) of blood stasis sign, hyperemia, edema, erosion, ulcer, and there was no significant difference (the P value is all greater than 0.05) between two values.

3.2.4 therapeutic effect to the disease of holding concurrently

3.2.4.1 therapeutic effect to pruritus ani

Table 13, to the therapeutic effect of pruritus ani

Grouping	Disappear (%)	Improve (%)	Invalid (%)	Add up to
					The treatment group	43(84.3％)	7(13.7％)	1(2.0％)	51
Matched group	42(80.8％)	9(17.3％)	1(1.9％)	52

As can be seen from the above table, the disappearance rate of hemorrhoid hemostasis granules treatment pruritus ani reaches 84.3%, improves above rate and reaches 98.0%.Show minimum percentage rate difference table, two groups of curative effect there was no significant differences (P＞0.05) through looking into two percentage rate difference.

3.2.4.2 to swelling and pain of anus therapeutic effect

Table 14, to the therapeutic effect of swelling and pain of anus

Grouping	Disappear (%)	Improve (%)	Invalid (%)	Add up to
					The treatment group	45(91.8％)	4(8.2％)	0	49
Matched group	42(87.5％)	6(12.5％)	0	48

As can be seen from the above table, the hemorrhoid hemostasis granules adds up to 100% to disappearance, the improvement rate of swelling and pain of anus, and wherein disappearance rate is 91.8%.Show minimum percentage rate difference table, there was no significant difference between two groups of curative effects (P＞0.05) through looking into two percentage rate difference.

3.2.4.3 to the therapeutic effect of being hard and dry

Table 15, therapeutic effect to being hard and dry

Grouping	Disappear (%)	Improve (%)	Invalid (%)	Add up to
					The treatment group	14(82.4％)	3(17.6％)	0	17
Matched group	17(94.4％)	1(5.6％)	0	48

As can be seen from the above table, the hemorrhoid hemostasis granules adds up to 100% to disappearance, the improvement rate of being hard and dry, and wherein disappearance rate is 82.4%.Show minimum percentage rate difference table, two groups of curative effect there was no significant differences (P＞0.05) through looking into two percentage rate difference.

3.2.4.4 to the not smooth therapeutic effect of stool

Table 16, to the not smooth therapeutic effect of stool

Grouping	Disappear (%)	Improve (%)	Invalid (%)	Add up to
					The treatment group	16(94.4％)	0	1(5.9％)	17
Matched group	15(93.8％)	1(6.2％)	0	16

As can be seen from the above table, the hemorrhoid hemostasis granules does not freely have defecating feces excretion preferably to stool, and disappearance, improvement rate add up to 100%, and wherein disappearance rate is 94.1%.Show minimum percentage rate difference table, there was no significant difference between two groups of curative effects (P＞0.05) through looking into two percentage rate difference.

3.3 safety observed result

The treatment group is observed case 100 examples, does not find obvious toxicity.Tried to have in the case 30 routine cases, " all have a blood test before and after the hemorrhoid hemostasis granules routine, platelet count, routine urinalysis, stool routine examination, liver function (paddy third enzyme, r-glutamyl transpeptidase), renal function (blood urea nitrogen, creatinine), Electrocardioscopy, its result is equal Non Apparent Abnormality before and after treatment taking.

3, model case

(1) Wang Guixiang, the woman, 50 years old, numbering was economized T011.Tell the gap outbreak 7 years of having blood in stool, nearly outbreak increased the weight of 7 days.Penetrate blood when now defecating, bleed, color is scarlet, measures about 30ml, and the thing that swells in the anus in the time of is just deviate from; Return voluntarily after an action of the bowels and receive in the anus.The companion stool is not smooth, just meaning sense not to the utmost, and anus slightly swells and ache.Red tongue, yellow, greasy and thin fur, the little number of soft pulse.The podex training is checked: calculi position 3,7-8,10-11 point, stride the swollen thing protuberance of tooth trace, about respectively 1 * 1 * 1cm, 1 * 1 * 1.5cm, 1 * 1 * 2.0cm size.Congested, edema is obvious, and is slight rotten to the corn, do not see ulcer, do not see the petechia.Yu Wei looks into and other is unusual.AD: the traditional Chinese medical science: internal hemorrhoid, stagnation of damp-heat type.Doctor trained in Western medicine: internal hemorrhoid second phase.According to medical history and whole body situation, meet the requirement of clothes hemorrhoid hemostasis granules, promptly give clothes hemorrhoid hemostasis granules, 1 time 5 gram, 3 times on the 1st from February 23rd, 1998.Behind the medicine 1 day, to have blood in stool and reduce gradually, swelling and pain of anus alleviates, disappearances of having blood in stool in 4 days behind the medicine, the swelling and pain of anus disappearance, defecation is unobstructed.Look into former hemorrhoid mucous hyperemia, edema is rotten to the corn to disappear.There is not any discomfort in the drug administration process.Have a blood test routine, routine urinalysis, stool routine examination, liver function, renal function, Electrocardioscopy is all no abnormal before and after the treatment.The result is judged as recovery from illness.

(2) open the faithful and upright person, the male, 40 years old, the workman came me to examine prescription on individual diagnosis by gate from March 22nd, 1998, numbering city T044.Stool is penetrated blood after patient's readme cause fatigue in ten days, and color is scarlet, and the about 15ml of each amount deviates from light red tongue with the swollen thing of anus simultaneously; The floating pulse string.Anus toposcopy, 3,5 of calculi positions are located to tie tooth and are become swollen thing grand, mucous hyperemia, diagnosis on inspection: the traditional Chinese medical science: mixed hemorrhoids, stagnancy of wind and heat card; Doctor trained in Western medicine: mixed hemorrhoid, give the hemorrhoid hemostasis granules, 5g, three times on the one.Serve on seven days, the back the 3rd day of taking medicine, hemorrhage obvious minimizing was taken medicine back five days, stopped bleeding, the swollen thing of anus is not seen, and mucous hyperemia disappears and accuses more.

(3) Liu Yongzhu, the woman, 64 years old, the peasant numbered normal T050.The main suit has thing to deviate to accompany hemorrhage the outbreak repeatedly 10 years in the anus just the time.Nearly outbreak increased the weight of 5 days, penetrated blood in the time of just, hemorrhage once about 15ml, and the thing that swells in the anus in the time of is just deviate from, after an action of the bowels Hui Na voluntarily.Companion's pruritus ani, be hard and dry, red tongue, yellow and thin fur, stringy and thready pulse, anus training check that 3,7,11 of calculi positions stride the swollen thing protuberance of tooth trace, and be congested, edema is obvious.AD: the traditional Chinese medical science: internal hemorrhoid, the stagnancy of wind and heat card, doctor trained in Western medicine: the internal hemorrhoid second phase, from March 21st, 1998, give " hemorrhoid hemostasis granules " 5 to restrain/time, 3 times on the 1st, serve on seven days.The 2nd day amount of bleeding in back of taking medicine obviously reduces, the hemorrhage disappearance of defecating in back four days of taking medicine, and pruritus ani disappears, and looks into former hemorrhoid mucous hyperemia, edema disappears and accuses more.

The patient does not have any discomfort in drug administration process, all make blood, urine, stool routine examination and electrocardiogram, liver function, kidney function test before and after the treatment, all no abnormal prompting of secondary check report.

Each phase internal hemorrhoid of Drug therapy of the present invention, mixed hemorrhoid stool hemorrhage, through clinical 100 example tests, its cure rate is respectively 74%, the above rate of produce effects is respectively 89%, total effective rate is respectively 97%.

Claims (6)

1, a kind of Chinese medicine preparation for the treatment of bleeding hemorrhoids is characterized in that pressing column weight amount proportioning raw material and makes:

1～3 part of 1～3 part of Herba Agrimoniae of 1～3 portion of Radix Sanguisorbae of 1～3 portion of Cacumen Platycladi of 1～3 part of Pericarpium Citri Reticulatae of 1～3 portion of Herba Schizonepetae of Flos Sophorae;

Above Six-element, Flos Sophorae is made solvent with the ethanol of 0%-95%, adopts percolation or infusion process, is prepared into fluid extract; Herba Schizonepetae, Pericarpium Citri Reticulatae, Cacumen Platycladi are extracted volatile oil, and volatile oil beta-schardinger dextrin-inclusion, the ratio of volatile oil and beta-schardinger dextrin-are 1: 1～20, and the aqueous solution behind extraction volatile oil device is in addition deposited; Herba Schizonepetae, Pericarpium Citri Reticulatae, Cacumen Platycladi is extracted the medicinal residues behind the volatile oil, with Radix Sanguisorbae, Herba Agrimoniae decocts with water 1-4 time, each 0.5～3.5 hour, collecting decoction filtered, filtrate merges with the aqueous solution that extracted volatile oil, relative density is 1.01～1.35 when being concentrated into hot thermometric degree and being 20～100 ℃, and cooling adds ethanol and transfers and contain the alcohol amount to 0%～95%, place more than 0 hour, get supernatant, reclaim ethanol, add the Flos Sophorae fluid extract, continue to reclaim ethanol, and relative density is 1.01～1.40 clear paste when being concentrated into hot thermometric degree and being 20～100 ℃, and qinghuo reagent adds adjuvant, the inclusion complex of volatile oil, mix homogeneously is made granule, tablet or capsule.

2, the Chinese medicine preparation of treatment bleeding hemorrhoids according to claim 1 is characterized in that making by following weight proportion crude drug: 1.5～2.5 parts of 1.5～2.5 parts of Herba Agrimoniaes of 1.5～2.5 portions of Radix Sanguisorbaes of 1.5～2.5 portions of Cacumen Platycladis of 1.5～2.5 parts of Pericarpium Citri Reticulataes of 1.5～2.5 portions of Herba Schizonepetae of Flos Sophorae; Make by the described method for making of claim 1.

3, the Chinese medicine preparation of treatment bleeding hemorrhoids according to claim 1 is characterized in that making by following weight proportion crude drug: 2 parts of 2 parts of Herba Agrimoniaes of 2 portions of Radix Sanguisorbaes of 2 portions of Cacumen Platycladis of 2 parts of Pericarpium Citri Reticulataes of 2 portions of Herba Schizonepetae of Flos Sophorae;

Above Six-element medicine, Flos Sophorae is made solvent with the ethanol of 50%-90%, adopts percolation or infusion process, is prepared into fluid extract; Herba Schizonepetae, Pericarpium Citri Reticulatae, Cacumen Platycladi are extracted volatile oil, and volatile oil beta-schardinger dextrin-inclusion, the ratio of volatile oil and beta-schardinger dextrin-are 1: 5～10, and the aqueous solution behind extraction volatile oil device is in addition deposited; Medicinal residues and Radix Sanguisorbae, Herba Agrimoniae that Herba Schizonepetae, Pericarpium Citri Reticulatae, Cacumen Platycladi are extracted behind the volatile oil decoct with water 2-3 time, each 1.5～3.5 hours, collecting decoction, filter, aqueous solution behind filtrate and the said extracted volatile oil merges, relative density is 1.15～1.30 when being concentrated into hot thermometric degree and being 40～70 ℃, cooling, add the ethanol accent and contain the alcohol amount, place more than 12 hours, get supernatant to 50%～80%, reclaim ethanol, add the Flos Sophorae fluid extract, continue to reclaim ethanol, and relative density is 1.20～1.40 clear paste when being concentrated into hot thermometric degree and being 40～70 ℃; Qinghuo reagent, the inclusion complex of adding adjuvant, volatile oil, mix homogeneously is made granule, tablet or capsule.

4, the Chinese medicine preparation of treatment bleeding hemorrhoids according to claim 3 is characterized in that:

Flos Sophorae is made solvent with 70% ethanol, uses percolation, makes the Flos Sophorae fluid extract routinely; Extract the volatile oil of Herba Schizonepetae, Pericarpium Citri Reticulatae and Cacumen Platycladi, volatile oil beta-schardinger dextrin-inclusion, the ratio of volatile oil and beta-schardinger dextrin-are 1: 8, and the aqueous solution behind extraction volatile oil device is in addition deposited; Medicinal residues and Radix Sanguisorbae, Herba Agrimoniae that Herba Schizonepetae, Pericarpium Citri Reticulatae, Cacumen Platycladi are extracted behind the volatile oil decoct with water 2 times, each 2 hours, collecting decoction, filter, aqueous solution behind filtrate and the said extracted volatile oil merges, be 1.25～1.30 to density when being concentrated into hot thermometric degree and being 50 ℃, cooling, add the ethanol accent and contain the alcohol amount, place more than 24 hours, get supernatant to 60%, reclaim ethanol, add the Flos Sophorae fluid extract, continue to reclaim ethanol, and relative density is 1.30～1.33 clear paste when being concentrated into hot thermometric degree and being 50 ℃; Qinghuo reagent, the inclusion complex of adding adjuvant, volatile oil, mix homogeneously is made granule, tablet or capsule.

5, the Chinese medicine preparation of treatment bleeding hemorrhoids according to claim 4 is characterized in that used adjuvant is a kind of in starch, dextrin, protein sugar, the Mel, or mixture.

6, treatment bleeding hemorrhoids Chinese medicine preparation according to claim 4 is characterized in that described preparation is a granule.