CN1228074C

CN1228074C - Chinese traditional medicine for treating immune hypofunction and disfunction

Info

Publication number: CN1228074C
Application number: CN 03135227
Authority: CN
Inventors: 薛永新
Original assignee: Individual
Current assignee: Individual
Priority date: 2003-06-18
Filing date: 2003-06-18
Publication date: 2005-11-23
Anticipated expiration: 2023-06-18
Also published as: CN1565552A

Abstract

The present invention relates to a traditional Chinese medicine for treating immune hypofunction and disfunction, which is mainly prepared by refining 10 to 20 portions of astragalus root, 3 to 9 portions of pilose asiabell root, 4 to 12 portions of white atractylodes rhizome, 6 to 18 portions of tuckahoe, 8 to 16 portions of epimedium herb and 5 to 15 portions of glossy privet fruit according to the requirement of each dosage form of preparation. The traditional Chinese medicine for treating immune hypofunction and disfunction has the functions of supplementing the spleen, tonifying the kidney, benefiting vital energy and consolidating the constitution and can be used for treating spleen-kidney vacuity, fatigued body and lack of strength caused insufficiency of right qi, poor appetite, limp aching lumbus and knees, edema and cough with dyspnea or chronic diseases accompanied with cell immune hypofunction and disfunction. The traditional Chinese medicine for treating immune hypofunction and disfunction has obvious functions of enhancing and regulating immune hypofunction or disfunction and has obvious effect on treating qi deficiency and edema (chronic nephritis). The dosage form of the present invention can be a tablet, a granule, a pill, a capsule and oral medicinal liquid.

Description

Treatment immunologic hypofunction or disorderly Chinese medicine

Affiliated technical field: the invention belongs to Chinese medicine and preparation method thereof, specifically is a kind of immunologic hypofunction or disorderly Chinese medicine for the treatment of.

Background technology: along with immunologic further investigation, in the developing of disease, immunologic function low or disorderlyly more and more cause people's attention regulated immunologic function referred consequence in the treatment of numerous disease.Immune dysfunction disease incidence height clinically, the immunomodulator demand is big.A large amount of studies show that Chinese medicine has better curative effect to many immune diseases.Many Chinese medicines and compound recipe can pass through number of ways, the immunologic function that enhancing body active immunity power, recovery body are weakened.Some Chinese medicines contain two kinds of compositions of mutual antagonism, act on paired regulation and control substance in the body, and low immunologic function was improved, and too high immunologic function is reduced, and show as dual regulation.Set upright the stability that the rule of treatment can the enhancing human body immunity function, can suppress the caused pathological change of immunoreation again.But significantly the Chinese patent medicine of raise immunity is actually rare at present, and especially when promoting immunity, the Chinese patent medicine with dual regulation is not seen as yet.

The objective of the invention is at above-mentioned condition, make full use of Chinese medicine and adjusting fuselage state.Transfer the characteristics of inherent resistance against diseases aspect, utilize the Chinese medicine strengthening the body resistance, unique advantages such as two-ways regulation, for people provide a kind of promoting that immunity is main effect, and treatment immunologic hypofunction or disorderly Chinese medicine that can the two-ways regulation immunologic derangement.

The objective of the invention is to realize by following technical proposals.

Summary of the invention: the present invention treats immunologic hypofunction or disorderly Chinese medicine, main raw material by following formulation by weight: Radix Astragali 10-20 part, Radix Codonopsis 3-9 part, Poria 6-18 part, Rhizoma Atractylodis Macrocephalae 4-12 part are refined into tablet, granule, pill, capsule or oral liquid by each dosage formulation requirement.

In the above-mentioned raw materials.Can also add Fructus Ligustri Lucidi 5-15 part and/or Herba Epimedii 8-16 part.

The present invention be the inventor from traditional Chinese medical science organic conception, under the thought guidance of determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, the technical scheme of the science practicality of summing up out by long-term practice.Prescription of the present invention is to show as the insufficient deficiency syndrome of healthy energy at immunologic hypofunction or not normal patient more; consolidate with reinforcing spleen and kidney, QI invigorating and to be the main rule of treatment; getting famous ancient prescription " YUPINGFENG SAN " and " decoction of four noble drugs " set upright adds and simplifies sanction; form by the Radix Astragali, Radix Codonopsis, Poria, the Rhizoma Atractylodis Macrocephalae, Fructus Ligustri Lucidi, Herba Epimedii; all medicines share, and QI invigorating is main, the nourishing YIN sun of holding concurrently; spleen benefiting and strengthen kidney, the lung benefiting nourishing the liver of holding concurrently.Full side is sweet light gentle, tonify without causing stagnation, taste and oiliness, and temperature and not dry, all suitable a little less than old and young woman.Its function of prescription of the present invention cures mainly and is reinforcing spleen and kidney, and QI invigorating consolidates.Can be used for weakness of the spleen and kidney, the fatigue and asthenia due to the positive QI-insufficiency, inappetence, soreness of the waist and knees, edema cough with asthma or chronic disease are low with cellular immunization, and the immunologic function disorder person has significant enhancing and regulating action to the low or disorder of immunologic function; Treatment deficiency of vital energy edema (chronic nephritis nephropathy type) effect is obvious.

We's dosage form has tablet, granule, pill, capsule, oral liquid.Title of the present invention can be stilbene Siberian cocklebur QI invigorating.

Further set forth the present invention below by embodiment, the present invention is not limited only to described embodiment.

The specific embodiment:

Embodiment one

Get 15 parts of the Radixs Astragali, 6 parts of Radix Codonopsis, 12 parts in Poria, 8 parts of the Rhizoma Atractylodis Macrocephalaes, above-mentioned primary crude drug mixture is decocted, each 100kg medical material adds the drinking water of 1000L approximately, boil after for the first time soaking 30min, decoct secondary, each 45～100 minutes, collect volatile oil simultaneously, get medicinal liquid; 200 mesh sieves filtration back concentrates with the triple effect concentrator, and one imitates 80 ℃ of temperature, two 70 ℃ of effects, 60 ℃ of triple effects, the clear paste of simmer down to relative density 1.08～1.18; Get the spray drying tower powder process of half clear paste, 160～180 ℃ of inlet temperature, 80～100 ℃ of leaving air temps get extract powder; Second half remaining clear paste and extract powder one-step palletizing airpillow-dry mechanism granule, 60～80 ℃ of inlet temperature, 45～70 ℃ of leaving air temps get granule, add above-mentioned volatile oil, mixing is made granule, be distributed into 5000 bags with the granule racking machine, every bag of 5g gets finished product.

Embodiment two

Get 18 parts of the Radixs Astragali, 8 parts of Radix Codonopsis, 15 parts in Poria, 10 parts of the Rhizoma Atractylodis Macrocephalaes, above-mentioned primary crude drug is mixed decocting, each 100kg medical material adds the drinking water of 1000L approximately, boil after for the first time soaking 30min, decoct secondary, each 45～100 minutes, collect volatile oil simultaneously, get medicinal liquid; 200 mesh sieves filtration back adds the triple effect concentrator and concentrates, and one imitates 80 ℃ of temperature, two 70 ℃ of effects, 60 ℃ of triple effects, is concentrated into the clear paste of relative density 1.08～1.18; Get the spray drying tower powder process of half clear paste, 160～180 ℃ of inlet temperature, 80～100 ℃ of leaving air temps get extract powder; Second half remaining clear paste and extract powder one-step palletizing airpillow-dry mechanism granule, 60～80 ℃ of inlet temperature, 45～70 ℃ of leaving air temps get granule; Add above-mentioned volatile oil and moderate lubrication agent or binding agent tabletting (0.48～0.52g/ sheet), reuse high-efficiency coating machine coating is distributed into 400 bottles, 120 every bottle, gets the tablet product.

Embodiment three

Get 12 parts of the Radixs Astragali, 5 parts of Radix Codonopsis, 7 parts in Poria, the Rhizoma Atractylodis Macrocephalae 5,6 parts of Fructus Ligustri Lucidi, 9 parts of steps of Herba Epimedii by embodiment one process grain products.

Embodiment four

Get 13 parts of 18 parts of the Radixs Astragali, 8 parts of Radix Codonopsis, 15 parts in Poria, the Rhizoma Atractylodis Macrocephalae 10,12 parts of Fructus Ligustri Lucidi, Herba Epimedii above-mentioned primary crude drug is ground into fine powder, sieve mixing, add refined honey and an amount of water and make soft material, use the pellet processing machine pill, cold drying, check gets the pill product.

Embodiment five

Get 16 parts of the Radixs Astragali, 6 parts of Radix Codonopsis, 14 parts in Poria, 8 parts of the Rhizoma Atractylodis Macrocephalaes, 13 parts of Fructus Ligustri Lucidi, 10 parts of Herba Epimedii, by the step of embodiment one process granule, further filled capsules on capsule filler, inspect by ready samples, the capsule product.

Embodiment six

Get 15 parts of the Radix Astragali Radixs Astragali, 5 parts of Radix Codonopsis, 12 parts in Poria, 8 parts of the Rhizoma Atractylodis Macrocephalaes, 10 parts of Fructus Ligustri Lucidi, 8 parts of Herba Epimedii, above-mentioned primary crude drug mixture is decocted, each 100kg medical material adds the drinking water of 1000L approximately, boil after for the first time soaking 40min, decoct secondary, each 45～100 minutes, collect volatile oil simultaneously, get medicinal liquid; Filter the back and be concentrated into every 1ml medicinal liquid with the energy-conservation concentrator of triple effect and be equivalent to crude drug 2g approximately, put coldly, add the remove impurity of ethanol precipitate with ethanol, stir evenly placement 24h.Filter, filtrate recycling ethanol does not extremely have the alcohol flavor, adds above-mentioned volatile oil, and with preparations such as an amount of water, syrup and adjuvants, embedding is in the control oral liquid bottle, and every bottle of 10ml with 100 ℃ of sterilization 30min, gets 5000 oral liquid finished products.

In addition, the Fructus Ligustri Lucidi in embodiment three to embodiment six raw materials, Herba Epimedii be in the two, also can only add wherein a kind of.

Further specify the beneficial effect of product of the present invention below by the clinical trial situation.

The II clinical trial phase situation of product of the present invention:

Product particle of the present invention is the health care medicine of treatment deficiency of vital energy edema (chronic nephritis, nephropathy type), participates in carrying out the II clinical trial phase by two tame hospitals of Shandong Tai'an City Hospital of Traditional Chinese Medicine.From year July in July, 1997-1999, observe deficiency of vital energy edema patient 240 examples altogether, wherein test group 180 people.Take product particle of the present invention; Matched group 60 people take " paecilomyces hepiall chen ".Observed result shows: test group total effective rate 86.11%, matched group total effective rate 88.33%.Two groups are not relatively had significant difference (P＞0.05).Result of the test shows that product particle treatment deficiency of vital energy edema of the present invention (chronic nephritis nephropathy type) has better curative effect.

Research purpose

Objective evaluation product particle of the present invention treatment chronic nephritis nephropathy type Chinese medical discrimination belongs to the clinical efficacy of deficiency of vital energy edema and to the safety of human body.

Physical data

The case source

Test group 180 people and matched group 60 people, be the Supreme People's Court and the Supreme People's Procuratorate's outpatient service and inpatient, clinically be divided into two groups at random, all, be diagnosed as chronic nephritis nephropathy type, except that objective indicator through routine blood test, routine urinalysis, stool routine examination, blood fat, kidney function test, every patient's clinical manifestation all possesses three-hypers, and (that is: high protein is urinated, the height edema, the hypercholesterolemia blood disorder), one low (that is: hypoproteinemia card) feature.All do not have significant difference at sex, age, the course of disease, clinical symptoms and aspects such as picture of the tongue, pulse condition before two patient's cases source and the treatment, two groups of cases have comparability.See table 1-8 for details.

1 test case ordinary circumstance

Two groups of patients' case source and sex do not have significant difference, see Table 1.

Table 1 liang group case source, sex comparison sheet

Group	n	Be in hospital		Outpatient service		The man		The woman
		Be in hospital		Outpatient service		The man		The woman		n	％	n	％	n	％	n	％
		The test group matched group	180 60	115 41	63.89 68.33	65 19	36.11 31.67	96 42	53.33 70.00	n	％	n	％	n	％	n	％	84 18	46.67 30.00

Learn by statistics and handle: case source X ²=0.26 P＞0.05

Sex ratio is than X ²=1.21 P＞0.05

2 ages

Two groups of patient age do not have significant difference, see Table 2

Table 2 a liang group patient age distributes and the mean age comparison sheet

Group	n	16 years old-		21 years old-		31 years old-		41 years old-		51 years old-		X±S
		16 years old-		21 years old-		31 years old-		41 years old-		51 years old-			n	％	n	％	n	％	n	％	n	％
		The test group matched group	180 60	72 16	40.00 27.00	54 14	30.00 23.00	27 18	15.00 30.00	9 10	5.00 16.70		n	％	n	％	n	％	n	％	n	％	18 2	10.00 3.30	28.16±13.20 36.12±12.72

Learn by statistics and handle X ²=2.85 P＞0.05.

3, two groups of courses of disease do not have significant difference, learn result X by statistics ²=0.015, P＞0.05 (full edition omits, and is as follows).

4. two groups of preceding mild symptoms weight classifications of patient do not have significant difference, learn result X by statistics ²=1.42 P＞0.05.

5, the tcm syndrome related symptoms does not relatively have significant difference, learns by statistics and handles, and the P value all＞0.05.

6, two groups of case picture of the tongues relatively do not have significant difference, learn by statistics and handle: two groups of patients compare X from body of the tongue ²=0.78 P＞0.05; Two groups of patients compare X from tongue fur ²=0.87P＞0.05.

7, two groups of patient's pulse conditions relatively do not have significant difference, learn by statistics and handle X ²=0.82P＞0.05.

8, two groups of preceding immune indexes of patient more all do not have significant difference, learn by statistics and handle, and the P value all＞0.05.

Test method

One, case choice criteria

(1) diagnostic criteria:

1, Western medicine diagnose standard (standard that meeting was drafted with reference to second national nephropathy science in 1985)

(1) onset is slow, state of an illness delay, the time heavy when light, renal function progressively goes down, anemia can appear in the later stage, electrolyte disturbance, situations such as blood urea nitrogen, serum creatinine rising.

(2) in various degree performances such as albuminuria, hematuria, edema and hypertension are arranged.

(3) can bring out acute attack because of reasons such as respiratory tract infection in the course of disease, the performance of similar acute nephritis occur, also have some cases can have automatic alleviation to separate the phase.

(4) can further divide into according to clinical manifestation:

Plain edition: the various symptoms of nephritis are arranged, but do not have outstanding behaviours;

Hypertension type: except that general nephritis symptom, hypertensive outstanding behaviours is arranged;

Acute attack type: the performance of acute nephritis syndrome in chronic process, occurs.

2, Chinese medical discrimination (" the chronic primary glomerulopathy Chinese medical discrimination typing tentative program " that pass through with reference to second national traditional Chinese medical science nephropathy Symposium in 1986)

(1) assertive evidence; Syndrome of qi deficiency of lung and kidney

In following 5 pattern of syndrome, all possess wherein any 3 persons, can be diagnosed as this card.

A, edema, shallow complexion; B, weak breath are unable; , easily catch a cold; D, ache of the spinal column; E, light red tongue, white and moist fur have the tooth seal, thready and weak pulse.

(2) standard card: water is wet, the turbid damp card.All possess following any 1 person, can determine.

A, indigestion and loss of appetite, n or V; B, heavy sensation of the body is sleepy or listlessness; C, the above edema of whole body moderate or hydrothorax, ascites; D, blood urea nitrogen, creatinine are higher.

3, chronic nephritis weight grade scale

The weight of the state of an illness mainly judges from aspects such as albuminuria, renal function, edema, hypertension, syndrome of blood stasis, and all possess following any 1 and can determine.

(1) severe

A, urine protein examination continue ++ +～++ ++, or the twenty-four-hour urine protein quantification is between 2.1～3.5g, serum albumin＞30g/L; B, renal function undesired (serum creatinine 〉=442 μ mol/L persons are not therein); C, obvious edema and hypertension; D, the performance of obvious syndrome of blood stasis is arranged.

(2) moderate

A, urine protein examination continue ++～+++, or the twenty-four-hour urine protein quantification continues between 1～2g, and renal function is normal: B, edema can gently can weigh, and hypertension can be arranged; C, the clinical manifestation of slight syndrome of blood stasis is arranged.

(3) slight

A, urine protein examination continue +～++, or the twenty-four-hour urine protein quantification continues below 1g, and renal function is normal; B, edema are not obvious, and blood pressure is normal; C, there is or do not have the syndrome of blood stasis clinical manifestation.

(4) Syndrome in TCM shape weight grade scale: see Table 3.

(2) test case standard

1, includes disease row standard in

The chronic nephritis patient of all serum creatinine＜5mg/dl (442 μ mol/L), and the person that meets the Chinese medical discrimination can include the test case in.

(3) test case quantity and group technology

1, test group 180 examples, matched group 60 examples adopt inpatient and clinic case, and wherein inpatient is no less than 60% of total routine number, and clinic case selects compliance good, the case of may command variable factor.

2, patient was divided into two groups at random by 3: 1, one group is test group totally 180 examples, and another group is matched group totally 60 examples.

Table 3 tcm symptom weight grade scale

Tcm symptom	Gently (+)	In (++)	Heavy (+++)
Tcm symptom	Gently (+)	In (++)	Heavy (+++)	Puffiness of the face and limbs	The depression that face and time body Mild edema are pressed is easily recovered	Edema is obvious, and the depression of more so pressing below the waist is difficult for recovering	The above hydrosarca of moderate is stayed for a long time and is not moved back, by depression be difficult to recover
Short breath	Breathe hard after the activity	Move slightly and promptly breathe hard	Also breathe hard usually	Puffiness of the face and limbs
Short breath	Breathe hard after the activity	Move slightly and promptly breathe hard	Also breathe hard usually	Spiritlessness and weakness	Lassitude can be supported physical work	Spirit is tired, adheres to routine work reluctantly	Spirit is extremely tired, can not support daily work
Ache of the spinal column	Idol has outbreak	Outbreak repeatedly	Continue outbreak, be difficult for alleviating	Spiritlessness and weakness	Lassitude can be supported physical work	Spirit is tired, adheres to routine work reluctantly	Spirit is extremely tired, can not support daily work
Ache of the spinal column	Idol has outbreak	Outbreak repeatedly	Continue outbreak, be difficult for alleviating	Poor appetite abdominal distention	Appetite is poor, appetite does not subtract, and slight abdominal distention disappears in 0.5 hour or alleviates	No appetite, appetite reduces in 1/2, abdominal distention more very continues 0.5-2 hour	No appetite, appetite descends more than 1/2, and serious abdominal distention continues more than 2 hours
Light red tongue or tooth seal is arranged				Poor appetite abdominal distention
Light red tongue or tooth seal is arranged				Control white and moist or white being bored with
Deep-slow pulse or thin and delicate				Control white and moist or white being bored with

Indicate: by light (+), in (++), heavy (+++) be designated as 1,2,3 fen respectively; Tongue, arteries and veins are with "+", "-" expression.

Two, Therapeutic Method

(1) treatment group: product of the present invention, every day 3 times, obey 3 grams at every turn.

(2) matched group: " paecilomyces hepiall chen ", every day 3 times, each 3.

(3) course of treatment:, serve on three courses of treatment all around.

(4) inactive any medicine relevant and Therapeutic Method before the treatment with primary disease.

Three, observation index

(1) safety observation:

A, general health check-up project: B, blood, urine, just routine test; C, the heart, liver, kidney function test.

(2) health giving quality observation:

1, symptom: puffiness of the face and limbs, weak breath is weak, ache of the spinal column, poor appetite abdominal distention etc. with gently+, in ++, heavy +++expression.

2, sign: shallow complexion, puffiness of the face and limbs by depression do not rise, have or not breast, ascites, the position of edema and degree etc. with gently+, in ++, heavy +++expression.

Tongue fur: white and moist, thin, thick etc.; Body of the tongue: light, red, dark etc.; Tongue shape: there is tooth seal on the limit, and is fat tender etc.; Pulse condition: thin, weak, heavy slow etc.

3, twenty-four-hour urine protein quantification, routine urinalysis and uropsammus examination;

Routine urinalysis is checked weekly once;

Urine sediments analyzer and twenty-four-hour urine protein quantification were checked, and were write down 1 time in every month;

Routine urianlysis is observed albumen, cast, erythrocyte and record.

4, immune indexes inspection: adopt single-phase agar diffusion method to measure periphery serum, immunoglobulin IgG, lgA, lgM and complement C before and after the treatment ₃Content value and record.Normally: data return to normal range, see Table 9,

5, kidney function test comprises serum creatinine, blood urea nitrogen etc.

6, blood fat: lipid examination comprises cholesterol, triglyceride determination.

Table 9 immune indexes normal value table

IgG	lgA	lgM	C ₃
IgG	lgA	lgM	C ₃	11.2±3.2g/L	1.7±0.56g/L	1.35±0.59g/L	0.5-1.5g/L

Four, curative effect determinate standard

(1) symptom curative effect determinate standard:

1, alleviation fully: symptom and sign complete obiterations such as edema, the lasting feminine gender of urine protein examination or " ± " are more than 2 months, or the twenty-four-hour urine protein quantification is lasting less than 0.2g, and urine erythrocyte disappears under the high power lens, and Urine sediments analyzer is counted normally, and renal function is normal.

2, produce effects; Symptom such as edema and sign disappear substantially, and the urine protein examination continuous decrease is more than 50%, and urine erythrocyte is no more than 3 under the high power lens, and the Urine sediments analyzer counting is near normal, and renal function normally or normal substantially (differ be no more than 15% with normal value).

3, effective: symptom such as edema and sign are clearly better 1 of urine protein examination continuous decrease "+"; Or twenty-four-hour urine protein quantification continuous decrease 25-49%, urine erythrocyte is no more than 5 under the high power lens, and renal function is normal or improvement arranged.

4, invalid: clinical manifestation and above-mentioned lab testing all do not have obvious improvement or the anti-person of increasing the weight of.

(2) tcm syndrome total effects criterion:

Formulate the traditional Chinese medical science according to integration method and wait total effects

Produce effects: n 〉=70%

Effectively: 70%＞n 〉=30%

Invalid: n＜30%

Result of the test

One, efficacy assessment standard:

Efficacy assessment standard mainly is that immune indexes is answered Chang Chengdu and formulated according to tcm syndrome curative effect, sign improvement, three-hypers one low characteristic change.

1, symptom general curative effect:

Two groups of whole curative effects compare: test group total effective rate 86.11%, and matched group total effective rate 88.33%, no significant difference, P＞0.05 sees Table 4.

Table 4 liang group patient symptom total effects comparison sheet

Group	n	Produce effects		Effectively		Invalid		Total effective rate %	P
		Produce effects		Effectively		Invalid				n	％	n	％	n	％
		The test group matched group	180 60	138 45	76.67 75.00	17 8	9.40 13.33			n	％	n	％	n	％	25 7	13.89 11.67	86.11 88.33	P＞0.05

Learn by statistics and handle: the symptom total effects is X relatively ²=1.23 P＞0.05

2, tcm symptom curative effect: the tcm symptom curative effect compares, and two groups of cases self are relatively treated each individual event symptom integral of back all than the preceding obviously decline of treatment, significant difference, and (P＜0.01) sees Table 5.

Comparison sheet before and after the table 5 liang group tcm symptom integration treatment

Project	n	Test group (180 example)			n	Matched group (60 example)
		Test group (180 example)				Matched group (60 example)			X±S	t	P	X±S	t	P
		The swollen spiritlessness and weakness of the floating glue of ache of the spinal column face is breathed to breathe hard and is received poor abdominal distension	180 180 159 138 160	Behind front 19.78 ± 0.69 medicines of medicine behind front 18.01 ± 0.17 medicines of 10.87 ± 0.28 medicines behind front 19.21 ± 0.38 medicines of 11.89 ± 0.90 medicines behind front 18.49 ± 0.85 medicines of 10.87 ± 0.28 medicines behind front 16.29 ± 0.71 medicines of 10.86 ± 0.60 medicines 10.89 ± 0.69		10.81 12.91 10.81 16.21 10.82	＜0.01 ＜0.01 ＜0.01 ＜0.01 ＜0.01	40 60 60 50 28	X±S	t	P	X±S	t	P	Behind front 19.21 ± 0.73 medicines of medicine behind front 17.16 ± 0.29 medicines of 10.97 ± 0.92 medicines behind front 18.17 ± 0.72 medicines of 12.01 ± 0.90 medicines behind front 18.56 ± 1.01 medicines of 11.48 ± 0.93 medicines behind front 16.72 ± 0.97 medicines of 10.92 ± 0.69 medicines 10.78 ± 0.79	7.45 12.01 8.99 8.01 6.02	＜0.01 ＜0.01 ＜0.01 ＜0.01 ＜0.01

3, the tongue arteries and veins improves situation

(1) the improvement situation of picture of the tongue:

Picture of the tongue improvement situation according to two groups of patients compares, no big variation before and after the treatment, but obvious with the fat improvement of pale tongue.See Table 6.

The table 6 liang unusual picture of the tongue situation of group

Test group (180 example)				Matched group (60 example)
Test group (180 example)				Matched group (60 example)				Pale tongue is fat		Tongue is greasy in vain		Pale tongue is fat		Tongue is greasy in vain
n	％	n	％	n	％	n	％	Pale tongue is fat		Tongue is greasy in vain		Pale tongue is fat		Tongue is greasy in vain
n	％	n	％	n	％	n	％	After treating before the treatment	138 127	76.67 70.56	129 112	71.67 62.22	40 32	66.67 53.33	41 36	68.33 60.00

(2) the improvement situation of pulse condition:

Two groups of patients' pulse condition changes with thready and weak pulse and improves obviously, sees Table 7.

The table 7 liang unusual pulse condition situation of group

Test group (180 example)						Matched group (60 example)
Test group (180 example)						Matched group (60 example)						Late heavy		Thin and delicate		Other		Late heavy		Thin and delicate		Other
n	％	n	％	n	％	n	％	n	％	n	％	Late heavy		Thin and delicate		Other		Late heavy		Thin and delicate		Other
n	％	n	％	n	％	n	％	n	％	n	％	After treating before treating	65 62	36.11 34.44	72 35	40.00 19.44	43 38	23.89 21.11	23 16	38.33 26.67	20 12	33.33 20.00	17 13	28.33 21.67

4, immune curative effect:

The immunity total effects compares: test group normalization rate 53.33%, 48.33%, two group of significant difference of matched group normalization rate (P＜0.05).Test group total effective rate 91.10%.The matched group total effective rate does not relatively have significant difference for 90.00%, two group, and (P＜0.05) sees Table 8.

The table 8 a liang group immune total effects comparison sheet in 30 table backs of taking medicine

Group	n	Multiple normal		Effectively		Invalid		Total effective rate %	P
		Multiple normal		Effectively		Invalid				n	％	n	％	n	％
		The test group matched group	180 60	96 29	53.33 48.33	68 25	37.78 41.67			n	％	n	％	n	％	16 6	8.89 10.00	91.10 90.00	＞0.05

Discuss

1, edema is disease, YIN edema is arranged, the branch of YANG edema, observe case and select the YIN edema case, onset is slow, disease deeply with the passing of time, edema with the edema below the waist very, by depression do not rise, dysuria, spinal column are aching and limp, spiritlessness and weakness, easy to catch cold, poor appetite abdominal distention, pale tongue with thin fur are white, deep,thready and forceless pulse, dialectically be the insufficiency of QI of the lung and kidney edema.

2, product of the present invention has the function of kidney and spleen invigorating, inducing diuresis to remove edema preferably, for the spleen deficiency of kidney-QI, and the imbalance of water liquid metabolic function, the water hydrorrhea improves significantly in the edema that skin forms.

3, two groups of patient's primary conditions: age, sex, the course of disease, the balanced equity of severity extent have comparability.

4, observed result shows: product of the present invention is apparent in view to the improvement of deficiency of vital energy symptom, and the average product score value descends 8.08%; Paecilomyces hepiall chen component value descends 6.78.Test group total effective rate 86.11%, matched group total effective rate 88.33%, (P＞0.05), two groups of curative effects relatively do not have significant difference.

5, to the improvement of immunologic function, test group normalization rate 53.33%, matched group normalization rate 48.33%, (P＜0.05); Therefore this medicine is to regulating body's immunity, and the resistance against diseases of enhancing body is got well, and therapeutical effect is preferably arranged.

6, all do not find any untoward reaction in the observation.

Conclusion

Product treatment chronic nephritis nephropathy type Chinese medical discrimination of the present invention belongs to deficiency of vital energy edema person, and clinical efficacy is definite, no obvious toxic-side effects.

Claims

1. treat immunologic hypofunction or disorderly Chinese medicine for one kind, it is characterized in that it is a raw material by following weight portion: Radix Astragali 10-20 part, Radix Codonopsis 3-9 part, Poria 6-18 part, Rhizoma Atractylodis Macrocephalae 4-12 part, through being processed into tablet, granule, pill, capsule or oral liquid.

2. treatment immunologic hypofunction according to claim 1 or disorderly Chinese medicine is characterized in that can also adding in the described raw material Fructus Ligustri Lucidi 5-15 part and/or Herba Epimedii 8-16 part.