CN1260204A - Medicament for treating diabetes and its preparation method - Google Patents

Abstract

The preparation method of Chinese patent medicine for curing diabetes includes the following steps: according to effective components and physical and chemical properties dividing 16 Chinese medicinal materials of pine pollen, gizzard lining, astragalus root, pseudostellaria root, phellodendron bark, corn silk, anemarrhena root, rehmannia root, polygonatum root and mulberry root bark, etc. into four groups, and respectively adopting the processes of decocting in water, decocting in water and alcohol precipitation, ethyl alcohol extraction and pulverizing, and making them into said invented capsule preparation. It is obvious in therapeutic effect, and has no toxic side effect.

Description

A kind of medicine for the treatment of diabetes and preparation method thereof

The present invention relates to treat the preparation method of Chinese patent medicine and this Chinese patent medicine of diabetes

The pathogeny of diabetes mainly is the β emiocytosis of pancreas and the function reduction of uelralante, secretion and uelralante absolute not enough (type 1 diabetes) and relative deficiency (type 2 diabetes mellitus), the glucagon content of the α cell of pancreas release simultaneously increases again relatively, cause hepatic glycogen to be decomposed into glucose, because the absolute deficiency or the relative deficiency of insulin content, descend with the amount of receptors bind, make fat, the ability drop of picked-up such as muscle and utilization sugar, the different muscle that causes, fat absorption makes the blood sugar content in the blood raise less than enough glucoses, cause the symptom of hyperglycemia, metabolism along with human body, sugar part is discharged from urine, produce glucose in urine, be diabetes.Suffering from the glycosuria patient and do not heal all the life, also often be attended by severe complications, is one of three big diseases that jeopardize the human life.

At present, the medicine of treatment diabetes is divided into three major types: 1, pure Western medicine, such medicine is representative with the sulfonylureas glyburide of the insulin and the second filial generation, advantage is that controlling symptoms is rapid, effect is remarkable, but pays effect obviously, not only can damage liver, renal function, but also can cause leukocyte, granulocyte and hematoblastic minimizing, and can cause patient's medicine secondary failure; 2, Chinese and Western is in conjunction with the medicine class, such medicine is representative with a diabetes pill in the Guangzhou No.1 Chinese Pharmacy Factory production, in the Main Ingredients and Appearance of a diabetes pill Radix Astragali is arranged, Radix Rehmanniae, Radix Trichosanthis and Western medicine glyburide, this medical instrument have YIN nourishing to support kidney, the characteristics that supplementing QI for promoting the production of body fluid and curative effect are fast, but still contain the Western medicine glyburide of 0.25mg in every ball, thereby also have the deficiency of damaging liver, renal function and causing patient's medicine secondary failure; 3, pure Chinese medicine though also have with the medicine of pure treatment by Chinese herbs diabetes, is 96105259 " a kind of medicine for the treatment of diabetes and preparation method thereof " as number of patent application, and effect is not fairly obvious, and the patient also will rely on insulin injection and treat.

The purpose of this invention is to provide the medicine that a kind of blood sugar lowering significantly and not damages the treatment diabetes of liver, renal function.

Another object of the present invention provides the preparation method of this treatment diabetes medicament.

The medicine of this treatment diabetes is become by the following components by weight parts numeral system:

Pollen Pini 6.0-8.0 Endothelium Corneum Gigeriae Galli 2.5-3.5

Radix Astragali 26.0-28.0 Radix Pseudostellariae 5.0-7.0

Cortex Phellodendri 5.5-6.5 Stigma Maydis 110.0-140.0

Rhizoma Anemarrhenae 3.5-4.5 Radix Rehmanniae 19.0-21.0

Rhizoma Polygonati 8.5-9.5 Cortex Mori 14.0-16.0

Rhizoma Dioscoreae 4.0-5.0 Semen Litchi 35.0-37.0

Radix Salviae Miltiorrhizae 4.0-5.0 Fructus Corni 5.5-6.5

Radix Et Rhizoma Rhei 2.5-3.5 Fructus Schisandrae Chinensis 5.5-6.5

The preferred weight umber scope for preparing each component of medicine of this treatment diabetes is:

Pollen Pini 6.5-7.5 Endothelium Corneum Gigeriae Galli 2.8-3.3

Radix Astragali 26.5-27.5 Radix Pseudostellariae 6.0-6.5

Cortex Phellodendri 5.8-6.3 Stigma Maydis 120.0-130.0

Rhizoma Anemarrhenae 4.0-4.2 Radix Rehmanniae 19.9-20.5

Rhizoma Polygonati 8.9-9.3 Cortex Mori 14.7-15.2

Rhizoma Dioscoreae 4.4-4.8 Semen Litchi 35.8-36.4

Radix Salviae Miltiorrhizae 4.4-4.8 Fructus Corni 5.8-6.2

Radix Et Rhizoma Rhei 2.8-3.3 Fructus Schisandrae Chinensis 5.8-6.2

The optimum weight umber for preparing each component of medicine of this treatment diabetes is:

Pollen Pini 7.0 Endothelium Corneum Gigeriae Galli 3.0

The Radix Astragali 27.0 Radix Pseudostellariaes 6.0

Cortex Phellodendri 6.0 Stigma Maydis 120.0

The Rhizoma Anemarrhenae 4.0 Radix Rehmanniae 20.0

Rhizoma Polygonati 9.0 Cortex Mori 15.0

Rhizoma Dioscoreae 4.5 Semen Litchis 36.0

Radix Salviae Miltiorrhizae 4.5 Fructus Corni 6.0

Radix Et Rhizoma Rhei 3.0 Fructus Schisandrae Chinensis 6.0

The preparation method of the medicine of this treatment diabetes is:

A, pre-treatment: get Endothelium Corneum Gigeriae Galli powder and be broken into 60 order fine powders; Getting Pollen Pini is ground into 60 order fine powders and places dry place; Spice in all the other 14 flavors in the component is processed into decoction pieces;

B, produce decocting medicine cream: by learn from else's experience the Radix Astragali after the pre-treatment of the parts by weight in the said medicine component, Radix Pseudostellariae, Cortex Phellodendri, spice in Stigma Maydis and the Rhizoma Anemarrhenae 5 flavors, put into 12 times of cold water of this 5 flavor spice gross weight, be heated to boiling, under the boiling condition, decocted 2 hours, win time decoction liquor of filtration, in 5 flavors after decocting for the first time, put into and the equivalent cold water that decocts institute's water for the first time in the spice again, be heated to boiling, under the boiling condition, decocted 1.5 hours, filter decoction liquor for the second time, merge this twice decoction liquor, relative density during again with this twice decoction liquor concentrating under reduced pressure to 50 ℃ temperature is the thick paste of 1.30-1.35, is decocting medicine cream;

C, produce water decoction-alcohol sedimentation medicine cream: by learn from else's experience Radix Rehmanniae after the pre-treatment of the parts by weight in the said medicine component, Rhizoma Polygonati, Cortex Mori, spice in Rhizoma Dioscoreae and Semen Litchi 5 flavors, put into 10 times of cold water of this 5 flavor spice gross weight, be heated to boiling, under the boiling condition, decocted 2 hours, win time decoction liquor of filtration, in 5 flavors after decocting for the first time, put into and the equivalent cold water that decocts institute's water for the first time in the spice again, be heated to boiling, under the boiling condition, decocted 2 hours, filter decoction liquor for the second time, merge this twice decoction liquor, and the relative density during with this twice decoction liquor concentrating under reduced pressure to 50 ℃ temperature is 1.08-1.12,1.5 times 95% ethanol that under abundant stirring condition, adds spice gross weight in this 5 flavor again, Cryoprecipitation 48 hours, filtering liquid medicine reclaims ethanol, relative density during concentrated medicament to 50 ℃ temperature is the thick paste of 1.30-1.35, is water decoction-alcohol sedimentation medicine cream;

D, produce alcohol extraction medicine cream: by learn from else's experience Radix Salviae Miltiorrhizae after the pre-treatment of the parts by weight in the said medicine component, Fructus Corni, spice in Radix Et Rhizoma Rhei and Fructus Schisandrae Chinensis 4 flavors, put into 10 times of 80% ethanol of this 4 flavor spice gross weight, reflux, extract, 3 hours, win time alcohol extract of filtration, in 4 flavors after the alcohol extraction first time, put into 8 times 80% ethanol in the spice again, reflux, extract, 2 hours, filter to such an extent that carry pure liquid for the second time, in 4 flavors after the alcohol extraction second time, put into 8 times 80% ethanol in the spice again, reflux, extract, 1 hour, filter alcohol extract for the third time, merge this three alcohol extracts, relative density during concentrating under reduced pressure to 50 ℃ temperature is the thick paste of 1.30-1.35, is alcohol extraction medicine cream;

E, produce the dried cream of medicine: water intaking boil medicine thing cream, water decoction-alcohol sedimentation medicine cream, alcohol extraction medicine cream and by the parts by weight in the said medicine component learn from else's experience Pollen Pini and Endothelium Corneum Gigeriae Galli after the pre-treatment, fully mixing is dried under 75 ℃-80 ℃ temperature, the dried cream of medicine;

F makes medicament capsule: the thing dried cream powder of getting it filled is broken, and mixing by every 0.5g, in 1000 capsules of packing into, gets medicament capsule.

Theory of Chinese medical science thinks that diabetes are to be this with the deficiency of YIN, and is scorching for marking, the moon is hindered then QI consumed, and QI consumed the moon is more hindered, the two reciprocal causation, cause deficiency of both vital energy and Yin, YIN fluid being insufficient is production of dryness-heat in the interior then, the scorching cloudy Tianjin of burning not to the utmost, and gram cuts down healthy energy, gas the moon is more hindered, owing to qi as the commander of blood, the capable then blood of gas is capable again, and the unable slow blood flow that then causes of deficiency of vital energy operation forms blood stasis.Each drug component of the present invention, be by the traditional Chinese medical science monarch, minister, help, make and carry out compatibility, wherein: the sweet temperature of the Radix Astragali is gone into spleen, QI invigorating power by force again can the lucid yang sending up, and QI invigorating can be promoted the production of body fluid, and the lucid yang sending up can cloth Tianjin, effect with supplementing QI for promoting the production of body fluid, Radix Rehmanniae sweetness and bitterness and tremble with fear Yin-nourishing and body fluid promoting, clearing heat and moistening dryness, shared with the Radix Astragali, can QI invigorating, again can yin nourishing, therefore, the Radix Astragali and Radix Rehmanniae are monarch drug altogether; Radix Pseudostellariae is sweet puts down into spleen, supplementing QI for promoting the production of body fluid, and Rhizoma Dioscoreae is sweet puts down into taste supplementing QI and nourishing YIN, the sweet light property of Rhizoma Polygonati is put down into the spleen kidney, supplementing QI and nourishing YIN, and the sour and astringent tepor of Fructus Corni is gone into kidney, the secret gas of controlling nocturnal emission with astringent drugs, reinforcing YIN-essence is supporing yang, supplementing QI and nourishing YIN, the sweet temperature of trimethyl gallic acid is gone into kidney, kidney nourishing water, supplementing QI for promoting the production of body fluid, tonify deficiency, the sweet temperature of Pollen Pini is gone into spleen, the moon of strengthening the spleen gas, above-mentioned six medicines are shared, and the principal drug assistance supplementing QI and nourishing YIN is ministerial drug altogether; The Rhizoma Anemarrhenae is bitter sweet and tremble with fear into kidney, and clearing away heat-fire is nourshing Yin and drynsessmoistening prescription, removing summer-heat is scorching, and the Cortex Phellodendri bitter cold is gone into kidney, clearing away heat-fire, shared with the Rhizoma Anemarrhenae, nourishing YIN and clearing away heat pathogenic fire purging power is strong, and Cortex Mori is sweet trembles with fear into spleen, the tonify deficiency QI invigorating is quenched one's thirst, shared its production of dryness-heat in the interior of controlling of three medicines, the Radix Salviae Miltiorrhizae bitter cold is gone into heart spleen kidney, invigorates blood circulation, clear stagnant heat, main yin nourishing blood, the Radix Et Rhizoma Rhei bitter cold is gone into taste, clearing away heat-fire, blood circulation and promoting silt, two medicines and the Radix Astragali share, and have QI invigorating to promote the capable effect of blood, and Semen Litchi is arduous and temperature is gone into taste, promoting QI to circulate and dispersing the agglomeration of the pathogens, with the Radix Salviae Miltiorrhizae compatibility, increase the effect that it is invigorated blood circulation, Endothelium Corneum Gigeriae Galli is sweet puts down into spleen, the promoting digestion and invigorating the stomach arresting seminal emission, above-mentioned seven medicines are adjuvant drug; The Stigma Maydis nature and flavor are sweet flat, and the blending property of medicine is with being messenger drug.Comprehensive medicine components of the present invention has the supplementing QI and nourishing YIN tonifying speen and tonifying kidney and strengthens it, and moistening for dryness and clearing away heat, blood circulation promoting and blood stasis dispelling are to take stopgap measures, and the medicine card is harmonious, and compatibility is proper, plays the effect of supplementing QI and nourishing YIN, moistening for dryness and clearing away heat, blood circulation promoting and blood stasis dispelling altogether.

Medicine of the present invention, according to the 16 contained active ingredients of flavor Chinese medicines and the physicochemical property of Main Ingredients and Appearance, in conjunction with modern pharmacology and Clinical Application, in preparation method, this 16 flavor Chinese medicine is divided into four parts of directly being used as medicine after decocting, water decoction-alcohol sedimentation, ethanol extraction and the pulverizing, and the suitable condition of each several part extract drugs carried out preferably, thereby determined rational preparation method:

1, the extraction of decocting medicine: the monarch drug Radix Astragali in the drug component, mainly contain astragaloside, multiple water soluble ingredient such as astragalus polysaccharides, astragalus polysaccharides has dual regulation to sugared mice, the blood glucose of glucose load mice is significantly descended, can resist again by the experimental blood glucose of phenformin induced mice and reduce.Radix Pseudostellariae, the Rhizoma Anemarrhenae, Cortex Phellodendri and Stigma Maydis mainly contain multiple water solublity active ingredients such as glycoside, polysaccharide, some composition does not dissolve in alcohol, so adopt herbal decoction directly to be used as medicine, on the basis of determining extracting method, by to amount of water to above 5 herbal medicines, the orthogonal test of extraction time (being the time) and degree of grinding three factors three levels, determined the medicine decoction pieces, added the water of 12 times of amounts, extracted twice, 2 hours for the first time, the best decocting method of 1.5 hours second time;

2, the extraction of water decoction-alcohol sedimentation medicine: under the preceding topic that guarantees drug quality, for reducing taking dose, to mainly containing the Radix Rehmanniae of water-soluble substances in the drug component, Rhizoma Polygonati, Rhizoma Dioscoreae, Cortex Mori, Semen Litchi 5 herbal medicines are according to the principle of " mix and fry in shallow oil solubilising ", adopt decoction alcohol precipitation method to extract active substance, earlier with each medicament mixed decocting, the ethanol that adds 1.5 times of amounts after decocting liquid concentrates again precipitates, to remove impurity, decocting to medicine in technical study has carried out preferably with the orthogonal test of three factors, three levels, determine to add the water of 10 times of amounts, decocting 2 times, each 2 hours, for suitable decocting condition, in the selection of alcohol precipitation concentration, by to adding 1,1.5,2.0 doubly measure alcoholic acid preferably, the ethanol of finding to add 1.5 times of amounts is the suitable condition of precipitate with ethanol:

3, the extraction of alcohol extraction medicine: to the Fructus Corni in the drug component, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis, Radix Et Rhizoma Rhei 4 herbal medicines, owing to contain fat-soluble ursolic acid respectively, tanshinone, deoxyschizandrin, schisandrin B, compositions such as emodin, contain water miscible organic acid with fashion, danshensu, protocatechualdehyde, the Radix Et Rhizoma Rhei glycoside, for fully extracting this two classes active ingredient, the employing alcohol heating reflux extracts, in extraction conditions is selected, to concentration of alcohol (80%, 70%, 60%), addition (10,12,14 times) and extraction time screen, determine to adopt 80% ethanol, add 10 times of water gagings, extracting 3 times is optimum extracting method;

4, Pollen Pini and Endothelium Corneum Gigeriae Galli directly are used as medicine: Endothelium Corneum Gigeriae Galli is still not obvious for more valuable medicine and active ingredient, according to traditional medication custom, for fully remaining with effective substance, its pulverizing for replacing adjuvant directly to add with the Pollen Pini of exquisiteness, is mixed in the extractum fine powder, after oven dry is pulverized, incapsulate, be finished product;

5, in the preparation process of extraction and dried cream,,, be not damaged with the main component of abundant each medicine of assurance so adopt concentrating under reduced pressure and cold drying for avoiding the destruction of active ingredient under the high temperature.

In order to show the effect of drug treatment of diabetic of the present invention, selection of clinical the 348 routine diabeticss of age of onset at 18-65 year, course of disease 0.5-30, be divided into two groups at random, wherein 232 examples are organized in treatment, and matched group 116 examples are in the treatment group, male's 119 examples, women's 113 examples, in matched group, male's 64 examples, women's 52 examples, its treatment situation is as follows:

1, medication: treatment group medicament capsule of the present invention, every day 3 times, each 5, take 30 minutes ante cibum, the matched group diabetes pill, every day 3 times, each 10, take 30 minutes ante cibum, two groups are 30 days courses of treatment, take continuously, observe three courses of treatment, during the medication, unified low in calories, low fat, low salt diet;

2, observational technique: observe patient's polydipsia, polyphagia, polyuria, weak, dizzy, cardinal symptom that limb is numb before and after the medication respectively, the variation of laboratory observation blood glucose, glucose in urine, glycolated hemoglobin, plasma insulin, blood fat, urinary albumin excretion rate, kidney merit, liver function;

3, efficacy assessment standard:

(1) produce effects: treatment back symptom disappears substantially, fasting glucose＜7.2mmOl/L, 2 hours after the meal blood glucose＜8.3mmOl/L, twenty-four-hour urine sugar quantitatively＜10.0g; Or blood glucose, twenty-four-hour urine sugar quantitatively descends more than 30% before the treatment;

(2) effective: treatment back symptom is obviously improved, fasting glucose＜8.3mmOl/L, two hours after the meal blood is half congealed＜10mmOl/L, twenty-four-hour urine sugar quantitatively＜25.0g; Or blood glucose, twenty-four-hour urine sugar quantitatively descends more than 10% before the treatment;

(3) invalid: treatment back symptom does not have obvious improvement, and blood glucose, glucose in urine descend and do not reach above-mentioned standard.

4, treatment is analyzed:

(1) total effects: as shown in Table 1, the obvious effective rate and the effective percentage of treatment group are better than matched group.

Table 1 treatment group and matched group curative effect are relatively

	The example number	Produce effects	Effectively	Invalid	Obvious effective rate	Effectively total
							The treatment group	??232	??93	??130	????9	??40.10	???96.1
Matched group	??116	??28	??56	????32	??24.10	???72.4
							The P value					??＜0.01	???＜0.01

(2) symptom curative effect: as shown in Table 2, treatment group and matched group are relatively, and be not obvious to polydipsia, polyphagia, therapeutical effect difference dizzy, the numb symptom of limb, but to the improvement of polyuria, weak symptom, the treatment group obviously is better than matched group.

Table 2 treatment group and matched group disease curative effect are relatively

The card shape	Group	The example number	Produce effects	Effectively	Invalid	Obvious effective rate	Total effective rate
								Polydipsia	The treatment group	??190	??106	??79	???5	??55.8	??97.3
Matched group	??97	??45	??41	???11	??46.4	??88.7
							Polyphagia		The treatment group	??155	??81	??54	???20	??52.3	??87.1
Matched group	??76	??38	??28	???10	??50.1	??86.8
								Polyuria	The treatment group	??206	??109	??69	???28	??52.9 **	??86.4 **
Matched group	??101	??27	??24	???50	??26.7	??50.4
							Weak		The treatment group	??211	??137	??55	???19	??64.9 **	??91.0 **
Matched group	??104	??32	??22	???50	??30.8	??51.9
								Dizzy	The treatment group	??69	??14	??39	???16	??20.3	??76.8
Matched group	??32	??6	??18	???8	??18.8	??75.0
							The limb fiber crops		The treatment group	??114	??14	??67	???33	??12.3	??71.1
Matched group	??55	??5	??31	???19	??9.1	??65.5

Annotate: * * is than matched group P＜0.01

(3) relation of the course of treatment and curative effect: as shown in Table 3, medicament capsule of the present invention, first week of medication can produce the good curing effect, but the back 4-8 week of taking medicine to produce curative effect.

The relation of the table 3 treatment group course of treatment and curative effect relatively

The course of treatment	Produce effects	Effectively	Invalid
				1 week	????18	????31
4 weeks	????37	????62
				8 weeks	????30	????30
12 weeks	????8	????7	????9

(4) relation of the course of disease and curative effect: as shown in Table 4, the curative effect of treatment group, matched group is all relevant with the course of disease, but the treatment group not significantly (P＞0.05) medicament capsule of the present invention is described, the course of disease than the elder, is still had the good curing effect.

Table 4 treatment group is imitated with the contrast course of disease and therapeutic effect relationship ratio

The course of disease	Group	The example number	Produce effects	Effectively	Invalid	Obvious effective rate	Total effective rate
								In 1 year	The treatment group	????53	????29	????24	????0	??54.7	??100
Matched group	????27	????15	????11	????1	??55.6	??96.3
							1-3		The treatment group	????80	????36	????43	????1	??45.0	??98.8
Matched group	????36	????8	????19	????9	??22.2	??75.0
								3-5	The treatment group	????54	????19	????33	????2	??35.1	??96.3
Matched group	????29	????3	????17	????9	??10.3	??68.9
							More than 5 years		The treatment group	????45	????9	????30	????6	??20.0	??86.7
Matched group	????24	????2	????9	????13	??8.3	??45.8

(5) metabolism of blood glucose situation: as shown in Table 5, the treatment group is taken medicament capsule of the present invention, and glycometabolic improvement is better than matched group.

Table 5 treatment group and matched group metabolism of blood glucose situation are relatively

X±S

		Fasting glucose (mmol/L)	2 hours after the meal blood glucose (mmol/L)	Glucose in urine is (g/24h) quantitatively	Glycolated hemoglobin (%)
						Treatment group (n=232)	Before the treatment	13.70±1.42	?18.12±2.14	?38.54±30.11	9.82±2.06
After the treatment	7.13±0.60 △ **	?11.06±1.93 ▲△ **	?13.67±15.02 △ **	8.03±2.61 **
					Matched group (n=116)		Before the treatment	12.96±1.30	?17.97±2.41	?40.96±31.04	9.04±2.01
After the treatment	9.03±0.07 **	?13.52±1.01 **	?20.71±21.88 *	8.26±1.97 *

Annotate: * is than the preceding P of treatment＜0.05, and * * is the preceding P of treatment＜0.01,

△ than treatment of control group after P＜0.05, △ △ than treatment of control group after P＜0.01.

(6) insulin metabolism situation: as shown in Table 6, the treatment group is taken medicament capsule of the present invention, has the effect of the high islets of langerhans mass formed by blood stasis of treatment.

Table 6 treatment group and matched group insulin metabolism situation are relatively

X±S

		Fasting plasma insulin (miu/ml)	2 hours after the meal plasma insulins (miu/ml)
				Treatment group (n=232)	Before the treatment	????19.01±3.96	??41.03±5.70
After the treatment	????12.97±2.02 **△△	??32.43±4.71 **△△
			Matched group (n=116)		Before the treatment	????18.93±3.01	??40.09±5.16
After the treatment	????26.47±1.38 **	??47.33±5.82 **

Annotate: * * is P＜0.01 before the treatment, △ △ than treatment of control group after P＜0.01.

(7) lipid metabolism situation: as shown in Table 7, the treatment group is taken medicament capsule of the present invention, and cholesterol and triglyceride all are significantly improved.

Table 7 treatment group and matched group lipid metabolism situation are compared

X±S

		Cholesterol (mmol/L)	Triglyceride (mmol/L)
				Treatment group (n=232)	Before the treatment	????6.32±0.24	????2.04±0.47
After the treatment	????5.60±0.18 *	????1.62±0.61 **△△
			Matched group (n=116)		Before the treatment	????6.14±0.19	????2.26±0.51
After the treatment	????5.96±0.22	????2.38±0.18

Annotate: * is P＜0.05 before the treatment, and * * is P＜0.01 before the treatment, △ △ than the matched group medication after P＜0.01.

(8) to kidney effect situation: as shown in Table 8, the treatment group is taken medicament capsule of the present invention, and kidney is had remarkable protective effect, shows the reduction (P＜0.01) of urinary albumin discharge rate.

Table 8 treatment group and matched group are to kidney effect situation relatively

X±S

		The example number	Blood urea nitrogen (umol/L)	Blood creatinine (umol/L)	Urinary albumin (ug/min)
						The treatment group	Before the treatment	????86	??6.03±0.49	??65.63±3.92	?24.41±18.13
After the treatment	????86	??5.96±0.37	??60.71±3.10	?15.21±14.08 **△△
					Matched group		Before the treatment	????37	??5.97±0.51	??64.96±4.01	?23.82±17.24
After the treatment	????37	??5.94±0.46	??63.77±3.74	?24.13±17.06

Annotate P＜0.01 before the treatment of 1:**, △ △ than the matched group medication after P＜0.01.

Annotate 2: this shows listed case is II phase (microalbuminuria phase) diabetic nephropathy patient data.

(9) to the situation of change of liver function: 232 routine patients are organized in the treatment of taking medicament capsule of the present invention, all find no the liver damaged condition, prove that this medicament capsule is safe and reliable.

(10) poison is paid effect and untoward reaction: treatment is organized 232 routine patients and is taken during the medicament capsule of the present invention, finds malicious pay effect and any untoward reaction, and none routine patient is because of the untoward reaction drug withdrawal.

Confirm by above-mentioned clinical data:

1, medicament capsule of the present invention has the good curing effect to diabetes.This effect shows following four aspects: the one, can significantly improve patient's clinical symptoms, and improve its quality of life; The 2nd, blood sugar lowering great efforts, effect are significantly reliable, and no matter empty stomach, post-prandial glycemia, all significantly reductions of glucose in urine obviously are better than the diabetes pill matched group; The 3rd, the blood sugar lowering scope is wide, this medicament capsule is adapted to all kinds of patients in the type 2 diabetes mellitus, especially longer to the course of disease, dialectical genus deficiency of both YIN and YANG, type of QI-stagnation and blood stasis patient, still have the good curing effect, this is one of effect characteristics of this medicine, and this medicament capsule is to the patient of sulfonylureas drugs for diabetes thing secondary failure, still having blood sugar reducing function preferably, is effective selection of " no medicine can be cured " patient; The 4th, effect in blood sugar lowering, has good blood fat reducing and kidney protective effect, thereby diabetes protopathy and complication is all had clinical efficacy preferably comprehensively, and this is the another characteristics of this medicine;

2, the effect of medicament capsule of the present invention has reliable experiment basis, laboratory detection result shows, this medicament capsule can improve the ubiquitous hyperinsulinemia phenomenon of 2 type patients, point out this medical instrument that the peripheral insulin resistance of improvement is arranged in view of the above, improve the effect of Insulin receptor INSR sensitivity, these are different with the Chinese patent medicine effect of rising insulin level in matched group and the general report, and this is another characteristics of this medicine

3, medicament capsule of the present invention is safe and reliable; this medicament capsule is a pure Chinese medicinal preparation; laboratory detects and confirms; this medicine does not have obvious hepatorenal damage and tangible kidney protective effect is arranged; do not find the untoward reaction of digestive tract and other any system during the medication, thereby be a hypoglycemic medicine safely and effectively.

Embodiment

A, get Endothelium Corneum Gigeriae Galli powder and be broken into 60 purpose fine powders, get Pollen Pini and be ground into 60 order fine powders and place dry place, the Radix Astragali, Radix Pseudostellariae, Cortex Phellodendri, Stigma Maydis, the Rhizoma Anemarrhenae, Radix Rehmanniae, Rhizoma Polygonati, Cortex Mori, Rhizoma Dioscoreae, Semen Litchi, Radix Salviae Miltiorrhizae, Fructus Corni, Radix Et Rhizoma Rhei and Fructus Schisandrae Chinensis are processed into decoction pieces respectively;

B, according to following kilogram parts by weight take by weighing respectively through A pulverize, spice among after the processing 16:

Pollen Pini 7.0 Endothelium Corneum Gigeriae Galli 3.0

The Radix Astragali 27.0 Radix Pseudostellariaes 6.0

Cortex Phellodendri 6.0 Stigma Maydis 120.0

The Rhizoma Anemarrhenae 4.0 Radix Rehmanniae 20.0

Rhizoma Polygonati 9.0 Cortex Mori 15.0

Rhizoma Dioscoreae 4.5 Semen Litchis 36.0

Radix Salviae Miltiorrhizae 4.5 Fructus Corni 6.0

Radix Et Rhizoma Rhei 3.0 Fructus Schisandrae Chinensis 6.0

Spice in C, the Radix Astragali that takes by weighing by the B kind, Radix Pseudostellariae, Cortex Phellodendri, Stigma Maydis and the Rhizoma Anemarrhenae 5 flavors is put into 12 times of cold water of this 5 flavor spice gross weight, is heated to boiling; Under the boiling condition, decocted 2 hours, win time decoction liquor of filtration, in 5 flavors after decocting for the first time, put into and the equivalent cold water that decocts institute's water for the first time in the spice again, be heated to boiling, under the boiling condition, decocted 1.5 hours, filter decoction liquor for the second time, merge this twice decoction liquor, relative density during again with this twice decoction liquor concentrating under reduced pressure to 50 ℃ temperature is the thick paste of 1.30-1.35, decocting medicine cream;

D, get the Radix Rehmanniae that takes by weighing among the B, Rhizoma Polygonati, Cortex Mori, spice in Rhizoma Dioscoreae and Semen Litchi 5 flavors, put into 10 times of cold water of this 5 flavor spice gross weight, be heated to boiling, under the boiling condition, decocted 2 hours, win time decoction liquor of filtration, in 5 flavor spices after decocting for the first time, put into and the equivalent cold water that decocts institute's water for the first time again, be heated to boiling, under the boiling condition, decocted 2 hours, filter decoction liquor for the second time, merge this twice decoction liquor, and the relative density during with this twice decoction liquor concentrating under reduced pressure to 50 ℃ temperature is 1.08-1.12,1.5 times 95% ethanol that under abundant stirring condition, adds spice gross weight in this 5 flavor again, Cryoprecipitation 48 hours, filtering liquid medicine reclaims ethanol, relative density during concentrated medicament to 50 ℃ temperature is the thick paste of 1.30-1.35, water decoction-alcohol sedimentation medicine cream;

E, get the Radix Salviae Miltiorrhizae that takes by weighing among the B, Fructus Corni, spice in Radix Et Rhizoma Rhei and Fructus Schisandrae Chinensis 4 flavors, put into 10 times of 80% alcohol of this 4 flavor spice gross weight, reflux, extract, 3 hours, win time alcohol extract of filtration, in 4 flavors after the alcohol extraction first time, put into 8 times 80% ethanol in the spice again, reflux, extract, 2 hours, filter alcohol extract for the second time, in 4 flavors after the alcohol extraction second time, put into 8 times 80% ethanol in the spice again, reflux, extract, 1 hour, filter alcohol extract for the third time, merge this three alcohol extracts, relative density during concentrating under reduced pressure to 50 ℃ temperature is the thick paste of 1.30-1.35, alcohol extraction medicine cream;

Pollen Pini, Endothelium Corneum Gigeriae Galli that F, water intaking are boiled medicine and taken by weighing among thing cream, water decoction-alcohol sedimentation medicine cream, alcohol extraction medicine cream and the B, fully mixing is dried under 75 ℃ of-80 ℃ of temperature, the dried cream of medicine;

G, broken, the mixing of thing dried cream powder of getting it filled by every 0.5g, in 1000 capsules of packing into, get medicament capsule, this medicament capsule called after flower stilbene Jiangtang capsule.

Claims (4)

1, a kind of medicine for the treatment of diabetes is characterized in that being become by the following components by weight parts numeral system:

Pollen Pini 6.0-8.0 Endothelium Corneum Gigeriae Galli 2.5-3.5

Radix Astragali 26.0-28.0 Radix Pseudostellariae 5.0-7.0

Cortex Phellodendri 5.5-6.5 Stigma Maydis 110.0-140.0

Rhizoma Anemarrhenae 3.5-4.5 Radix Rehmanniae 19.0-21.0

Rhizoma Polygonati 8.5-9.5 Cortex Mori 14.0-16.0

Rhizoma Dioscoreae 4.0-5.0 Semen Litchi 35.0-37.0

Radix Salviae Miltiorrhizae 4.0-5.0 Fructus Corni 5.5-6.5

Radix Et Rhizoma Rhei 2.5-3.5 Fructus Schisandrae Chinensis 5.5-6.6

2, to rescue the medicine of 1 described treatment diabetes according to right, it is characterized in that the preferred weight umber scope of each component is:

Pollen Pini 6.5-7.5 Endothelium Corneum Gigeriae Galli 2.8-3.3

Radix Astragali 26.5-27.5 Radix Pseudostellariae 6.0-6.5

Cortex Phellodendri 5.8-6.3 Stigma Maydis 120.0-130.0

Rhizoma Anemarrhenae 4.0-4.2 Radix Rehmanniae 19.9-20.5

Rhizoma Polygonati 8.9-9.3 Cortex Mori 14.7-15.2

Rhizoma Dioscoreae 4.4-4.8 Semen Litchi 35.8-36.4

Radix Salviae Miltiorrhizae 4.4-4.8 Fructus Corni 5.8-6.2

Radix Et Rhizoma Rhei 2.8-3.3 Fructus Schisandrae Chinensis 5.8-6.2

3, according to the sharp medicine that requires 1 described treatment diabetes of tree, it is characterized in that the optimum weight umber of each component is:

Pollen Pini 7.0 Endothelium Corneum Gigeriae Galli 3.0

The Radix Astragali 27.0 Radix Pseudostellariaes 6.0

Cortex Phellodendri 6.0 Stigma Maydis 120.0

The Rhizoma Anemarrhenae 4.0 Radix Rehmanniae 20.0.1

Rhizoma Polygonati 9.0 Cortex Mori 15.0

Rhizoma Dioscoreae 4.5 Semen Litchis 36.0

Radix Salviae Miltiorrhizae 4.5 Fructus Corni 6.0

Radix Et Rhizoma Rhei 3.0 Fructus Schisandrae Chinensis 6.0

4, according to the preparation method of the medicine of claim 1,2 or 3 described treatment diabetes, it is characterized in that:

A, pre-treatment: get Endothelium Corneum Gigeriae Galli powder and be broken into 60 order fine powders; Getting Pollen Pini is ground into 60 order fine powders and places dry place; All the other 14 flavor spices in the component are processed into decoction pieces;

B, produce decocting medicine cream: by learn from else's experience the Radix Astragali after the pre-treatment of the parts by weight in the said medicine component, Radix Pseudostellariae, Cortex Phellodendri, spice in Stigma Maydis and the Rhizoma Anemarrhenae 5 flavors, put into 12 times of cold water of this 5 flavor spice gross weight, be heated to boiling, under the boiling condition, decocted 2 hours, win time decoction liquor of filtration, in 5 flavors after decocting for the first time, put into and the equivalent cold water that decocts institute's water for the first time in the spice again, be heated to boiling, under the boiling condition, decocted 1.5 hours, filter decoction liquor for the second time, relative density when merging this twice decoction liquor concentrating under reduced pressure to 50 ℃ temperature is the thick paste of 1.30-1.35, is decocting medicine cream;

C, produce water decoction-alcohol sedimentation medicine cream: by the learn from else's experience Radix Rehmanniae of pre-treatment of the parts by weight in the said medicine component, Rhizoma Polygonati, Cortex Mori, spice in Rhizoma Dioscoreae and Semen Litchi 5 flavors, put into 10 times of cold water of this 5 flavor spice gross weight, be heated to boiling, under the boiling condition, decocted 2 hours, win time decoction liquor of filtration, in 5 flavors after decocting for the first time, put into and the equivalent cold water that decocts institute's water for the first time in the spice again, be heated to boiling, under the boiling condition, decocted 2 hours, filter decoction liquor for the second time, merge this twice decoction liquor, and the relative density during with this twice decoction liquor concentrating under reduced pressure to 50 ℃ temperature is 1.08-1.12,1.5 times 95% alcohol that under abundant stirring condition, adds spice gross weight in this 5 flavor again, Cryoprecipitation 48 hours, filtering liquid medicine reclaims ethanol, relative density during concentrated medicament to 50 ℃ temperature is the thick paste of 1.30-1.35, is water decoction-alcohol sedimentation medicine cream;

D, produce alcohol extraction medicine cream: by learn from else's experience Radix Salviae Miltiorrhizae after the pre-treatment of the parts by weight in the said medicine component, Fructus Corni, spice in Radix Et Rhizoma Rhei and Fructus Schisandrae Chinensis 4 flavors, put into 10 times of 80% ethanol of this 4 flavor spice gross weight, reflux, extract, 3 hours, win time alcohol extract of filtration, in 4 flavors after the alcohol extraction first time, put into 8 times 80% ethanol in the spice again, reflux, extract, 2 hours, filter alcohol extract for the second time, relative density when putting into 8 times concentrating under reduced pressure to 50 ℃ temperature again in the spice in 4 flavors after the alcohol extraction second time is the thick paste of 1.30-1.35, is alcohol extraction medicine cream;

E, produce the dried cream of medicine: water intaking boil medicine thing cream, water decoction-alcohol sedimentation medicine cream, alcohol extraction medicine cream and by the parts by weight in the said medicine component learn from else's experience Pollen Pini and Endothelium Corneum Gigeriae Galli after the pre-treatment, fully mixing is dried under 75 ℃-80 ℃ temperature, the dried cream of medicine;

F, make medicament capsule: the thing dried cream powder of getting it filled is broken, and mixing is packed in 1000 capsules by every 0.5g, medicament capsule.