Traditional Chinese medicine composition, and preparation and application thereof

Abstract

A traditional Chinese medicine composition for treating cardiovascular disease, and a preparation thereof, particularly a micro drop pill preparation thereof, and a method for preparing the preparation; the method for preparing the micro drop pill preparation can be used to prepare drop pills, coated drop pills, and drop pill capsules with a high drug loading capacity.

Description

TABLE 13
Grouping and administration
				Pre-admin-
		Concentrate		istration
	Group	(mg/kg)	Dose	time
	S group	110	1 ml/100 g	7 d
	M group	223	1 ml/100 g	7 d
	Y group	4.5	1 ml/100 g	7 d
	G group	115	1 ml/100 g	7 d
	F group	84	1 ml/100 g	7 d

4. Results

4.1 Effect on MIR

The results were in Table 14. As shown in Table 14, 7 days after pre-administration, MIR in M group was significantly higher than that in S group, suggesting the successful modeling. MIR in G group and F group were respectively 3.38% and 3.32%, significantly lower than that in M group (5.07%), having a significant difference (p<0.01). It was indicated that both samples had a certain effect against acute myocaudial infarction. However, there was no significantly statistical difference (p>0.05) in comparison to those in G group and F group.

TABLE 14
effect of CSDP in each group on MIR
		Average wet	Average wet
		weight of	weight of in-
Group	N	whole heart (g)	farction area (g)	MIR (%)
S group	8	0.8254 ± 0.0294	0.0000 ± 0.0000	0.00 ± 0.00
M group	10	0.8207 ± 0.0447	0.0414 ± 0.0051	5.07 ± 0.75
Y group	9	0.8783 ± 0.0571	0.0233 ± 0.0038	2.65 ± 0.33*
G group	10	0.8493 ± 0.0641	0.0288 ± 0.0052	3.38 ± 0.49*#
F group	10	0.8061 ± 0.0668	0.0268 ± 0.0054	3.32 ± 0.59*#
Note:
compared with the M group,
*p < 0.01; compared with the Y group,
#p < 0.01

4.2 Effect on Heart Rate in Rats with Myocardial Infarction

As shown in Table 15, the descending order of heart rate in each group was F group, G group, M group, Y group and S group within observation time and 0˜1 hour after ligation. 1 hour later, the heart rate in each group was decreased. Within observation time, the variation of heart rate in Y group and S group was relatively stable. There was no significant difference on heart rate in rats among groups.

TABLE 15
effect of CSDP in each group on heart rate (beat/min)
Group	N	0 s	5 s	10 s	5 min	10 min	30 min	1 h	2 h	3 h	4 h
S group	8	390 ± 50	390 ± 52	400 ± 51	407 ± 43	401 ± 57	386 ± 69	394 ± 58	417 ± 44	364 ± 42	358 ± 36
M group	10	416 ± 83	447 ± 72	436 ± 67	444 ± 43	423 ± 39	423 ± 32	399 ± 31	361 ± 45	363 ± 46	336 ± 59
Y group	9	377 ± 48	423 ± 39	419 ± 41	424 ± 29	431 ± 17	413 ± 34	421 ± 47	416 ± 33	380 ± 66	395 ± 52
G group	10	431 ± 43	452 ± 21	444 ± 24	445 ± 29	424 ± 27	422 ± 25	397 ± 25	392 ± 40	347 ± 39	331 ± 38
F group	10	449 ± 28	498 ± 7	468 ± 34	474 ± 35	466 ± 34	426 ± 40	412 ± 40	388 ± 51	377 ± 60	365 ± 56

5. Conclusion

At dose of this study, the medicines in each group were proven to have a certain effect against myocardial infarction in ligature rats on coronary artery; especially the CSMDP of the present invention (84 mg/kg) had MIR of 3.38±0.49%, having a similar efficacy of MIR (3.32±0.59%) with the commercially available CSDP (115 mg/kg). Obviously, the CSMDP at a dose of 84 mg/kg reached the same effect with the commercially available CSDP at 115 mg/kg. The CSMDP had a better efficacy than the commercially available CSDP, having the merits of high bioavailability, reduced administration dose and good compliance to the patients.

Claims

1. A Chinese medicine composition consisting of the following materials by weight percentage: 50.0%˜99.9% of Salvia miltiorrhiza and panax notoginseng extract and 0.1%˜50.0% of borneol, wherein the Salvia miltiorrhiza and panax notoginseng extract comprises the following ingredients by weight percentage:

Danshensu:Salvianolic acid T:protocatechuic aldehyde: Salvianolic acid D:rosmarinic acid:Salvianolic acid B:Salvianolic acid A:panax notoginseng Saponin R1:Ginsenoside Rg1:Ginsenoside Re:Ginsenoside Rb1:Ginsenoside Rd:dihydrotanshinone I:tanshinone I:cryptotanshinone:tanshinone IIA=(2˜6):(0.5˜2): (1˜3):(0.2˜1):(0.2˜1):(0.5˜2):(0.5˜2):(0.2˜1):(1˜4): (0.1˜0.5):(1˜4):(0.1˜1):(0.01˜0.05):(0.05˜0.1): (0.02˜0.1):(0.1˜0.5).

2. The Chinese medicine composition according to claim 1, wherein said Chinese medicine composition consists of the following materials by weight percentage: 75.0%˜99.9% of Salvia miltiorrhiza and panax notoginseng extract and 0.1%˜25.0% of borneol.

3. The Chinese medicine composition according to claim 1, wherein said traditional Chinese medicine composition is composed of the following materials by weight percentage: 90.0%˜99.9% of Salvia miltiorrhiza and panax notoginseng extract and 0.1%˜10.0% of borneol.

4. The Chinese medicine composition according to claim 1, wherein the Salvia miltiorrhiza and panax notoginseng extract comprises the following ingredients by weight parts:

Danshensu:Salvianolic acid T:protocatechuic aldehyde: Salvianolic acid D:rosmarinic acid:Salvianolic acid B:Salvianolic acid A:panax notoginseng Saponin R1: Ginsenoside Rg1:Ginsenoside Re:Ginsenoside Rb1:Ginsenoside Rd:dihydrotanshinone I:tanshinone I:cryptotanshinone:tanshinone IIA=(3˜4):(0.9˜1.2): (1.4˜2.0):(0.5˜0.7):(0.5˜0.9):(1˜1.6):(0.7˜1.2): (0.5˜0.9):(1.8˜2.8):(0.2˜0.4):(1.7˜2.2):(0.2˜0.6): (0.03˜0.04):(0.07˜0.08):(0.05˜0.06):(0.26˜0.28).

5. The Chinese medicine composition according to claim 4, wherein the Salvia miltiorrhiza and panax notoginseng extract comprises the following ingredients by weight parts:

Danshensu:Salvianolic acid T:protocatechuic aldehyde: Salvianolic acid D:rosmarinic acid:Salvianolic acid B:Salvianolic acid A:panax notoginseng Saponin R1: Ginsenoside Rg1:Ginsenoside Re:Ginsenoside Rb1:Ginsenoside Rd:dihydrotanshinone I:tanshinone I: cryptotanshinone: tanshinone IIA=3.6:1.1:1.7:0.6:0.7:1.3:0.9:0.7:2.4:0.3:1.8:0.4:0.03:0.07:0.06:0.27.

6. The Chinese medicine composition according to claim 1, wherein the Salvia miltiorrhiza and panax notoginseng extract is prepared with the following crude medicine by weight parts: Salvia miltiorrhiza 75˜90 parts and panax notoginseng 10˜25 parts.

7. The Chinese medicine composition according to claim 6, wherein the Salvia miltiorrhiza and panax notoginseng extract is prepared with the following crude medicine by weight parts: Salvia miltiorrhiza 82˜84 parts, panax notoginseng 16˜17 parts.

8. A pharmaceutical preparation comprising the Chinese medicine composition according to claim 1 and pharmaceutically acceptable carriers.

9. The pharmaceutical preparation according to claim 8, wherein said pharmaceutical preparation is in a dosage form of drop pill or micro drop pill, wherein said micro drop pill is prepared with the Chinese medicine composition and drop pill matrix in a ratio of 1:5˜5:1 by weight.

10. The pharmaceutical preparation according to claim 9, wherein said pharmaceutical preparation is a compound Salvia micro drop pill.

11. The Chinese medicine composition according to claim 4, wherein said traditional Chinese medicine composition is composed of the following materials by weight percentage: 90.0%˜9.9% of Salvia miltiorrhiza and panax notoginseng extract and 0.1%˜10.0% of borneol.

12. The Chinese medicine composition according to claim 4, wherein the Salvia miltiorrhiza and panax notoginseng extract is prepared with the following crude medicine by weight parts: Salvia miltiorrhiza 75-90 parts and panax notoginseng 10-25 parts.

13. A pharmaceutical preparation comprising the Chinese medicine composition according to claim 4 and pharmaceutically acceptable carriers.