CN1308018C - Medicine xinqin tablet for treating allergic rhintis and its prepn - Google Patents

Abstract

The present invention discloses a xinqin tablet which is composed of 67% to 84% of effective ingredients and 16% to 33% of excipient, wherein the effective ingredients are prepared from the water extracting products of the raw materials of equiponderant manchurian wildginger, baical skullcap root fineleaf schizonepeta herb, cassia twig, dahurian angelica root, xanthium, grassleaf sweetflag rhizome, milkvetch root, white atractylodes rhizome and ledebouriella root, and the excipient contains a filling agent, a disintegrating agent, a lubricating agent and/or coating adjuvant materials. The specification of each tablet is 0.8g, and each oral dose is 2.4g. The present invention also discloses a preparing method of the tablet.

Description

Medicine xinqin tablet of a kind of treatment of allergic rhinitis and preparation method thereof

Technical field

The present invention relates to a kind of improvement of pharmaceutical dosage form, is that the XINQIN electuary changes the XINQIN tablet into specifically.The invention still further relates to the preparation method of this tablet.

Background technology

Allergic rhinitis is otorhinolaryngologic commonly encountered diseases, frequently-occurring disease, account for about 40% of whole cacorhinias, serve as main performance with rhinocnesmus, sneeze, snivel, nasal obstruction clinically, while is with conjunctival congestion, pharyngeal discomfort even bring out asthma, and cause anosmia, and has outbreak repeatedly, the characteristics that should not effect a radical cure.The treatment by Chinese herbs allergic rhinitis has the advantages that to improve the antibody mediated immunity function, reduce the human body hypersensitive state, safety, stable, curative effect is sure.The XINQIN electuary is exactly a kind of Chinese patent medicine of treatment of allergic rhinitis determined curative effect.The XINQIN electuary is that to select Herba Asari 100g, Radix Scutellariae 100g, Herba Schizonepetae 100g, Ramulus Cinnamomi 100g, Radix Angelicae Dahuricae 100g, Fructus Xanthii 100g, Rhizoma Acori Graminei 100g, Radix Astragali 100g, Rhizoma Atractylodis Macrocephalae 100g and Radix Saposhnikoviae 100g for use be raw material, and water decocts twice, 1.5 hours for the first time; 1 hour for the second time, merge decocting liquid, filter, filtrate is condensed into clear paste, and it is an amount of to add cane sugar powder, dextrin and ethanol, makes granule, dry below 80 ℃, makes 2000g.Boiled water is taken after mixing it with water, each 20 grams, every day 3 times, 20 days courses of treatment.Although also developed sugar-free medicinal granules (XINQIN granule), reduced sucrose, reduced dose,, also there is following defective in the XINQIN granule: (1) dose is big, each 5g; (2) mouthfeel is poor, takes the band bitter taste after adding water-solubleization; (3) take inconvenience, take after the boiled water of need heating dissolves; (4) supplementary product consumption is many, and adjuvant needs 3.2g in 1 dosage, has increased cost; (5) carry inconvenience.

For this reason, the inventor tries hard to reduce the consumption of adjuvant under the prerequisite that does not change extraction process of effective component, thereby reduces dose.The inventor adopts concentrating under reduced pressure and spray drying process that the decocting liquid of effective ingredient is made extract powder for this reason, selects appropriate excipients success tabletting then.Because extract powder is the unusual difficulty of compressed tablets under only with the condition of a small amount of excipient, so the inventor has found appropriate excipients through screening in a large number, has successfully reduced the consumption of excipient and has been pressed into qualified tablet, thereby finished the present invention.

Summary of the invention

Purpose of the present invention just provides a kind of determined curative effect but the xinqin tablet of dose minimizing.

Another object of the present invention provides the preparation method of this xinqin tablet.

Xinqin tablet of the present invention is made up of the excipient of 67～84% active ingredients and 16～33%, and wherein said active ingredient is that Herba Asari, Radix Scutellariae, Herba Schizonepetae, Ramulus Cinnamomi, the Radix Angelicae Dahuricae, Fructus Xanthii, Rhizoma Acori Graminei, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae and the Radix Saposhnikoviae of equivalent is the water extract of raw material; Excipient comprises filler, disintegrating agent, lubricant and/or coating adjuvant, and filler is one or more in starch, pregelatinized Starch, dextrin, lactose and the microcrystalline Cellulose; Disintegrating agent is one or more in starch, carboxymethylstach sodium, polyvinylpolypyrrolidone, cross-linked carboxymethyl cellulose sodium and the low-substituted hydroxypropyl cellulose; Lubricant is one or more in Pulvis Talci, magnesium stearate and the micropowder silica gel.Preferred filler account for sheet heavy 13～21%, disintegrating agent account for sheet heavy 2.9～11% and lubricant account for sheet heavy 0.1～1%.

In order to finish the foregoing invention purpose, the inventor has mainly adopted following mode, does not change extraction process, still, decocting liquid is carried out drying make extract powder after concentrating.

The Herba Asari, Radix Scutellariae, Herba Schizonepetae, Ramulus Cinnamomi, the Radix Angelicae Dahuricae, Fructus Xanthii, Rhizoma Acori Graminei, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae and the Radix Saposhnikoviae that are specially equivalent are raw material, water decocts, with decocting liquid concentrating under reduced pressure, preferably being concentrated to relative density is 1.12～1.20, and drying is made extract powder as effective ingredient.

Wherein concentration technology preferably adopts concentrating under reduced pressure, and condition is an effect temperature: 75～85 ℃, two imitate temperature: 65～75 ℃; One imitates vacuum: 0.02～0.04MP _a, two imitate vacuum: 0.04～0.06MP _a,, better keep the effective ingredient in the prescription because the medicinal liquid boiling point lowering can prevent or reduce the decomposition of heat-sensitive substance.

The preferred constant pressure and dry of drying process, drying under reduced pressure (vacuum drying) and three kinds of modes of spray drying compare test, though the result is that the constant pressure and dry equipment needed thereby is simple, but drying time is long, and meeting is because of the overheated destruction that causes effective ingredient, and the difficult pulverizing in dry back; Vacuum drying (vacuum is: 3.3～8.0kPa, 70～80 ℃ of temperature) is temperature required lower, and product matter pine is easy to pulverize, and is suitable for big production; Spray drying (inlet temperature: 140～150 ℃, leaving air temp: 90～100 ℃; Dry required time is short, and dried extract powder is crisp, and dissolubility is good, is suitable for big production.Still select for use spray drying and vacuum drying to prepare extract powder.

Because the extract powder amount is big in the prescription, and the adjuvant amount is little, moulding process is difficult to realize, so the selection of excipient is very crucial, if select inappropriately, can't suppress in flakes, even compacting does not meet the requirement of tablet in flakes yet in other indexs such as disintegration, hardness at all.We find to select amount of excipient to account for sheet at heavy 16～33% o'clock through screening, and are more satisfactory.

Select excipient then.General excipient comprises filler, disintegrating agent, lubricant, wetting agent etc., and the adjuvant that we are used to screen mainly contains following several: 1. filler has starch, pregelatinized Starch, dextrin, lactose, microcrystalline Cellulose; 2. disintegrating agent has starch, carboxymethylstach sodium, polyvinylpolypyrrolidone (PVPP), cross-linked carboxymethyl cellulose sodium (CCNa), low-substituted hydroxypropyl cellulose (L-HPC); 3. lubricant has Pulvis Talci, magnesium stearate and micropowder silica gel; 4. wetting agent has water, ethanol.The index of screening is tablet appearance, disintegration and content of baicalin, carry out the prescription screening experiment, the consumption that found that filler preferably account for sheet heavy 13～21%, the consumption of disintegrating agent preferably account for sheet heavy 2.9～11%, the consumption of lubricant preferably account for sheet heavy 0.1～1%.The repeatability that is combined in moulding process and the stable aspect of preferred following excipient meet the preparation requirement.These are combined as:

1) filler is that starch, disintegrating agent are starch and/or carboxymethylstach sodium and magnesium stearate;

2) filler is a lactose, and disintegrating agent is that cross-linked carboxymethyl cellulose sodium and lubricant are micropowder silica gel and/or magnesium stearate.

3) filler is a starch, and disintegrating agent is that cross-linked carboxymethyl cellulose sodium and lubricant are magnesium stearate.

4) filler is a lactose, and disintegrating agent is that polyvinylpolypyrrolidone and lubricant are micropowder silica gel.

Another preparation method of the present invention is the airpillow-dry granulation that adopts conventional wet granulation outer.Specifically be that Herba Asari, Radix Scutellariae, Herba Schizonepetae, Ramulus Cinnamomi, the Radix Angelicae Dahuricae, Fructus Xanthii, Rhizoma Acori Graminei, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae and Radix Saposhnikoviae by equivalent is raw material, water decocts and concentrates, and concentrated solution and filler, disintegrating agent are granulated through Fluidbedgranulatingdrier, adds lubricant, mixing, tabletting.

Wherein to be preferably inlet temperature be 75～85 ℃ to drying condition, and temperature of charge is 60～70 ℃, and leaving air temp is 50～60 ℃.

According to oral the taking of XINQIN tablet of above-mentioned steps preparation, one time 3,3 times on the one, 20 days is a course of treatment.Specification is every heavy 0.8 gram.That is to say that dose is by each 20 grams of XINQIN electuary, particulate each 5 grams of sugar-free XINQIN reduce to each 2.4 grams of the present invention.Xinqin tablet is 3/25 of an XINQIN electuary dose, is 1/2 of sugar-free XINQIN granule dose.Following experimental data has confirmed the successful compacting of tablet.

Table 1 demonstration test result (n=3)

Numbering	Tablet weight variation (%)	Hardness (Kg)	Disintegration (min)	Content of baicalin (mg/ sheet)
					1 2 3 4 5 6	＜±5 ＜±5 ＜±5 ＜±5 ＜±5 ＜±5	8.2 8.5 7.8 8.7 7.6 8.9	25 23 23 24 22 21	17.86 18.18 17.99 17.25 17.36 17.54

The result of above table 1 shows that repeatability, the stability of prescription compression molding technology meet the preparation requirement, so above-mentioned prescription all can be used as xinqin tablet preparations shaping prescription.

In the used excipient of the present invention, filler is preferably starch, and disintegrating agent is preferably carboxymethylstach sodium: lubricant is preferably magnesium stearate; Wetting agent is preferably 95% ethanol.

The best of breed of tablet of the present invention and consumption thereof are: more preferably:

1) active ingredient is 75%, and starch is 15.8%, carboxymethylstach sodium be 8.4% and magnesium stearate be 0.8%;

2) active ingredient is 70%, and starch is 19.8%, carboxymethylstach sodium be 9.5% and magnesium stearate be 0.7%.

3) active ingredient is 80%, and starch is 14.8%, carboxymethylstach sodium be 4.6% and magnesium stearate be 0.6%.

The selection of above-mentioned excipient has just prepared tablet, still also must consider the hygroscopicity problem when tablet stores.

In order to investigate the hygroscopicity of plain sheet, sample thief 1 places the hermetic container of different humidity, weighs once every 12 hours, draws moisture equilibrium at dry side figure and sucting wet curve, sees chart 2,3,4,5,6,7.

Table 2 moisture equilibrium at dry side figure result

Relative humidity %	42	52	65	75	86
						Hydroscopicity %	4.76	6.48	10.43	11.12	13.06

Table 3 sucting wet curve (RH42%)

Time (h)	0	12	24	36	48	60	72	84	96
										Hygroscopic capacity (g)	0	0.0277	0.0568	0.0741	0.0932	0.1184	0.1268	0.1371	0.1378

Table 4 sucting wet curve (RH52%)

Time (h)	0	12	24	36	48	60	72	84	96
										Hygroscopic capacity (g)	0	0.0652	0.0996	0.1123	0.1306	0.1547	0.1709	0.1879	0.1894

Table 5 sucting wet curve (RH65%)

Time (h)	0	12	24	36	48	60	72	84	96
										Hygroscopic capacity (g)	0	0.0814	0.1145	0.1345	0.1665	0.2078	0.2227	0.2358	0.2431

Table 6 sucting wet curve (RH75%)

Time (h)	0	12	24	36	48	60	72	84	96
										Hygroscopic capacity (g)	0	0.0854	0.1325	0.1648	0.1986	0.2361	0.2629	0.2927	0.2988

Table 7 sucting wet curve (RH86%)

Time (h)	0	12	24	36	48	60	72	84	96
										Hygroscopic capacity (g)	0	0.1168	0.1917	0.2349	0.2721	0.3047	0.3430	0.3657	0.3773

From above chart as can be seen, the hygroscopicity of the plain sheet of this product is stronger, therefore, in order to prevent tablet moisture absorption in the preservation process, must be to this product coating such as sugar-coat or film-coat.

We have carried out screening and have preferably packed film-coat the adjuvant that packs film-coat and use.The consumption of coating adjuvant be no more than sheet heavy 4%.The coating adjuvant consists of hydroxypropyl emthylcellulose, plasticizer, colorant, opacifier and distilled water.Wherein plasticizer is preferably glycerol, and opacifier is preferably titanium dioxide.

Because this strain extractum sheet, hygroscopicity is strong, and we investigate the hygroscopicity of coated tablet emphatically, and the following 4 kinds of coating fluid prescription of result all can obviously reduce the hygroscopicity of plain sheet, and do not influence the mensuration of other project of tablet.

The prescription screening result of table 8 coating solution

Adjuvant	①	②	③	④
					Hydroxypropyl methylcellulose glycerol polyethylene glycol titanium dioxide talcum powder color lake distilled water is made into	An amount of 240ml of 4.8g 12ml--3.6g--3.6g	An amount of 240ml of--6.4g 10ml 4.0g--3.6g	6.4g--an amount of 240ml of 8ml 2.4g 3.6g 3.6g	4.8g 12ml--an amount of 240ml of 1.2g 2.4g 3.6g

Annotate: the color lake is that adsorbent such as aluminium oxide, Pulvis Talci or calcium sulfate adsorpting pigment are made, and can prevent that soluble pigment is moved in dry run in the coated tablet, and the overcover of the mottle sheet heart in the film-coat.

The investigation of the moisture absorption situation of coated tablet.Prescription 1～4 gained tablet is pressed film coating operation preparation Film coated tablets, investigated the hygroscopicity situation of Film coated tablets, see Table 9～13 with method.

The hygroscopicity situation of table 9 Film coated tablets

Relative humidity (%RH)	42	52	65	75	86
						Hydroscopicity (%)	2.97	4.15	6.82	7.21	8.46

Table 10 sucting wet curve (RH42%)

Time (h)	0	12	24	36	48	60	72	84	96
										Hygroscopic capacity (g)	0	0.0185	0.0379	0.0494	0.0621	0.0789	0.0845	0.0914	0.0919

Table 11 sucting wet curve (RH52%)

Time (h)	0	12	24	36	48	60	72	84	96
										Hygroscopic capacity (g)	0	0.0423	0.0654	0.0718	0.0853	0.1002	0.1187	0.1216	0.1219

Table 12 sucting wet curve (RH65%)

Time (h)	0	12	24	36	48	60	72	84	96
										Hygroscopic capacity (g)	0	0.0526	0.0723	0.0864	0.1075	0.1322	0.1415	0.1489	0.1497

Table 13 sucting wet curve (RH75%)

Time (h)	0	12	24	36	48	60	72	84	96
										Hygroscopic capacity (g)	0	0.0522	0.0857	0.1068	0.1325	0.1547	0.1721	0.1893	0.1898

Table 14 sucting wet curve (RH86%)

Time (h)	0	12	24	36	48	60	72	84	96
										Hygroscopic capacity (g)	0	0.0749	0.1238	0.1517	0.1773	0.1985	0.2156	0.2207	0.2215

Under different humidity, outward appearance, disintegration and content of baicalin result before and after its moisture absorption compare, and see Table 15 to plain sheet and coated tablet.

Testing result before and after plain sheet of table 15 and the coated tablet moisture absorption

* annotate: blank 1 is plain sheet before the fuchsin(e)test; Blank 2 are Film coated tablets before the fuchsin(e)test.

Show that from experimental result plain sheet is after film coating is handled, the tablet hygroscopicity significantly reduces, and outward appearance, disintegration, content of baicalin all meet the quality standard requirement.

In order to verify the stability of prescription, to have manufactured experimently three batch samples and investigated, experimental result sees Table 16.

Table 16 three batch sample testing results

Inspection item	Quality standard	Lot number
					010508	010509	010510
		Character	Should be yellowish pink Film coated tablets, unilateral complete bright and clean, color and luster is even; Remove film-coat, show yellowish-brown	Be yellowish pink Film coated tablets, unilateral complete bright and clean, color and luster is even; Remove film-coat, show yellowish-brown				Be yellowish pink Film coated tablets, unilateral complete bright and clean, color and luster is even; Remove film-coat, show yellowish-brown	Be yellowish pink Film coated tablets, unilateral complete bright and clean, color and luster is even; Remove film-coat, show yellowish-brown
Differentiate	(1) test sample should show same blob with the Herba Asari control medicinal material				Detect Herba Asari control medicinal material same blob	Detect Herba Asari control medicinal material same blob	Detect Herba Asari control medicinal material same blob
		(2) test sample should show same blob with the baicalin reference substance	Detect baicalin reference substance same blob	Detect baicalin reference substance same blob				Detect baicalin reference substance same blob
	(3) test sample should show same blob with Radix Angelicae Dahuricae control medicinal material				Detect Radix Angelicae Dahuricae control medicinal material same blob	Detect Radix Angelicae Dahuricae control medicinal material same blob	Detect Radix Angelicae Dahuricae control medicinal material same blob
		(4) test sample should show same blob with the astragaloside reference substance	Detect astragaloside reference substance same blob	Detect astragaloside reference substance same blob				Detect astragaloside reference substance same blob
	(5) test sample should show same blob with the Fructus Xanthii control medicinal material				Detect Fructus Xanthii control medicinal material same blob	Detect Fructus Xanthii control medicinal material same blob	Detect Fructus Xanthii control medicinal material same blob
		Hardness (Kg)	＞5Kg	13.6				14.3	13.7
Disintegration (minute)	Should be in 60 minutes disintegrate and pass through screen cloth fully				27	29	30
		Assay (mg/ sheet)	Every contains baicalin and must not be lower than 12mg	17.21				17.48	17.55

Produce three batches as a trial, situation sees Table 17,18,19,20.

The preparation of table 17 extract powder

Lot number	Feed intake the date	Inventory (Kg)	Receive cream amount (Kg)	Receive cream rate (%)
					010604	2001.6.4	33.3	6.74	20.24
010605	2001.6.5	33.3	6.41	19.25
					010606	2001.6.6	33.3	6.58	19.76

Table 18 preparation of granules

Lot number	Feed intake the date	Supplementary material		Grain amount (Kg)	Granule yield (%)
						Title	Quantity (Kg)
		010604	2001.6.10					Extract powder	5.6	7.65	95.6
Starch	1.58
				Carboxymethylstach sodium	0.76
95%7 alcohol	In right amount
				010605	2001.6.11	Extract powder	5.6	7.72	96.5
Starch	1.58
		Carboxymethylstach sodium	0.76
95% ethanol	In right amount
		010606	2001.6.12			Extract powder	5.6			7.64	95.5
Starch	1.58
				Carboxymethylstach sodium	0.76
95% ethanol	In right amount

Table 19 preparation tablets

Lot number	The tabletting date	Grain amount (Kg)	Amounts of lubrication (g)	Plain sheet amount (Kg)	Film coated tablets (Kg)	Finished product number (plate)	Product yield (%)
								010604	2001.6.11	7.65	53.5	7.50	7.68	802	96.2
010605	2001.6.12	7.72	54.0	7.58	7.78	790	94.8
								010606	2001.6.13	7.64	53.4	7.45	7.60	794	95.3

Three batches of pilot products of table 20 are examined the result entirely

Inspection item	Quality standard	Lot number
					010604	010605	010606
		Character	Should be yellowish pink Film coated tablets, unilateral complete bright and clean, color and luster is even	Be yellowish pink Film coated tablets, unilateral complete bright and clean, color and luster is even; Remove film-coat, show yellowish-brown				Be yellowish pink Film coated tablets, unilateral complete bright and clean, color and luster is even; Remove film-coat, show yellowish-brown	Be yellowish pink Film coated tablets, unilateral complete bright and clean, color and luster is even; Remove film-coat, show yellowish-brown
Differentiate	(1) test sample should show same blob with the Herba Asari control medicinal material				Detect Herba Asari control medicinal material same blob	Detect Herba Asari control medicinal material same blob	Detect Herba Asari control medicinal material same blob
		(2) test sample should show same blob with the baicalin reference substance	Detect baicalin reference substance same blob	Detect baicalin reference substance same blob				Detect baicalin reference substance same blob
	(3) test sample should show same blob with Radix Angelicae Dahuricae control medicinal material				Detect Radix Angelicae Dahuricae control medicinal material same blob	Detect Radix Angelicae Dahuricae control medicinal material same blob	Detect Radix Angelicae Dahuricae control medicinal material same blob
		(4) test sample should show same blob with the astragaloside reference substance	Detect astragaloside reference substance same blob	Detect astragaloside reference substance same blob				Detect astragaloside reference substance same blob
	(5) test sample should show same blob with the Fructus Xanthii control medicinal material				Detect Fructus Xanthii control medicinal material same blob	Detect Fructus Xanthii control medicinal material same blob	Detect Fructus Xanthii control medicinal material same blob
		Hardness (Kg)	＞5Kg	9.8				10.7	9.8
Disintegration (minute)	Should be in 60 minutes disintegrate and pass through screen cloth fully				23	24	20
		Assay (mg/ sheet)	Every contains baicalin and must not be lower than 12mg	18.09				17.87	17.38
Limit test of microbe	Antibacterial :≤1000/g				＜10/g	＜10/g	＜10/g
		Mycete :≤100/g	＜10/g	＜10/g				＜10/g
	Escherichia coli: must not detect				Do not detect	Do not detect	Do not detect
		Demodicid mite lives: must not detect	Do not detect	Do not detect				Do not detect

As can be seen from the above results, the preparation technology of XINQIN Film coated tablets is basicly stable.

The preparation of embodiment 1 plain sheet

With Herba Asari 333g, Radix Scutellariae 333g, Herba Schizonepetae 333g, Ramulus Cinnamomi 333g, Radix Angelicae Dahuricae 333g, Fructus Xanthii 333g, Rhizoma Acori Graminei 333g, Radix Astragali 333g, Rhizoma Atractylodis Macrocephalae 333g and Radix Saposhnikoviae 333g raw material, water decocts twice, adds the water of 10 times of amounts for the first time, extracts 1.5 hours; Add for the second time the water of 8 times of amounts, extracted 1 hour, merge decocting liquid, concentrating under reduced pressure is to relative density 1.12～1.15, and spray drying makes extract powder as effective ingredient, and wherein concentration technology adopts concentrating under reduced pressure: one imitates temperature: 75～85 ℃, two imitate temperature: 65～75 ℃; One imitates vacuum: 0.02～0.04MP _a, two imitate vacuum: 0.04～0.06MP _aThen, according to following prescription film-making:

1000 consumptions of supplementary material title (g)

Extract powder 576

Starch 158

Carboxymethylstach sodium 70

95% ethanol is an amount of

Magnesium stearate 5

Make 1000.

The preparation of embodiment 2 coated tablet

The preparation of coating solution:

1000 consumptions of supplementary material title (g)

Hypromellose 4.8

Glycerol 12ml

Titanium dioxide (titanium dioxide) 3.6

The color lake ^#3.6

Distilled water is an amount of

Be made into 240ml

Adopt conventional coating method to give embodiment the plain coating tablets of 1 preparation with above-mentioned coating solution.

Embodiment 3:

Method according to embodiment 1 prepares effective ingredient; Use 1000 of following prescription systems and coating then: extract powder 600g, starch 133g, carboxymethylstach sodium 67g, magnesium stearate 7g, ethanol is an amount of.

Embodiment 4:

Method according to embodiment 1 prepares effective ingredient; Use 1000 of following prescription systems and coating then: extract powder 560g, starch 158g, carboxymethylstach sodium 76g, magnesium stearate 5.6g, ethanol is an amount of.

Embodiment 5:

Method according to embodiment 1 prepares effective ingredient; Use 1000 of following prescription systems and coating then: extract powder 640g, starch 118g, carboxymethylstach sodium 37g, magnesium stearate 5.6g, ethanol is an amount of.

Embodiment 6:

Method according to embodiment 1 prepares effective ingredient; Use following prescription film-making and coating then: extract powder 600g, lactose 133g, cross-linked carboxymethyl cellulose sodium 67g, micropowder silica gel 2g, magnesium stearate 2g, ethanol is an amount of.

Embodiment 7:

Method according to embodiment 1 prepares effective ingredient; Use following prescription film-making and coating then: extract powder 600g, starch 133g, cross-linked carboxymethyl cellulose sodium 67g, magnesium stearate 8g, ethanol is an amount of;

Embodiment 8:

Method according to embodiment 1 prepares effective ingredient; Use following prescription film-making and coating then: extract powder 600g, microcrystalline Cellulose 133g, cross-linked carboxymethyl cellulose sodium 67g, magnesium stearate 8g, ethanol is an amount of.

Embodiment 9:

Method according to embodiment 1 prepares effective ingredient; Use following prescription film-making and coating then: extract powder 600g, lactose 133g, polyvinylpolypyrrolidone 67g, micropowder silica gel 8g, ethanol is an amount of.

Embodiment 10:

Method according to embodiment 1 prepares effective ingredient; Use following prescription film-making and coating then: extract powder 600g, microcrystalline Cellulose 133g, carboxymethylstach sodium 67g, magnesium stearate 8g, ethanol is an amount of.

Claims (19)

1. the medicine xinqin tablet of a treatment of allergic rhinitis, it is characterized in that it is made up of the excipient of 67～84% active ingredients and 16～33%, wherein said active ingredient is that Herba Asari, Radix Scutellariae, Herba Schizonepetae, Ramulus Cinnamomi, the Radix Angelicae Dahuricae, Fructus Xanthii, Rhizoma Acori Graminei, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae and the Radix Saposhnikoviae of equivalent is the extract powder that water extract is spray-dried or vacuum drying obtains of raw material, and wherein the extract powder as active ingredient is 75%; Excipient comprises filler, disintegrating agent, lubricant and/or coating adjuvant, filler is one or more in starch, pregelatinized Starch, dextrin, lactose and the microcrystalline Cellulose, wherein filler account for sheet heavy 13～21%, be 15.8% as the starch of filler; Disintegrating agent is one or more in starch, carboxymethylstach sodium, polyvinylpolypyrrolidone, cross-linked carboxymethyl cellulose sodium and the low-substituted hydroxypropyl cellulose, wherein disintegrating agent account for sheet heavy 2.9～11%, be 8.4% as the carboxymethylstach sodium of disintegrating agent; Lubricant is one or more in Pulvis Talci, magnesium stearate and the micropowder silica gel, wherein lubricant account for sheet heavy 0.1～1%, be respectively 0.8% as the magnesium stearate of lubricant.

2. xinqin tablet according to claim 1, wherein active ingredient is 70%, starch is 19.8%, carboxymethylstach sodium be 9.5% and magnesium stearate be 0.7%.

3. xinqin tablet according to claim 1, wherein active ingredient is 80%, starch is 14.8%, carboxymethylstach sodium be 4.6% and magnesium stearate be 0.6%.

4. xinqin tablet according to claim 1, wherein filler is a lactose, disintegrating agent is that cross-linked carboxymethyl cellulose sodium and lubricant are micropowder silica gel and/or magnesium stearate.

5. xinqin tablet according to claim 1, wherein filler is a starch, disintegrating agent is that cross-linked carboxymethyl cellulose sodium and lubricant are magnesium stearate.

6. xinqin tablet according to claim 1, wherein filler is a lactose, disintegrating agent is that polyvinylpolypyrrolidone and lubricant are micropowder silica gel.

7. according to the described xinqin tablet of claim 1～6, it has the coating adjuvant, accounts for sheet and heavily is no more than 4%.

8. xinqin tablet according to claim 7, its coating adjuvant is made up of hydroxypropyl emthylcellulose, plasticizer, colorant, opacifier and distilled water.

9. treatment of allergic rhinitis medicine xinqin tablet according to claim 8, wherein plasticizer is a glycerol, opacifier is a titanium dioxide.

10. the preparation method of any described treatment of allergic rhinitis medicine xinqin tablet in the claim 1～6, it comprises the following steps:

Herba Asari, Radix Scutellariae, Herba Schizonepetae, Ramulus Cinnamomi, the Radix Angelicae Dahuricae, Fructus Xanthii, Rhizoma Acori Graminei, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae and Radix Saposhnikoviae by equivalent are raw material, and water decocts, and decocting liquid concentrating under reduced pressure and drying are made extract powder as effective ingredient; Add the excipient compacting in flakes.

11. according to the described preparation method of claim 10, wherein one of concentrating under reduced pressure effect temperature is 75～85 ℃, two effect temperature are 65～75 ℃; One effect vacuum is 0.02～0.04MPa, and two effect vacuums are 0.04～0.06MPa.

12. according to the described preparation method of claim 10, wherein drying mode is vacuum drying or spray drying.

13. according to the described preparation method of claim 12, wherein spray-dired condition is an inlet temperature: 140～150 ℃, leaving air temp: 90～95 ℃, dry run control negative pressure reaches 400 handkerchiefs.

14. according to the described preparation method of claim 12, wherein vacuum drying condition is that vacuum is: 3.3～8.0kPa, temperature is: 70～80 ℃.

15. according to the preparation method of the described treatment of allergic rhinitis medicine of claim 1～6 xinqin tablet, it comprises the following steps:

Herba Asari, Radix Scutellariae, Herba Schizonepetae, Ramulus Cinnamomi, the Radix Angelicae Dahuricae, Fructus Xanthii, Rhizoma Acori Graminei, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae and Radix Saposhnikoviae by equivalent are raw material, and water decocts and concentrates, and concentrated solution and filler, disintegrating agent are granulated through Fluidbedgranulatingdrier, adds lubricant, mixing, tabletting.

16. according to the preparation method of the described treatment of allergic rhinitis medicine of claim 15 xinqin tablet, wherein drying condition is an inlet temperature: 75～85 ℃, temperature of charge: 60～70 ℃, leaving air temp: 50～60 ℃.

17. according to any one described preparation method in the claim 10～16, it also comprises coating steps, coating adjuvant wherein be no more than sheet heavy 4%.

18. preparation method according to claim 17, its coating adjuvant is made up of hydroxypropyl emthylcellulose, plasticizer, colorant/opacifier, color lake and distilled water.

19. preparation method according to claim 18, wherein plasticizer is a glycerol, and opacifier is a titanium dioxide.