L-???? ????????? C??? ??, ??, ??

??? ??

White or almost white, crystalline powder.

??

Excipient.

?? ??

Lactose is a natural disaccharide consisting of galactose and glucose, and is present in the milk of most mammals. Commercially, lactose is produced from the whey of cows’ milk; whey being the residual liquid of the milk following cheese and casein production. Cows’ milk contains 4.4–5.2% lactose; lactose constitutes 38% of the total solid content of milk.
a-Lactose monohydrate is prepared by crystallization from supersaturated solutions below 93.5°C. Various crystalline shapes are prism, pyramidal, and tomahawk; these are dependent on the method of precipitation and crystallization. Direct compression grades of a-lactose monohydrate are prepared by granulation/ agglomeration and spray-drying.

Pharmaceutical Applications

Lactose is widely used as a filler and diluent in tablets and capsules, and to a more limited extent in lyophilized products and infant formulas. Lactose is also used as a diluent in dry-powder inhalation; seeLactose, Inhalation. Various lactose grades are commercially available that have different physical properties such as particle size distribution and flow characteristics. This permits the selection of the most suitable material for a particular application; for example, the particle size range selected for capsules is often dependent on the type of encapsulating machine used. Usually, fine grades of lactose are used in the preparation of tablets by the wet-granulation method or when milling during processing is carried out, since the fine size allows better mixing with other formulation ingredients and utilizes the binder more efficiently.
Other applications of lactose include use in lyophilized products, where lactose is added to freeze-dried solutions to increase plug size and aid cohesion. Lactose is also used in combination with sucrose (approximately 1 : 3) to prepare sugar-coating solutions. It may also be used in intravenous injections.
Lactose is also used in the manufacture of dry powder formulations for use as aqueous film-coating solutions or suspensions. Direct-compression grades of lactose monohydrate are available as granulated/agglomerated a-lactose monohydrate, containing small amounts of anhydrous lactose.
Direct-compression grades are often used to carry lower quantities of drug and this permits tablets to be made without granulation.
Other directly compressible lactoses are spray-dried lactose and anhydrous lactose; see Lactose, Spray-Dried and Lactose, Anhydrous.

??

Mold growth may occur under humid conditions (80% relative humidity and above). Lactose may develop a brown coloration on storage, the reaction being accelerated by warm, damp conditions. The purities of different lactoses can vary and color evaluation may be important, particularly if white tablets are being formulated. The color stabilities of various lactoses also differ. Solutions show mutarotation.
Lactose should be stored in a well-closed container in a cool, dry place.

? ???

A Maillard-type condensation reaction is likely to occur between lactose and compounds with a primary amine group to form brown, or yellow-brown-colored products. The Maillard interaction has also been shown to occur between lactose and secondary amine. However, the reaction sequence stops with the formation of the imine, and no yellow-brown coloration develops.
Lactose is also incompatible with amino acids, amfetamines, and lisinopril.

Regulatory Status

GRAS listed. Included in the FDA Inactive Ingredients Database (IM, IV, and SC: powder for injections; oral: capsules and tablets; inhalation preparations; vaginal preparations). Included in nonparenteral and parenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.

L-???? ????????? ?? ?? ? ???

???

?? ??

L-???? ????????? ?? ??

???	??	???	??	?? ?	??
Hebei Chuanghai Biotechnology Co., Ltd	+8615531157085	abby@chuanghaibio.com	China	8808	58
Hebei Mujin Biotechnology Co.,Ltd	+86 13288715578 +8613288715578	sales@hbmojin.com	China	12809	58
Hebei Yanxi Chemical Co., Ltd.	+8617531153977	allison@yan-xi.com	China	5854	58
Hebei Junhua Import and Export Co., LTD	+86-18503288844 +86-18503288844	junhua1@hb-junhua.com	China	978	58
Henan Tianfu Chemical Co.,Ltd.	+86-0371-55170693 +86-19937530512	info@tianfuchem.com	China	21628	55
Hubei Jusheng Technology Co.,Ltd.	18871490254	linda@hubeijusheng.com	CHINA	28172	58
Xiamen AmoyChem Co., Ltd	+86-86-5926051114 +8615060885618	sales@amoychem.com	China	6383	58
BOC Sciences	+1-631-485-4226	inquiry@bocsci.com	United States	19552	58
Antai Fine Chemical Technology Co.,Limited	18503026267	info@antaichem.com	CHINA	9636	58
Career Henan Chemica Co	+86-0371-86658258 +8613203830695	laboratory@coreychem.com	China	30231	58

L-???? ????????? ?? ??: